FDA Grants Full Approval to Pfizer/BioNTech Vaccine

Eight months after the Food and Drug Administration (FDA) granted emergency use authorization (EAU) to the Pfizer/BioNTech COVID-19 vaccine, the agency today gave the vaccine full approval. As Infection Control Today^® reported, the FDA’s move might go a long way to mitigate vaccine hesitancy, not only among the public, but among health care professionals as well. Infection preventionists are often tasked with the job of trying to encourage their hesitant fellow heath care workers into getting vaccinated.

The Pfizer/BioNTech vaccine becomes the first COVID-19 vaccine given Biologics License Application (BLA)—or full approval. The BLA was given for the companies’ COVID-19 vaccine BNT162b2 (Comirnaty). The fully approved vaccine is for people 16 and older; the EUA version is available for children aged 12–15 years and as a third “booster” dose in immunocomrpomised patients.

Health care experts have been pushing the FDA to grant full approval to the COVID-19 vaccines as soon as possible as a way of inducing the vaccine hesitant to get inoculated in the hope that that will stem the rising tide of the delta variant, which has become the dominant strain in the United States.

The FDA’s granting full approval of the Pfizer/BioNTech vaccine comes at a time of a renewed push for vaccinations, booster doses, and the recommendation to wear masks again—even for the fully vaccinated.

This newest decision by the FDA comes while new cases of the pandemic virus have reached their highest in the US this year and COVID-19 vaccination rates nearly plateaued last month, although the Centers for Disease Control and Prevention (CDC) has seen a significant improvement in vaccination rates the last few weeks. The CDC states that as “of August 19, the 7-day average number of administered vaccine doses reported (by date of CDC report) to CDC per day was 823,355, a 17.78% increase from the previous week.” Yesterday, the White House reported that more than 800,000 vaccine doses were administered; marking the fifth consecutive days that about 700,000 COVID-19 vaccine doses have been administered. That’s an increase of 25% in the last 2 weeks

About the Vaccine

BNT162b2 is a nucleoside-modified messenger RNA (mRNA) vaccine encoded with the SARS-CoV-2 full-length Spike protein glycoprotein. It was selected for continued assessment against 3 other candidates by Pfizer and BioNTech investigators in July 2020, and was granted Fast Track Designation by the FDA around the same time.

The FDA granted the vaccine EUA in December 2020, based on supporting data showing a 95% overall vaccine efficacy in preventing symptomatic COVID-19 among Phase 3 trial participants without previous SARS-CoV-2 infection prior to 7 days after their second vaccine dose.

The EUA was also backed by a 17-4-1 vote in favor of the vaccine’s benefit-risk profile from the Vaccines and Related Biological Products Advisory Committee (VRBPAC) at the time. Pfizer and BioNTech’s BLA submission was granted Priority Review by the FDA last month, streamlining the regulatory review and decision-making timeline for the vaccine.

What the Approval Means

Peter Hotez, MD, PhD, Professor in the Departments of Pediatrics, Molecular Virology & Microbiology at Baylor College of Medicine, told Contagion^®, Infection Control Today^®’s sister publication, that one of the benefits of the FDA’s approval is that it will come with new prescribing capabilities granted through the BLA, noting physicians will now have “more wiggle room” in strategically reducing COVID-19 risk among their patients.

Carlos del Rio, MD, Executive Associate Dean of Emory School of Medicine & Grady Health System, expressed concern that vaccine-hesitant groups will continue to reject the validity of COVID-19 vaccines regardless of FDA designations. He told Contagion^® that the BLA, in regard to public response, may land somewhere between a small win and a non-factor; he estimated that 1 or 2 of every 10 unvaccinated US adults may be now persuaded to seek immunization because of the BLA.

Del Rio believes the full approvals will rather change the scope of employer-level vaccine mandates. Many health care systems and public work industries—including transportation—have already begun to establishing COVID-19 vaccination mandates for workers.

“Full approvals are going to make mandates a lot easier, and that will make people get vaccinated,” del Rio explained. “You’re going to see an explosion of mandates happening when the full approval occurs.”

Going Forward

The delta variant has been largely to blame for this newest spike in COVID-19 cases, hospitalizations, and deaths. Per the CDC, the now-prominent strain is estimated to be more than 2-fold more contagious than previous SARS-CoV-2 variants, has been linked to more severe illness among unvaccinated persons and more breakthrough infections in vaccinated persons.

However, the CDC reiterates the benefit of authorized COVID-19 vaccines in reducing risk of infection, serious illness, and death from the delta variant, as well as in reducing risk of virus spread from a vaccinated person to others.

Other vaccine regulation strategies are currently at play in the US. Earlier this month, the FDA granted EUA to Pfizer/BioNTech and Moderna for third “booster” doses of their respective mRNA vaccines in severely immunocompromised patients. Days later, a report revealed the Biden administration’s plan to advocate for COVID-19 vaccine booster dose availability for all Americans at 8 months following their final dose. Their timeline, dependent on FDA allowance, would authorize booster doses for the adults by mid-September.

The national push for booster dose-improved immunity against a surging virus, as well as expanded vaccine indications to include children, will likely to play out in the coming months. Today’s designation by the FDA marks a new precedent for the scientific response against COVID-19—a mark which Hotez anticipates Moderna and Johnson & Johnson developers will also reach soon.

“I welcome the development and think it will happen for all 3 vaccines we have, hopefully before the end of the year,” he said.

This article first appeared in Contagion®.