FDA Seeks to Fully Approve COVID-19 Vaccine

FDA aims to fully approve Pfizer’s COVID-19 vaccine by early September

(RxWiki News) Federal health officials are planning to approve one of the COVID-19 vaccines by early September.

The US Food and Drug Administration (FDA) has decided to speed up its timeline for giving full approval to the two-dose Pfizer COVID-19 vaccine, according to The New York Times. The new goal is to approve the mRNA vaccine by the beginning of September.

The FDA has granted an emergency use authorization (EUA) to three COVID-19 vaccines. While the agency granted these EUAs because it appeared that the vaccines were safe and effective, an EUA is not the same as a full approval.

As the Delta variant of COVID-19 increases case numbers, hospitalizations and deaths across the United States, the move to approve the Pfizer vaccine may come at a good time, officials said.

Vaccines are still showing strong protection against all known variants of the coronavirus, according to the FDA. Even though breakthrough infections do happen in some vaccinated people, those people are less likely than unvaccinated people to become seriously ill.

FDA officials said they hope a full approval of the Pfizer vaccine might encourage more Americans to get vaccinated, reported The New York Times. As of publication time, around 70 percent of adults in the US had been vaccinated, and the pace of new vaccinations had slowed down in recent weeks.

The Pfizer vaccine is the most common of the three vaccines currently authorized under EUAs, according to The New York Times. The second most common is the Moderna vaccine. Moderna applied for full approval but had not yet finished submitting the required data. The manufacturer of the third most common vaccine, the one-dose Johnson & Johnson vaccine, had not yet applied for full approval as of publication time.

Some officials expect that full approval of vaccines might make vaccine mandates more common in workplaces, colleges and government settings.

If you have questions or concerns about any of the available COVID-19 vaccines, speak with your doctor or community pharmacist.

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Review Date: 
August 9, 2021