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.

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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: 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.

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.

 

Food and Drug Administration coronavirus update: June 8, 2020

June 8, 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:

  • The FDA issued a guidance, titled “Temporary Policy on Prescription Drug Marketing Act Requirements for Distribution of Drug Samples During the COVID-19 Public Health Emergency.” The guidance addresses questions FDA has received concerning prescription drug sample distribution under the Prescription Drug Marketing Act of 1987 (PDMA) during the COVID-19 public health emergency. The guidance explains that, on a temporary basis, the FDA does not intend to object to the delivery of prescription drug samples to patients’ homes if requested by their licensed health care professional, and the guidance describes the agency’s current policy regarding the signature required at time of delivery of drug samples, to promote public health.
  • On June 8, 2020, the FDA added the BioMedInnovations SuppleVent Ventilator to the list of ventilators authorized under the March 24, 2020, EUA for certain ventilators, ventilator tubing connectors, and ventilator accessories. This ventilator provides continuous ventilatory support for adult patients who require mechanical ventilation. The ventilator is intended for institutional use by qualified, trained personnel under the direction of a doctor. Institutional use includes use in an intensive care unit or other hospital environments such as during intra-hospital transport and in temporary hospital facilities. Lawrence Livermore National Laboratory collaborated in the design of the ventilator.
  • FDA published two new web pages to help the public access information: (1) Innovation to Respond to COVID-19 provides an overview of FDA’s innovative approaches to respond to COVID-19 as quickly and safely as possible and (2) Educational Resources provides links to FDA-produced COVID-19-related resources that help explain FDA’s work.
  • Testing updates:
    • To date, the FDA has authorized 125 tests under EUAs, which include 107 molecular tests, 17 antibody tests, and 1 antigen test.

Additional Resources:

Media Contact: Lee.Herring@fda.hhs.gov, 240-402-6386
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.