The United States’ Food and Drug Administration (FDA) says it believes the first COVID-19 vaccines work and are safe for people over 16-year-old. The FDA made the disclosure after spending weeks scrutinizing data provided by Pfizer.
In its report on the safety of the vaccine, the FDA was satisfied.
“Safety data from approximately 38,000 participants [greater than or equal to] 16 years of age randomized 1:1 to vaccine or placebo with a median of 2 months of follow up after the second dose suggest a favorable safety profile, with no specific safety concerns identified that would preclude issuance of an EUA,” the FDA wrote.
The report also highlighted some of the most common reactions to the vaccine which include a skin reaction at the injection site, followed by fatigue or headaches, chills, and muscle pain.
The data also indicates the vaccine works equally men in men and women, and among people of different races and ethnicities.
The report also pointed to some areas where there isn’t enough data on the Pfizer vaccine. This includes how it works in people with medical conditions like HIV/AIDS, in people who have recovered from COVID-19 infection, or how long the protection lasts.
The report also highlights that while the Pfizer vaccine prevents recipients from getting sick, there isn’t enough data yet to know if the vaccine is effective enough at preventing all transmission of the disease.