The US Food and Drug Administration’s (FDA’s) Vaccines and Related Biological Products Advisory Committee (VRBPAC) has supported the grant of an Emergency Use Authorisation (EUA) to Moderna’s Covid-19 vaccine candidate, mRNA-1273.

The US Food and Drug Administration’s (FDA’s) Vaccines and Related Biological Products Advisory Committee (VRBPAC) has supported the grant of an Emergency Use Authorisation (EUA) to Moderna’s Covid-19 vaccine candidate, mRNA-1273.

The positive recommendation comes after 20 VRBPAC members voted for EUA grant with no members voted against and one abstained.

Earlier this week, the FDA stated in its briefing document that Moderna’s vaccine is 94.1% effective in preventing symptomatic Covid-19.

Moderna CEO Stéphane Bancel said: “We thank the committee for their review and for their positive recommendation in support of Emergency Use Authorisation.            

“We have been working with the US Centers for Disease Control and Prevention and Operation Warp Speed to prepare for the distribution of mRNA-1273 if the FDA chooses to grant an Emergency Use Authorisation.”

The VRBPAC recommendation comes from the totality of scientific data provided by Moderna, including a data analysis from the Phase III COVE study.

Researchers conducted primary efficacy analysis on 196 cases, which showed a vaccine efficacy rate of 94.1%.

Safety data is being collected and the National Institutes of Health (NIH)-appointed independent Data Safety Monitoring Board (DSMB) is monitoring the study. 

Article transferred from pharmaceutical-technology.com