FDA advisors recommend Emergency Use Authorization of Moderna vaccine
The US Food and Drug Administration's advisory panel, comprising external experts, has given an emergency use approval to Moderna's COVID-19 vaccine, making it the second drug after Pfizer to receive such an authorization in less than a week. FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC), voted 20-0 with one abstention to recommend Emergency Use Authorization for the Moderna COVID-19 vaccine mRNA-1273.
Commissioner of Food and Drugs Stephen Hahn said, "Following the positive advisory committee meeting outcome about the Moderna COVID-19 vaccine, the FDA has informed Moderna that it will rapidly work toward finalization and issuance of an Emergency Use Authorization." The agency has notified the Centers for Disease Control and Prevention (CDC)and Operation Warp Speed, so they can execute their plans for timely vaccine distribution.
The VRBPAC based its recommendation on the totality of scientific evidence shared by the company, including a data analysis from the pivotal Phase 3 clinical study announced on November 30. The primary efficacy analysis conducted on 196 cases indicated a vaccine efficacy rate of 94.1%.
Moderna CEO, Stephane Bancel said, "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 Authorization." "We look forward to getting our vaccine to help address this ongoing public health emergency," he added.
On December 11, FDA 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.
Moderna has expanded the handling guidance for mRNA-1273 to include local transport under controlled conditions in a liquid state at 2-8 degree Celsius (36 to 46 F). This important update will help facilitate distribution to the final site of administration. Recognizing that shipping and handling of the product can be a barrier to vaccination, Moderna remains committed to supporting efficient distribution, the company said.