In late August, the FDA officially approved the Pfizer-BioNTech COVID-19 vaccine, which will officially be marketed as Comirnaty. This is the first FDA-approved vaccine for the prevention of COVID-19 and potentially serious outcomes including hospitalization and death.
Until now, COVID-19 vaccines had only received emergency use authorization (EUAs). EUAs are declarations that circumstances exist to justify the emergency use of drugs and biological products that have not been FDA-approved, particularly when no other effective alternatives are available, assuming the benefits appear to outweigh the risks. Full FDA approval means that a drug has undergone the FDA’s full standard process for reviewing the quality, safety, and effectiveness of medical products.
Based on results from the clinical trial, the vaccine was 91% effective in preventing COVID-19 disease. More than half of the clinical trial participants were followed for safety outcomes for at least four months after the second dose. Overall, approximately 12,000 recipients have been followed for at least 6 months.
Common side effects were pain, redness and swelling at the injection site, fatigue, headache, muscle or joint pain, chills, and fever.
In related news, more developments have occurred regarding COVID-19 vaccine booster shots.
In early August, the FDA amended the EUAs for the Pfizer and Moderna vaccines to allow for an additional dose in certain immunocompromised individuals. The update was made specifically for those immunocompromised in a manner similar to those who have undergone solid organ transplant or those who are diagnosed with conditions considered to have an equivalent level of immunocompromise.
Roughly a week later, the White House announced plans to make COVID-19 boosters available for adults starting the week of September 20th. Boosters can only be administered eight months after an individual’s second dose of the Pfizer or Moderna vaccine, which means that the initial start of booster administration would apply only to early receivers of the vaccine, such as healthcare workers and nursing home residents.
The White House’s decision coincides with recommendations from the Department of Health and Human Services (HHS) and the CDC.
Following these updates, the FDA amended the EUA for the Pfizer COVID-19 vaccine to allow for the use of a single booster dose, to be administered at least six months after the completion of the primary series in certain populations.
Impacted populations include:
- Individuals age 65 and older
- Individuals age 18 to 64 at high risk of severe COVID-19
- Individuals age 18 to 64 whose frequent institutional or occupational exposure to SARS-COV-2 puts them at high risk of serious complications of COVID-19 including severe COVID-19
The CDC then quickly endorsed this update.