FDA committee paperwork on Moderna’s COVID-19 vaccine discover ‘no particular security considerations’

A Food and Drug Administration committee evaluation of Moderna’s coronavirus vaccine emergency use authorization software discovered “no particular security considerations” in subgroup analyses by age, race, ethnicity, medical comorbidities or prior SARS-CoV-2 an infection, probably paving the way in which for a second COVID-19 jab to enter the scene.

In paperwork posted forward of Thursday’s Vaccines and Related Biological Products Advisory Committee assembly, the panel additionally discovered that the vaccine diminished the chance of confirmed COVID-19 – together with extreme instances – occurring at the least 14 days after the second dose.

The committee was cautious to notice that there wasn’t sufficient information to judge the length of safety in relation to the vaccine, effectiveness in sure high-risk populations comparable to immunocompromised people, effectiveness in people who’ve beforehand been contaminated with SARS-CoV-2 or effectiveness in pediatric populations. There additionally wasn’t sufficient information for the committee to judge future vaccine effectiveness in relation to modifications within the virus, effectiveness towards asymptomatic an infection, and effectiveness towards long-term results of COVID-19, effectiveness towards mortality or effectiveness towards transmission of SARS-CoV-2.


Not not like Pfizer and BioNTech’s vaccine, the Moderna jab did elicit non-serious adversarial reactions comparable to ache at injection web site, fatigue, headache, muscle ache, joint ache and chills. The reactions have been characterised as usually gentle to reasonable.

The FDA did think about three severe adversarial reactions as associated to the vaccine, together with nausea and vomiting, and facial swelling. An incident of Bell’s palsy additionally occurred in a vaccine recipient, “for which a causal relationship to vaccination can’t be concluded at the moment.”


There have been additionally 13 deaths reported within the research cohort, six of which occurred in contributors who acquired the vaccine, and 7 who acquired the placebo. Two deaths within the vaccine group have been contributors over age 75 with pre-existing cardiac illness, and two others have been discovered deceased at residence with the reason for dying unsure. Another dying within the vaccine group occurred in a participant with Crohn’s illness and brief bowl syndrome who was hospitalized for thrombocytopenia and acute kidney failure as a consequence of obstructive nephrolithiasis, and the sixth died of suicide 21 days after dose one.

“Safety information from a November 11, 2020 interim evaluation of roughly 30,350 contributors > 18 years of age randomized 1:1 to vaccine or placebo with a median of seven weeks of follow-up after the second dose supported a good security profile, with no particular security considerations that will preclude issuance of an EUA,” the doc said. “These security information are the first foundation of FDA’s security evaluation.”


Should the panel endorse Moderna’s vaccine on Thursday, the vote will then go earlier than FDA officers who will resolve whether or not to grant emergency use authorization (EUA) based mostly on the committee’s findings. Such approval would come a few week after the regulatory company granted EUA to Pfizer’s COVID-19 vaccine, which states have begun rolling out to well being care staff.

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