Review: ‘The Body Fights Back,’ starring Josephine Morondiya, Imogen Fox, Rory Brown, Hannah Webb and Michaela Ginghell

August 2, 2021

by Carla Hay

Attendees of The Real Catwalk, a “flash mob” event promoting body positivity in London in 2019, in “The Body Fights Back” (Photo courtesy of Gravitas Ventures)

“The Body Fights Back”

Directed by Marian Võsumets

Culture Representation: Taking place primarily in the London area, the documentary film “The Body Fights Back” features a predominantly white group of people (with some black people and Asians) representing the working-class and middle-class.

Culture Clash: Most of the people in the documentary speak out against diet culture, which they say can do psychological and physical harm to people who think being thin is the answer to happiness.

Culture Audience: “The Body Fights Back” will appeal primarily to people who are interested in getting a sociological context for why diet culture has become so pervasive and what can be done to prevent people from falling into diet culture’s dangerous traps.

Josephine “Mojo” Morondiya in “The Body Fights Back” (Photo courtesy of Gravitas Ventures)

The documentary film “The Body Fights Back” is very up front with its agenda: It’s a blistering indictment of the harm caused by diet culture and the diet industry’s responsibility in causing this damage. This movie does not promote obesity or unhealthy eating habits. Instead, it examines what causes people to believe the myth that being thin automatically equals happiness. There’s also considerable discussion about what can be done to foster a culture where people can have more acceptance of various body types for themselves and others.

“The Body Fights Back” is the feature-film debut of Estonian director Marian Võsumets, who chose to focus most of her interviews and other filmed footage on people who live in the London area. The documentary could have benefited from a wider inclusion of people who live in countries outside of the United Kingdom. A few people in the U.S. and Australia are interviewed by videoconference calls, but viewers can assume that the filmmakers had budget constraints that prevented them from traveling around the world to get a truly global and in-person view of this problem. The perspectives voiced in the movie are a fairly good representation of what many people in Western countries experience and think about diet culture.

It’s important to distinguish between “diet culture” and “health and fitness culture.” “The Body Fights Back” is not a criticism of health and fitness culture, which is when people want to take care of their bodies in healthy ways through diet and exercise. By contrast, diet culture promotes the idea that only thin or toned people are healthy and happy, and that in order to achieve a certain level of health and happiness, people need to diet by whatever means necessary.

Diet culture has been sold to people as an aspirational lifestyle, and it has become a gigantic industry that generates billions in profits. Although men and boys can certainly get caught up in diet culture and in wanting to look a certain way, women and girls are more likely to develop the most harmful effects of diet culture—eating disorders, such as anorexia and bulimia. Bodybuilding and weight lifting (which can lead to steroid abuse) often overlap with diet culture, since people who are obsessed with having certain muscle tones are usually obsessed with dieting.

The documentary interviews several experts who give their opinions of diet culture, but the movie also puts a spotlight on five individuals (in their 20s or 30s) who have personally experienced the harmful effects of diet culture. These five people are:

  • Rory Brown, a personal fitness trainer who says he developed an eating disorder when he was obsessed with his diet and workout routines.
  • Imogen Fox, who has gone through extreme weight gain and weight loss that have left her with permanent health damage.
  • Michaela Ginghell, who has had lifelong insecurities about being big and tall.
  • Josephine “Mojo” Morondiya, who has been plus-sized all of her life and admits that her past childhood traumas have contributed to her weight issues.
  • Hannah Webb, a recovering anorexic who developed her eating disorder when she was 15.

According to what these five interview subjects talk about in the documentary, they all have something in common: They admit that they had low self-esteem since their childhoods. Some of them have been in therapy over these self-esteem issues, but acceptance of their bodies is still a daily struggle for them.

The general consensus in the documentary is that people with harmful obesity and/or eating disorders need to be treated for psychological issues that are causing these health problems instead of thinking that changing their diets will be enough. Diet culture can take advantage of people who are vulnerable to insecurities about their bodies. And in many cases, the results are disastrous and dangerous to people’s health.

Brown says that when he was a kid, he got constant criticism from certain family members. It spilled over into how he felt about his physical looks, and he began to think, “When I look like this [toned], then I’ll be happy.” He confesses that he became addicted to fitness workouts and weight lifting in his quest to make himself look muscular.

For years, Brown says, he thought of food of being in two categories: “good” or “bad.” And so, he was fanatical about counting the food calories that he would consume. He got into the habit of having grueling workout sessions every day, and then “rewarding” himself about once a week by eating piles of junk food in one sitting.

Brown says that he would often force himself to vomit if he felt like he over-ate. And the binging caused him enough shame that he would over-exert himself in workouts, out of fear of gaining wait from his eating binges. “I started to lose my mind,” he says. He also admits his diet/workout obsession ended up ruining a relationship that he had with a girlfriend.

Brown adds that he didn’t understand until it was almost too late that this vicious cycle of extreme dieting and binging was the very definition of an eating disorder. He credits his recovery to being in therapy. And now, he says that he no longer sets rules for himself on what he can and cannot eat. He also imparts the same philosophy to his clients as a fitness trainer.

Fox was very overweight for most of her life. At one point, she had to use a wheelchair to move around, so she knows what it’s like to experience discrimination as a disabled person. Her eating habits got so damaging that she was hospitalized for lung failure, heart failure and sepsis. She lost such a drastic amount of weight in a short period of time that she now has very wrinkled, sagging skin on her abdomen, arms and legs. She also has a breathing apparatus implanted in her chest. And she says that social gatherings that involve food still give her some anxiety.

In the documentary, Fox says one of the lowest points in her up-and-down weight journey was when she was in the hospital, and a nurse started lecturing Fox while Fox was suffering on the hospital bed. Fox was conscious but unable to respond because of a tube in her mouth. According to Fox, the nurse berated her and shamed her by saying that Fox wouldn’t have been in this situation if she hadn’t been overweight.

Fox says that even though she now has a thin physique, most people wouldn’t know that underneath her clothes, she has sagging skin wrinkles where parts of her body had excessive fat. She comments that people come up to her and tell her that she looks great simply because she’s thin. She says it’s an example of how people have no idea that she has health problems and assume she’s healthy because she’s thin on the outside.

Fox credits her wife with helping her through tough times in this difficult weight journey. Fox says that being in a relationship with her lifetime love partner gave her the motivation not go back to the type of weight that almost killed Fox. “I wanted to transform,” she says of her weight loss to a healthier size.

Ginghell says that being big and tall made her the target of teasing and bullying when she was in school. And she says that when her parents got divorced when she was 8 years old, it deeply affected her. Her father was very strict about what types of food she could eat, while her mother was very lenient. The mixed messages confused her and added to her turmoil about her body weight.

Ginghell comments, “Growing up, I definitely turned to food to escape.” She says she knew her eating habits were becoming a serious issue when her father took her to a dietician. At the time the documentary was filmed, Ginghell says she’s still struggling with being a certain size, but she’s trying to learn not to let herself or other people make her feel bad about it.

Morondiya, who has the liveliest personality of all the interview subjects, believes that almost everyone who has eating disorders or who over-eats is in some kind of emotional pain and is trying to compensate for it by how and what they eat. She includes herself in this profile, because she says she’s a survivor of abuse and has had lifelong issues with low self-esteem.

“My biological mother was really abusive to me and my body,” Morondiya says. “And that’s when I started really hating who I was. She’d always say to me that my face was beautiful and I was really pretty, but it was a shame that my body didn’t match. And hearing that, your mum’s voice becomes your voice. You are the product of your environment.”

Morondiya also opens up about being a survivor of sexual abuse. She says that she was molested by a biological family member when she was an underage child. “That was never really dealt with,” she says of this abuse. “I was told it was my fault. ”

More sexual abuse continued in her life when she was raped at age 13. She got involved in a series of abusive relationships as an adult, which she describes as letting people violate her body because she didn’t respect herself. Morondiya says that she’s still working on her self-esteem, but she’s in a much better place now than she was in the past because she’s learning that she doesn’t need other people’s approval to like herself.

Hannah Webb talks about her harrowing experience being hospitalized for anorexia for several months. Her illness caused her to drop out of school. Her mother Joyce Webb, who’s also interviewed in the documentary, says she still feels guilty for not having noticed earlier that Hannah’s initial weight loss might have been a sign of something more disturbing. Hannah says that she developed an eating disorder around the same time that her father had been diagnosed with throat cancer and she was being teased at school because of how she looked.

Hannah comments that her parents, other family members and her close friends (whom she all describes as loving and supportive) helped save her life because they didn’t give up on her, even though she often wanted to give up on herself. Mother and daughter also talk about how Hannah had a hard time adjusting to recovery at first because food was really a control issue for her, and she angrily resented anyone who told her what to eat.

Kimberly Wilson, a chartered psychologist, explains in the documentary: “Eating disorders are never about food. When something goes wrong with eating, we know there’s something [else] really fundamentally going wrong. That’s why treatments for eating disorders are long and complex and intense.”

While most people with anorexia and bulimia are females who want to be thin, males tend to get eating disorders that are generally related to wanting to be muscular. Scott Griffiths, a body image researcher at Australia’s University of Melbourne, talks about muscle dysmorphia, a psychological affliction (which mostly affects young men) to obsessively want a muscular physique. “It’s not dangerous, per se, but it is debilitating,” Griffiths says. “People who have high levels of anxiety, it can ruin their life. And we see a similar thing with muscle dysmorphia.”

Alan Flanagan, a nutrition researcher at the University of Surrey, has this scathing comment about diet culture: “I think it’s celebrating a disordered behavior in relationship with food. And it’s an attempt to legitimize the behavior by giving it another name. Take the ‘cheat meal’ concept and look at it for what it is. I think it’s fairly obvious that it’s a disordered behavior to engage with, with food.”

The experts in the film say that a big problem with diet culture is that diet plans are mass-produced as a “one size fits all” remedy for everyone. In reality, not everyone can lose weight in the same way and at the same pace, just by buying a so-called “diet remedy.” The fashion, beauty and media industries get a lot of blame in this documentary for perpetuating “ideal” body images and physiques that are unattainable for most people.

In addition, diets are notorious for failing over a long-term basis. People can temporarily lose weight through a diet plan, but it’s harder to stick with that plan for longer periods of time. Jenna Daku, a disordered eating therapist, compares misguided weight-loss plans that consist of extreme dieting and eating binges to being like trying to push a beach ball into the water.

Registered dietitian Pixie Turner and linguist/body image researcher Maxine Ali each comment that diet culture puts pressure on people to be thin because being thin is equated with an image of being more likely to be a “good person.” Turner comments, “Just because dieting is popular doesn’t mean it’s risk-free either.” Nadia Craddock, a body image researcher at the University of the West of England, adds: “The diet industry wouldn’t be as profitable if we didn’t subscribe that being fat is bad.”

There are also socioeconomic and gender issues in diet culture. Women are the majority of target customers for diet culture because in most societies, women are under more pressure than men not to be overweight. People judge women’s weight more harshly than they judge men’s weight, and these judgments have an effect on how people perceive attractiveness and power. If you don’t believe it, think about how many overweight men become leaders of countries, compared to overweight women. Think about how female celebrities are much more likely than male celebrities to get media coverage for how their bodies look.

National Health Service surgical doctor Joshua Wolrich comments, “There is an element of diet culture coming from a patriarchal society where women are told what they should look like. And a lot of the time, it has been from men. And so, I think it’s very appropriate that feminism touches on diet culture and definitely has a role to play in combating it.”

Author/speaker Kelsey Miller says that anti-fat biases extend to many areas of society, including education and the justice system. “It’s much more than ‘I don’t like the way the person looks.’ It really affects all areas of life.” It’s mentioned in the documentary that low-income areas are more likely to have cheap fast-food places that have low-quality food with high fat content, which is why obesity can affect low-income people disproportionately higher than people with higher incomes who can afford healthier diets. Low-income areas are also less likely than higher-income areas to have access to fresh and organic food.

“The Body Fights Back” has interviews with two very different immigrants living in London who are examples of how contrasting perspectives can be, when it comes to “privilege” and how people are treated, based on their physical looks. Tenisha Pascal, who is originally from a Caribbean country that she does not name, says she experienced culture shock when she moved to England at age 17, because of how differently people perceive big women.

“Where I’m [originally] from,” Pascal says, “the thicker you are, the more celebrated you are. Men don’t have a problem with your size. It was very different to transition from the love I had felt for myself as a 17-year-old coming to the U.K. Women, instead of complimenting themselves, would always talk negatively about their bodies … They don’t want to show their curves.” The documentary shows Pascal and Morondiya attending the annual Notting Hill Carnival (a street event for Caribbean culture), which they both say is one of the few public events in London where large-sized women can feel welcome to show off their bodies.

Johannes Schrey, who’s originally from Germany, admits that he has “thin privilege” and that he knows because he is tall man who is not overweight, people automatically see him as an authoritative figure. Schrey comments that his culture shock in moving to London was to see that fast-food places are much more prevalent than in Germany. He also admits that he’s very judgmental when he sees an overweight person eating junk food.

And even though white men hold the vast majority of power and wealth from diet culture and other industries that benefit from diet culture, Schrey doesn’t believe it’s fair to say that white men have a lot of control over weight-related images that affect people’s self-esteem. Schrey comments, “Everybody loves targeting us [white men as villains], but there’s no actual proof of that, no board of white men saying, ‘We need to have these things’ … I’m certainly not part of it.” Dr. Wolrich, who is white, has this counterpoint: “When men say [of sexist patriarchy], ‘It’s not me’ or ‘It’s not all men,” I don’t think that’s helpful.”

Someone like Schrey would like to dismiss the reality that there are no corporate boards of white men who decide what goes in the marketplace of diet culture. But the fact is that white men really are the majority of the corporate boards of companies that make decisions on what are Western standards of “attractiveness,” when it comes to people’s weight. That doesn’t mean that all men on these corporate boards are sexist. However, it’s an issue when the majority of diet culture is aimed at women, and yet women are not the majority who control the companies, media images and decisions on how weight can affect people’s lives.

Think about how women are pressured to lose pregnancy weight as soon as possible after giving birth, and you have an idea of how diet culture tends to negatively affect women a lot more than it negatively affects men. Morondiya admits that at this point in her life, she doesn’t want to have any children, mainly because she’s terrified of any pregnancy weight she might not be able to lose after giving birth. It’s also mentioned in the documentary that social media platforms have made it worse in giving people “physique envy” that puts more pressure on people to fall into diet culture’s traps.

Some grassroots groups are starting to push back against the patriarchal ways that try to dictate how people should feel about their body weight. The documentary includes footage of Health at Every Size, a social justice movement that is aimed at deconstructing the myth that being thin always equals health and happiness. There’s also the Anti-Diet Riot Club, whose founder Rebecca Young Brown is also shown briefly in the film. And the documentary features a 2019 “flash mob” event called The Real Catwalk (founded by Khrystyanna Kazakova) that took place in London’s Trafalgar Square, where dozens of people (many of them scantily clad) gathered to celebrate body positivity and acceptance.

“The Body Fights Back” acknowledges that in the 21st century, some progress has been made in the fashion industry giving more representation to plus-sized people in ads, on runways and in clothing options. However, some fashion brands are still resistant to change and deliberately exclude larger sizes. Several people in the documentary comment that people have the power to vote with their wallets, by being informed about which companies brands have inclusivity values that align with theirs and by supporting those companies accordingly.

“The Body Fights Back” clearly advocates this belief: People who’ve lived with insecurities over their weight don’t need to be body-shamed but should be shown compassion when it comes to weight that can improve their physical and mental health. It’s a much more difficult journey for some than it is for others. And many times, people who lecture others about their weight might not know the entire health history of the people who are on the receiving end of the lecture.

These lectures could be well-meaning, but they could also be doing psychological damage that will cause people to feel even worse about themselves, which could lead to more unhealthy eating. In other words, unless you are that person’s medical doctor, telling someone how they should lose weight can not only be inappropriate but could also do more harm to that person. Weight loss that goes beyond losing a few pounds or a few kilograms should be something that’s a personal decision and should be discussed with an individual’s medical doctor.

“The Body Strikes Back” does a very good job at showing the human side of these personal and often and painfully sensitive issues. Rather than waste time trying to single out any particular diet culture companies that are the most damaging (which might have led the documentary to include information that could easily become outdated), director Võsumets wisely focused on individuals who are pro-actively making improvements in their lives and the lives of others, when it comes to self-esteem and body inclusivity. When people are discriminated against because of their weight, it’s not just an aesthetic issue or health issue. It’s a civil rights issue.

Gravitas Ventures released “The Body Fights Back” on digital and VOD on July 13, 2021.

Nordstrom provides grant to the Trans Lifeline x FOLX Hormone Replacement Therapy (HRT) Care Fund

May 17, 2021

The following is a press release from Nordstrom:

As part of Pride month, Nordstrom announced today it will be providing a grant to the Trans Lifeline x FOLX Hormone Replacement Therapy (HRT) Care Fund, to support transgender, nonbinary and gender nonconforming individuals. For anyone struggling to access hormone care, this fund will underwrite their choice of Hormone Replacement Therapy (HRT) care through FOLX, with 75% of funds reserved for Black and Indigenous people, and people of color (BIPOC)

Additionally, Trans Lifeline is the giveback partner for our BP. Be Proud brand with 10% of net sales being donated towards the peer support and crisis hotline, and microgrants providing financial resources directly to transgender people across the U.S. and Canada. Between these efforts, Nordstrom hopes to give $350,000 in support of the Transgender community.

“We’ve long believed that we’re all made better by the diversity that exists both within our communities and our workforce. Our values are centered on the notion of creating a place where every customer and employee is welcome, respected, appreciated and able to be their authentic selves,” said Farrell Redwine, senior vice president of human resources, Nordstrom, Inc. “This year, we are honored to partner with Trans Lifeline to extend those values and support the transgender community in accessing resources that make their lives easier.” 

“Trans Lifeline is thrilled to be partnering with Nordstrom to invest in the transformational power of peer support and redistribute resources to trans people,” said Bri Barnett, director of advancement, Trans Lifeline. “This historic gift will be instrumental in helping us answer over 25,000 calls this year and it will also provide 100 people with a year of life saving medical care.”

Nordstrom will also be highlighting brands founded or designed by the LGBTQ+ community. It is Nordstrom’s priority to support the community year-round by offering a dynamic assortment of products and experiences, including:

The BP. Be Proud collection features a range of silhouettes for people of all gender expressions. The lead designer for this collection is queer and we engaged different members from the LGBTQ+ community to provide insight on what they see as missing from the current apparel landscape. Sizes range from XXS – 4X and prices range from $25 – $59.

MANTL, co-founded by Karamo Brown – the best-selling author, producer and Emmy-nominated host on Netflix’s Emmy-winning series Queer Eye – will be available at Nordstrom. Karamo created the skincare line for both the face and scalp after going through his own balding journey, with the mission to empower the bald and balding to live their fullest lives comfortably and confidently.

Packaged in pink and conceived beyond the gender binary, Boy Smells makes loving your identity a daily ritual. Co-founders and real-life partners Matthew Herman and David Kien created Boy Smells as items they’d want to use on a daily basis and products that were fluid and essential.

Leeway Home launched in March 2021 and is launching on Nordstrom.com in May. Leeway Home celebrates everyone at every stage of life and offers products to fit them. Founded by partners Sam Dumas and Lyle Maltz, they’ve leaned into the way real people live and offer everything you need to set your table your way. 

Leeway Home (Photo courtesy of Nordstrom)

Nordstrom is kicking off an ongoing partnership with The Phluid Project with an exclusive Pride capsule featuring gender-free accessories including hats, bags and socks starting at $12, launching at the end of May. The Phluid Project launched in March 2018 in NYC and online as a gender free fashion brand and is known for breaking the binary. The Phluid Project joined a movement of humans committed to challenging the ethos of traditions of the past that inhibit freedom and self-expression.

Year-round, Nordstrom provides grants and funding to LGBTQIA+ organizations like the Hetrick-Martin InstitutePride Foundation God’s Love We DeliverHuman Rights Campaign and more.

Nordstrom’s celebration of Pride Month and support of the LGBTQIA+ community are a part of the company’s broader efforts and commitments to diversity, inclusion and belonging (DIB). The company recently set goals to guide its DIB efforts and reports annually on its progress. To learn more about the company’s DIB strategy, goals and programs visit Nordstrom.com.

ABOUT NORDSTROM

Nordstrom, Inc. is a leading fashion retailer based in the U.S. Founded in 1901 as a shoe store in Seattle, today Nordstrom operates 357 stores in the U.S. and Canada, including 100 Nordstrom stores; 248 Nordstrom Rack stores; two clearances stores; and seven Nordstrom Local service hubs. Additionally, customers are served online through Nordstrom.comNordstrom.caNordstromRack.com and TrunkClub.com. Nordstrom, Inc.’s common stock is publicly traded on the NYSE under the symbol JWN.

ABOUT TRANS LIFELINE

Trans Lifeline connects trans people to the community, resources, and support they need to survive and thrive–building a resilient trans community through trans-led direct services. Trans Lifeline’s Hotline provides peer support and crisis support, and their Microgrants program provides low-barrier grants to trans people in need of legal name changes and updated IDs, HRT, and funds for incarcerated trans people.

ABOUT FOLX HEALTH

Launched in December 2020, FOLX Health is an LGBTQIA+ healthcare service provider built to serve the community’s specific needs. The company delivers a new standard of healthcare that’s built to serve LGBTQIA+ people, rather than treat them as problems to be solved. For more information, visit folxhealth.com

Food and Drug Administration coronavirus update: April 23, 2021

April 23, 2021

 

The following is a press release from the U.S. Food & Drug Administration:

Following a thorough safety review, including two meetings of the CDC’s Advisory Committee on Immunization Practices, the U.S. Food and Drug Administration and the U.S. Centers for Disease Control and Prevention have determined that the recommended pause regarding the use of the Johnson & Johnson (Janssen) COVID-19 Vaccine in the U.S. should be lifted and use of the vaccine should resume.

The pause was recommended after reports of six cases of a rare and severe type of blood clot in individuals following administration of the Janssen COVID-19 Vaccine. During the pause, medical and scientific teams at the FDA and CDC examined available data to assess the risk of thrombosis involving the cerebral venous sinuses, or CVST (large blood vessels in the brain), and other sites in the body (including but not limited to the large blood vessels of the abdomen and the veins of the legs) along with thrombocytopenia, or low blood platelet counts. The teams at FDA and CDC also conducted extensive outreach to providers and clinicians to ensure they were made aware of the potential for these adverse events and could properly manage and recognize these events due to the unique treatment required for these blood clots and low platelets, also known as thrombosis-thrombocytopenia syndrome (TTS).

The two agencies have determined the following:

  • Use of the Janssen COVID-19 Vaccine should be resumed in the United States.
  • The FDA and CDC have confidence that this vaccine is safe and effective in preventing COVID-19.
  • The FDA has determined that the available data show that the vaccine’s known and potential benefits outweigh its known and potential risks in individuals 18 years of age and older.
  • At this time, the available data suggest that the chance of TTS occurring is very low, but the FDA and CDC will remain vigilant in continuing to investigate this risk.
  • Health care providers administering the vaccine and vaccine recipients or caregivers should review the Janssen COVID-19 Vaccine Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) and Fact Sheet for Recipients and Caregivers, which have been revised to include information about the risk of this syndrome, which has occurred in a very small number of people who have received the Janssen COVID-19 Vaccine.

CDC’s independent Advisory Committee on Immunization Practices met today to discuss the latest data on TTS, hearing from the vaccine manufacturer Janssen and the COVID-19 Vaccine Safety Technical (VaST) Subgroup, as well as a risk benefit analysis. ACIP is committed to be vigilant and responsive to additional information that could impact the risk benefit analysis of any of these vaccines. Vaccine safety monitoring will continue and any new information about TTS will be brought to ACIP as needed.

“Safety is our top priority. This pause was an example of our extensive safety monitoring working as they were designed to work—identifying even these small number of cases. We’ve lifted the pause based on the FDA and CDC’s review of all available data and in consultation with medical experts and based on recommendations from the CDC’s Advisory Committee on Immunization Practices. We have concluded that the known and potential benefits of the Janssen COVID-19 Vaccine outweigh its known and potential risks in individuals 18 years of age and older. We are confident that this vaccine continues to meet our standards for safety, effectiveness and quality. We recommend people with questions about which vaccine is right for them have those discussions with their health care provider,” said Janet Woodcock, M.D., Acting FDA Commissioner.

“Above all else, health and safety are at the forefront of our decisions,” said CDC Director Dr. Rochelle P. Walensky. “Our vaccine safety systems are working. We identified exceptionally rare events – out of millions of doses of the Janssen COVID-19 administered – and we paused to examine them more carefully. As we always do, we will continue to watch all signals closely as more Americans are vaccinated. I continue to be encouraged by the growing body of real-world evidence that the authorized COVID-19 vaccines are safe and effective, and they protect people from disease, hospitalization, and death. I urge anyone with questions about the COVID-19 vaccines to speak with their healthcare provider or local public health department.”

Assessment of Available Data

Medical and scientific teams at the FDA and CDC reviewed several sources of information and data related to the Janssen COVID-19 Vaccine to reach today’s decision.

Specifically, the agencies assessed reports submitted to the Vaccine Adverse Event Reporting System (VAERS), reviewed the medical literature and considered the information from global regulatory partners about thrombosis with thrombocytopenia that have been reported following use of a similar, yet not identical, COVID-19 vaccine using a virus from the adenovirus family that has been modified to contain the gene for making a protein from SARS-CoV-2.

Update on Adverse Events

On April 13, the FDA and CDC announced that, out of more than 6.8 million doses administered, six reports of a rare and severe type of blood clot combined with low blood platelet levels occurring in people after receiving the Janssen COVID-19 Vaccine had been reported to VAERS. In these cases, a type of blood clot called cerebral venous sinus thrombosis (CVST) was seen in combination with low levels of blood platelets (thrombocytopenia).

Today, the agencies can confirm that a total of 15 cases of TTS have been reported to VAERS, including the original six reported cases. All of these cases occurred in women between the ages of 18 and 59, with a median age of 37 years. Reports indicated symptom onset between 6 and 15 days after vaccination.

Monitoring for Safety Will Continue

The surveillance systems that are in place to monitor the safety of COVID-19 vaccines authorized for emergency use are working, as demonstrated by both agencies’ quick work to identify and investigate these rare, but serious adverse events. The FDA and CDC will continue with these efforts to closely monitor the safety of these vaccines.

Reports of adverse events following vaccination can be made to the Vaccine Adverse Event Reporting System.

Additional Resources:

Consumer InquiriesEmail or 888-INFO-FDA

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products. 

 

The following is a press release from Johnson & Johnson:

Johnson & Johnson (NYSE: JNJ) (the Company) today announced that vaccinations with the Company’s COVID-19 single-shot vaccine will resume for all adults aged 18 years and older in the U.S., under Emergency Use Authorization (EUA), following a decision from the United States Centers for Disease Control (CDC) and Food and Drug Administration (FDA).

The decision was based on a recommendation from the U.S. CDC Advisory Committee on Immunization Practices (ACIP), which followed a rigorous evaluation of data relating to a very rare adverse event involving blood clots in combination with low platelet counts (thrombosis with thrombocytopenia) observed within approximately one to two weeks following vaccination.

“As the global pandemic continues to devastate communities around the world, we believe a single-shot, easily transportable COVID-19 vaccine with demonstrated protection against multiple variants can help protect the health and safety of people everywhere. We will collaborate with health authorities around the world to educate healthcare professionals and the public to ensure this very rare event can be identified early and treated effectively,” said Paul Stoffels, Chief Scientific Officer of Johnson & Johnson.

Johnson & Johnson has updated the EUA Fact Sheets for Healthcare Providers Administering Vaccine (Vaccination Providers), and Recipients and Caregivers for the Company’s COVID-19 vaccine, to include information about the diagnosis and treatment of thrombosis with thrombocytopenia. The revised EUA fact sheets is available at: www.janssencovid19vaccine.com.  

The CDC, FDA and American Society of Hematology have made information available about the proper recognition and management of this medical condition, and the unique treatment required for this type of blood clot. The health authorities advise that people who have received our COVID-19 vaccine and develop severe headache, chest pain, swelling in the leg, abdominal pain, tiny blood spots under the skin or excessive bruising within two weeks after vaccination should immediately contact their health care provider.

The Company continues to work with other healthcare authorities and regulators around the world to ensure this information is included in product labels for the Company’s COVID-19 vaccine. On April 20, the European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) also issued a recommendation, confirming the overall benefit-risk profile of the Company’s COVID-19 vaccine remains positive.

Johnson & Johnson’s COVID-19 Vaccine
The Johnson & Johnson COVID-19 Vaccine, developed by the Janssen Pharmaceutical Companies of Johnson & Johnson, received EUA from the FDA on February 27, 2021, to prevent COVID-19 in individuals 18 years of age and older.

This decision was based in part on the totality of scientific evidence, including data from the Phase 3 ENSEMBLE study that demonstrated the vaccine was 66.1 percent effective in preventing moderate to severe/critical disease and 85 percent effective in preventing severe/critical disease across all regions studied, 28 days post-vaccination. The vaccine showed protection against COVID-19 related hospitalization and death, beginning 28 days after vaccination.

The terms of the EUA allow use of the vaccine while more data are gathered. The Company plans to file for a Biologics License Application (BLA) with the FDA later in 2021.

On April 21, 2021, Johnson & Johnson announced the publication of primary data from the Phase 3 ENSEMBLE clinical trial in the New England Journal of MedicineThe primary analysis of the Company’s single-dose COVID-19 vaccine follows the topline efficacy and safety data announced in January, showing the trial met all primary and key secondary endpoints and prevented COVID-19 related hospitalization and death across all study participants 28 days after vaccination. The data also show the vaccine to be consistently effective against symptomatic infection, including in South Africa and Brazil where there was a high prevalence of rapidly emerging SARS-CoV-2 variants.   

For more information on the Company’s multi-pronged approach to helping combat the pandemic, visit: www.jnj.com/covid-19.

# # #

Authorized Use
The Janssen COVID-19 vaccine is authorized for use in the U.S. under an Emergency Use Authorization (EUA) for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 18 years of age and older.

IMPORTANT SAFETY INFORMATION
WHAT SHOULD YOU MENTION TO YOUR VACCINATION PROVIDER BEFORE YOU GET THE JANSSEN COVID-19 VACCINE?
Tell the vaccination provider about all of your medical conditions, including if you:

  • have any allergies
  • have a fever
  • have a bleeding disorder or are on a blood thinner
  • are immunocompromised or are on a medicine that affects your immune system
  • are pregnant or plan to become pregnant
  • are breastfeeding
  • have received another COVID-19 vaccine

WHO SHOULD NOT GET THE JANSSEN COVID-19 VACCINE?
You should not get the Janssen COVID-19 Vaccine if you:

  • had a severe allergic reaction to any ingredient of this vaccine.

HOW IS THE JANSSEN COVID-19 VACCINE GIVEN?
The Janssen COVID-19 Vaccine will be given to you as an injection into the muscle. The Janssen COVID-19 Vaccine vaccination schedule is a single dose.

WHAT ARE THE RISKS OF THE JANSSEN COVID-19 VACCINE?
Side effects that have been reported with the Janssen COVID-19 Vaccine include:

  • Injection site reactions: pain, redness of the skin, and swelling.
  • General side effects: headache, feeling very tired, muscle aches, nausea, fever.

There is a remote chance that the Janssen COVID-19 Vaccine could cause a severe allergic reaction. A severe allergic reaction would usually occur within a few minutes to one hour after getting a dose of the Janssen COVID-19 Vaccine. For this reason, your vaccination provider may ask you to stay at the place where you received your vaccine for monitoring after vaccination. Signs of a severe allergic reaction can include:

  • Difficulty breathing
  • Swelling of your face and throat
  • A fast heartbeat
  • A bad rash all over your body
  • Dizziness and weakness

Blood clots involving blood vessels in the brain, abdomen, and legs along with low levels of platelets (blood cells that help your body stop bleeding), have occurred in some people who have received the Janssen COVID-19 Vaccine. In people who developed these blood clots and low levels of platelets, symptoms began approximately one to two-weeks following vaccination. Most people who developed these blood clots and low levels of platelets were females ages 18 through 49 years. The chance of having this occur is remote. You should seek medical attention right away if you have any of the following symptoms after receiving Janssen COVID-19 Vaccine:

  • Shortness of breath,
  • Chest pain,
  • Leg swelling,
  • Persistent abdominal pain,
  • Severe or persistent headaches or blurred vision,
  • Easy bruising or tiny blood spots under the skin beyond the site of the injection.

These may not be all the possible side effects of the Janssen COVID-19 Vaccine. Serious and unexpected effects may occur. The Janssen COVID-19 Vaccine is still being studied in clinical trials.

WHAT SHOULD I DO ABOUT SIDE EFFECTS?
If you experience a severe allergic reaction, call 9-1-1, or go to the nearest hospital.
Call the vaccination provider or your healthcare provider if you have any side effects that bother you or do not go away.

Report vaccine side effects to FDA/CDC Vaccine Adverse Event Reporting System (VAERS). The VAERS toll-free number is 1-800-822-7967 or report online to https://vaers.hhs.gov/reportevent.html. Please include “Janssen COVID-19 Vaccine EUA” in the first line of box #18 of the report form. In addition, you can report side effects to Janssen Biotech, Inc. at 1-800-565-4008.

The FDA EUA Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) and full EUA Prescribing Information are available at www.JanssenCOVID19Vaccine.com/EUA-factsheet

About Johnson & Johnson
At Johnson & Johnson, we believe good health is the foundation of vibrant lives, thriving communities and forward progress. That’s why for more than 130 years, we have aimed to keep people well at every age and every stage of life. Today, as the world’s largest and most broadly-based healthcare company, we are committed to using our reach and size for good. We strive to improve access and affordability, create healthier communities, and put a healthy mind, body and environment within reach of everyone, everywhere. We are blending our heart, science and ingenuity to profoundly change the trajectory of health for humanity. Learn more at www.jnj.com. Follow us at @JNJNews.

About the Janssen Pharmaceutical Companies of Johnson & Johnson
At Janssen, we’re creating a future where disease is a thing of the past. We’re the Pharmaceutical Companies of Johnson & Johnson, working tirelessly to make that future a reality for patients everywhere by fighting sickness with science, improving access with ingenuity, and healing hopelessness with heart. We focus on areas of medicine where we can make the biggest difference: Cardiovascular & Metabolism, Immunology, Infectious Diseases & Vaccines, Neuroscience, Oncology, and Pulmonary Hypertension. Learn more at www.janssen.com. Follow us at @JanssenGlobal.

Cautions Concerning Forward-Looking Statements
This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 regarding development of a potential preventive vaccine for COVID-19. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of the Janssen Pharmaceutical Companies, and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson’s Annual Report on Form 10-K for the fiscal year ended January 3, 2021, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in the company’s most recently filed Quarterly Report on Form 10-Q, and the company’s subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.govwww.jnj.com or on request from Johnson & Johnson. None of the Janssen Pharmaceutical Companies nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.

Food and Drug Administration coronavirus update: April 13, 2021

April 13, 2021

 

The following is a press release from the U.S. Food and Drug Administration:

The following statement is attributed to Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research and Dr. Anne Schuchat, Principal Deputy Director of the CDC

As of April 12, more than 6.8 million doses of the Johnson & Johnson (Janssen) vaccine have been administered in the U.S. CDC and FDA are reviewing data involving six reported U.S. cases of a rare and severe type of blood clot in individuals after receiving the J&J vaccine. In these cases, a type of blood clot called cerebral venous sinus thrombosis (CVST) was seen in combination with low levels of blood platelets (thrombocytopenia). All six cases occurred among women between the ages of 18 and 48, and symptoms occurred 6 to 13 days after vaccination. Treatment of this specific type of blood clot is different from the treatment that might typically be administered. Usually, an anticoagulant drug called heparin is used to treat blood clots. In this setting, administration of heparin may be dangerous, and alternative treatments need to be given.

CDC will convene a meeting of the Advisory Committee on Immunization Practices (ACIP) on Wednesday to further review these cases and assess their potential significance. FDA will review that analysis as it also investigates these cases. Until that process is complete, we are recommending a pause in the use of this vaccine out of an abundance of caution. This is important, in part, to ensure that the health care provider community is aware of the potential for these adverse events and can plan for proper recognition and management due to the unique treatment required with this type of blood clot.

Right now, these adverse events appear to be extremely rare. COVID-19 vaccine safety is a top priority for the federal government, and we take all reports of health problems following COVID-19 vaccination very seriously. People who have received the J&J vaccine who develop severe headache, abdominal pain, leg pain, or shortness of breath within three weeks after vaccination should contact their health care provider. Health care providers are asked to report adverse events to the Vaccine Adverse Event Reporting System at https://vaers.hhs.gov/reportevent.html.

CDC and FDA will provide additional information and answer questions later today at a media briefing. A recording of that media call will be available on the FDA’s YouTube channel.

Consumer Inquiries: 888-INFO-FDA

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Food and Drug Administration coronavirus update: February 27, 2021

February 27, 2021

The following is a press release from the U.S. Food and Drug Administration:

Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the third vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The EUA allows the Janssen COVID-19 Vaccine to be distributed in the U.S for use in individuals 18 years of age and older.

“The authorization of this vaccine expands the availability of vaccines, the best medical prevention method for COVID-19, to help us in the fight against this pandemic, which has claimed over half a million lives in the United States,” said Acting FDA Commissioner Janet Woodcock, M.D. “The FDA, through our open and transparent scientific review process, has now authorized three COVID-19 vaccines with the urgency called for during this pandemic, using the agency’s rigorous standards for safety, effectiveness and manufacturing quality needed to support emergency use authorization.”

The FDA has determined that the Janssen COVID-19 Vaccine has met the statutory criteria for issuance of an EUA. The totality of the available data provides clear evidence that the Janssen COVID-19 Vaccine may be effective in preventing COVID-19. The data also show that the vaccine’s known and potential benefits outweigh its known and potential risks, supporting the company’s request for the vaccine’s use in people 18 years of age and older. In making this determination, the FDA can assure the public and medical community that it has conducted a thorough evaluation of the available safety, effectiveness and manufacturing quality information.

The Janssen COVID-19 Vaccine is manufactured using a specific type of virus called adenovirus type 26 (Ad26). The vaccine uses Ad26 to deliver a piece of the DNA, or genetic material, that is used to make the distinctive “spike” protein of the SARS-CoV-2 virus. While adenoviruses are a group of viruses that are relatively common, Ad26, which can cause cold symptoms and pink eye, has been modified for the vaccine so that it cannot replicate in the human body to cause illness. After a person receives this vaccine, the body can temporarily make the spike protein, which does not cause disease, but triggers the immune system to learn to react defensively, producing an immune response against SARS-CoV-2.

“After a thorough analysis of the data, the FDA’s scientists and physicians have determined that the vaccine meets the FDA’s expectations for safety and effectiveness appropriate for the authorization of a vaccine for emergency use,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. “With today’s authorization, we are adding another vaccine in our medical toolbox to fight this virus. At the same time, the American people can be assured of the FDA’s unwavering commitment to public health through our comprehensive and rigorous evaluation of the data submitted for vaccines to prevent COVID-19.”

FDA Evaluation of Available Safety Data

The Janssen COVID-19 Vaccine is administered as a single dose. The available safety data to support the EUA include an analysis of 43,783 participants enrolled in an ongoing randomized, placebo-controlled study being conducted in South Africa, certain countries in South America, Mexico, and the U.S. The participants, 21,895 of whom received the vaccine and 21,888 of whom received saline placebo, were followed for a median of eight weeks after vaccination. The most commonly reported side effects were pain at the injection site, headache, fatigue, muscle aches and nausea. Most of these side effects were mild to moderate in severity and lasted 1-2 days.

As part of the authorization, the FDA notes that it is mandatory for Janssen Biotech Inc. and vaccination providers to report the following to the Vaccine Adverse Event Reporting System (VAERS) for Janssen COVID-19 Vaccine: serious adverse events, cases of Multisystem Inflammatory Syndrome and cases of COVID-19 that result in hospitalization or death.

It is also mandatory for vaccination providers to report all vaccine administration errors to VAERS for which they become aware and for Janssen Biotech Inc. to include a summary and analysis of all identified vaccine administration errors in monthly safety reports submitted to the FDA.

FDA Evaluation of Available Effectiveness Data

The effectiveness data to support the EUA include an analysis of 39,321 participants in the ongoing randomized, placebo-controlled study being conducted in South Africa, certain countries in South America, Mexico, and the U.S. who did not have evidence of SARS-CoV-2 infection prior to receiving the vaccine. Among these participants, 19,630 received the vaccine and 19,691 received saline placebo. Overall, the vaccine was approximately 67% effective in preventing moderate to severe/critical COVID-19 occurring at least 14 days after vaccination and 66% effective in preventing moderate to severe/critical COVID-19 occurring at least 28 days after vaccination.

Additionally, the vaccine was approximately 77% effective in preventing severe/critical COVID-19 occurring at least 14 days after vaccination and 85% effective in preventing severe/critical COVID-19 occurring at least 28 days after vaccination.

There were 116 cases of COVID-19 in the vaccine group that occurred at least 14 days after vaccination, and 348 cases of COVID-19 in the placebo group during this time period. There were 66 cases of COVID-19 in the vaccine group that occurred at least 28 days after vaccination and 193 cases of COVID-19 in the placebo group during this time period. Starting 14 days after vaccination, there were 14 severe/critical cases in the vaccinated group versus 60 in the placebo group, and starting 28 days after vaccination, there were 5 severe/critical in the vaccine group versus 34 cases in the placebo group.

At this time, data are not available to determine how long the vaccine will provide protection, nor is there evidence that the vaccine prevents transmission of SARS-CoV-2 from person to person.

The EUA Process

On the basis of the determination by the Secretary of the Department of Health and Human Services on Feb. 4, 2020, that there is a public health emergency that has a significant potential to affect national security or the health and security of United States citizens living abroad, and issued declarations that circumstances exist justifying the authorization of emergency use of unapproved products, the FDA may issue an EUA to allow unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat, or prevent COVID-19 when there are no adequate, approved, and available alternatives.

The issuance of an EUA is different than an FDA approval (licensure) of a vaccine, in that a vaccine available under an EUA is not approved. In determining whether to issue an EUA for a product, the FDA evaluates the available evidence to determine whether the product may be effective and also assesses any known or potential risks and any known or potential benefits If the product meets the effectiveness standard and the benefit-risk assessment is favorable, the product is made available during the emergency. Once a manufacturer submits an EUA request for a COVID-19 vaccine to the FDA, the agency then evaluates the request and determines whether the relevant statutory criteria are met, taking into account the totality of the scientific evidence about the vaccine that is available to the FDA.

The EUA also requires that fact sheets that provide important information, including dosing instructions, and information about the benefits and risks of the Janssen COVID-19 Vaccine, be made available to vaccination providers and vaccine recipients.

Janssen Biotech Inc. has submitted a pharmacovigilance plan to the FDA describing its commitment to monitor the safety of Janssen COVID-19 Vaccine. The pharmacovigilance plan includes a plan to complete longer-term safety follow-up for participants enrolled in ongoing clinical trials. The pharmacovigilance plan also includes other activities aimed at monitoring the safety profile of the Janssen COVID-19 Vaccine and ensuring that any safety concerns are identified and evaluated in a timely manner.

The FDA also expects manufacturers whose COVID-19 vaccines are authorized under an EUA to continue their clinical trials to obtain additional safety and effectiveness information and pursue approval (licensure).

The EUA for the Janssen COVID-19 Vaccine was issued to Janssen Biotech Inc., a Janssen Pharmaceutical Company of Johnson & Johnson. The authorization will be effective until the declaration that circumstances exist justifying the authorization of the emergency use of drugs and biologics for prevention and treatment of COVID-19 is terminated. The EUA for Janssen COVID-19 Vaccine may be revised or revoked if it is determined the EUA no longer meets the statutory criteria for issuance.

Additional Resources:


Consumer Inquiries: 888-INFO-FDA

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

 

The following is a press release from Johnson & Johnson:

Johnson & Johnson (NYSE: JNJ) (the Company) announced that the U.S. Food and Drug Administration (FDA) has issued Emergency Use Authorization (EUA) for its single-dose COVID-19 vaccine, developed by the Janssen Pharmaceutical Companies of Johnson & Johnson, to prevent COVID-19 in individuals 18 years of age and older.

This decision was based on the totality of scientific evidence, including data from the Phase 3 ENSEMBLE study that demonstrated the vaccine was 85 percent effective in preventing severe disease across all regions studied, and showed protection against COVID-19 related hospitalization and death, beginning 28 days after vaccination.

The terms of the EUA allow use of the vaccine while more data are gathered. The Company plans to file for a Biologics License Application (BLA) with the FDA later in 2021.

“This milestone follows a year of incredible work by our dedicated teams and unprecedented collaboration with health leaders around the world – all of whom shared a goal of bringing a single-shot vaccine to the public,” said Alex Gorsky, Chairman and Chief Executive Officer at Johnson & Johnson. “We will do everything we can to help bring this pandemic to an end, in the United States and throughout the world.”

“We believe the Johnson & Johnson single-shot COVID-19 vaccine is a critical tool for fighting this global pandemic, particularly as it shows protection across countries with different variants. A vaccine that protects against COVID-19, especially against the most dire outcomes of hospitalization and death, will help ease the burden on people and the strain on health systems worldwide,” said Paul Stoffels, M.D., Vice Chairman of the Executive Committee and Chief Scientific Officer, Johnson & Johnson. “We look forward to our continued efforts around the world as we collectively aim to change the trajectory of this global pandemic.”

Johnson & Johnson is committed to making its COVID-19 vaccine available on a not-for-profit basis for emergency pandemic use. The Company has begun shipping its COVID-19 vaccines to the U.S. government and expects to deliver enough single-shot vaccines by the end of March to enable the full vaccination of more than 20 million people in the U.S. The Company plans to deliver 100 million single-shot vaccines to the U.S. during the first half of 2021. The U.S. government will manage allocation and distribution of the vaccine in the U.S. This will be prioritized according to the populations identified by the CDC’s Advisory Committee on Immunization Practices (ACIP) guidelines.

Johnson & Johnson also recently announced its submission of a European Conditional Marketing Authorisation Application to the European Medicines Agency as well as its filing for an Emergency Use Listing (EUL) with the World Health Organization for its COVID-19 vaccine candidate. In addition, rolling submissions for the single-dose COVID-19 vaccine candidate have been initiated in several countries worldwide.

The EUA follows a unanimous vote by the U.S. FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC), on February 26, 2021.

“We are thankful for the efforts of all those who have volunteered to participate in our clinical trials, our scientists, collaborators, clinical trial sites and investigators. Through the combined commitment of everyone involved, we have been able to discover, develop and manufacture a single-shot COVID-19 vaccine to protect people around the world,” said Mathai Mammen, M.D., Ph.D., Global Head, Janssen Research & Development, Johnson & Johnson. 

Manufacturing and Supply Chain Information
The Johnson & Johnson COVID-19 single-dose vaccine is compatible with standard vaccine storage and distribution channels with ease of delivery to remote areas. The vaccine is estimated to remain stable for two years at -4°F (-20°C), and a maximum of three months at routine refrigeration at temperatures of 36-46°F (2 to 8°C). The Company will ship the vaccine using the same cold chain technologies it uses today to transport treatments for cancer, immunological disorders and other medicines. The COVID-19 vaccine should not be re-frozen if distributed at temperatures of 36°F–46°F (2°-8°C).

Johnson & Johnson’s COVID-19 Vaccine
The Company’s COVID-19 vaccine leverages the AdVac® vaccine platform, a unique and proprietary technology that was also used to develop and manufacture Janssen’s European Commission-approved Ebola vaccine regimen and construct its investigational Zika, RSV, and HIV vaccines.

The Janssen COVID-19 vaccine has not been approved or licensed by the U.S. Food and Drug Administration (FDA), but has been authorized by FDA through an Emergency Use Authorization (EUA) for active immunization to prevent Coronavirus Disease 2019 (COVID-19) in individuals 18 years of age and older. There is no FDA-approved vaccine to prevent COVID-19.

The FDA EUA Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) and full EUA Prescribing Information available are at https://www.janssenlabels.com/emergency-use-authorization/Janssen+COVID-19+Vaccine-HCP-fact-sheet.pdf.

Phase 3 ENSEMBLE Study Design
The Phase 3 ENSEMBLE study is a randomized, double-blind, placebo-controlled clinical trial in individuals 18 years of age and older. The study was designed to evaluate the safety and efficacy of the Company’s vaccine candidate in protecting against both moderate and severe COVID-19 disease, with assessment of efficacy as of day 14 and as of day 28 as co-primary endpoints. The study enrolled a total of 43,783 participants.

The trial, conducted in eight countries across three continents, includes a diverse and broad population including 34 percent of participants over age 60.

The study enrolled 44 percent of participants in the United States. Seventy-four percent of participants in the U.S. are White/Caucasian; 15 percent are Hispanic and/or Latinx; 13 percent are Black/African American; 6 percent are Asian and 1 percent are Native American.

Forty-one percent of participants in the study had comorbidities associated with an increased risk for progression to severe COVID-19.

Research and development activities for the Company’s COVID-19 vaccine, including the ENSEMBLE clinical trial and the delivery of doses for the U.S., have been funded in part with federal funds from the U.S. Department of Health and Human Services, Office of the Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority (BARDA), under Contract No. HHSO100201700018C, and in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH) at the U.S. Department of Health and Human Services (HHS). 

Johnson & Johnson has worked with BARDA since 2015 on innovative solutions for influenza, chemical, biological, radiation and nuclear threats and emerging infectious diseases such as Ebola.

For more information on the Company’s multi-pronged approach to helping combat the pandemic, visit: www.jnj.com/coronavirus.

Authorized Use
The Janssen COVID-19 vaccine is authorized for use under an Emergency Use Authorization (EUA) for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 18 years of age and older.

Important Safety Information

WHAT SHOULD YOU MENTION TO YOUR VACCINATION PROVIDER BEFORE YOU GET THE JANSSEN COVID-19 VACCINE?
Tell the vaccination provider about all of your medical conditions, including if you:

  • have any allergies
  • have a fever
  • have a bleeding disorder or are on a blood thinner
  • are immunocompromised or are on a medicine that affects your immune system
  • are pregnant or plan to become pregnant
  • are breastfeeding
  • have received another COVID-19 vaccine

WHO SHOULD NOT GET THE JANSSEN COVID-19 VACCINE?
You should not get the Janssen COVID-19 Vaccine if you:

  • had a severe allergic reaction to any ingredient of this vaccine.

HOW IS THE JANSSEN COVID-19 VACCINE GIVEN?
The Janssen COVID-19 Vaccine will be given to you as an injection into the muscle.  The Janssen COVID-19 Vaccine vaccination schedule is a single dose.

WHAT ARE THE RISKS OF THE JANSSEN COVID-19 VACCINE?
Side effects that have been reported with the Janssen COVID-19 Vaccine include:

  • Injection site reactions: pain, redness of the skin, and swelling.
  • General side effects: headache, feeling very tired, muscle aches, nausea, fever.

There is a remote chance that the Janssen COVID-19 Vaccine could cause a severe allergic reaction. A severe allergic reaction would usually occur within a few minutes to one hour after getting a dose of the Janssen COVID-19 Vaccine. For this reason, your vaccination provider may ask you to stay at the place where you received your vaccine for monitoring after vaccination. Signs of a severe allergic reaction can include:

  • Difficulty breathing
  • Swelling of your face and throat
  • A fast heartbeat
  • A bad rash all over your body
  • Dizziness and weakness

These may not be all the possible side effects of the Janssen COVID-19 Vaccine. Serious and unexpected effects may occur. The Janssen COVID-19 Vaccine is still being studied in clinical trials.

WHAT SHOULD I DO ABOUT SIDE EFFECTS?
If you experience a severe allergic reaction, call 9-1-1, or go to the nearest hospital.
Call the vaccination provider or your healthcare provider if you have any side effects that bother you or do not go away.

Report vaccine side effects to FDA/CDC Vaccine Adverse Event Reporting System (VAERS). The VAERS toll-free number is 1-800-822-7967 or report online to https://vaers.hhs.gov/reportevent.html. Please include “Janssen COVID-19 Vaccine EUA” in the first line of box #18 of the report form. In addition, you can report side effects to Janssen Biotech, Inc. at 1-800-565-4008.

About Johnson & Johnson
At Johnson & Johnson, we believe good health is the foundation of vibrant lives, thriving communities and forward progress. That’s why for more than 130 years, we have aimed to keep people well at every age and every stage of life. Today, as the world’s largest and most broadly-based healthcare company, we are committed to using our reach and size for good. We strive to improve access and affordability, create healthier communities, and put a healthy mind, body and environment within reach of everyone, everywhere. We are blending our heart, science and ingenuity to profoundly change the trajectory of health for humanity. Learn more at www.jnj.com. Follow us at @JNJNews.

About the Janssen Pharmaceutical Companies of Johnson & Johnson
At Janssen, we’re creating a future where disease is a thing of the past. We’re the Pharmaceutical Companies of Johnson & Johnson, working tirelessly to make that future a reality for patients everywhere by fighting sickness with science, improving access with ingenuity, and healing hopelessness with heart. We focus on areas of medicine where we can make the biggest difference: Cardiovascular & Metabolism, Immunology, Infectious Diseases & Vaccines, Neuroscience, Oncology, and Pulmonary Hypertension. Learn more at www.janssen.com. Follow us at @JanssenGlobal.

Cautions Concerning Forward-Looking Statements
This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 regarding development of a potential preventive vaccine for COVID-19. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of the Janssen Pharmaceutical Companies, and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson’s Annual Report on Form 10-K for the fiscal year ended January 3, 2021, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in the company’s most recently filed Quarterly Report on Form 10-Q, and the company’s subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.govwww.jnj.com or on request from Johnson & Johnson. None of the Janssen Pharmaceutical Companies nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.

Review: ’76 Days,’ starring Yang Li and Tian Dingyuan

December 20, 2020

by Carla Hay

A COVID-19 patient (center) accompanied by two nurses in Wuhan, China, in “76 Days” (Photo courtesy of MTV Documentary Films)

“76 Days”

Directed by Weixi Chen, Hao Wu and Anonymous

Mandarin with subtitles

Culture Representation: Taking place in Wuhan, China, the documentary “76 Days” features an all-Asian group of medical professionals, patients and family members who were affected by the COVID-19 shutdown when the city was the epicenter of the virus.

Culture Clash: The documentary chronicles what the crisis was like for four overwhelmed hospitals, which had to turn patients away due to overcrowding and prevented people from visiting patients due to the medical dangers of spreading the virus.

Culture Audience: “76 Days” will appeal primarily to people who are interested in an inside look at how Chinese medical facilities and staffers handled the COVID-19 crisis at the beginning of the outbreak.

A doctor and a COVID-19 patient in Wuhan, China, in “76 Days” (Photo courtesy of MTV Documentary Films)

The COVID-19 pandemic has been the subject of numerous documentaries and news reports, with many focusing on what went wrong during this worldwide health crisis. The impactful documentary “76 Days” doesn’t have a political agenda, nor is it interested in placing any blame on why the virus spread to devastating proportions. Instead, the film is an unflinching look inside four of the hospitals in Wuhan, China, during the 76 days of lockdown that that city experienced when it was the COVID-19 epicenter.

Directed by Weixi Chen, Hao Wu and a Chinese news journalist who wants to remain anonymous, “76 Days” is filmed in the best format for this subject matter: completely cinéma vérité, with no archival footage, no interviews with talking heads, no voiceover narration, no re-enactments and no animation. The film is so minimalist that there isn’t even any music to trigger certain emotions.

The lockdown in Wuhan (a city of about 11 million people) began on January 23, 2020, and ended on April 8, 2020. Production of the documentary began in early February 2020. To get access inside these hospitals during the beginning of the COVID-19 crisis, the “76 Days” directors had to follow the same safety protocols as everyone else in the hospitals. (Wuhan Red Cross Hospital is one of the medical facilities in the documentary. )

According to the production notes for “76 Days,” Chen and the anonymous co-director are both news journalists who filmed the actual footage. Wu (a Chinese filmmaker who splits his time between living in the U.S. and China) stayed in the U.S. during filming, and he did the editing for the film. Although there is some footage of people outside of the hospitals, the majority of the film takes place in a hospital setting.

Wu explains in the “76 Days” production notes: “In production there were many discussions about what aspects of Wuhan’s city life to cover, and whether and how much to contrast the Wuhan stories with the increasingly global pandemic stories. Once I started editing, however, I quickly realized that the strongest footage was that shot in the hospitals. And since the worldwide media were already reporting extensively on the chronology of the pandemic’s evolution, I decided to tell our story in the barest fashion possible, to focus on the individual experiences and forego any illustration of the bigger environment that these personal stories happen in.”

He adds, “A few of the hardest-hit hospitals only allowed reporters and filming crews thoroughly vetted by the authorities. But that strict control was not applied uniformly to all hospitals or throughout the entire lockdown period. Early in the lockdown when the situation was dire and chaotic and there was a severe shortage of medical supplies, many hospitals actually welcomed media exposure to help them look for help. Some of the medical teams sent from elsewhere in China to support Wuhan were also open to being filmed, partly due to their desire to have their own images documented in this historical moment.”

All of this information is important context to explain the filmmakers’ choices in what is shown and what is not shown in the documentary. What viewers won’t see are bodies being taken out of hospitals, people dying on camera or other images that would be considered too disturbing or exploitative. That doesn’t mean that there aren’t any raw and emotional moments in the documentary, but there’s a real sense that the filmmakers wanted to respectfully show the toll that the COVID-19 crisis took on not just the patients but also the health care workers on the front lines.

The opening scene is one of those painful emotional moments in the film: A female hospital employee in a hazmat suit wails and sobs because her father has died in the hospital and she wasn’t able to say goodbye to him. She is comforted by co-workers, but they also have to deal with the reality that she can’t take time off from work because the hospital is overwhelmed and understaffed.

One of her co-workers tells her to try to pull herself together: “What will you do if you fall sick? We all have to work in the afternoon.” It’s a situation that’s experienced by untold numbers of health care workers on the front lines of the COVID-19 pandemic: Not only do they have the enormous pressure of trying to save lives, but they too could be dealing with a loss of a loved one who died of COVID-19.

Another poignant moment is when a middle-aged male patient is shown having an emotional breakdown over his COVID-19 diagnosis because he is afraid of dying. As he sobs to someone about it over the phone, whoever is on the other line doesn’t seem to be very sympathetic, because the person tells him to stop crying because the doctors must be tired of seeing him get emotional. Through the tears, the man insists that he’s still a good Communist and loyal to the Community Party.

There are only two people in the documentary who are identified by name: a nurse named Yang Li and a doctor named Tian Dingyuan. Everyone else is “anonymous,” but there are certain people who featured more prominently than others. The way the documentary is edited, viewers get to see what happens to these featured individuals at various points during the lockdown.

Yang mentions all the ID cards, phones and other personal possessions of dead patients that are stored in containers in a certain part of the hospital. The loved ones of the deceased have to be notified to claim these possessions. And toward the end of the film, Yang is the one who’s shows doing this very emotionally difficult task. In one scene, she breaks down in tears when she goes outside to meet the daughter of a dead female patient and hand over the patient’s possessions. She makes a sincere apology for not being able to save this mother, and her daughter ends up crying too.

Tian is also shown to be a compassionate hospital worker. While speaking with an elderly man who is a COVID-19 patient, the patient says of the health care workers who treat the patients: “It’s so dangerous being in contact with us. You are all fearless soldiers.” The doctor replies, “Stay strong. Your wife is waiting for you.”

One of the memorable patients who gets the most screen time is an elderly man in his 70s who keeps complaining about being confined in the hospital. He’s feisty and constantly talks about how he can’t wait to leave the hospital. At one point, he tries to leave the hospital on his own around 10 p.m., but he’s confused because he thinks it’s daytime. The hospital workers gently detain him before he leave the hospital, since he’s still under quarantine.

This patient survives, and an interesting thing happens when he’s ready to be discharged: He says he doesn’t want to leave the hospital. Why? He reveals: “My hometown is too backward.” And he says of the dwelling where he lives: “There are already too many people under one roof. And they like to pick on me.”

It’s an example of how the stories of these COVID-19 patients and hospital patients in general can be much more complex than they first appear to be. This patient who at first seems to be a cranky old man who hates being in the hospital turns out to be someone who is hurting in other ways that a hospital can’t necessarily fix. This documentary only focuses on in-patient care, but it will make people wonder about what happens to COIVD-19 patients after they leave hospitals and how they will be cared for during their outpatient recoveries.

Also featured in “76 Days” is footage of a few pregnant women who gave birth while having COVID-19. Fortunately, their babies survived, but the babies had to be quarantined from the parents. One young couple couldn’t bring their baby daughter (their firstborn child) home for a period of time that’s not stated in the movie but it’s implied to be at least two weeks. The documentary has some brief footage of the couple at home as they prepare to bring their daughter home.

When they arrive at the hospital on homecoming day, the wife comments to the husband that she hopes that their daughter is pretty. The husband says that she should be more concerned with their daughter being healthy. The wife replies confidently that she knows their daughter is healthy and it would be great if she’s also pretty. When these new parents finally get to bring their child home, there are the expected tears and emotions.

Early on in “76 Days,” the problem of not having enough room for patients is shown when a female nurse and a male co-worker have to literally barricade themselves behind a door, where people are frantically pounding to get inside. The nurse has to yell that only people with COVID-19 symptoms are allowed inside, and only a few people at a time. It’s an order that many of the people outside aren’t too happy with, but they have no choice, since many hospitals hit hard by COVID-19 had to have the same policy.

Even though some groups of people are at higher risk of dying from COVID-19, the virus doesn’t care who it infects. Yang makes this comment: “Rich, poor, revered or despised—fate befalls all.” There will continue to be debates over the politics and solutions for the COVID-19 pandemic. And even though “76 Days” takes place in China, the documentary insightfully shows how compassion and the challenging pandemic effects on patients, their loved ones and health care professionals have more similarities than differences around the world.

MTV Documentary Films released “76 Days” in select U.S. virtual cinemas on December 4, 2020. Paramount+ will premiere the movie on March 4, 2021. Paramount Home Entertainment will release the movie on digital and VOD on March 5, 2021.

Food and Drug Administration coronavirus update: December 18, 2020

 

The following is a press release from the U.S. Food and Drug Administration:

Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the second vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The emergency use authorization allows the Moderna COVID-19 Vaccine to be distributed in the U.S. for use in individuals 18 years of age and older.

“With the availability of two vaccines now for the prevention of COVID-19, the FDA has taken another crucial step in the fight against this global pandemic that is causing vast numbers of hospitalizations and deaths in the United States each day,” said FDA Commissioner Stephen M. Hahn, M.D. “Through the FDA’s open and transparent scientific review process, two COVID-19 vaccines have been authorized in an expedited timeframe while adhering to the rigorous standards for safety, effectiveness, and manufacturing quality needed to support emergency use authorization that the American people have come to expect from the FDA. These standards and our review process, which are the same we have used in reviewing the first COVID-19 vaccine and intend to use for any other COVID-19 vaccines, included input from independent scientific and public health experts as well as a thorough analysis of the data by the agency’s career staff.”

The FDA has determined that the Moderna COVID-19 Vaccine has met the statutory criteria for issuance of an EUA. The totality of the available data provides clear evidence that the Moderna COVID-19 Vaccine may be effective in preventing COVID-19. The data also show that the known and potential benefits outweigh the known and potential risks—supporting the company’s request for the vaccine’s use in people 18 years of age and older. In making this determination, the FDA can assure the public and medical community that it has conducted a thorough evaluation of the available safety, effectiveness, and manufacturing quality information.

The Moderna COVID-19 Vaccine contains messenger RNA (mRNA), which is genetic material. The vaccine contains a small piece of the SARS-CoV-2 virus’s mRNA that instructs cells in the body to make the virus’s distinctive “spike” protein. After a person receives this vaccine, their body produces copies of the spike protein, which does not cause disease, but triggers the immune system to learn to react defensively, producing an immune response against SARS-CoV-2.   

“Guided by science and data, the agency’s career staff determined that the vaccine’s known and potential benefits clearly outweigh its known and potential risks, and although not an FDA approval,  the FDA’s expectations described in our June and October guidance documents have been met,” said Peter Marks, M.D., Ph.D., Director of the FDA’s Center for Biologics Evaluation and Research. “Today’s authorization demonstrates our steadfast commitment to the health of the American people, with the assurance that our scientific standards and the integrity of our review process have been maintained. This achievement is yet another testament to the dedication of FDA’s career scientists and physicians, who have been working urgently to conduct comprehensive and rigorous evaluations of the data submitted for vaccines to prevent COVID-19.”

FDA Evaluation of Available Safety Data

Moderna COVID-19 Vaccine is administered as a series of two doses, one month apart. The available safety data to support the EUA include an analysis of 30,351 participants enrolled in an ongoing randomized, placebo-controlled study conducted in the U.S. These participants, 15,185 of whom received the vaccine and 15,166 of whom received saline placebo, were followed for a median of more than two months after receiving the second dose. The most commonly reported side effects, which typically lasted several days, were pain at the injection site, tiredness, headache, muscle pain, chills, joint pain, swollen lymph nodes in the same arm as the injection, nausea and vomiting, and fever. Of note, more people experienced these side effects after the second dose than after the first dose, so it is important for vaccination providers and recipients to expect that there may be some side effects after either dose, but even more so after the second dose.

It is mandatory for ModernaTX, Inc. and vaccination providers to report the following to the Vaccine Adverse Event Reporting System (VAERS) for Moderna COVID-19 Vaccine: all vaccine administration errors, serious adverse events, cases of Multisystem Inflammatory Syndrome (MIS), and cases of COVID-19 that result in hospitalization or death.

FDA Evaluation of Available Effectiveness Data

The effectiveness data to support the EUA include an analysis of 28,207 participants in the ongoing randomized, placebo-controlled U.S. study who did not have evidence of SARS-CoV-2 infection prior to the first dose of vaccine. Among these participants, 14,134 received the vaccine and 14,073 received placebo. The vaccine was 94.1% effective in preventing COVID-19 disease among these clinical trial participants with 11 cases of COVID-19 in the vaccine group and 185 in the placebo group. At the time of the analysis of these 196 COVID-19 cases, none in the vaccine group and 30 in the placebo group were classified as severe. After the analysis of these 196 cases was completed, one severe case in the vaccine group was identified and is awaiting confirmation. At this time, data are not available to determine how long the vaccine will provide protection, nor is there evidence that the vaccine prevents transmission of SARS-CoV-2 from person to person.

The EUA Process

On the basis of the determination by the Secretary of the Department of Health and Human Services on Feb. 4, 2020, that there is a public health emergency that has a significant potential to affect national security or the health and security of United States citizens living abroad, and issued declarations that circumstances exist justifying the authorization of emergency use of unapproved products, the FDA may issue an EUA to allow unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat, or prevent COVID-19 when there are no adequate, approved, and available alternatives.

The issuance of an EUA is different than an FDA approval (licensure) of a vaccine, in that a vaccine available under an EUA is not approved. In determining whether to issue an EUA for a product, the FDA evaluates the available evidence to determine whether the product may be effective and also assesses any known or potential risks and any known or potential benefits. If the product meets the effectiveness standard and the benefit-risk assessment is favorable, the product is made available during the emergency. Once a manufacturer submits an EUA request for a COVID-19 vaccine to the FDA, the agency then evaluates the request and determines whether the relevant statutory criteria are met, taking into account the totality of the scientific evidence about the vaccine that is available to the FDA.

The EUA also requires that fact sheets that provide important information, including dosing instructions, and information about the benefits and risks of the Moderna COVID-19 Vaccine, be made available to vaccination providers and vaccine recipients.

ModernaTX, Inc. has submitted a pharmacovigilance plan to the FDA to monitor the safety of Moderna COVID-19 Vaccine. The pharmacovigilance plan includes a plan to complete longer-term safety follow-up for participants enrolled in ongoing clinical trials. The pharmacovigilance plan also includes other activities aimed at monitoring the safety profile of the Moderna COVID-19 vaccine and ensuring that any safety concerns are identified and evaluated in a timely manner.

The FDA also expects manufacturers whose COVID-19 vaccines are authorized under an EUA to continue their clinical trials to obtain additional safety and effectiveness information and pursue approval (licensure).

The EUA for the Moderna COVID-19 Vaccine was issued to ModernaTX, Inc. The authorization will be effective until the declaration that circumstances exist justifying the authorization of the emergency use of drugs and biologics for prevention and treatment of COVID-19 is terminated. The EUA for Moderna COVID-19 Vaccine may be revised or revoked if it is determined the EUA no longer meets the statutory criteria for issuance.

Consumer Inquiries: 888-INFO-FDA

Food and Drug Administration coronavirus update: December 11, 2020

The following is a press release from the U.S. Food and Drug Administration:

Today, the U.S. Food and Drug Administration issued the first emergency use authorization (EUA) for a vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 16 years of age and older. The emergency use authorization allows the Pfizer-BioNTech COVID-19 Vaccine to be distributed in the U.S.

“The FDA’s authorization for emergency use of the first COVID-19 vaccine is a significant milestone in battling this devastating pandemic that has affected so many families in the United States and around the world,” said FDA Commissioner Stephen M. Hahn, M.D. “Today’s action follows an open and transparent review process that included input from independent scientific and public health experts and a thorough evaluation by the agency’s career scientists to ensure this vaccine met FDA’s rigorous, scientific standards for safety, effectiveness, and manufacturing quality needed to support emergency use authorization. The tireless work to develop a new vaccine to prevent this novel, serious, and life-threatening disease in an expedited timeframe after its emergence is a true testament to scientific innovation and public-private collaboration worldwide.”

The FDA has determined that Pfizer-BioNTech COVID-19 Vaccine has met the statutory criteria for issuance of an EUA. The totality of the available data provides clear evidence that Pfizer-BioNTech COVID-19 Vaccine may be effective in preventing COVID-19. The data also support that the known and potential benefits outweigh the known and potential risks, supporting the vaccine’s use in millions of people 16 years of age and older, including healthy individuals. In making this determination, the FDA can assure the public and medical community that it has conducted a thorough evaluation of the available safety, effectiveness and manufacturing quality information.

The Pfizer-BioNTech COVID-19 Vaccine contains messenger RNA (mRNA), which is genetic material. The vaccine contains a small piece of the SARS-CoV-2 virus’s mRNA that instructs cells in the body to make the virus’s distinctive “spike” protein. When a person receives this vaccine, their body produces copies of the spike protein, which does not cause disease, but triggers the immune system to learn to react defensively, producing an immune response against SARS-CoV-2.    

“While not an FDA approval, today’s emergency use authorization of the Pfizer-BioNTech COVID-19 Vaccine holds the promise to alter the course of this pandemic in the United States,” said Peter Marks, M.D., Ph.D., Director of the FDA’s Center for Biologics Evaluation and Research. “With science guiding our decision-making, the available safety and effectiveness data support the authorization of the Pfizer-BioNTech COVID-19 Vaccine because the vaccine’s known and potential benefits clearly outweigh its known and potential risks. The data provided by the sponsor have met the FDA’s expectations as conveyed in our June and October guidance documents. Efforts to speed vaccine development have not sacrificed scientific standards or the integrity of our vaccine evaluation process. The FDA’s review process also included public and independent review from members of the agency’s Vaccines and Related Biological Products Advisory Committee. Today’s achievement is ultimately a testament to the commitment of our career scientists and physicians, who worked tirelessly to thoroughly evaluate the data and information for this vaccine.”

FDA Evaluation of Available Safety Data

Pfizer BioNTech COVID-19 Vaccine is administered as a series of two doses, three weeks apart. The available safety data to support the EUA include 37,586 of the participants enrolled in an ongoing randomized, placebo-controlled international study, the majority of whom are U.S. participants. These participants, 18,801 of whom received the vaccine and 18,785 of whom received saline placebo, were followed for a median of two months after receiving the second dose. The most commonly reported side effects, which typically lasted several days, were pain at the injection site, tiredness, headache, muscle pain, chills, joint pain, and fever. Of note, more people experienced these side effects after the second dose than after the first dose, so it is important for vaccination providers and recipients to expect that there may be some side effects after either dose, but even more so after the second dose.

It is mandatory for Pfizer Inc. and vaccination providers to report the following to the Vaccine Adverse Event Reporting System (VAERS) for Pfizer-BioNTech COVID-19 Vaccine: all vaccine administration errors, serious adverse events, cases of Multisystem Inflammatory Syndrome (MIS), and cases of COVID-19 that result in hospitalization or death.

FDA Evaluation of Available Effectiveness Data

The effectiveness data to support the EUA include an analysis of 36,523 participants in the ongoing randomized, placebo-controlled international study, the majority of whom are U.S. participants, who did not have evidence of SARS-CoV-2 infection through seven days after the second dose. Among these participants, 18,198 received the vaccine and 18,325 received placebo. The vaccine was 95% effective in preventing COVID-19 disease among these clinical trial participants with eight COVID-19 cases in the vaccine group and 162 in the placebo group. Of these 170 COVID-19 cases, one in the vaccine group and three in the placebo group were classified as severe. At this time, data are not available to make a determination about how long the vaccine will provide protection, nor is there evidence that the vaccine prevents transmission of SARS-CoV-2 from person to person.

The EUA Process

On the basis of the determination by the Secretary of the Department of Health and Human Services on February 4, 2020, that there is a public health emergency that has a significant potential to affect national security or the health and security of United States citizens living abroad, and then issued declarations that  circumstances exist justifying the authorization of emergency use of unapproved products, the FDA may issue an EUA to allow unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat, or prevent COVID-19 when there are no adequate, approved, and available alternatives.

The issuance of an EUA is different than an FDA approval (licensure) of a vaccine. In determining whether to issue an EUA for a product, the FDA evaluates the available evidence and assesses any known or potential risks and any known or potential benefits, and if the benefit-risk assessment is favorable, the product is made available during the emergency. Once a manufacturer submits an EUA request for a COVID-19 vaccine to the FDA, the agency then evaluates the request and determines whether the relevant statutory criteria are met, taking into account the totality of the scientific evidence about the vaccine that is available to the FDA.

The EUA also requires that fact sheets that provide important information, including dosing instructions, and information about the benefits and risks of the Pfizer-BioNTech COVID-19 Vaccine, be made available to vaccination providers and vaccine recipients.

The company has submitted a pharmacovigilance plan to FDA to monitor the safety of Pfizer-BioNTech COVID-19 Vaccine. The pharmacovigilance plan includes a plan to complete longer-term safety follow-up for participants enrolled in ongoing clinical trials. The pharmacovigilance plan also includes other activities aimed at monitoring the safety profile of the Pfizer-BioNTech COVID-19 vaccine and ensuring that any safety concerns are identified and evaluated in a timely manner.

The FDA also expects manufacturers whose COVID-19 vaccines are authorized under an EUA to continue their clinical trials to obtain additional safety and effectiveness information and pursue approval (licensure).

The EUA for the Pfizer-BioNTech COVID-19 Vaccine was issued to Pfizer Inc. The EUA will be effective until the declaration that circumstances exist justifying the authorization of the emergency use of drugs and biologics for prevention and treatment of COVID-19 is terminated, and may be revised or revoked if it is determined the EUA no longer meets the statutory criteria for issuance.

Additional Resources:

Consumer Inquiries: 888-INFO-FDA

Food and Drug Administration coronavirus update: December 4, 2020

 

December 4, 2020

The following is a press release from the U.S. Food and Drug Administration:

Today, the U.S. Food and Drug Administration authorized the first diagnostic test for at home collection of patient samples to detect both COVID-19 and influenza A and B (flu). The FDA authorized Quest Diagnostics RC COVID-19 +Flu RT-PCR Test for prescription use with the Quest Diagnostics Self-Collection Kit for COVID-19 +Flu by individuals who are suspected of respiratory viral infection consistent with COVID-19 when home collection is determined to be appropriate by an individual’s healthcare provider. Under a health care provider’s order, patients can collect a sample at home and ship it to a Quest Diagnostics laboratory for analysis following the instructions included with the self-collection kit.

“Today’s authorization for a COVID-19 plus flu test using samples collected at home is a significant step toward FDA’s nationwide response to COVID-19. With the authorization of this test, the FDA is helping to address the ongoing fight against COVID-19 while in the middle of the flu season, which is important for many, including the most vulnerable of Americans. This is another example of the FDA working with test developers to bring important diagnostics to Americans,” said FDA Commissioner Stephen M. Hahn, M.D. “With just one swab or sample, combination tests that are authorized for use with home-collected samples can be used to get answers to Americans faster, in the comfort and relative safety of their home, which allows patients to continue to quarantine while awaiting results. This efficiency can go a long way to providing timely information for those sick with an unknown respiratory ailment.”

Additional Resources:

Consumer Inquiries: 888-INFO-FDA

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

SOURCE U.S. Food and Drug Administration

Review: ‘Totally Under Control,’ starring Rick Bright, Kathleen Sebelius, Michael Bowen, Scott Becker, Eva Lee, Taison Bell and Max Kennedy Jr.

October 13, 2020

by Carla Hay

Doctors treating COVID-19 patients in a scene from “Totally Under Control” (Photo courtesy of Neon)

“Totally Under Control”

Directed by Alex Gibney, Suzanne Hillinger and Ophelia Harutyunyan

Culture Representation: The documentary “Totally Under Control” features a predominantly white group (with a few Asians and one African American) of scientists, medical professionals, journalists and bureaucrats discussing how the U.S. government handled the COVID-19 (coronavirus) pandemic in the first several months of the pandemic.

Culture Clash: Several people in the documentary say that Donald Trump’s Republican administration, allies and other supporters frequently contradicted and ignored the advice and warnings of scientists on how to prevent the spread of the virus.

Culture Audience: “Totally Under Control” will appeal to primarily to people who want a closer look at what has already been reported in the media about the U.S. government’s response to the coronavirus pandemic.

Drive-by COVID-19 testing in a scene from “Totally Under Control” (Photo courtesy of Neon)

It’s clear from watching “Totally Under Control” that the title is a sarcastic reference to Donald Trump and his presidential administration’s “we’ve got this under control” initial response to the COVID-19 pandemic. The COVID-19 virus was first discovered in late 2019 (with origins in Wuhan, China), but it wasn’t until 2020 that the virus spread to the point it has infected and devastated millions of people around the world. It should come as no surprise that the documentary’s overwhelming conclusions are that, contrary to the movie’s title, things got out of control very quickly, and the impact will be felt for years to come.

Directed by Alex Gibney, Suzanne Hillinger and Ophelia Harutyunyan, “Totally Under Control” is a documentary that feels urgent in its message but also prone to being outdated within a short period of time because the pandemic is an ever-evolving situation. Even though “Totally Under Control” will be rendered obsolete a lot quicker than other documentaries because of rapidly developing news stories about the COVID-19 pandemic, the movie is best viewed as a time capsule for what went wrong in the first crucial months of the pandemic.

Written and narrated by Gibney, “Totally Under Control” was filmed using social-distancing guidelines: Many of the interviewees were interviewed remotely with video cameras that the filmmakers sent to them. Others who were interviewed in person were placed far-enough apart from the film crew, with plastic shielding separating people and equipment. This social-distancing is seen and mentioned in the movie.

Because there have already been copious amounts of news coverage about the COVID-19 pandemic, a lot of the information in “Totally Under Control” will not surprise people who have been closely following the news. But for everyone else, the documentary is sure to be an eye-opener in many ways, beginning with how much scientists and politicians in the United States knew about how to respond to a pandemic scenario, but U.S. government leaders were ill-prepared anyway.

It’s mentioned at the end of “Totally Under Control” that officials from the Trump administration, the Centers for Disease Control and Prevention (CDC), the Department of Health and Human Services (DHHS or HHS) and the U.S. Food and Drug Administration (FDA)—the institutions that get the most criticism in the movie—declined to be interviewed or provide commentary for this documentary. Dr. Anthony Fauci, who has been the director of the National Institute of Allergy and Infectious Diseases since 1984, is not interviewed in the documentary either. However, the documentary points out that Fauci is one of the U.S. government’s few high-profile advisers in the 2020 COVID-19 pandemic who has actual medical/scientific experience, since most of Trump’s appointees who are advising him on the pandemic are people with backgrounds in business or law.

Even though “Totally Under Control” doesn’t have interviews with the highest level of U.S. government officials involved in the COVID-19 pandemic in 2020, the movie still has a good cross-section of interviewees. They include:

  • Scott Becker, CEO of the Association of Public Health Laboratories
  • Dr. Taison Bell, COVID ICU Director at the University of Virginia Medical Center
  • Michael Bowen, executive vice president of Prestige Ameritech
  • Rick Bright, former director of the Biomedical Advanced Research and Development Authority (BARDA)
  • Beth Cameron, former senior director for global health security and biodefense on the National Security Council
  • Caroline Chen, ProPublica health care reporter
  • Dr. Tom Frieden, former director of the CDC
  • Dr. Alex Greninger, assistant director of the University of Washington’s Clinical Virology Lab
  • Dr. Kim Jin Yong, infectious disease doctor at Incheon Medical Center (South Korea)
  • Max Kennedy Jr., former White House COVID-19 supply-chain volunteer
  • Victoria Kim, Seoul correspondent for Los Angeles Times,
  • Dr. James Lawler, infectious disease specialist at University of Nebraska Medical Center
  • Dr. Eva Lee, infectious disease specialist at Georgia Tech (Georgia Institute of Technology)
  • Dr. Francis Riedo, medical director of infection control and prevention at Evergreen Health (Seattle)
  • Kathleen Sebelius, former secretary of Health and Human Services
  • Michael Shear, White House correspondent for The New York Times
  • Dr. Vladimir Zelenko, family medicine doctor

Bright, who is one of the star whistleblowers in the documentary, says that there is “absolutely a playbook on how to deal with a pandemic.” It’s called the Crimson Contagion, a report that was distributed to the highest levels of U.S. government in 2019, after a series of mock pandemic drills and studies were conducted in 12 states. Bright comments on the major takeaway from these studies: “The challenge has always been ‘Who’s in charge?'” The success or failure of responding to a pandemic can be found in answering that question.

It’s a question that sounds easy to answer. But in the chaos that followed after the first reported COVID-19 patient in the United States in January 2020, it became sadly clear that no one really wanted to take charge of the problem. Before the United States was largely shut down in mid-March 2020, Trump and other officials in his administration were downplaying the spreading outbreak to the media. The documentary repeatedly holds up South Korea as an example of a country that did things correctly in containing the pandemic, by having mandatory testing, quarantines and mask wearing on a national level until the pandemic was under control in the country’s borders.

Bright says that behind the scenes, HHS assistant secretary Robert Kadlec rebuffed Bright’s request to form a disaster leadership group. And when Bright said in a meeting with HHS secretary Alex Azar that an approximate $10 billion would be needed to for the U.S. government to properly deal with a pandemic in the United States, Bright was told later by people in the meeting that this request greatly angered Azar and other officials who thought the projected cost was outrageously high.

The documentary doesn’t hesitate to make Azar and Kadlec (who are Trump appointees) two of the biggest villains in the coronavirus pandemic’s devastation of the United States. It’s noted in the movie that during his tenure, Kadlec cut spending on research for infectious diseases and eliminated a program that manufactured N-95 masks, which are crucial personal protective equipment for medical workers in the fight against highly contagious diseases like COVID-19.

And the documentary says there’s more blame to go around, besides blaming the obvious people at the top: Trump and U.S. Vice President Mike Pence, whom Trump placed in charge of a national coronavirus task force. John Bolton (former U.S. ambassador to the United Nations), who was ousted by Trump in September 2019, is also blamed for eliminating a global health security team that could’ve helped the U.S. respond better to the pandemic. And the documentary also blames Trump adviser (and Trump son-in-law) Jared Kushner, who formed his own COVID-19 task force, called the White House COVID-19 Supply Chain.

Several media reports have exposed Kushner’s task force as inept and comprised of mostly inexperienced volunteers in their 20s who received little to no training on what do. Volunteers on this task force have told the media that they were forced to get into bidding wars for PPE supplies, without being told important details, such as how high they could bid or how payment transactions would be completed. “Totally Under Control” confirms those reports about the Kushner-led task force, mainly through whistleblower Max Kennedy Jr., a former volunteer on this task force and a grandson of Robert F. Kennedy.

In the documentary, Kennedy describes in the documentary that volunteers were left to fend for themselves and figure out who to call for COVID-19 supply assistance. He also claims that Kushner and other task-force supervisors never delivered on promises, and the volunteers had to sign nondisclosure agreements (NDAs). Kennedy acknowledges that he’s breaking the NDA agreement by being interviewed for this documentary. But considering that he comes from a wealthy and powerful political family, it’s doubtful he’ll face any legal consequences.

Kennedy claims that he wanted to volunteer for Kushner’s nonpartisan task force to help any way he could. However, critics could easily accuse Kennedy of having a political agenda and being a “mole” for the Democrats by being on this task force, because the Kennedys are the most famous Democratic family in the United States. The documentary could have used more input from another person on that task force (someone not associated with a political family that’s famously opposed to Republicans), even if it that person or person didn’t want to be interviewed on camera.

Ameritech’s Bowen, who says he voted for Trump in 2016, comments that a big problem was that most mask manufacturers that were in the United States eventually left to do business in countries outside the United States. And so, when the pandemic happened and there was a shortage of masks, the U.S. was woefully unprepared and had to spend an untold higher amount of money for masks to be imported from other countries.

The American divide between political conservatives (who are usually Republicans) and political liberals (who are usually Democrats) has been the fuel behind the firestorm over requirements to wear masks during the pandemic. The documentary points out that during the pandemic, the U.S. was the only major industrial country in the world to have such a political response to wearing masks. “Totally Under Control” doesn’t reveal much that’s new, except to side with the scientists, who believe that wearing masks, social distancing, washing hands frequently and getting tested for COVID-19 are the best known ways to prevent the spread of the virus until a vaccine is found.

The documentary also has plenty of criticism for the Trump administration’s decision to let state governments create their own COVID-19 policies, compared to having a national policy that was effective for other countries that were able to contain and decrease the spread of COVID-19 within their borders. In America, state governments got into bidding wars over PPEs and testing equipment. The Trump administration feuded with state governors (almost always Democratic governors) who openly criticized Trump and his administration. These governors then accused the Trump administration of deliberately withholding federal disaster funding for their states for political reasons.

But even the U.S. system of COVID-19 testing failed on many levels in the first few months of the pandemic. The documentary details how the CDC had sent out flawed test kits that created a “total nightmare,” says Becker, who adds: “It was like we were flying blind, and we knew it.”

Becker, Bright and others interviewed in the film sometimes get emotional when they think about all the time wasted trying to get U.S. government approval for things that should have been quickly approved if the pandemic had been taken more seriously earlier than it was. Bright says about the shortage of N95 respirators: “I sounded the alarm every day,” but he says he was mostly ignored by the Trump administration and Trump appointees until it was too late.

And about that vaccine. The documentary mentions that one of the biggest problems is all the contradictory claims about when a vaccine is expected to be available. There’s also a lot of misinformation about what drugs work the best on COVID-19 patients. The controversial drug hydroxychloroquine, which was touted and endorsed by Trump, is inevitably mentioned as an example of a drug that has not been scientifically proven to get rid of COVID-19 in a patient, even though some people claim that it does.

One of those people is Zelenko—an ardent Trump supporter who practices medicine in Monroe, New York—and who says that hydroxychloroquine has worked on several of his COVID-19 patients, even though Zelenko admits he has no scientific proof or studies to back up that claim. None of these supposed “miracle patients” is interviewed in “Totally Under Control.” In the documentary, Zelenko seems more concerned about bragging how he was able to get the attention of Trump quickly through social media than about discussing the urgent medical issues related to COVID-19.

In his interview, Zelenko says that the day after he made a YouTube video about hydroxychloroquine, he was contacted by White House chief of staff Mark Meadows, and that led to Zelenko’s first meeting with Trump. Zelenko also seems very impressed with himself that he was able to go from being a self-described obscure doctor with a small family practice into the upper echelons of Trump medical advisers about COVID-19.

Meanwhile, Bright (who was BARDA director from 2016 to 2020) says in his “Totally Under Control” interview that his breaking point with the Trump administration was when he got email messages from several U.S. government officials—including HHS secretary Kadlec, HHS assistant director Brett Giroir and Federal Emergency Management Agency (FEMA) director Pete Gaynor—pressuring Bright to push hydroxychloroquine into as many U.S. pharmacies as possible, even though the drug had not been approved by the FDA for Emergency Use Authorization (EUA).

Bright says that he refused to go along with that plan, and he was soon removed from his BARDA position. And when he filed a whistleblower complaint and later testified in a U.S. House of Representatives hearing in May 2020, Bright was vilified by the Trump administration as a disgruntled former employee. Meanwhile, even with a vaccine, it remains to be seen how the spread of the COVID-19 virus can be contained and decreased in the U.S. when many people in the U.S. are divided over what should be required by the government and how the government should enforce those requirements in helping prevent the spread of COVID-19.

Toward the end of the documentary, Sebelius (who was HHS secretary from 2009 to 2014) comments on the billions of dollars that the U.S. spends on military defense equipment and training: “We have to take health security as seriously as we take defense security.” The one question that the documentary won’t be able to answer is what future American leaders will learn from the mistakes that were made during the COVID-19 crisis and how prepared the United States will be the next time there is a rapidly spreading, deadly pandemic.

Neon released “Totally Under Control” on digital and VOD on October 13, 2020. The movie will premiere on Hulu on October 20, 2020.