The Food and Drug Administration advisory committee has recommended the agency give the green light to Novavax’s Covid-19 vaccine, which offers a more traditional, non-mRNA alternative to the Pfizer and Moderna shots.
The FDA’s Vaccines and Related Biological Products Committee voted 21-0, with one abstention, to recommend the vaccine for emergency use authorization.
"The Advisory Committee's positive recommendation acknowledges the strength of our data and the importance of a protein-based COVID-19 vaccine developed using an innovative approach to traditional vaccine technology," Novavax president and CEO Stanley Erck said Tuesday.
“We have heard in today’s VRBPAC meeting the significant support for our vaccine from physicians, healthcare organizations, and consumers who are eagerly anticipating a protein-based vaccine option,” he added.
The data Novavax presented to the committee showed the vaccine was 90 percent effective in preventing mild and severe Covid-19, although the two large clinical trials were conducted before the Omicron wave. Additionally, the vaccine had a "reassuring safety profile," the company said.
Erck said there is a market for the company in the U.S. among the "tens of millions of people who have not had their primary vaccine for one reason or another." Additionally, other potential markets include children and those who need booster shots.
"We do have a problem with vaccine uptake that is very serious in the United States, and anything we can do to get people more comfortable to be able to accept these potentially life-saving medical products is something that we feel we are compelled to do," said Dr. Peter Marks, director of the Center for Biologics Evaluation and Research.Dr. Eric Rubin, editor-in-chief of the New England Journal of Medicine and a member of VRBPAC, asked in the meeting why there is a need for another Covid-19 vaccine in the United States when three have been authorized or approved: those from Pfizer/BioNTech, Moderna and Johnson & Johnson's Janssen."The Janssen vaccine is currently not being used as a frontline vaccine the same way as the mRNA vaccines, which leaves the issue of vaccines for those who might not want to take an mRNA vaccine because of concerns they might have," Marks responded, referring to the vaccines developed by Pfizer/BioNTech and Moderna."Having a protein-based alternative may be more comfortable for some in terms of their acceptance of vaccine," Marks said. (CNN)
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Novavax's Covid-19 shot is currently available in more than 40 countries.
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