FDA Issues Emergency Use Authorisation for First COVID-19 Vaccine

December 14, 2020

The US Food and Drug Administration (FDA) issued the first emergency use authorisation (EUA) for a vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals aged 16 years and older.

The EUA allows Pfizer’s mRNA-based BNT162b2 vaccine to be distributed in the United States. The EUA will be effective until the declaration that circumstances exist justifying the authorisation of the emergency use of drugs and biologics for prevention and treatment of COVID-19 is terminated, and may be revised or revoked if it is determined the EUA no longer meets the statutory criteria for issuance.

The FDA determined that the BNT162b2 vaccine has met the statutory criteria for issuance of an EUA. The totality of the available data provides clear evidence that the BNT162b2 vaccine may be effective in preventing COVID-19. The data also support that the known and potential benefits outweigh the known and potential risks, supporting the vaccine’s use in millions of people aged 16 years and older, including healthy individuals. In making this determination, the FDA can assure the public and medical community that it has conducted a thorough evaluation of the available safety, effectiveness, and manufacturing quality information.

The Pfizer-BioNTech COVID-19 Vaccine contains messenger RNA (mRNA), which is genetic material. The vaccine contains a small piece of the SARS-CoV-2 virus’s mRNA that instructs cells in the body to make the virus’s distinctive “spike” protein. When a person receives this vaccine, their body produces copies of the spike protein, which does not cause disease, but triggers the immune system to learn to react defensively, producing an immune response against SARS-CoV-2.

It is mandatory for Pfizer and vaccination providers to report the following to the Vaccine Adverse Event Reporting System (VAERS): all vaccine administration errors, serious adverse events, cases of Multisystem Inflammatory Syndrome (MIS), and cases of COVID-19 that result in hospitalization or death.

Safety and efficacy data were from a large, ongoing, randomised, blinded, placebo-controlled trial of more than 43,000 participants. The German study (BNT162-01) included participants aged 18 to 55 years and the US study (C4591001) included participants aged 18 to 55 years and 65 to 85 years. All participants will be followed for 2 years.

A total of 43,448 participants have received 1 dose of the vaccine they were randomised to and 37,706 have received 2 doses. Over 19,000 participants are now 2 months post second-dose. The vaccine is given 21 days apart.

Results showed that 30 mcg doses of BNT162b2 induced neutralising antibody titres comparable or higher than natural infection.

There were 8 cases of COVID-19 among the 18,198 participants randomised to receive the BNT162b2 vaccine compared with 162 cases among the 18,325 randomised to receive a placebo vaccine, translating to a vaccine efficacy of 95%. Efficacy was high across subgroups, regardless of age, race/ethnicity, and those with underlying conditions (diabetes, obesity, etc.).

The most commonly reported side effects, which typically lasted several days, were pain at the injection site, tiredness, headache, muscle pain, chills, joint pain, and fever. Of note, more people experienced these side effects after the second dose than after the first dose, so it is important for vaccination providers and recipients to expect that there may be some side effects after either dose, but even more so after the second dose.

At this time, data are not available to make a determination about how long the vaccine will provide protection, nor is there evidence that the vaccine prevents transmission of SARS-CoV-2 from person to person.

Pfizer has submitted a pharmacovigilance plan to FDA to monitor the safety of the vaccine. The pharmacovigilance plan includes a plan to complete longer-term safety follow-up for participants enrolled in ongoing clinical trials. The pharmacovigilance plan also includes other activities aimed at monitoring the safety profile of the vaccine and ensuring that any safety concerns are identified and evaluated in a timely manner.

The FDA also expects manufacturers whose COVID-19 vaccines are authorized under an EUA to continue their clinical trials to obtain additional safety and effectiveness information and pursue approval (licensure).

Reference: https://www.fda.gov/news-events/press-announcements/fda-takes-key-action...

SOURCE: US Food and Drug Administration