FDA committee documents on Moderna's COVID-19 vaccine find 'no specific safety concerns'

The committee will meet Thursday to discuss its findings and vote

A Food and Drug Administration committee review of Moderna’s coronavirus vaccine emergency use authorization application found “no specific safety concerns” in subgroup analyses by age, race, ethnicity, medical comorbidities or prior SARS-CoV-2 infection, potentially paving the way for a second COVID-19 jab to enter the scene.

In documents posted ahead of Thursday’s Vaccines and Related Biological Products Advisory Committee meeting, the panel also found that the vaccine reduced the risk of confirmed COVID-19 – including severe cases – occurring at least 14 days after the second dose.

The committee was careful to note that there wasn’t enough data to evaluate the duration of protection in relation to the vaccine, effectiveness in certain high-risk populations such as immunocompromised individuals, effectiveness in individuals who have previously been infected with SARS-CoV-2 or effectiveness in pediatric populations. There also wasn’t enough data for the committee to evaluate future vaccine effectiveness in relation to changes in the virus, effectiveness against asymptomatic infection, and effectiveness against long-term effects of COVID-19, effectiveness against mortality or effectiveness against transmission of SARS-CoV-2.


Not unlike Pfizer and BioNTech’s vaccine, the Moderna jab did elicit non-serious adverse reactions such as pain at injection site, fatigue, headache, muscle pain, joint pain and chills. The reactions were characterized as generally mild to moderate.

The FDA did consider three serious adverse reactions as related to the vaccine, including nausea and vomiting, and facial swelling. An incident of Bell’s palsy also occurred in a vaccine recipient, “for which a causal relationship to vaccination cannot be concluded at this time.”


There were also 13 deaths reported in the study cohort, six of which occurred in participants who received the vaccine, and seven who received the placebo. Two deaths in the vaccine group were participants over age 75 with pre-existing cardiac disease, and two others were found deceased at home with the cause of death uncertain. Another death in the vaccine group occurred in a participant with Crohn’s disease and short bowl syndrome who was hospitalized for thrombocytopenia and acute kidney failure due to obstructive nephrolithiasis, and the sixth died of suicide 21 days after dose one.

“Safety data from a November 11, 2020 interim analysis of approximately 30,350 participants > 18 years of age randomized 1:1 to vaccine or placebo with a median of 7 weeks of follow-up after the second dose supported a favorable safety profile, with no specific safety concerns that would preclude issuance of an EUA,” the document stated. “These safety data are the primary basis of FDA’s safety review.”


Should the panel endorse Moderna’s vaccine on Thursday, the vote will then go before FDA officials who will decide whether to grant emergency use authorization (EUA) based on the committee’s findings. Such approval would come about a week after the regulatory agency granted EUA to Pfizer’s COVID-19 vaccine, which states have begun rolling out to health care workers.