The company’s COVID-19 vaccine is awaiting FDA authorization. But is there a need for it?
https://www.phillyvoice.com/novavax-covid-19-vaccine-fda-authorization-mrna-alternative/
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Although the U.S. commitment eventually expanded to $1.8 billion, hardly any Novavax shots have found arms due to manufacturing issues, and most of the world has moved on. Novavax stock has plummeted from $290 a share in February 2021 to around $50 recently.
The FDA finally appears poised to authorize the company’s vaccine, however. If it does, Novavax would target the tens of millions of Americans who are not vaccinated against COVID-19 or would benefit from boosters but have avoided mRNA vaccines because of health concerns or conspiracy theories about their dangers.
In clinical trials, Novavax’s two-dose vaccine has worked well and had few safety problems. It appears to cause fewer unpleasant reactions — fever, chills and exhaustion — associated with mRNA vaccines produced by Moderna and Pfizer-BioNTech.
Novavax also relies on a more time-tested technology, using recombinant proteins grown in cell cultures. An influenza vaccine produced much the same way as Novavax’s shot has been on the market in the United States for nearly a decade.
“I do think there is a minority group who would take a protein vaccine over an mRNA vaccine,” said Dr. Kathleen Neuzil, director of the Center for Vaccine Development and Global Health at the University of Maryland. She was a researcher in a major U.S. trial of the Novavax vaccine, which found it 100% effective at preventing anything worse than mild COVID-19.
With the FDA’s authorization, Novavax’s product would be the first vaccine produced in India for U.S. consumption. Novavax turned to the Serum Institute of India, a seasoned manufacturer that makes vaccines for poor countries, when its subcontractor in Texas, Fujifilm Diosynth Biotechnologies, stopped producing the vaccine last summer after it was dinged by FDA inspectors for inadequate contamination control, missing records and other problems.
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https://www.phillyvoice.com/novavax-covid-19-vaccine-fda-authorization-mrna-alternative/
Even with FDA authorization, Novavax may be too late. While its vaccine is licensed in 41 countries and at least 42 million doses have been distributed, the world is overstocked with COVID-19 vaccine.
“They are applying for an emergency authorization” from the FDA, said Manon Cox, a vaccine industry consultant and the former CEO of Protein Sciences Corp., which made a similar vaccine. “What’s the emergency?”
Demand for COVID-19 vaccines is sluggish everywhere. About 13 million doses of the Novavax vaccine had been distributed in European Union countries as of mid-April, but fewer than 200,000 were administered. Distribution of the vaccine has been negligible since then.
Gavi, a nongovernmental organization, has suspended a 2021 agreement to buy at least 350 million Novavax doses for the COVAX program, which distributes vaccines at a deep discount to poor countries.
The U.S. market, however, shows promise for Novavax’s shot as an alternative to mRNA vaccines, especially now that the FDA has limited the use of a fourth vaccine, made by Johnson & Johnson, because of a serious though rare safety risk.
For Dr. Neuzil, the only reason why people would choose the mRNA vaccine over the Novavaxx product is that the mRNA vaccine was the only one approved and available. They would not be a minority group like she opines.
That's the rub.
My prediction is that the FDA will not approve Novovax, not because it doesn't work but because it does.
By approving Novovax, it will immediately put an end to the oversupplied, but still EUA-approved drugs by Pfizer and Moderna, because Novovax will make it available in the United States (unlike Pfizer which withheld Comirnaty until the experimental stock was used up).
So, the FDA will protect the profits of Big Pharma instead of the health of Americans by not approving the vaccine that does work in order to protect the profits of the drugs that don't work.
-PJ