FDA approves Pfizer-BioNTech COVID-19 vaccine

The FDA today granted Pfizer and BioNTech full U.S. approval of their Covid-19 vaccine.

The vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine, and will now be marketed as Comirnaty, for the prevention of COVID-19 disease in individuals 16 years of age and older.

This action is expected to result in numerous mandates by institutions, companies, and state/local governments to require vaccination that can only result in a positive impact on the viral pandemic.

Many individuals had been postponing vaccinations pending this approval, by perhaps up to 30% as polled by the Kaiser Family Foundation.

Up to now, the various COVID-19 vaccines have been administered on an emergency basis.

According to the FDA, the mRNA vaccine also continues to be available under emergency use authorization (EUA), including for individuals 12 through 15 years of age and for the administration of a third dose in certain immunocompromised individuals.

Until now, the Pfizer shot has been administered under an emergency use authorization since December.

Since then, more than 204 million of the Pfizer shots have been administered, according to data from the Centers for Disease Control and Prevention (CDC).

Vaccines from Moderna and Johnson + Johnson continue to be administered under EAU after meeting the FDA’s safety and efficacy requirements.

Acting FDA Commissioner Janet Woodcock noted in a statement that the Pfizer vaccine met the FDA’s strict standards for safety, effectiveness, and manufacturing quality.

“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,” she said in the statement.

As the highly infectious Delta variant spreads, the United States continues to experience a surge in Covid-19 cases.

The CDC has noted that the overwhelming majority of Covid-19 hospitalizations and deaths in this country are among unvaccinated people.

Full approval may convince some Americans that the shots are safe, according to officials.

The approval, which is the first among the available vaccines, was based on data gleaned from 44,000 clinical trial participants in the US, EU, Turkey, South Africa, and South America.

Pfizer’s data indicated that the vaccine was 91% effective in preventing infection, which was down 4% from the efficacy rate initially reported when the vaccine was granted approval for emergency use in late 2020.

That decrease according to Pfizer, reflected the fact that researchers had more time to catch people who became infected.

The next critical step for the FDA is the determination of whether or not to authorize booster shots.

If this is approved, individuals who received the Pfizer or Moderna vaccines can receive a booster 8 months after the second injections beginning September 20. This timing is important because of the waning potency of the vaccines and the presence of the Delta variant.

The application for full approval of the Moderna’s vaccine is ongoing and may following today’s action in a few weeks.

Johnson + Johnson should be applying soon for full approval.

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