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FDA grants emergency use authorisation for mRNA 1273 for COVID-19.- Moderna

Read time: 1 mins
Published:20th Dec 2020
The FDA has issued an emergency-use authorisation (EUA) for mRNA 1273, from Moderna, allowing the rollout of a second COVID-19 vaccine in the US. The decision comes a day after near unanimous backing by an FDA advisory panel, and about a week after Pfizer and BioNTech's vaccine BNT 162b2 secured the first EUA and began shipping across the country.Approval was based on the totality of scientific evidence shared by the Company, including a data analysis from the pivotal Phase III clinical study announced on November 30. The primary efficacy analysis conducted on 196 cases indicated a vaccine efficacy rate of 94.1%.The most common solicited adverse reactions (ARs) after the two-dose series included injection site pain (88.2%), erythema (8.6%), swelling (12.2%), and ipsilateral lymphadenopathy (14.2%). While the majority of these ARs were grade 1 (mild) or grade 2 (moderate), there was a higher occurrence of grade 3 (severe) reactions in the mRNA-1273 group and after the second injection. The majority of local solicited ARs occurred within the first one to two days after injection and generally persisted for a median of one to two days. Safety data continue to accrue, and the study continues to be monitored by an independent Data Safety Monitoring Board (DSMB) appointed by the National Institutes of Health (NIH). All participants in the COVE study will be monitored for two years after their second dose to assess long-term protection and safety.
Condition: Coronavirus/COVID-19 Infection
Type: drug

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