19 Vaccines

01/04/2021

FDA Assertion on Following the Licensed Dosing Schedules for COVID-19 Vaccines

Following the Licensed Dosing Schedules for COVID-19 Vaccines

Press Launch / Public Assertion 12/28/2020

Coronavirus (COVID-19) Replace

The FDA posts an up to date letter of authorization, well being care supplier truth sheet and regularly requested questions relating to the variety of Pfizer-BioNTech doses in a vial, up to date the Gadget Scarcity Record, and offers a testing replace.

Press Launch / Public Assertion 12/28/2020

Video Dialogue: COVID-19 Vaccines

On this 30-minute video dialogue, FDA Commissioner Dr. Stephen Hahn and Heart for Biologics Analysis and Analysis (CBER) Director Dr. Peter Marks discuss with WebMD about what we all know, what we do not know, and what we would be taught sooner or later about COVID-19 vaccines.

Podcast / Video 12/22/2020

Coronavirus (COVID-19) Replace

The FDA posts translations of the Moderna COVID-19 Vaccine truth sheet in a number of languages, points new ANDAs, and offers a testing replace.

Press Launch / Public Assertion 12/21/2020

Coronavirus (COVID-19) Replace

The FDA posts translations of the Pfizer-BioNTech COVID-19 Vaccine truth sheet in a number of languages, points a brand new steerage, and offers a testing replace.

Press Launch / Public Assertion 12/18/2020

FDA Media Briefing

FDA Commissioner Stephen Hahn and CBER Director Peter Marks focus on the EUA issued for the Moderna COVID-19 Vaccine, December 18, 2020.

Occasion 12/18/2020

FDA Takes Further Motion in Battle Towards COVID-19 By Issuing Emergency Use Authorization for Second COVID-19 Vaccine

At present, the FDA issued an emergency use authorization (EUA) for the second vaccine for the prevention of coronavirus illness 2019 (COVID-19) attributable to extreme acute respiratory syndrome coronavirus 2 (SARS-CoV-2).

Press Launch / Public Assertion 12/18/2020

Inform Me Extra About Vaccine Security

Study extra about COVID-19 vaccine security monitoring from FDA Commissioner Dr. Stephen Hahn

Podcast / Video 12/17/2020

FDA Assertion on Vaccines and Associated Organic Merchandise Advisory Committee Assembly

Following right this moment’s optimistic advisory committee assembly final result relating to the Moderna COVID-19 vaccine, the FDA has knowledgeable the sponsor that it’ll quickly work towards finalization and issuance of an emergency use authorization.

Press Launch / Public Assertion 12/17/2020

Vaccines and Associated Organic Merchandise Advisory Committee

The Vaccines and Associated Organic Merchandise Advisory Committee will meet in open session to debate Emergency Use Authorization (EUA) of the Moderna Inc. COVID-19 Vaccine for the prevention of COVID-19 in people 18 years and older. View livestream recording

Occasion 12/14/2020

Coronavirus Vaccine FDA Replace

Peter W. Marks, M.D., Ph.D. and Stephen M. Hahn, M.D. return to JAMA’s Q&A sequence to debate the Pfizer/BioNTech and Moderna vaccines: the info, the weekend’s EUA designation (Pfizer/BioNTech), and the method for future full licensure and postmarketing security surveillance.

Podcast / Video 12/12/2020

Digital Press Convention: First COVID-19 Vaccine

As a part of the FDA’s dedication to transparency, we invite you to look at our digital press convention, to be dwell streamed over the FDA’s YouTube, Fb and Twitter accounts on December 12, 2020, at 9:00 AM ET.

Occasion 12/11/2020

FDA Takes Key Motion in Battle Towards COVID-19 By Issuing Emergency Use Authorization for First COVID-19 Vaccine

At present, the FDA issued the primary emergency use authorization (EUA) for a vaccine for the prevention of coronavirus illness 2019 (COVID-19) attributable to extreme acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in people 16 years of age and older.

Press Launch / Public Assertion 12/11/2020

FDA Assertion on Vaccines and Associated Organic Merchandise Advisory Committee Assembly

Assertion by FDA Commissioner Stephen M. Hahn, M.D., and Heart for Biologics Analysis and Analysis Director Peter Marks, M.D., Ph.D.

Press Launch / Public Assertion 12/10/2020

Coronavirus (COVID-19) Replace: FDA Holds Advisory Committee Assembly to Talk about Authorization of COVID-19 Vaccine Candidate as A part of Company’s Assessment of Security and Effectiveness Knowledge

Assertion by FDA Commissioner Stephen M. Hahn, M.D. 

Press Launch / Public Assertion 12/10/2020

Vaccines and Associated Organic Merchandise Advisory Committee

The FDA’s Heart for Biologics Analysis and Analysis’s Vaccines and Associated Organic Merchandise Advisory Committee (VRBPAC) will meet in open session to debate Emergency Use Authorization (EUA) of the Pfizer-BioNTech COVID-19 Vaccine for the prevention of COVID-19 in people 16 years of age and older. View livestream

Occasion 12/04/2020 Remarks by Dr. Hahn to the Nationwide Academy of Medication City Corridor on the COVID-19 Vaccine Occasion 11/30/2020

Coronavirus (COVID-19) Replace: FDA Pronounces Advisory Committee Assembly to Talk about Second COVID-19 Vaccine Candidate 

The FDA has scheduled a gathering of its Vaccines and Associated Organic Merchandise Advisory Committee (VRBPAC) on Dec. 17 to debate the request for emergency use authorization (EUA) for a COVID-19 vaccine from Moderna Inc.

Press Launch / Public Assertion 11/20/2020

Coronavirus (COVID-19) Replace: FDA Pronounces Advisory Committee Assembly to Talk about COVID-19 Vaccine Candidate

The FDA has scheduled a gathering of its Vaccines and Associated Organic Merchandise Advisory Committee (VRBPAC) on Dec. 10 to debate the request for emergency use authorization (EUA) of a COVID-19 vaccine from Pfizer, Inc. in partnership with BioNTech Manufacturing GmbH.

Press Launch / Public Assertion 11/20/2020

The FDA revealed new details about the vaccine growth and overview course of: 

Client Data 11/19/2020

FDA and Vaccinate Your Household Speak COVID With Minority Neighborhood Leaders

FDA leaders take part in a digital assembly with racial and ethnic minority neighborhood members about FDA’s COVID-19 vaccine work.

Occasion 11/17/2020

COVID-19 Replace: FDA’s Ongoing Dedication to Transparency for COVID-19 EUAs

Assertion reaffirming FDA’s dedication to transparency across the EUA course of and updates on FDA’s plan to supply extra details about choices to concern, revise or revoke EUAs for medication and organic merchandise, together with vaccines.

Press Launch / Public Assertion 11/09/2020

FDA Presents Steerage to Improve Variety in Medical Trials, Encourage Inclusivity in Medical Product Growth

Assertion by FDA Commissioner Dr. Stephen Hahn a few remaining steerage Issued right this moment that gives the company’s present considering on steps to boost range in scientific trials of any medical product comparable to remedies or vaccines for COVID-19 – in addition to medical merchandise extra broadly. 

Press Launch / Public Assertion 11/01/2020

Classes Discovered From COVID

Remarks by Dr. Stephen Hahn for the World Pharmaceutical Manufacturing Management Discussion board

Occasion 10/27/2020

I am the FDA level particular person on COVID-19 vaccines. We’ll ensure that they’re protected and efficient.

FDA Heart for Biologics Analysis and Analysis Director Dr. Peter Marks

Opinion 10/27/2020

FDA Commissioner Stephen Hahn on the Radio: COVID-19 & FDA

FDA Commissioner Stephen Hahn joins a radio morning present to debate the FDA’s position within the struggle towards COVID-19.

Podcast 10/22/2020

Vaccines and Associated Organic Merchandise Advisory Committee 

The Committee will meet in open session, to debate, normally, the event, authorization and/or licensure of vaccines to stop COVID-19. No particular software can be mentioned at this assembly. View webcast

Occasion 10/22/2020

FDA Commissioner Talks to AARP About COVID-19 Vaccines

Dr. Stephen Hahn explains the FDA’s position in guaranteeing security, effectiveness of COVID-19 vaccines.

Client Data 10/20/2020

The FDA’s Vaccines and Associated Organic Merchandise Advisory Committee and its Position in Advising the Company on COVID-19 Vaccines

This week, the FDA’s Vaccines and Associated Organic Merchandise Advisory Committee is assembly to debate, normally, the event, authorization and/or licensure of vaccines to stop COVID-19. 

Weblog Submit 10/20/2020

Advisory Committee on COVID-19 Vaccines

Dr. Peter Marks offers an replace on COVID-19 vaccines and discusses the upcoming Vaccines and Associated Organic Merchandise Advisory Committee assembly.

Podcast / Video 10/16/2020

Emergency Use Authorization of Covid Vaccines — Security and Efficacy Comply with-up Issues

Opinion 10/08/2020

The Assessment Course of for Vaccines to Forestall COVID-19: A Dialogue

FDA Commissioner Dr. Steven Hahn mentioned the COVID-19 vaccine overview course of with the Heart for Infectious Illness Analysis and Coverage and others.

Podcast / Video 10/08/2020

Interview: FDA Commissioner on COVID-19 Vaccines and Different Medical Countermeasures

FDA Commissioner Dr. Steven Hahn spoke concerning the COVID-19 vaccine growth course of and different medical countermeasures for COVID-19.

Podcast / Video 10/07/2020

Coronavirus Vaccine Replace

A dialog with Heart for Biologics Analysis and Analysis director Peter Marks, M.D., Ph.D. 

Podcast / Video 10/06/2020

FDA In Transient: FDA Points Steerage on Emergency Use Authorization for COVID-19 Vaccines

Suggestions for vaccine sponsors relating to the scientific knowledge and knowledge that will help the issuance of an emergency use authorization (EUA) for an investigational vaccine supposed to stop COVID-19.

Press Launch / Public Assertion 10/06/2020

Inform Me Extra About Vaccines

Study extra about how vaccines are developed from U.S. Division of Well being and Human Providers leaders.

Podcast / Video 09/30/2020

Remarks by Dr. Hahn to the World Coalition for Regulatory Science Analysis

Occasion 09/29/2020

Dr. Hahn’s remarks to the Nationwide Shoppers League on the vaccine overview course of

Client Views on the Covid-19 Pandemic: A Dialog with the FDA

Occasion 09/29/2020

Remarks by Commissioner Hahn to Buddies of Most cancers Analysis

Occasion 09/23/2020

COVID-19: An Replace on the Federal Response – FDA Opening Remarks

Listening to earlier than the Senate Committee on Well being, Schooling, Labor and Pensions; FDA Commissioner Stephen M. Hahn, M.D., testifies for the FDA.

Occasion 09/21/2020

Watch out for Fraudulent Coronavirus Checks, Vaccines and Remedies

Study extra about learn how to determine fraudulent claims and false data on merchandise that declare to diagnose, deal with, or forestall coronavirus.

Client Data 09/11/2020

The FDA’s Scientific and Regulatory Oversight of Vaccines is Very important to Public Well being

FDA is dedicated to creating choices relating to the authorization or approval of COVID-19 vaccines which can be guided by science and knowledge.

Weblog Submit 08/28/2020

Coronavirus (COVID-19) Replace: FDA Pronounces Advisory Committee Assembly to Talk about COVID-19 Vaccines

FDA introduced {that a} public assembly of the Vaccines and Associated Organic Merchandise Advisory Committee can be held on Oct. 22, 2020.

Press Launch / Public Assertion 08/20/2020

FDA Management to Speed up the Restoration from COVID-19

Remarks by Deputy Commissioner for Medical and Scientific Affairs Anand Shah, M.D. to the Alliance for Well being Coverage

Occasion 08/18/2020

Guaranteeing The Security And Effectiveness Of A COVID-19 Vaccine

Weblog Submit 08/18/2020

Well being Fraud and COVID-19

Dr. Judy McMeekin, the Affiliate Commissioner for Regulatory Affairs, joins Dr. Shah on the present to debate FDA’s struggle towards well being fraud in the course of the COVID-19 pandemic.

Podcast / Video 08/10/2020

The Crucial Position of Well being Care Practitioners throughout COVID-19

Remarks by FDA Commissioner Stephen M. Hahn, M.D., as ready for a video dialog with well being professionals. 

Occasion 08/07/2020

Unwavering Regulatory Safeguards for COVID-19 Vaccines

Opinion 08/05/2020

FDA commissioner: It doesn’t matter what, solely a protected, efficient vaccine will get our approval

Opinion 07/30/2020

COVID-19 and the FDA

Dr, Hahn discusses the company’s position in responding to the COVID-19 pandemic.

Podcast / Video 07/28/2020

FDA Perception: Vaccines for COVID-19, Half 2

Dr. Peter Marks returns for a extra complete dialogue on vaccines as they relate to COVID-19. Discover out extra about “herd immunity,” Operation Warp Velocity, and vaccine distribution on this episode.

Podcast / Video 07/21/2020

FDA Perception: Vaccines for COVID-19, Half 1

In Half 1 of FDA Perception’s vaccine sequence, Dr. Shah welcomes Dr. Peter Marks, director of FDA’s Heart for Biologics Analysis and Analysis, to debate the fundamentals of COVID-19 vaccine growth.

Podcast / Video 06/30/2020

COVID-19: Replace on Progress Towards Safely Getting Again to Work and Again to Faculty 

Listening to earlier than the Senate Committee on Well being, Schooling, Labor and Pensions; FDA Commissioner Stephen M. Hahn, M.D., testified for the FDA.
Written testimony

Occasion 06/30/2020

Coronavirus (COVID-19) Replace: FDA Takes Motion to Assist Facilitate Well timed Growth of Protected, Efficient COVID-19 Vaccines

The FDA revealed a steerage doc to facilitate the well timed growth of protected and efficient vaccines to stop COVID-19, giving suggestions for these creating COVID-19 vaccines for the last word function of licensure. 

Press Launch / Public Assertion 06/25/2020

Partnering with the European Union and World Regulators on COVID-19

The FDA and the European Union, together with the European Fee and its European Medicines Company, are collaborating on many scientific and regulatory fronts as a part of our COVID-19 response.

Weblog Submit 06/23/2020

Home Committee on Power & Commerce Listening to: Oversight of the Trump Administration’s Response to the COVID-19 Pandemic

FDA Commissioner Stephen M. Hahn, M.D., can be testifying for the FDA.
Written testimony

Occasion 06/01/2020

Remarks by Commissioner Stephen Hahn, M.D.—The COVID-19 Pandemic—Discovering Options, Making use of Classes Discovered

Commissioner Hahn speaks to the Alliance for a Stronger FDA

Occasion 05/12/2020

Listening to – COVID-19: Safely Getting Again to Work and Again to Faculty

FDA Commissioner Stephen M. Hahn testified earlier than the U.S. Senate Committee on Well being, Schooling, Labor and Pensions

Occasion 04/17/2020

NIH to launch public-private partnership to hurry COVID-19 vaccine and remedy choices

The FDA will take part within the ACTIV partnership aimed toward creating a collaborative framework amongst all companions to quickly reply to COVID-19 and future pandemics.

Press Launch / Public Assertion 04/10/2020

A Perspective on the FDA’s COVID-19 Response

The FDA is integral within the struggle towards the coronavirus, utilizing science and modern approaches to take a broad vary of actions that advance our nation’s response.

Weblog Submit 03/23/2020

FDA and EMA Collaborate to Facilitate SARS-CoV-2 Vaccine Growth

FDA and the European Medicines Company collectively chaired the primary international regulators assembly to debate methods to streamline the event of SARS-CoV-2 vaccines.

Weblog Submit 03/03/2020

HHS officers testified at a Senate HELP Listening to, An Rising Illness Menace: How the U.S. Is Responding to COVID-19, the Novel Coronavirus.

  • Remarks by Dr. Anne Schuchat, Principal Deputy Director, Facilities for Illness Management and Prevention; Dr. Anthony Fauci, Director, Nationwide Institute of Allergy and Infectious Ailments, Nationwide Institutes of Well being; Dr. Robert Kadlec, Assistant Secretary for Preparedness and Response, U.S. Division of Well being and Human Providers; and Dr. Stephen Hahn, Commissioner, U.S. Meals and Drug Administration
Occasion 02/14/2020

FDA’s Actions in Response to 2019 Novel Coronavirus at Dwelling and Overseas

FDA is an lively associate within the Novel Coronavirus (COVID-19) response, working carefully with our authorities and public well being companions throughout the U.S. Division of Well being and Human Providers, in addition to with our worldwide counterparts. Our work is multifaceted, specializing in actively facilitating efforts to diagnose, deal with and forestall the illness; surveilling the medical product provide chain for potential shortages or disruptions and serving to to mitigate such impacts, as obligatory; and leveraging the total breadth of our public well being instruments as we oversee the protection and high quality of FDA-regulated merchandise for American sufferers and shoppers.

Press Launch / Public Assertion

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