FDA Approves Pfizer-BioNTech COVID-19 Vaccine

The US Food and Drug Administration (FDA) has granted Biologics License Application (BLA) approval to Pfizer-BioNTech for the companies’ COVID-19 vaccine BNT162b2 (Comirnaty).

The indication granted Monday makes the 2-dose vaccine the very first approved by the FDA for the prescribed prevention of COVID-19. It comes 9 months after the historic product was granted Emergency Use Authorization (EUA) for patients aged ≥16 years.

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 have nearly plateaued. As numerous virology and vaccinology experts explained to Contagion®, a full FDA approval for a proven COVID-19 vaccine may better public health efforts geared toward curbing the highly transmissible Delta variant of SARS-CoV-2.

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

A COVID-19 vaccine highly efficacious for reduced risk of symptomatic disease and hospitalization or death due to the virus has just been approved for marketing and prescribed use by the FDA. Experts believe the indication itself may improve public perception of the vaccine’s benefits.

Peter Hotez, MD, PhD, Professor in the Departments of Pediatrics, Molecular Virology & Microbiology at Baylor College of Medicine, told Contagion this and future COVID-19 vaccine approvals by the FDA are important for the sake of assuaging vaccine-hesitant people’s concerns that emergency-authorized vaccines are not as reliable nor safe as fully approved vaccines.

“I don’t know how much of a difference it will really make, because I think they will just turn around and come up with another reason for (avoiding vaccination),” Hotez said. “There’s about a dozen different fake talking points that anti-vaccine groups use, but at least this will take it off the table.”

FDA Acting Commissioner Janet Woodcock, MD, acknowledged the public's lacking confidence in the vaccines in a statement accompanying the Monday decision.

“While this and other vaccines have met the FDA’s rigorous, scientific standards for emergency use authorization, as the first FDA-approved COVID-19 vaccine, the public can be very confident that this vaccine meets the high standards for safety, effectiveness, and manufacturing quality the FDA requires of an approved product,” Woodcock said. “While millions of people have already safely received COVID-19 vaccines, we recognize that for some, the FDA approval of a vaccine may now instill additional confidence to get vaccinated."

Hotez anticipates greater benefit will come from the 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, echoed Hotez’s concerns over vaccine-hesitant groups continuing 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 healthcare systems and public work industries—including transportation—have already begun to set COVID-19 vaccination mandates among their eligible workforce.

“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

As of last week, the US reportedly had a COVID-19 vaccine surplus of approximately 100 million doses, as Pfizer-BioNTech, Moderna, and Johnson & Johnson developers’ 2020 rush to manufacture now-authorized vaccines was met by a middling national immunization push in 2021. About 52% of the national population is fully vaccinated against COVID-19 at the time of this writing—a mere 2.6 percentage-point increase since late July.

In the same time frame, the country’s 7-day average for new COVID-19 cases has increased 153%—from approximately 60,000 on July 21 to more than 150,000 on August 21. 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 adult general public 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.