FDA Grants EUA to Pfizer/BioNTech COVID-19 Vaccine

The FDA has granted emergency use authorization (EUA) to the Pfizer/BioNTech coronavirus disease 2019 (COVID-19) messenger RNA (mRNA) vaccine.

The agency’s authorization follows a virtual meeting of outside experts held on Thursday. The Vaccines and Related Biological Products Advisory Committee recommended Pfizer and BioNTech’s vaccine candidate BNT162b2 for emergency authorization.

Related: FDA Panel Recommends Pfizer/BioNTech COVID-19 Vaccine for Emergency Use

The United States trails the United Kingdom and Canada in authorizing the Pfizer/BioNTech COVID-19 vaccine, as the UK Medicines & Healthcare Products Regulatory Agency (MHRA) authorized the vaccine last week, and Canada gave the OK on Wednesday, December 9.

Pfizer and BioNTech submitted their EUA request to the FDA in late November. Data from clinical trials demonstrated an efficacy rate of 95% overall, as well as an efficacy rate of over 94% in adults older than 65 years of age – age has shown to be a risk factor for severe illness from COVID-19, according to the CDC.

Now, the US must expedite the distribution of the vaccines to Americans. According to Operation Warp Speed (OWS) officials and Health and Human Services (HHS) Secretary Alex Azar, MD, 40 million doses of the authorized vaccine could be available by the end of 2020. This allocation would be able to inoculate 20 million Americans. OWS Chief Operating Officer Gen. Gustave Perna said that, “We will begin distribution of the vaccine within 24 hours after Emergency Use Authorization is approved,” with weekly vaccine deliveries to each state.

With a COVID-19 vaccination authorized, pharmacies must also be at the ready to assist the health care system and help administer 2 doses of the vaccine to 300 million Americans throughout 2021, as well as answer any questions and concerns from patients about efficacy, risks, and adverse effects.