FDA finds Moderna’s Covid-19 vaccine to have no specific safety concerns

16 December 2020 (Last Updated December 16th, 2020 12:09)

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.

FDA finds Moderna’s Covid-19 vaccine to have no specific safety concerns
Proposed use of Moderna vaccine under an EUA is for active immunisation for Covid-19 prevention in adults. Credit: Arek Socha from Pixabay.

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.

In a separate development, Panama approved the emergency use of Pfizer and BioNtech’s vaccine.

Reuters quoted Panama Health Vice Minister Ivette Barrio as saying that the first batch of the dose could reach in the first quarter next year.

Furthermore, the European Medicines Agency (EMA) will meet on 21 December to analyse vaccine made by Pfizer and BioNtech. This meeting was initially scheduled as late as 29 December.

Last week, the US FDA advisory committee released a briefing document confirming safety and efficacy data of Pfizer and BioNTech’s Covid-19 vaccine candidate, BNT162b2.

The vaccine was later approved for emergency use against Covid-19 in individuals aged 16 years and above in the US.

Separately, the researchers from the University of Cambridge in the UK have found that remdesivir could be a highly effective antiviral against Covid-19 in a new single-patient study.

In the study, the vaccine was tested on a Covid-19 patient with a rare immune disorder and showed improvement in symptoms and the disappearance of the virus.