Members of the Vaccines and Related Biological Products Advisory Committee, FDA's adviser, have voted 20 to 0, with one abstention, in favor of recommending the vaccine developed by Moderna for an emergency use authorization for ages 18 and above.
This makes the Moderna COVID-19 vaccine the second one to receive a green light from the FDA, bringing the United States closer to adding another vaccine to its toolkit in its fight against COVID-19.
Moderna Vaccine Waiting for FDA's Emergency Use Authorization
Moderna's COVID-19 vaccine is said to have a 95% efficacy against the virus, and the FDA is expected to accept the recommendation from its advisors. If they are given the emergency use authorization, they can begin distributing their vaccines to health workers and high-risk populations, NBC News reported.
"We're in an unparalleled crisis, and I did not think an EUA was the way to go, but since the train has left the station, I appreciate that Moderna has given us a very transparent and thorough study that even from the beginning seemed very well organized," said associate professor of microbiology A. Oveta Fuller at the University of Michigan. She is also a temporary voting member of the committee.
Only Dr. Michael Kurilla, a National Institutes of Health infectious disease expert, abstained from the vote stating that he is not convinced that the benefits of the vaccine will outweigh its risks of useforf all of the age groups. He preferred to see the vaccine to be used by people who are at the category of a high risk of a serious or life-threatening form of COVID-19.
According to Vox, the vote in favor of the vaccine comes after a week when Pfizer and BioNTech's COVId-19 vaccine received emergency authorization from the FDA. Both Pfizer and Moderna have used the novel mRNA platform to create their vaccines which will be administered in two doses spaced several weeks apart. The UK and the US have already started giving Pfizer's vaccines to their people.
What Does It Mean To Have An Emergency Use Authorization from the FDA?
When Pfizer and BioNTech's COVID-19 received the emergency use authorization from the FDA, they have immediately started sending doses of the vaccine to the US. In a similar fashion, if Moderna received the same authorization, it also means a green light to increase manufacturing the vaccine and deliver protection from COVID-19 to more Americans.
But like Pfizer, the doses will not be enough yet to cater to the needs of all people right away so the government should make the right decisions on who will get the vaccines first.
Lastly, an emergency use authorization is just a step closer to getting full approval from the FDA to be used in hospitals. That means some critical questions are still needed to be addressed about the vaccine by conducting further trials.
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