USFDA panel recommends emergency use authorisation of Moderna Covid vaccine

 

The US Food and Drug Administration's advisory panel, comprising external experts, has given an emergency use approval to Moderna Covid-19 vaccine

The US Food and Drug Administration's advisory panel, comprising external experts, has given an emergency use approval to Moderna COVID-19 vaccine, making it the second drug after Pfizer to receive such an authorisation in less than a week.

FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC), made up of independent scientific and public health experts, at its meeting on Thursday voted 20-0 with one abstention to recommend Emergency Use Authorization for the Moderna COVID-19 vaccine mRNA-1273.

The FDA on Friday allowed the emergency use of the country's first COVID-19 vaccine developed by American pharmaceutical giant Pfizer and its German partner BioNTech to combat the disease that has killed over 310,000 people in the country.

Commissioner of Food and Drugs Stephen Hahn said that following the positive advisory committee meeting outcome about the Moderna COVID-19 vaccine, the FDA has informed the company that it will rapidly work toward finalisation and issuance of an emergency use authorisation.

The agency has also notified the US Centers for Disease Control and Prevention and Operation Warp Speed, so they can execute their plans for timely vaccine distribution, he said.

We were grateful for the opportunity to present the clinical data package for our mRNA vaccine against COVID-19 to the FDA's advisory committee today. We thank the committee for their review and for their positive recommendation in support of Emergency Use Authorization, said Stphane Bancel, CEO of Moderna.