COVID-19 Vaccines | FDA

08/19/2022

FDA Roundup: August 19, 2022

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.

FDA Authorizes Emergency Use of Novavax COVID-19 Vaccine, Adjuvanted

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.

FDA Roundup: July 8, 2022

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.

Coronavirus (COVID-19) Update: FDA Recommends Inclusion of Omicron BA.4/5 Component for COVID-19 Vaccine Booster Doses

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.

FDA Authorizes Moderna and Pfizer-BioNTech COVID-19 Vaccines for Children Down to 6 Months of Age

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.

FDA Expands Eligibility for Pfizer-BioNTech COVID-19 Vaccine Booster Dose to Children 5 through 11 Years

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.

FDA Limits Use of Janssen COVID-19 Vaccine to Certain Individuals

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.

FDA Roundup: April 29, 2022

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.

Coronavirus (COVID-19) Update: FDA Announces Tentative Advisory Committee Meeting Schedule Regarding COVID- 19 Vaccines

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.

FDA Roundup: April 15, 2022

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 FDAs continued commitment to support the development of innovative, appropriately accurate and reliable diagnostic tests that increase testing options for COVID-19.

FDA Roundup: April 1, 2022

The FDA published two FDA voices - Give Your Community a Boost: Combatting Misinformation Through Communication and Research and FDAs 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.

FDA Roundup: March 29, 2022

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.

Coronavirus (COVID-19) Update: FDA Authorizes Second Booster Dose of Two COVID-19 Vaccines for Older and Immunocompromised Individuals

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.

Coronavirus (COVID-19) Update: FDA to Hold Advisory Committee Meeting on COVID-19 Vaccines to Discuss Future Boosters

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.

FDA Roundup: March 11, 2022

As part of the FDAs 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.

FDA Postpones Advisory Committee Meeting to Discuss Request for Authorization of Pfizer-BioNTech COVID-19 Vaccine for Children 6 Months Through 4 Years of Age

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 agencys 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.

Coronavirus (COVID-19) Update: FDA Advisory Committee Meeting to Discuss Request for Authorization of Pfizer-BioNTech COVID-19 Vaccine for Children 6 Months Through 4 Years of Age

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.

FDA Takes Key Action By Approving Second COVID-19 Vaccine

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.

FDA Roundup: January 11, 2022

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).

Coronavirus (COVID-19) Update: FDA Shortens Interval for Booster Dose of Moderna COVID-19 Vaccine to Five Months

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.

FDA Takes Multiple Actions to Expand Use of Pfizer-BioNTech COVID-19 Vaccine

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.

Coronavirus (COVID-19) Update

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).

Coronavirus (COVID-19) Update

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.

Coronavirus (COVID-19) Update: FDA Expands Eligibility for Pfizer-BioNTech COVID-19 Booster Dose to 16- and 17-Year-Olds

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.

Coronavirus (COVID-19) Update: FDA Actively Working to Investigate, Address Potential Impacts of Omicron Variant; Urges Vaccination and Boosters

FDA is working with federal partners, international regulators and medical product companies to quickly address any potential impacts of the omicron variant.

FDA Expands Eligibility for COVID-19 Vaccine Boosters

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.

Coronavirus (COVID-19) Update

The FDA discussed the agencys 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.

FDA Authorizes COVID-19 Vaccine in Children 5 through 11

The authorization was based on the FDAs 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.

Vaccines and Related Biological Products Advisory Committee Meeting

The committee will discuss a request to amend Pfizer-BioNTechs Emergency Use Authorization (EUA) for administration of their COVID-19 mRNA vaccine to children 5 through 11 years of age. View livestream.

Coronavirus (COVID-19) Update

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-BioNTechs Emergency Use Authorization (EUA) for administration of their COVID-19 mRNA vaccine to children 5 through 11 years of age.

FDA Takes Additional Actions on the Use of a Booster Dose for COVID-19 Vaccines

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.

Vaccines and Related Biological Products Advisory Committee Meeting

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.

FDA to Hold Advisory Committee Meetings to Discuss Emergency Use Authorization for Booster Doses and COVID-19 Vaccines for Younger Children

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.

Coronavirus (COVID-19) Update

The FDA authorizes an emergency use authorization for one additional batch of the Janssen COVID-19 vaccine and the FDAs Acting Commissioner, Dr. Janet Woodcock, discusses the authorization of a single booster dose of the Pfizer-BioNTech COVID-19 Vaccine.

Stakeholder Call: Pfizer-BioNTech COVID-19 Vaccine Booster Dose

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 Authorizes Booster Dose of Pfizer-BioNTech COVID-19 Vaccine for Certain Populations

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.

Podcast: COVID-19 Vaccine Boosters and COVID-19 Vaccines for Kids

Acting FDA Commissioner Dr. Janet Woodcock discusses additional shots of the COVID-19 vaccine ("boosters") and COVID-19 vaccines for kids under 12

Coronavirus (COVID-19) Update

The FDA took the following actions in the agencys 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.

Vaccines and Related Biological Products Advisory Committee

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.

Coronavirus (COVID-19) Update

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 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.

FDA's Dr. Janet Woodcock on COVID-19 Vaccines and Treatments

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.

FDA In Brief: FDA to Hold Advisory Committee Meeting to Discuss Pfizer-BioNTechs Application for COVID-19 Booster

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.

Coronavirus (COVID-19) Update

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.

FDA Approves First COVID-19 Vaccine

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.

Joint Statement from HHS Public Health and Medical Experts on COVID-19 Booster Shots

Public health and medical experts from the U.S. Department of Health and Human Services released a statement on the Administrations plan for COVID-19 booster shots for the American people.

Coronavirus (COVID-19) Update

A new FDA Consumer Update highlights 5 Things to Know about COVID-19 Vaccination for Adolescents and FDAs 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.

FDA Authorizes Additional Vaccine Dose for Immunocompromised People

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.

Coronavirus (COVID-19) Update

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.

Coronavirus (COVID-19) Update

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COVID-19 Vaccines | FDA