U.S. FDA grants full approval to Pfizer-BioNTech COVID-19 vaccine without public hearing

Updated

Reuters is reporting the U.S. Food and Drug Administration (F.D.A.) has granted full approval to the Pfizer Inc COVID-19 vaccine that had earned emergency-use authorization (EUA) in December, making it the first to secure such an F.D.A. validation.

The full approval marks a regulatory switch for Pfizer’s shot away from an experimental (EUA) therapy. The F.D.A.’s move was expected in early Fall but the timeline was fast-tracked potentially fueling the very ‘vaccine hesitancy’ government agencies are trying to eliminate.

The vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine, and will now be marketed as Comirnaty writes the F.D.A.. The shot is officially approved for Americans over the age of 16, while the EUA remains in effect for patients between 12 and 15.

The approval was telegraphed days earlier on Friday when “people familiar with the planning, who were not authorized to speak publicly about it” leaked the news to the New York Times causing shares of Pfizer stock to rise at Monday’s market opening.

Zerohedge is reporting:

Full approval opens the door to several activities that were barred under the emergency authorization: Pfizer can now advertise the jab, and it can now continue to vaccinate people even after the COVID “emergency” is deemed over. Pfizer can also now raise the price of the vaccine. They have already raised the price of the jab in the EU.

One of the first to seize on the full approval is the U.S. military who will move to mandate the COVID-19 vaccine for all service members now that the Pfizer vaccine has full approval. The Defense Department is preparing “guidance to the force” to make the vaccine mandatory, with a timeline to be provided in the coming days, Pentagon press secretary John Kirby told reporters. 

Previous EUA’s for both Pfizer, Moderna and J&J were greeted with customary public hearings held by the F.D.A. to review the science, allow for public comment before decisions were made and operate in full transparency. With Pfizer’s shot moving to market at record speed with boosters already announced, the lack of promised transparency by the F.D.A. has some worried that the decision was politically driven and may lower standards for future biologics license application approvals.

Last year the FDA said it was “committed to use an advisory committee composed of independent experts to ensure deliberations about authorisation or licensure are transparent for the public.” But in a statement, the FDA told The BMJ that it did not believe a meeting was necessary ahead of the expected granting of full approval.

Pfizer-BioNTech is now planning to quickly ask the F.D.A. to approve a third dose as a booster shot after the first two-shot series has been found stop neither infection or virus transmission in a growing percentage of recipients.

The medical community, as well as public health officials, have voiced their concern at the Biden administration’s announcement last week that fully vaccinated adults should prepare to get their booster shots eight months after they received their second doses beginning Sept. 20.

The public proclamation broke from basic scientific and regulatory processes by leapfrogging both the F.D.A. or the U.S. Centers for Disease Control and Prevention’s (C.D.C.) ACIP committee. In doing so, the Biden administration eliminated the chance for both bodies to meet and review data on the booster’s safety and efficacy in the adult populations.

Diana Zuckerman, president of the National Center for Health Research, who has also spoken at recent VRBPAC meetings, told The BMJ, “It’s obvious that the FDA has no intention of hearing anyone else’s opinion. But if you make decisions behind closed doors it can feed into hesitancy. It’s important to have a public discussion about what kind of data are there and what the limitations are. As we think about risk versus benefit, we need to know.”

Read the F.D.A.’s news release regarding the approval here:
https://www.fda.gov/news-events/press-announcements/fda-approves-first-covid-19-vaccine

Jefferey Jaxen

Jefferey Jaxen is a health journalist and featured in his weekly segment, ’The Jaxen Report’, on The HighWire. As an investigative journalist, researcher, and compelling writer, Jefferey serves as Lead editor of The HighWire News and Opinion Team.

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