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In a 21-Zero vote with one abstention, advisers to the Meals and Drug Administration beneficial that the company authorize Novavax’s two-dose COVID-19 vaccine.
In feedback to the committee earlier than its vote, Dr. Peter Marks, the FDA’s high vaccines official, mentioned, “We spoke to make an alternative choice obtainable to those that won’t in any other case get vaccinated.”
In the course of the panel’s deliberations, Dr. Eric Rubin, editor-in-chief of The New England journal of drugs, He mentioned the info for the Novavax vaccine carefully resembles that for mRNA vaccines made by Moderna and Pfizer-BioNTech.
By the identical regulatory standards, he mentioned, “it isn’t such a tough resolution now” to advocate authorization. Nevertheless, he mentioned he was disenchanted that there was no extra information on how the Novavax vaccine carried out towards present strains of the coronavirus. “We’re efficacy towards strains that now not exist,” he mentioned.
An FDA abstract discovered that the Novavax COVID vaccine was 90% efficient in defending individuals towards delicate, average, and extreme sickness. The principle research the company used to evaluate the effectiveness of the Novavax vaccine included about 30,000 sufferers within the US and Mexico. However information assortment led to late September 2021, months earlier than omicron was detected within the US.
The Novavax vaccine makes use of copies of the SARS-CoV-2 spike protein produced in a manufacturing unit as an alternative of bits of genetic code to sign cells within the physique to make the protein that triggers an immune response. Each approaches have confirmed profitable towards COVID-19.
There may be some proof that the Novavax vaccine could cause a uncommon irritation of the guts that additionally generally happens in individuals receiving 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 just not required to take action.
If the company licenses the Novavax vaccine, the ultimate step earlier than it may be rolled out could be endorsement from the Facilities for Illness Management and Prevention.