FDA panel recommends authorization of Pfizer-BioNTech vaccine

Yesterday, a Food and Drug Administration (FDA) independent advisory committee recommended emergency use authorization (EUA) of the Pfizer-BioNTech COVID-19 vaccine. Here’s what you can expect to happen next.

The Vaccines and Related Biological Products Advisory Committee (VRBPAC)voted 17-4-1 to recommend authorization of the Pfizer-BioNTech COVID-19 vaccine for emergency use.

The recommendation was based on “the totality of scientific evidence shared by the companies, including data from a pivotal phase 3 clinical study,” said the companies.

“The FDA has embraced full transparency in their reviews of COVID vaccines,” BIO’s Dr. Michelle McMurry-Heath told CNN. “Not only are they considering this in record time, but they’re doing it in full light of day.”

The committee had a “robust discussion” with “a lot of tough questions,” particularly about the vaccine’s side effect profile and contraindications, which are “not uncommon” with any drug or biologic approval, she continued.

The FDA is expected to accept the committee’s recommendation in the coming days, per reports. Next, the vaccine will be reviewed for a recommendation by the CDC’s Advisory Committee On Immunization Practices (ACIP) in a 2-day meeting today and Sunday. The ACIP will create specific recommendations for use in populations that the states can follow in their allocations. After authorization and recommendations, states could immediately begin giving the vaccine to the phase 1a priority group: health care workers and people in long-term care facilities.

And then? “All trial participants will continue to be monitored for an additional two years after their second dose to assess long-term protection and safety,” the companies said. “Additional studies are planned to evaluate BNT162b2 in pregnant women, children younger than 12 years, and those in special risk groups, such as the immunocompromised.”

Want to know more about the vaccine development process? Visit www.COVIDVaccineFacts.org. 

More Health Care News:

CNN: Fauci wants people to know that one of lead scientists who developed the COVID-19 vaccine is a Black woman
Dr. Kizzmekia Corbett “is the National Institute of Health's lead scientist for coronavirus vaccine research. She is part of a team that worked with the biotechnology company Moderna on one of the two mRNA vaccines expected to receive emergency use authorization from the US Food and Drug Administration this month.”

They aim to make the agriculture industry and policy development more inclusive of Black professionals, reports Agri-Pulse—from Capitol Hill to the private sector.

Black Professionals in Food and Agriculture (BPFA)was founded by five Black industry leaders, including Karis Gutter, Lead of U.S. Government and Industry Affairs at Corteva, and Kellie Adesina, Director of Federal Government Affairs at Bayer, both BIO member companies.

The first step: “For now, the group is focused on the ‘opportunity that’s right in front of us’ as a result of the election, Gutter said, including about 250 political appointments opening at USDA,” reports Agri-Pulse. 

The group has five key objectives aimed at USDA,as they explained in an op-ed:

• Diversity, inclusion, and equity in USDA political staffing;
• Diversity metrics for the Administration as it relates to political appointments at USDA;
• Diverse candidate slates and interview panels for all vacancies;
• Mandatory diversity and inclusion training; and
• Designation of a Chief Diversity & Inclusion Officer who reports directly to the Secretary (or Deputy Secretary).

Learn more about Black Professionals in Food and Agriculture (BPFA). 

BIO applauds the launch of this group and looks forward to working with them, and all of our members, to improve diversity and inclusion in the biotech industry. Visit www.bio.org/bioequality-agenda to learn more about our initiative to promote health equity, invest in minority scientists and engineers, and expand opportunities for underrepresented populations in the industry.

More Agriculture and Environment News: 

Bloomberg: Lab-grown meat is getting closer to supermarket shelves
“Singapore approved Eat Just Inc. to sell cultured chicken, at a time when interest in alternative proteins is growing.”

President Trump’s Friday: No public events scheduled.

President-elect Biden’s Friday: A few more appointee picks to know, including former Iowa Gov. Tom Vilsack for Agriculture Secretary (again), and Susan Rice to lead domestic policy. 

What’s Happening on Capitol Hill: “Washington is broken,” says POLITICO. The Senate has just a few hours to vote on the one-week stopgap funding bill before the government shuts down.