The FDA has regulatory processes in place to facilitate the development of COVID-19 vaccines that meet the FDA's rigorous scientific standards.
Fact sheets for health care providers and patients included
Report vaccine side effects toll-free at 1-800-822-7967 or online
Today, the U.S. Food and Drug Administration granted emergency use authorization (EUA) for an updated version of the Novavax COVID-19 vaccine that more closely targets currently circulating variants to provide better protection against serious consequences of COVID-19, including hospitalization and death.
Today, the U.S. Food and Drug Administration approved and granted emergency use authorization (EUA) for updated mRNA COVID-19 vaccines (2024-2025 formula) to include a monovalent (single) component that corresponds to the Omicron variant KP.2 strain of SARS-CoV-2.
On Thursday, the FDA updated its advice to manufacturers of COVID-19 vaccines (2024-2025 Formula). Based on the most current available data, along with the recent rise in cases of COVID-19 in areas of the country, the agency has further determined that the preferred JN.1-lineage for the COVID-19 vaccines (2024-2025 Formula) is the KP.2 strain, if feasible.
Today, the FDA announced that it has advised the manufacturers of the licensed and authorized COVID-19 vaccines that the COVID-19 vaccines (2024-2025 Formula) for use in the United States should be monovalent (single strain) JN.1 vaccines to more closely match currently circulating SARS-CoV-2 viruses.
On June 5, 2024, the committee will meet in open session to discuss and make recommendations on the selection of the 2024-2025 Formula for COVID-19 vaccines. View live webcast.
Today, the FDA’s Center for Biologics Evaluation and Research (CBER) is announcing that the May 16, 2024, meeting of the Vaccines and Related Biological Products Advisory Committee (VRBPAC) is being rescheduled to June 5, 2024.
On May 16, 2024, the Committee will meet in open session to discuss and make recommendations on the selection of strain(s) to be included in the 2024-2025 Formula for COVID-19 vaccines. Watch the webcast.
The U.S. Food and Drug Administration (FDA) letter to the Florida Department of Health regarding the safety of COVID-19 vaccines.
Monitoring vaccine safety is an important responsibility shared by the Centers for Disease Control and Prevention (CDC) and the U.S. Food and Drug Administration (FDA).
The Food and Drug Administration (FDA) is advising healthcare providers who administer the Moderna COVID-19 Vaccine (2023-2024 Formula) to individuals 6 months through 11 years of age to ensure that the correct volume of the vaccine (0.25 mL) is withdrawn from the vial, so that the correct dose is administered to the vaccine recipient.
Today, the U.S. Food and Drug Administration amended the emergency use authorization (EUA) of the Novavax COVID-19 Vaccine, Adjuvanted for use in individuals 12 years of age and older to include the 2023-2024 formula.
Today, the U.S. Food and Drug Administration took action on updated COVID-19 vaccines formulated to more closely target currently circulating variants and to provide better protection against the most serious outcomes, including hospitalization and death. Today’s actions relate to the updated mRNA vaccines for 2023-2024 made by Moderna and Pfizer-BioNTech.
The FDA posted information regarding the formula for COVID-19 vaccines for the 2023-2024 fall and winter seasons. The FDA has advised manufacturers seeking to update their COVID-19 vaccines that they should develop vaccines with a monovalent XBB.1.5 composition.
The committee will discuss and make recommendations on the selection of strain(s) to be included in the periodic updated COVID-19 vaccines for the 2023-2024 vaccination campaign. This discussion will include consideration of the vaccine composition for fall to winter, 2023-2024. View webcast.
On Thursday, the FDA revoked the emergency use authorization (EUA) of the Janssen COVID-19 Vaccine. On May 22, Janssen Biotech Inc. requested the voluntary withdrawal of the EUA for this vaccine.
Today, the FDA authorized the following uses of the Pfizer-BioNTech COVID-19 Vaccine, Bivalent for individuals 6 months through 4 years of age with certain types of immunocompromise who have previously received three 0.2 mL doses (Pfizer-BioNTech COVID-19 Vaccine or Pfizer-BioNTech COVID-19 Vaccine, Bivalent):
FDA and the Biomedical Advanced Research and Development Authority (BARDA) are hosting a virtual workshop to provide: 1) a forum for product sponsors to discuss progress and technical challenges in the manufacturing when changing strain composition to currently circulating variants of SARS-CoV-2; and 2) an open forum for collaborative discussions to facilitate advancement of recombinant protein-based COVID-19 vaccines. (agenda)
Today, the U.S. Food and Drug Administration amended the emergency use authorizations (EUAs) of the Moderna and Pfizer-BioNTech COVID-19 bivalent mRNA vaccines to simplify the vaccination schedule for most individuals. This action includes authorizing the current bivalent vaccines (original and omicron BA.4/BA.5 strains) to be used for all doses administered to individuals 6 months of age and older, including for an additional dose or doses for certain populations.
The FDA amended the emergency use authorization (EUA) of the Pfizer-BioNTech COVID-19 Vaccine, Bivalent to provide for a single booster dose in children 6 months through 4 years of age at least 2 months after completion of primary vaccination with three doses of the monovalent Pfizer-BioNTech COVID-19 Vaccine.
Yesterday, the Janssen COVID-19 Vaccine Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) was revised to include a Warning conveying that reports of adverse events following use of the vaccine under emergency use authorization suggest increased risks of myocarditis and pericarditis, particularly within the period 0 through 7 days following vaccination.
The U.S. Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) continue to diligently monitor a variety of data sources to identify any potential risks of the vaccines and to ensure that information is available to the public.
On January 26, 2023, the FDA will hold a meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) to consider whether and how the composition for primary doses of the currently available COVID-19 vaccines should be modified and how and whether the composition and schedule for booster doses should be adjusted moving forward.
The FDA amended the emergency use authorizations (EUAs) of the updated (bivalent) Moderna and Pfizer-BioNTech COVID-19 vaccines to include use in children down to 6 months of age.
On Wednesday, the FDA authorized the Novavax COVID-19 Vaccine, Adjuvanted for use as a first booster dose to individuals 18 years of age and older for whom an FDA-authorized mRNA bivalent COVID-19 booster vaccine is not accessible or clinically appropriate and to individuals 18 years of age and older who elect to receive the Novavax COVID-19 Vaccine, Adjuvanted because they would otherwise not receive a booster dose of a COVID-19 vaccine.
The FDA amended the emergency use authorizations (EUAs) of the Moderna COVID-19 Vaccine, Bivalent and the Pfizer-BioNTech COVID-19 Vaccine, Bivalent to authorize their use as a single booster dose in younger age groups.
On Monday, the FDA reissued the Aug. 19, 2022, letter of authorization for Novavax COVID-19 Vaccine, Adjuvanted to revise the conditions of authorization related to the Vaccine Adverse Event Reporting System (VAERS) reporting requirements for vaccination providers and Novavax, Inc. to include myocarditis and pericarditis.
The FDA amended the emergency use authorizations (EUAs) of the Moderna COVID-19 Vaccine and the Pfizer-BioNTech COVID-19 Vaccine to authorize bivalent formulations of the vaccines for use as a single booster dose at least two months following primary or booster vaccination.
On Thursday, FDA approved a single dose vial presentation of COMIRNATY (COVID-19 Vaccine, mRNA). The single-dose vials have gray caps and labels with gray borders, and the vaccine must not be diluted before use.
Today, the FDA authorized the emergency use of Novavax COVID-19 Vaccine, Adjuvanted for the prevention of Coronavirus Disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 12 through 17 years of age.
The FDA issued an emergency use authorization (EUA) for the Novavax COVID-19 Vaccine, Adjuvanted for the prevention of COVID-19 caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 18 years of age and older.
The FDA announced approved COMIRNATY (COVID-19 Vaccine, mRNA) for active immunization to prevent COVID-19 in individuals 12 through 15 years of age. The agency also finalized the Guidance for Industry (GFI) #245: Hazard Analysis and Risk-Based Preventive Controls for Food for Animals. Additionally, the agency will continue hosting virtual town halls for test developers for SARS-CoV-2 on July 27 and August 24 from 12:05 p.m. – 1 p.m. ET.
The FDA has advised manufacturers seeking to update their COVID-19 vaccines that they should develop modified vaccines that add an omicron BA.4/5 spike protein component to the current vaccine composition to create a two component (bivalent) booster vaccine, beginning in Fall 2022.
Today, the U.S. Food and Drug Administration authorized emergency use of the Moderna COVID-19 Vaccine and the Pfizer-BioNTech COVID-19 Vaccine for the prevention of COVID-19 to include use in children down to 6 months of age.
Today, the U.S. Food and Drug Administration amended the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 Vaccine, authorizing the use of a single booster dose for administration to individuals 5 through 11 years of age at least five months after completion of a primary series with the Pfizer-BioNTech COVID-19 Vaccine.
Today, the U.S. Food and Drug Administration has limited the authorized use of the Janssen COVID-19 Vaccine to individuals 18 years of age and older for whom other authorized or approved COVID-19 vaccines are not accessible or clinically appropriate, and to individuals 18 years of age and older who elect to receive the Janssen COVID-19 Vaccine because they would otherwise not receive a COVID-19 vaccine.
On Thursday, the FDA updated the page, At-Home OTC COVID-19 Diagnostic Tests, to include expiration date information to help consumers find the current expiration date for any FDA authorized at-home OTC COVID-19 diagnostic test.
Today, the FDA is announcing its plans to hold virtual meetings of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) in anticipation of complete submissions of emergency use authorization (EUA) requests in the coming months that have been publicly announced by COVID-19 vaccine manufacturers.
On April 14, the FDA issued an emergency use authorization (EUA) to InspectIR Systems for their InspectIR COVID-19 Breathalyzer test. The InspectIR COVID-19 Breathalyzer test is the first COVID-19 diagnostic test that detects chemical compounds in breath samples associated with SARS-CoV-2 infection. The authorization for the InspectIR COVID-19 Breathalyzer test is an example of the FDA’s continued commitment to support the development of innovative, appropriately accurate and reliable diagnostic tests that increase testing options for COVID-19.
The FDA published two FDA voices - “Give Your Community a Boost: Combatting Misinformation Through Communication and Research” and “FDA’s Technology and Data Modernization in Action in 2022.” The FDA also published findings from a facility inspection of Abbott Nutrition in Sturgis, Michigan, revised the guidance: Emergency Use Authorization for Vaccines to Prevent COVID-19, denied two the request in two citizen petitions, published the FDA voices announced the extension of a public comment period, approved a new animal drug, updated a list of which regions in which the drug Sotrovimab is not authorized, approved a medical device to treat defects or legions that can occur in cartilage covering bones in the knee joint, authorized marketing of a medical device for measuring the brain temperature of neonates (infants less than four weeks old) and updated a fact sheet and FAQ regarding dosing information of Evusheld.
Today, the FDA authorized a manufacturing change for the Moderna COVID-19 Vaccine to include an additional presentation of the vaccine for booster vaccination doses only.
The FDA authorized a second booster dose of either the Pfizer-BioNTech or the Moderna COVID-19 vaccines for older people and certain immunocompromised individuals.
On Wed., April 6, FDA will hold a virtual meeting of its Vaccines and Related Biological Products Advisory Committee to discuss considerations for future COVID-19 vaccine booster doses and the strain selection process to address current and emerging variants during the Fall season 2022.
As part of the FDA’s effort to protect consumers, on March 7, the agency issued a warning letter jointly with the Federal Trade Commission to Viraldine, LLC for selling unapproved products with fraudulent COVID-19 claims. On March 4, the FDA authorized an extension for the shelf life of the refrigerated Janssen COVID-19 Vaccine, from six to nine months, allowing the product to be stored at 2-8 degrees Celsius. Update: The FDA updated this safety communication to clarify that the ACON Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing) in dark blue packaging is a product of ACON Biotech (Hangzhou) Co., Ltd.
The FDA has been notified by Pfizer that new data have recently emerged regarding its emergency use authorization request for the use of the Pfizer-BioNTech COVID-19 Vaccine in children 6 months through 4 years of age. Based on the agency’s preliminary assessment, and to allow more time to evaluate additional data, we believe additional information regarding the ongoing evaluation of a third dose should be considered as part of our decision-making for potential authorization.
FDA announced a virtual meeting of its Vaccines and Related Biological Products Advisory Committee on Feb. 15 to discuss the request for emergency use authorization of the Pfizer-BioNTech COVID-19 Vaccine for use in children 6 months through 4 years of age.
The FDA approved a second COVID-19 vaccine. The vaccine has been known as the Moderna COVID-19 Vaccine; the approved vaccine will be marketed as Spikevax for the prevention of COVID-19 in individuals 18 years of age and older.
The FDA announced in a letter of enforcement discretion that it does not intend to object to the use of certain qualified health claims regarding the consumption of magnesium and a reduced risk of high blood pressure (hypertension).
Today, the FDA amended the emergency use authorization (EUA) for the Moderna COVID-19 Vaccine to shorten the time between the completion of a primary series of the vaccine and a booster dose to at least five months for individuals 18 years of age and older.
The FDA amended the emergency use authorization for the Pfizer-BioNTech COVID-19 Vaccine to take several actions that will expand the use of the vaccine in certain populations.
The FDA approved a manufacturing change for Comirnaty to include a formulation that uses a different buffer; and an abbreviated new drug application for increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines (a class of neurotransmitters).
The Janssen COVID-19 fact sheets have been updated to include contraindications for people with a history of thrombosis with thrombocytopenia following the Janssen COVID-19 Vaccine or any other adenovirus-vectored COVID-19 vaccine.
Today, the FDA amended the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 Vaccine, authorizing the use of a single booster dose for administration to individuals 16 and 17 years of age at least six months after completion of primary vaccination with the Pfizer-BioNTech COVID-19 Vaccine.
FDA is working with federal partners, international regulators and medical product companies to quickly address any potential impacts of the omicron variant.
The FDA amended the emergency use authorizations (EUA) for both the Moderna and Pfizer-BioNTech COVID-19 vaccines authorizing use of a single booster dose for all individuals 18 years of age and older after completion of primary vaccination with any FDA-authorized or approved COVID-19 vaccine.
The FDA discussed the agency’s actions to expand the use of a single booster dose for COVID-19 vaccines in eligible populations. In addition, the FDA authorized the 11th over-the-counter (OTC) COVID-19 test and is investigating certain imported medical gloves that appear to have been reprocessed, cleaned or recycled and sold as new.
The authorization was based on the FDA’s thorough and transparent evaluation of the data that included input from independent advisory committee experts who overwhelmingly voted in favor of making the vaccine available to children in this age group.
The committee will discuss a request to amend Pfizer-BioNTech’s Emergency Use Authorization (EUA) for administration of their COVID-19 mRNA vaccine to children 5 through 11 years of age. View livestream.
Today, the FDA began posting materials for the next Vaccine and Related Biological Products Advisory Committee (VRBPAC) meeting, happening on Tuesday, Oct. 26. The committee will meet in open session to discuss a request to amend Pfizer-BioNTech’s Emergency Use Authorization (EUA) for administration of their COVID-19 mRNA vaccine to children 5 through 11 years of age.
The FDA took additional actions regarding booster doses of COVID-19 vaccines, including authorizing heterologous (or “mix and match”) booster doses in eligible individuals following completion of primary vaccination with a different available COVID-19 vaccine. Listen to media call.
The committee will discuss the Emergency Use Authorization (EUA) of the ModernaTX Inc. COVID-19 vaccine and the Janssen Biotech Inc. COVID-19 vaccine for the administration of an additional dose, or “booster” dose, following completion of the primary series, to individuals 18 years of age and older. View October 14 livestream. View October 15 livestream.
The FDA is announcing two upcoming meetings of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) to discuss newly available data for the currently available COVID-19 vaccines.
The FDA authorizes an emergency use authorization for one additional batch of the Janssen COVID-19 vaccine and the FDA’s Acting Commissioner, Dr. Janet Woodcock, discusses the authorization of a single booster dose of the Pfizer-BioNTech COVID-19 Vaccine.
Acting FDA Commissioner, Janet Woodcock, M.D. and Director, FDA Center for Biologics Evaluation and Research, Peter Marks, M.D., Ph.D., discuss the Pfizer-BioNTech COVID-19 Vaccine booster dose.
FDA amended the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 Vaccine to allow for the use of a single booster dose, to be administered at least six months after completion of the primary series with the Pfizer-BioNTech COVID-19 Vaccine in certain populations.
Acting FDA Commissioner Dr. Janet Woodcock discusses additional shots of the COVID-19 vaccine ("boosters") and COVID-19 vaccines for kids under 12
The FDA took the following actions in the agency’s ongoing response to the COVID-19 pandemic: issued a Letter to Health Care Providers about the potential for false positive results with Abbott Alinity m SARS-CoV-2 AMP and Alinity m Resp-4-Plex AMP Kits; revised the Emegency Use Authorization (EUA) for bamlanivimab and etesevimab, administered together, to include an emergency use as post-exposure prophylaxis for COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kilograms) who are at high risk for progression to severe COVID-19; issued a revised guidance to help expand the availability of face masks, barrier face coverings and face shields for the general public, including health care personnel, as well as surgical masks and particulate filtering facepiece respirators (FFRs) (including N95 respirators) for health care personnel for the duration of the COVID-19 public health emergency; and authorized the use, under the EUA for the Janssen COVID-19 vaccine, of two additional batches of vaccine drug substance manufactured at the Emergent facility.
The Vaccines and Related Biological Products Advisory Committee will meet in open session to discuss the matter of additional doses of COVID-19 vaccines and specifically to discuss the Pfizer-BioNTech supplemental Biologics License Application for administration of a third (“booster”) dose of Comirnaty (COVID-19 Vaccine, mRNA) in individuals 16 years of age and older. View livestream.
The FDA approved an abbreviated new drug application indicated for the sedation of initially intubated and mechanically ventilated patients during treatment in an intensive-care setting, authorized the use--under the emergency use authorization (EUA) for the Janssen COVID-19 vaccine--of one additional batch of vaccine drug substance manufactured at the Emergent facility, and issued a revised guidance which provides general recommendations to prospective generic drug applicants in the form of questions and answers that have been addressed during the COVID-19 public health emergency. The FDA also posted a statement titled “FDA Will Follow The Science On COVID-19 Vaccines For Young Children”.
FDA leadership outlines steps the FDA will take to ensure the safety and efficacy of COVID-19 vaccines for young children.
Acting FDA Commissioner Janet Woodcock, M.D., discusses COVID-19 vaccines for kids, additional vaccine doses, and the latest on COVID-19 treatments with WebMD.
Today, the U.S. Food and Drug Administration announced a virtual meeting of its Vaccines and Related Biological Products Advisory Committee to discuss the matter of additional doses of COVID-19 vaccines and specifically to discuss the Pfizer-BioNTech supplemental Biologics License Application for administration of a third (“booster”) dose of Comirnaty (COVID-19 Vaccine, mRNA) in individuals 16 years of age and older.
The FDA updated the Pfizer-BioNTech emergency use authorization (EUA) to support the extension of shelf-life of the Pfizer-BioNTech COVID-19 Vaccine stored at -90 degrees to -60 degrees Celsius from 6 months to 9 months.
Today, the U.S. Food and Drug Administration approved the first COVID-19 vaccine, known as the Pfizer-BioNTech COVID-19 Vaccine, now marketed as Comirnaty (koe-mir'-na-tee), for the prevention of COVID-19 disease in individuals 16 years of age and older.
Public health and medical experts from the U.S. Department of Health and Human Services released a statement on the Administration’s plan for COVID-19 booster shots for the American people.
A new FDA Consumer Update highlights 5 Things to Know about COVID-19 Vaccination for Adolescents and FDA’s vaccine expert, Dr. Peter Marks, participated in the HHS Ask An Expert video series to answer some of your most frequently asked questions about COVID-19 vaccination.
Today, the U.S. Food and Drug Administration amended the emergency use authorizations (EUAs) for both the Pfizer-BioNTech COVID-19 Vaccine and the Moderna COVID-19 Vaccine to allow for the use of an additional dose in certain immunocompromised individuals, specifically, solid organ transplant recipients or those who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise.
Today, FDA announced that it has found certain lots of Astra Zeneca COVID-19 vaccine drug substance manufactured at the Emergent facility in Baltimore, Maryland, to be acceptable for use for potential export. The AstraZeneca vaccine is not authorized for use in the U.S., but FDA understands that these AstraZeneca lots, or vaccine made from the lots, will now be exported for use.
In mid-July, the FDA held a stakeholder call to discuss COVID-19 vaccines, including preliminary reports of Guillain-Barré Syndrome following Janssen (Johnson & Johnson) COVID-19 vaccination. Acting FDA Commissioner Janet Woodcock, M.D. and the Director of FDA's Center for Biologics Evaluation and Research, Peter Marks, M.D., Ph.D. were featured speakers. The call can be found on the FDA’s YouTube page.
On Wednesday, the FDA authorized an extension for the shelf life of the refrigerated Janssen (Johnson & Johnson) COVID-19 Vaccine, allowing the product to be stored at 2-8 degrees Celsius for six months.
The FDA formally accepts Priority Review designation for the Biologics License Application (BLA) for their mRNA vaccine to prevent COVID-19 in individuals 16 years of age and older.
The FDA announces revisions to the vaccine recipient and vaccination provider fact sheets for the Johnson & Johnson (Janssen) COVID-19 Vaccine.
Americans who have been fully vaccinated do not need a booster shot at this time. FDA, CDC, and NIH are engaged in a science-based, rigorous process to consider whether or when a booster might be necessary.
The FDA holds a stakeholder call with Vaccinate Your Family and pediatric and healthcare groups.
The FDA authorized the use, under the emergency use authorization (EUA) for the Janssen COVID-19 vaccine, of an additional batch of vaccine drug substance manufactured at the Emergent facility. Additionally, the FDA issued an updated Letter to Health Care Personnel and Facilities stating that the FDA no longer authorizes use of non-NIOSH-approved or decontaminated disposable respirators.
Acting FDA Commissioner Janet Woodcock, M.D. and the Director of FDA's Center for Biologics Evaluation and Research, Peter Marks, M.D., Ph.D., discuss the suggested increased risks of myocarditis and pericarditis following COVID19 vaccination.
The FDA announced revisions to the patient and provider fact sheets for the Moderna and Pfizer-BioNTech COVID-19 vaccines regarding the suggested increased risks of myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the tissue surrounding the heart) following vaccination; and reached a milestone of approving 1,000 original and supplemental generic drug applications to help in the treatment of patients with COVID-19 since the start of the pandemic.
The FDA posts updated translations for the Pfizer-BioNTech COVID-19 Vaccine Fact Sheet for Recipients and Caregivers and issues an updated FDA COVID-19 Response At-A-Glance Summary.
Following careful review and deliberation, the U.S. Food and Drug Administration is taking important steps that will allow a critically needed supply of the Janssen (Johnson & Johnson) COVID-19 Vaccine to be made available.
The Vaccines and Related Biological Products Advisory Committee will meet in open session to discuss, in general, data needed to support authorization and/or licensure of COVID-19 vaccines for use in pediatric populations. View livestream
The FDA updated its guidance, Emergency Use Authorization for Vaccines to Prevent COVID-19, to include a new section that clarifies how the agency intends to prioritize review of EUA requests for the remainder of the COVID-19 public health emergency. Additionally, the FDA issued a report that describes some of the approaches used by the South Korean government to address COVID-19, particularly regarding development, authorization and use of diagnostic tests.
FDA authorized undiluted, thawed Pfizer-BioNTech COVID-19 Vaccine vials to be stored in the refrigerator at 2°C to 8°C (35°F to 46°F) for up to 1 month.
The FDA expanded the emergency use authorization for the Pfizer-BioNTech COVID-19 Vaccine to include 12 – 15 year olds and issued an updated FDA COVID-19 Response At-A-Glance Summary.
Hearing before the U.S. Senate Committee on Health, Education, Labor and Pensions; Director of the FDA Center for Biologics Evaluation and Research, Peter Marks, M.D., Ph.D. testifies for the FDA. View written testimony.
Today, the U.S. Food and Drug Administration expanded the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 Vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) to include adolescents 12 through 15 years of age. View press briefing.
The U.S. Food and Drug Administration’s Center for Biologics Evaluation and Research (CBER) will convene a virtual meeting of the Vaccines and Related Biological Products Advisory Committee (VRBPAC) on June 10, 2021, via webcast. During the meeting the agency will provide a status update on our approach to emergency use authorization (EUA) for COVID-19 vaccines intended for use in individuals 12 through 17 years of age.
The FDA lifted the recommended pause on the use of Janssen (Johnson & Johnson) COVID-19 Vaccine following a thorough safety review; and issued warning letters to companies selling unapproved products with fraudulent COVID-19 claims.
Following a thorough safety review, 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.
The FDA takes its responsibility to ensure medical product quality, safety and effectiveness very seriously. The American public puts its trust in the agency to ensure that all medical products, including COVID-19 vaccines, meet the agency’s standards for quality, safety and effectiveness.
The FDA issues a statement regarding the Janssen COVID-19 vaccine, issues a warning letter and updates a frequently asked question about the Moderna COVID-19 vaccine.
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.
As FDA celebrates National Minority Health Month, we’re working to address concerns about vaccines among diverse communities, and to protect and promote the health of diverse populations by focusing our efforts on strategies that address health disparities.
Today, the U.S. Food and Drug Administration announced two revisions regarding the number of doses per vial available for the Moderna COVID-19 Vaccine.
The FDA issues an emergency use authorization (EUA) to a company for the SARS-CoV-2 NGS Assay and provides a consumer update on common questions about COVID-19 vaccines.
Answers from the FDA to common questions about COVID-19 vaccines.
FDA leadership will participate in the House Subcommittee on Oversight and Investigations of the Committee on Energy and Commerce hearing entitled, "Leading the Way Forward: Biden Administration Actions to Increase COVID-19 Vaccinations."
FDA’s Office of Minority Health and Health Equity discusses the agency’s efforts to stop fraudulent products from reaching our markets, especially those claiming to prevent, treat, or cure COVID-19.
The FDA is well-equipped to identify and thwart medical product scams while vaccine distribution is underway throughout the country.
The FDA issues Voices on protecting consumers against COVID-19 vaccine scams and issues a warning letter to a company selling unapproved products with fraudulent COVID-19 claims.
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).
Following today’s positive advisory committee meeting outcome regarding the Janssen Biotech Inc. COVID-19 Vaccine, the FDA has informed the sponsor that it will rapidly work toward finalization and issuance of an emergency use authorization.
Today, the FDA added new devices to the device discontinuance list, including sterilization products and oxygen conservers.
The Vaccines and Related Biological Products Advisory Committee will meet in open session to discuss Emergency Use Authorization (EUA) of the Janssen Biotech Inc. COVID-19 Vaccine for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 18 years and older. View livestream
Today, the FDA announced that it is allowing undiluted frozen vials of the Pfizer-BioNTech COVID-19 Vaccine to be transported and stored at conventional temperatures commonly found in pharmaceutical freezers for a period of up to two weeks.
FDA issued guidances for medical product developers to address the emergence and potential future emergence of variants of SARS-CoV-2.
Today, the FDA issued guidances for medical product developers, specifically covering vaccines, diagnostics and therapeutics products, to address the emergence and potential future emergence of variants of SARS-CoV-2, the virus that causes COVID-19.
FDA issued an emergency use authorization (EUA) for the treatment of mild to moderate COVID-19 in adults and pediatric patients and also revised its guidance, Investigational COVID-19 Convalescent Plasma.
The FDA has scheduled a meeting of its Vaccines and Related Biological Products Advisory Committee; alerted health care professionals and compounders of potential risks associated with compounding remdesivir drug products; revised the Letter of Authorization for COVID-19 convalescent plasma; and issued a statement that FDA continues important work to support medical product development to address new virus variants.
The FDA has scheduled a meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Feb. 26, 2021, to discuss the request for emergency use authorization (EUA) for a COVID-19 vaccine from Janssen Biotech Inc.
As the public health agency responsible for regulating medical products, we must ensure that health care providers have the most up-to-date diagnostics, treatments and vaccines in their toolbox to fight this pandemic.
The FDA placed all alcohol-based hand sanitizers from Mexico on a country-wide import alert; issued warning letters jointly with the Federal Trade Commission to two companies selling unapproved products with fraudulent COVID-19 claims; and updated the COVID-19 frequently asked questions (FAQ).
Peter W. Marks, M.D., Ph.D., discusses COVID-19 vaccines with the American Medical Association in Episode 5: Vaccine Safety and Delivery in the What Physicians Need to Know webinar series.
An FDA staff member discusses how her former hesitancy and fear grew into hope and a willingness to receive a COVID-19 vaccine.
Following the Authorized Dosing Schedules for COVID-19 Vaccines
The FDA posts an updated letter of authorization, health care provider fact sheet and frequently asked questions regarding the number of Pfizer-BioNTech doses in a vial, updated the Device Shortage List, and provides a testing update.
In this 30-minute video discussion, FDA Commissioner Dr. Stephen Hahn and Center for Biologics Evaluation and Research (CBER) Director Dr. Peter Marks talk with WebMD about what we know, what we don't know, and what we might learn in the future about COVID-19 vaccines.
The FDA posts translations of the Moderna COVID-19 Vaccine fact sheet in multiple languages, issues new ANDAs, and provides a testing update.
The FDA posts translations of the Pfizer-BioNTech COVID-19 Vaccine fact sheet in multiple languages, issues a new guidance, and provides a testing update.
FDA Commissioner Stephen Hahn and CBER Director Peter Marks discuss the EUA issued for the Moderna COVID-19 Vaccine, December 18, 2020.
Today, the FDA 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).
Learn more about COVID-19 vaccine safety monitoring from FDA Commissioner Dr. Stephen Hahn
Following today’s positive advisory committee meeting outcome regarding the Moderna COVID-19 vaccine, the FDA has informed the sponsor that it will rapidly work toward finalization and issuance of an emergency use authorization.
The Vaccines and Related Biological Products Advisory Committee will meet in open session to discuss Emergency Use Authorization (EUA) of the Moderna Inc. COVID-19 Vaccine for the prevention of COVID-19 in individuals 18 years and older. View livestream recording
Peter W. Marks, M.D., Ph.D. and Stephen M. Hahn, M.D. return to JAMA's Q&A series to discuss the Pfizer/BioNTech and Moderna vaccines: the data, the weekend's EUA designation (Pfizer/BioNTech), and the process for future full licensure and postmarketing safety surveillance.
As part of the FDA’s commitment to transparency, we invite you to watch our virtual press conference, to be live streamed over the FDA’s YouTube, Facebook and Twitter accounts on December 12, 2020, at 9:00 AM ET.
Today, the FDA 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.
Statement by FDA Commissioner Stephen M. Hahn, M.D., and Center for Biologics Evaluation and Research Director Peter Marks, M.D., Ph.D.
Statement by FDA Commissioner Stephen M. Hahn, M.D.
The FDA's Center for Biologics Evaluation and Research’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) will meet in open session to discuss Emergency Use Authorization (EUA) of the Pfizer-BioNTech COVID-19 Vaccine for the prevention of COVID-19 in individuals 16 years of age and older. View livestream
The FDA has scheduled a meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Dec. 17 to discuss the request for emergency use authorization (EUA) for a COVID-19 vaccine from Moderna Inc.
The FDA has scheduled a meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Dec. 10 to discuss the request for emergency use authorization (EUA) of a COVID-19 vaccine from Pfizer, Inc. in partnership with BioNTech Manufacturing GmbH.
The FDA published new information about the vaccine development and review process:
FDA leaders participate in a virtual meeting with racial and ethnic minority community members about FDA’s COVID-19 vaccine work.
Statement reaffirming FDA’s commitment to transparency around the EUA process and updates on FDA's plan to provide more information about decisions to issue, revise or revoke EUAs for drugs and biological products, including vaccines.
Statement by FDA Commissioner Dr. Stephen Hahn about a final guidance Issued today that provides the agency’s current thinking on steps to enhance diversity in clinical trials of any medical product such as treatments or vaccines for COVID-19 – as well as medical products more broadly.
Remarks by Dr. Stephen Hahn for the Global Pharmaceutical Manufacturing Leadership Forum
FDA Center for Biologics Evaluation and Research Director Dr. Peter Marks
FDA Commissioner Stephen Hahn on the Radio: COVID-19 & FDA
FDA Commissioner Stephen Hahn joins a radio morning show to discuss the FDA's role in the fight against COVID-19.
The Committee will meet in open session, to discuss, in general, the development, authorization and/or licensure of vaccines to prevent COVID-19. No specific application will be discussed at this meeting. View webcast
Dr. Stephen Hahn explains the FDA’s role in ensuring safety, effectiveness of COVID-19 vaccines.
This week, the FDA’s Vaccines and Related Biological Products Advisory Committee is meeting to discuss, in general, the development, authorization and/or licensure of vaccines to prevent COVID-19.
Dr. Peter Marks provides an update on COVID-19 vaccines and discusses the upcoming Vaccines and Related Biological Products Advisory Committee meeting.
FDA Commissioner Dr. Steven Hahn discussed the COVID-19 vaccine review process with the Center for Infectious Disease Research and Policy and others.
FDA Commissioner Dr. Steven Hahn spoke about the COVID-19 vaccine development process and other medical countermeasures for COVID-19.
A conversation with Center for Biologics Evaluation and Research director Peter Marks, M.D., Ph.D.
Recommendations for vaccine sponsors regarding the scientific data and information that would support the issuance of an emergency use authorization (EUA) for an investigational vaccine intended to prevent COVID-19.
Learn more about how vaccines are developed from U.S. Department of Health and Human Services leaders.
Consumer Perspectives on the Covid-19 Pandemic: A Conversation with the FDA
Hearing before the Senate Committee on Health, Education, Labor and Pensions; FDA Commissioner Stephen M. Hahn, M.D., testifies for the FDA.
Learn more about how to identify fraudulent claims and false information on products that claim to diagnose, treat, or prevent coronavirus.
FDA is committed to making decisions regarding the authorization or approval of COVID-19 vaccines that are guided by science and data.
FDA announced that a public meeting of the Vaccines and Related Biological Products Advisory Committee will be held on Oct. 22, 2020.
Remarks by Deputy Commissioner for Medical and Scientific Affairs Anand Shah, M.D. to the Alliance for Health Policy
Dr. Judy McMeekin, the Associate Commissioner for Regulatory Affairs, joins Dr. Shah on the show to discuss FDA's fight against health fraud during the COVID-19 pandemic.
Remarks by FDA Commissioner Stephen M. Hahn, M.D., as prepared for a video conversation with health professionals.
Dr, Hahn discusses the agency's role in responding to the COVID-19 pandemic.
Dr. Peter Marks returns for a more comprehensive discussion on vaccines as they relate to COVID-19. Find out more about “herd immunity,” Operation Warp Speed, and vaccine distribution in this episode.
In Part 1 of FDA Insight’s vaccine series, Dr. Shah welcomes Dr. Peter Marks, director of FDA’s Center for Biologics Evaluation and Research, to discuss the basics of COVID-19 vaccine development.
Hearing before the Senate Committee on Health, Education, Labor and Pensions; FDA Commissioner Stephen M. Hahn, M.D., testified for the FDA.
Written testimony
The FDA published a guidance document to facilitate the timely development of safe and effective vaccines to prevent COVID-19, giving recommendations for those developing COVID-19 vaccines for the ultimate purpose of licensure.
The FDA and the European Union, including the European Commission and its European Medicines Agency, are collaborating on many scientific and regulatory fronts as part of our COVID-19 response.
FDA Commissioner Stephen M. Hahn, M.D., will be testifying for the FDA.
Written testimony
Commissioner Hahn speaks to the Alliance for a Stronger FDA
FDA Commissioner Stephen M. Hahn testified before the U.S. Senate Committee on Health, Education, Labor and Pensions
The FDA will participate in the ACTIV partnership aimed at developing a collaborative framework among all partners to rapidly respond to COVID-19 and future pandemics.
The FDA is integral in the fight against the coronavirus, using science and innovative approaches to take a broad range of actions that advance our nation’s response.
FDA and the European Medicines Agency jointly chaired the first global regulators meeting to discuss ways to streamline the development of SARS-CoV-2 vaccines.
FDA is an active partner in the Novel Coronavirus (COVID-19) response, working closely with our government and public health partners across the U.S. Department of Health and Human Services, as well as with our international counterparts. Our work is multifaceted, focusing on actively facilitating efforts to diagnose, treat and prevent the disease; surveilling the medical product supply chain for potential shortages or disruptions and helping to mitigate such impacts, as necessary; and leveraging the full breadth of our public health tools as we oversee the safety and quality of FDA-regulated products for American patients and consumers.
August 13, 2024: Are you a health care professional getting ready for the 2024-2025 fall respiratory virus season? Clinicians will hear directly from the FDA and CDC about the latest on the respiratory virus vaccine and therapeutic approval processes, medical products currently available, recommendations, and resources.
The FDA Center for Biologics Evaluation and Research discusses updated COVID-19 vaccines for use in the U.S. beginning in fall 2024. (August 2024)
A short video discussing how FDA-approved vaccines undergo a rigorous evaluation by FDA to ensure their safety and effectiveness. (March 15, 2024)