FDA Approval on Pfizer-BioNTech COVID-19 Vaccine May Come Monday

According to reports, the Food and Drug Administration (FDA) is preparing for a full approval of the Pfizer-BioNTech COVID-19 vaccine possibly on Monday. Eight months after it was granted an FDA Emergency Use Authorization (EUA), the full approval of the Pfizer-BioNTech vaccine would set into motion the ability of government bodies, businesses, and individuals to get the vaccine.

This threshold of full approval has been the traditional gold standard in American medicine.

The emergence of the Delta variant, which has become the predominant strain in the United States, has prompted public health officials and the federal government to act. There has been a renewed push for vaccinations, booster doses, and the recommendation to wear masks again—even for the fully vaccinated.

Whereas, with the FDA EUA, many people, companies, and governments have waited to act on the vaccine, a full approval signals the vaccine is safe, efficacious and opens up the possibility of mandating it for employees. There is an expectation that some medical centers, the Defense department, and the City of San Francisco will all mandate vaccinations. And this is just some of who has been reported to mandate it. Others will surely follow including Fortune 500 companies and smaller employers.

Vaccine Boosters

In addition to the possibility of more people getting their first series of vaccines, for those who are fully vaccinated, the FDA approval of the Pfizer-BioNTech vaccine will lend support to the discussion on booster doses.

Booster doses already have the weight and support of the full federal government as was apparent in a joint statement from several branches of the Department of Health and Human Services (HHS) released on Wednesday.

The statement was attributed to the following officials: Rochelle Walensky, MD, director of the Centers for Disease Control and Prevention (CDC); Janet Woodcock, MD, acting commissioner, Food and Drug Administration (FDA); Vivek Murthy, MD, US surgeon general; Francis Collins, MD, director of the National Institutes of Health (NIH); Anthony Fauci, MD, chief medical advisor to President Joe Biden and director of the National Institute of Allergy and Infectious Diseases (NIAID); Rachel Levine, MD, assistant secretary for Health; David Kessler, MD, chief science officer for the COVID-19 Response; and Marcella Nunez-Smith, MD, chair of the COVID-19 Health Equity Task Force.

“The available data make very clear that protection against SARS-CoV-2 infection begins to decrease over time following the initial doses of vaccination, and in association with the dominance of the Delta variant, we are starting to see evidence of reduced protection against mild and moderate disease,” the joint statement read. “Based on our latest assessment, the current protection against severe disease, hospitalization, and death could diminish in the months ahead, especially among those who are at higher risk or were vaccinated during the earlier phases of the vaccination rollout. For that reason, we conclude that a booster shot will be needed to maximize vaccine-induced protection and prolong its durability.”

Earlier this week, Pfizer-BioNTech submitted phase 1 data that evaluated the safety, tolerability, and immunogenicity of a third dose of the COVID-19 vaccine in US adult participants from the Phase 1 trial of the two-dose series. Trial participants received a 30-µg booster dose of the vaccine 8 to 9 months after receiving the second dose. Results from this participant group show that the third dose elicited significantly higher neutralizing antibodies against the initial SARS-CoV-2 virus (wild type) compared to the levels observed after the two-dose primary series, as well as against the Beta variant and the highly infectious Delta variant.

Phase 3 results evaluating the third dose are expected shortly and will be submitted to the FDA, the European Medicines Agency, and other regulatory authorities worldwide, Pfizer announced.

“Vaccination is our most effective means of preventing COVID-19 infection–especially severe disease and hospitalization–and its profound impact on protecting lives is indisputable. Still, with the continuing threat of the Delta variant and possible emergence of other variants in the future, we must remain vigilant against this highly contagious virus,” Pfizer CEO Albert Bourla said in a statement. “The data we’ve seen to date suggest a third dose of our vaccine elicits antibody levels that significantly exceed those seen after the two-dose primary schedule.”

With the expectation the approval will happen, vaccinations will increase, boosters will commence, and so the remaining question that exists is will this be enough to slow down the Delta variant and the US can begin to feel things shift to where Americans felt just a few weeks ago?