The coronavirus vaccine made by US biotech firm Moderna is 94.5% efficient, with “no specific safety concerns identified that would preclude” issuance of emergency use authorization (EUA), the US drug regulatory body said Tuesday.
A US Food and Drug Administration’s (FDA) report came ahead of Thursday’s public meeting where experts will discuss vaccine’s sufficiency for the EUA.
“The vaccine elicited increased local and systemic adverse reactions as compared to those in the placebo arm, usually lasting a few days,” the report said.
“The most common solicited adverse reactions were pain at injection site (91.6%), fatigue (68.5%), headache (63.0%), muscle pain (59.6%), joint pain (44.8%), and chills (43.4%),” it added.
Serious adverse reactions were “generally mild to moderate” with 0.2% to 9.7% and they were more frequent after dose two on people below 65 years of age.
The proposed regimen is 2 doses, 100 microgram each, administered one month apart.
While the vaccine is 94.5% effective at least two weeks after the second dose, the study found it is 86.4% effective in people aged 65 and older and 95.6% effective in those 18 to 65.
The emergency use authorization is under consideration “for active immunization for the prevention of COVID-19 caused by SARS-CoV-2 in individuals 18 years of age and older.”
If approved, Moderna’s vaccine will be the second coronavirus vaccine in the US after Pfizer/BioNTech’s vaccine, which was authorized by FDA on Friday.
A New York health care worker received the first dose of the Pfizer/BioNTech vaccine on Monday.
The country’s coronavirus-related deaths are more than 300,000 and over 16.5 million cases have been registered so far, according to a running tally of Johns Hopkins University.
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