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

The US Food and Drug Administration (FDA) in its briefing document stated 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.

The planned dosing regimen is two 100μg doses of the vaccine to be given one month apart.

A safety data from a 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.

It showed no specific safety concerns that could preclude the issuance of an emergency use authorisation (EUA), the FDA briefing document stated.

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, Central American country 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, indicating that Europeans could get vaccines before the year-end.

This meeting was initially scheduled as late as 29 Dec.

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.