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 American, 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 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.

Food and Drug Administration coronavirus update: July 2, 2020

July 2, 2020

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

The U.S. Food and Drug Administration (FDA) today continued to take action in the ongoing response to the COVID-19 pandemic:

  • The U.S. Food and Drug Administration (FDA) issued an updated FDA COVID-19 Response At-A-Glance Summary that provides a quick look at facts, figures, and highlights of the agency’s response efforts.
  • As part of continued action to protect the American public, the FDA is warning consumers and health care professionals about hand sanitizer products that contain methanol (a.k.a. wood alcohol), a substance often used to create fuel and antifreeze. Methanol is not an acceptable active ingredient for hand sanitizer products and can be toxic when absorbed through the skin as well as life-threatening when ingested. The agency has seen an increase in hand sanitizer products that are labeled as containing ethanol (also known as ethyl alcohol) but that have tested positive for methanol contamination. State officials have also reported recent adverse events from adults and children ingesting hand sanitizer products contaminated with methanol, including blindness, hospitalizations and death.
  • Testing updates:
    • To date, the FDA has currently authorized 162 tests under EUAs; these include 136 molecular tests, 25 antibody tests, and 1 antigen test.

Additional Resources:

Consumer Inquiries: 888-INFO-FDA

Food and Drug Administration coronavirus update: June 24, 2020

June 24, 2020

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

The U.S. Food and Drug Administration today continued to take action in the ongoing response to the COVID-19 pandemic:

  • Today, FDA launched the first “FDA Insight” podcast, featuring FDA Commissioner Stephen Hahn, M.D., and FDA Deputy Commissioner for Medical and Scientific Affairs Anand Shah, M.D., discussing FDA’s COVID-19 efforts, including the drug development process for a COVID-19 treatment. Future FDA Insight podcasts will feature Hahn, Shah, and other FDA leaders’ insights into issues facing the agency — including the COVID-19 pandemic and other emerging topics.

  • FDA Commissioner Stephen Hahn, M.D., spoke at the German Marshall Fund’s Brussels Forum 2020. This 15th edition of the forum, live-streamed/posted on YouTube, featured a 25-minute conversation with Dr. Hahn, moderated by Axios Health Care Editor Sam Baker.

  • Today, U.S. Secretary of Agriculture Sonny Perdue and FDA Commissioner Stephen Hahn, M.D., issued the following joint USDA-FDA statement regarding food export restrictions pertaining to COVID-19:

    The United States understands the concerns of consumers here domestically and around the world who want to know that producers, processors and regulators are taking every necessary precaution to prioritize food safety especially during these challenging times. However, efforts by some countries to restrict global food exports related to COVID-19 transmission are not consistent with the known science of transmission.

    There is no evidence that people can contract COVID-19 from food or from food packaging. The U.S. food safety system, overseen by our agencies, is the global leader in ensuring the safety of our food products, including product for export.

  • Testing updates:
    • To date, there are 149 currently-authorized tests under EUAs; these include 125 molecular tests, 23 antibody tests, and 1 antigen test.

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.

Food and Drug Administration coronavirus update: June 15, 2020

June 15, 2020

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

The U.S. Food and Drug Administration today continued to take action in the ongoing response to the COVID-19 pandemic:

  • Today, FDA revoked the emergency use authorization (EUA) that allowed for chloroquine phosphate and hydroxychloroquine sulfate donated to the Strategic National Stockpile to be used to treat certain hospitalized patients with COVID-19 when a clinical trial was unavailable, or participation in a clinical trial was not feasible. Based on its ongoing analysis of the EUA and emerging scientific data, the FDA determined that chloroquine and hydroxychloroquine are unlikely to be effective in treating COVID-19 for the authorized uses in the EUA. Additionally, in light of ongoing serious cardiac adverse events and other potential serious side effects, the known and potential benefits of chloroquine and hydroxychloroquine no longer outweigh the known and potential risks for the authorized use. The agency issued a Press Release and posted FAQs about this action.
  • Today, FDA is warning health care providers about a newly discovered potential drug interaction related to the investigational antiviral drug remdesivir, which has received emergency use authorization for the treatment of hospitalized COVID-19 patients with severe disease. Based on a recently completed non-clinical laboratory study, the FDA is revising the fact sheet for health care providers that accompanies the drug to state that co-administration of remdesivir and chloroquine phosphate or hydroxychloroquine sulfate is not recommended, as it may result in reduced antiviral activity of remdesivir. The agency issued a Press Release about this action.
  • On June 12, the FDA approved an abbreviated new drug application for succinylcholine chloride injection USP 200 mg/10 mL, which is indicated, in addition to general anesthesia, to facilitate tracheal intubation and to provide skeletal muscle relaxation during surgery or mechanical ventilation. Side effects of succinylcholine chloride injection include anaphylaxis, hyperkalemia, and malignant hyperthermia.
  • The FDA recognizes the increased demand for certain products during the COVID-19 public health emergency, and we remain deeply committed to facilitating access to safe and effective medical products to help address critical needs of the American public.
  • To learn more about keeping your pets safe during the coronavirus (COVID-19) pandemic, watch this new video.
  • Testing updates:
    • To date, the FDA has authorized 138 tests under EUAs, which include 117 molecular tests, 20 antibody tests, and 1 antigen test.

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.