FDA advisory committee recommends authorizing Novavax COVID-19 vaccine

0 0

The FDA’s Vaccines and Related Biological Products Advisory Committee on Tuesday voted 21-0, with one abstention, in favor of granting an Emergency Use Authorization for Novavax’s traditional style COVID-19 vaccine. File Photo by Jim Lo Scalzo/EPA-EFE

An independent advisory committee voted Tuesday overwhelmingly in favor of authorizing biotech company Novavax’s protein-based COVID-19 vaccine.

The Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee voted 21-0 with one abstention, in favor of granting Emergency Use Authorization status for the traditional style vaccine.

The final decision rests with the FDA. The committee is scheduled to meet again June 14-15.

Maryland-based Novax applied for the approval in February of an EUA based on data showing it “would prevent COVID-19 in individuals 18 years of age and older.”

The Novavax vaccine is a more traditional protein-based type of vaccine, employing a whole, deactivated virus.

The two widely used vaccines by Moderna and Pfizer, which have already been approved by the FDA, are mRNA-based.

The single-dose Johnson & Johnson COVID-19 vaccine is the only non-mRNA shot approved for use in the United States by the FDA, though it was limited in May to adults who can’t receive other versions of the vaccine.

Dozens of speakers voiced their support or concerns during the more-than seven-hour virtual meeting, with proponents arguing giving people the choice will help boost vaccination rates.

“The emergency use authorization request by Novavax for a vaccine to prevent COVID-19 in individuals 18 years of age and older, should be granted. Data, from two separate studies involving over 30,000 participants, demonstrated a composite efficacy of approximately 90% in preventing significant infection,” said Dr. Mitchell Goldstein, one of the speakers and a professor of pediatric medicine at Loma Linda University.

“This vaccine product is the first traditional protein-based vaccine to achieve this level of protection. The vaccine has been authorized for emergency use by the World Health Organization and can be used in over 170 countries worldwide,” said Goldstein, before touching on the need to gain the trust among certain members of the public.

“The frequent need for boosters and the broad public perception of these (mRNA) technologies as untested, and thus, untrusted, demonstrates the need for a traditional protein-based technology that mirrors those of the more trusted traditional vaccine products currently on the market for other viral diseases.”

Britain’s Medicines and Healthcare products Regulatory Agency granted Novavax conditional marketing authorization for the vaccine in February, for use in adults 18 and older.

In April, the company applied to expand that for use in adolescents between 12 and 17.

Japan gave the vaccine the green light in April.

Source

Leave A Reply

Your email address will not be published.