FDA Could Authorize Novavax COVID Vaccine by February, But Is It ‘Safe and Effective?’
The Novavax COVID vaccine, approved last month by the World Health Organization for use in the European Union, could be available in the U.S. within the next two months.
The company has filed for emergency authorization in the U.S. and nine other countries, Novavax CEO Stanley Erck on Monday told CNBC’s “Squawk on the Street.”
“I expect in the next 90 days we could have all 10 of them,” Erck said. The vaccine is currently available in 170 countries.
According to Erck, the company submitted its final data to the U.S. Food and Drug Administration (FDA) on Dec. 31, 2021, and expects a decision in February.
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“Unlike mRNA vaccines, the spike protein is already premade in the Novavax vaccine. It’s a shortcut,” explained Dr. Florescu, who led the clinical trial. “All the synthesis happens outside the body and we just give the end product: the spike protein.”
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Clinical trials suggest the vaccine also has fewer side effects than Pfizer or Moderna, both in terms of frequency and duration, as summarized by Novavax and published in the New England Journal of Medicine.
Side effects among the vaccinated were shown to be similar to those experienced by the placebo group. Also, unlike the mRNA vaccines, Novavax does not contain polyethylene glycol, an ingredient to which some individuals are allergic.
The trials showed Novavax had initial efficacy on a par with Pfizer and Moderna against prior strains of COVID, and potentially superior results as a booster against Omicron.
Against prior strains of COVID, Novavax was shown to be 90% effective against infection and 100% effective against moderate or severe disease, including hospitalization and death. The Omicron picture is more complicated.
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It is not known, however, if the spike protein delivered by the new vaccine is itself safe. Byram Bridle, Ph.D. professor of Immunology at the University of Guelph, Ontario, found based on the review of a Pfizer vaccine biodistribution study, that the spike protein as delivered by the mRNA is a dangerous toxin.
The company has filed for emergency authorization in the U.S. and nine other countries, Novavax CEO Stanley Erck on Monday told CNBC’s “Squawk on the Street.”
“I expect in the next 90 days we could have all 10 of them,” Erck said. The vaccine is currently available in 170 countries.
According to Erck, the company submitted its final data to the U.S. Food and Drug Administration (FDA) on Dec. 31, 2021, and expects a decision in February.
...
“Unlike mRNA vaccines, the spike protein is already premade in the Novavax vaccine. It’s a shortcut,” explained Dr. Florescu, who led the clinical trial. “All the synthesis happens outside the body and we just give the end product: the spike protein.”
...
Clinical trials suggest the vaccine also has fewer side effects than Pfizer or Moderna, both in terms of frequency and duration, as summarized by Novavax and published in the New England Journal of Medicine.
Side effects among the vaccinated were shown to be similar to those experienced by the placebo group. Also, unlike the mRNA vaccines, Novavax does not contain polyethylene glycol, an ingredient to which some individuals are allergic.
The trials showed Novavax had initial efficacy on a par with Pfizer and Moderna against prior strains of COVID, and potentially superior results as a booster against Omicron.
Against prior strains of COVID, Novavax was shown to be 90% effective against infection and 100% effective against moderate or severe disease, including hospitalization and death. The Omicron picture is more complicated.
...
It is not known, however, if the spike protein delivered by the new vaccine is itself safe. Byram Bridle, Ph.D. professor of Immunology at the University of Guelph, Ontario, found based on the review of a Pfizer vaccine biodistribution study, that the spike protein as delivered by the mRNA is a dangerous toxin.
