Dr. Stephaun Wallace, who leads the worldwide exterior relations methods for the COVID-19 Prevention Community on the Fred Hutchinson Most cancers Analysis Middle in Seattle, receives his second injection from Dr. Tia Babu throughout the Novavax vaccine section 3 medical trial in February 2021.
Karen Ducey/Getty Photographs
cover caption
toggle caption
Karen Ducey/Getty Photographs
Dr. Stephaun Wallace, who leads the worldwide exterior relations methods for the COVID-19 Prevention Community on the Fred Hutchinson Most cancers Analysis Middle in Seattle, receives his second injection from Dr. Tia Babu throughout the Novavax vaccine section 3 medical trial in February 2021.
Karen Ducey/Getty Photographs
In a 21-0 vote with one abstention, advisers to the Meals and Drug Administration advisable that the company authorize Novavax’s two-dose vaccine towards COVID-19.
In feedback to the committee earlier than its vote, Dr. Peter Marks, the FDA’s high vaccine official mentioned, “We communicate to creating out there an alternative choice for individuals who won’t in any other case take a vaccine.”
Throughout the panel’s deliberations, Dr. Eric Rubin, editor in chief of The New England Journal of Medication, mentioned that information for the Novavax vaccine look so much like these for the mRNA vaccines made by Moderna and Pfizer-BioNTech.
By the identical regulatory standards, he mentioned, “it isn’t that troublesome a choice now” to suggest authorization. Nonetheless, he mentioned he was dissatisfied that there wasn’t extra information about how the Novavax vaccine carried out towards present variants of the coronavirus. “We’re efficacy towards strains that do not exist any longer,” he mentioned.
An FDA abstract discovered the Novavax COVID vaccine had 90% efficacy in protecting people towards delicate, reasonable and extreme illness. The principle research that the company used to guage the Novavax vaccine’s efficacy included about 30,000 sufferers within the U.S and Mexico. However information assortment led to late September 2021, months earlier than omicron was detected in the U.S.
The Novavax vaccine makes use of copies of the SARS-CoV-2 spike protein produced in a manufacturing facility relatively than snippets of genetic code to instruct the physique’s cells to make the protein that prompts an immune response. Each approaches have proved succesful towards COVID-19.
There may be some proof the Novavax vaccine might trigger a uncommon swelling of the center that additionally happens generally in individuals who get one of many different COVID-19 vaccines. The issue has additionally been seen with mRNA vaccines. However the committee concluded that the advantages of the Novavax vaccine outweigh the dangers.
The FDA usually follows the suggestions of its advisers however is not sure to take action.
If the company authorizes the Novavax vaccine, the ultimate step earlier than it might be rolled out can be an endorsement by the Facilities for Illness Management and Prevention.
