While a panel of independent experts are deliberating endorsement for the vaccine Friday, staff at the Food and Drug Administration released documents earlier this week, finding the jab had a "favorable safety profile with no specific concerns identified that would preclude issuance of an EUA."
The briefing documents noted no COVID-19-related deaths in the vaccinated trial group as of Feb. 5, suggesting the vaccine reduces COVID-19-related mortality. There were seven coronavirus-related deaths in the placebo group.
The most common reactions associated with the vaccine included pain at the injection site, headache, fatigue and myalgia, which were mostly "mild and moderate," resolving within two days post-vaccination. Participants ages 18-59 experienced reactions occurring soon after vaccination more often than those aged over 60.
"There were no specific safety concerns identified in subgroup analyses by age, race, ethnicity, medical comorbidities, or prior SARS-CoV-2 infection," per the documents. The committee noted five cases of urticaria, or red swelling, among vaccinated participants, compared to one in the placebo group. The committee said this non-serious event was "possibly related to the vaccine." Further, insufficient data behind blood clots and tinnitus couldn’t pin a "causal relationship between these events and the vaccine."