FDA Approves the First COVID-19 Vaccine by Pfizer-BioNTech

  • The Pfizer-BioNTech vaccine becomes the “first” to receive FDA approval.

  • Its marketing name will be “Comirnaty” (pronounced as koe-mir'na-tee).

On August 23, 2021, the US Food and Drug Administration granted full approval to the COVID-19 Vaccine by Pfizer-BioNTech to prevent COVID-19 in individuals aged above 16 years. Now, it will be marketed as Comirnaty. Nevertheless, the vaccine remains applicable for emergency use (under EUA) in younger individuals aged 12 through 15 years. Plus, the administration of the third dose of vaccine in patients with immunocompromised conditions continues to be available under EUA.

Since December 11, 2020, the Pfizer-BioNTech vaccine has been available for emergency use for individuals aged 16 years and above, which was later expanded on May 10, 2021, to younger individuals aged between 12 to 15 years.

The vaccine has been named “Comirnaty” with the purpose to include a couple of words in it, namely Community, COVID-19, Immunity, and mRNA. Moreover, Comirnaty comprises a kind of genetic material called mRNA (messenger RNA) that is used to create a copy of proteins in the SARS-CoV-2 (the virus that causes coronavirus disease). As a result, the immune system of the individual receiving this vaccine will give a defensive response to it. It must be administered in two doses given three weeks apart.

Evaluation of Safety & Efficacy

Individuals were randomized 1:1 to receive either the vaccine or a placebo in the observer-blind study. There were two components to the research. In phase one of the study, researchers aimed to identify preferred vaccination candidates and dose levels, then in phases two and three, they evaluated the vaccine's efficacy in a larger patient group.

The trial's major endpoints were COVID-19 infection prevention in individuals who had not been infected with SARS-CoV-2 before vaccination and virus prevention in all patients, regardless of whether they had previously been infected with SARS-CoV-2. Further, the prevention of severe COVID-19 in those patient subgroups was a secondary end aim.

The vaccine's safety was tested in roughly 22,000 people aged 16 and up who received the vaccine and another 22,000 who received a placebo. Moreover, half of the participants were monitored for at least four months after receiving their second dose for safety reasons. A total of 12,000 people were tracked for at least six months.

Pain, redness, chills, headache, muscular or joint pain, swelling at the injection site, and fever were the most common side effects reported by patients. The vaccine was found to be effective in preventing the infection and consequences like hospitalization or death.

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