FDA review of Pfizer vaccine clears way for emergency authorization
The FDA's vaccine advisory committee released a detailed analysis on Tuesday finding that Pfizer's coronavirus vaccine appears to meet the safety and efficacy requirements necessary for an emergency use authorization (EUA).
Why it matters: The FDA's initial review suggests that the agency will issue an EUA after its advisory committee meets on Thursday. The publication of the analysis comes the same day that the U.K. began administering its first doses of the Pfizer vaccine, which regulators cleared for emergency use last week.
Details: The FDA found that there are no specific safety concerns from Pfizer's vaccine by race, age, ethnicity, medical co-morbidities, or a prior COVID infection.
- The most common negative side effects of vaccination were fatigue, headache, muscle pain, chills, joint pain, and fever.
- Severe adverse reactions only occurred in 0.0% to 4.6% of Pfizer's study participants, and were more frequent after the second dose than the first dose. Adults under 55 experienced less serious side effects.
- Pfizer's data suggests that the vaccine could help prevent COVID infections following the first dose, but available data did not allow for a firm conclusion, the FDA said.
Of note: Two people in the vaccine group died over the course of the study — one participant with pre-existing atherosclerosis and another participant that went through cardiac arrest after the second dose and died three days later.
The bottom line: The FDA writes that although Pfizer's data shows the vaccine is highly effective against symptomatic COVID-19 patients, data from more people is needed to determine how effective the vaccine is at saving lives.
- It is also possible that the vaccine's efficacy against asymptomatic infection is lower than its efficacy against against symptomatic infection, per the FDA.
- Additional testing is needed to see how effective the vaccine is in preventing the transmission of the virus.
What's next: The FDA's advisory committee will meet on Dec. 10 to discuss Pfizer's request for an emergency use authorization and whether further study on the vaccine is needed.