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FDA finds Moderna’s Covid-19 vaccine to have no specific safety concerns
  • Publisher:Phexcom
  • Publication:2020/12/18

The US Food and Drug Administration (FDA) has stated in its briefing document that Moderna’s experimental Covid-19 vaccine, mRNA-1273, is 94.1% effective in preventing symptomatic Covid-19.


The US Food and Drug Administration (FDA) has stated in its briefing document that Moderna’s experimental Covid-19 vaccine, mRNA-1273, is 94.1% effective in preventing symptomatic Covid-19.

This development comes ahead of a meeting by FDA advisers who will vote whether to recommend the grant of emergency approval for the vaccine in the US before a final FDA decision, Bloomberg reported.

The Moderna vaccine is based on SARS-CoV-2 spike glycoprotein (S) antigen encoded by RNA and formulated in lipid nanoparticles.

The proposed use of vaccine under an EUA is for active immunisation for Covid-19 prevention in adults.

Under the planned dosing regimen, two 100μg doses of the vaccine are to be given one month apart.

A safety data from an 11 November interim analysis of around 30,350 adults, who were randomly given the vaccine or placebo with a median of seven weeks of follow-up on receiving the second dose, showed a favourable safety profile.

Earlier this month, Moderna announced that the primary efficacy analysis data from the Phase III COVE study of mRNA-1273 indicated 100% vaccine efficacy against severe Covid-19.

The vaccines of Moderna and Pfizer are based on messenger RNA technology, which was earlier not used in inoculations.