Tuesday, February 15, 2022

Now this fellow remains

 Silent on the merits of his COMMERCIAl endorsement over BCG

Is he just another undercover paid endorser?

Ask him

The New Kid on the Covid-Vaccine Block

Novavax, up for FDA authorization, will be a good booster option.

PHOTO: FRANK HOERMANN/SVEN SIMON/ZUMA PRESS

I’m usually cautious about prescribing new vaccines and treatments for my patients. For a year after the Food and Drug Administration’s 2017 approval of Shingrix,GlaxoSmithKline’s vaccine for shingles, I was reluctant to administer it, choosing to wait for the thousands of people who took it in the clinical trial to turn into millions in the real world. But now that I’m confident it’s well-tolerated and effective, I offer it to any patient over 50.

With the Covid emergency I suspended my practice of waiting and began recommending the mRNA vaccines as soon as they were available. I’m very glad I did. But Covid fatigue, fear of novel technology, and a sense that the mRNA vaccines may not be up to the task against future variants have held many people back from taking the vaccine in the first place or getting a booster. 

There will soon likely be an alternative. Novavax last month applied to the FDA for emergency-use authorization of its “protein adjuvant” Covid shot—the same technology on which Shingrix is based. The Novavax shot has already been approved in other countries, including the U.K. 

Data released by the company in December shows immune protection against the Omicron variant. An Oxford study found it to be effective against Omicron when given as a booster following another Covid vaccine, including those from Pfizer and Moderna. 

The Novavax vaccine is based on tried and true technology. It involves growing the virus’s spike protein in moth cells and then combining it with an adjuvant, a chemical that amplifies the protein’s effect on the immune system. Whereas the mRNA vaccines signal human cells to make part of the protein, Novavax injects it directly as a “nanoparticle,” which induces a robust immune response (antibodies and T-cells). Side effects appear to be minimal: flulike symptoms, headache, temporary fatigue and pain at the injection site.

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There are several reasons to think that Novavax may give a more powerful boost than a third or fourth mRNA shot. For one thing, the nanoparticle includes the whole spike protein, which could provoke a more complete immunity. So could the glycosylation of the spike—the addition of a sugar molecule in insect cells, which isn’t what the virus is expecting. Perhaps most important, the adjuvant (known as Matrix-M1), which comes from the inner bark of a Chilean soapbark tree, is very high in quality and has been used to make a malaria vaccine effective. 

If you take Novavax as your original vaccine, would there be an advantage to an mRNA booster? Not likely, since the Novavax vaccine is already introducing the spike protein of the virus into the body—unless the mRNA shot was specifically designed to target an emerging variant.

The Omicron wave is receding fast, but other variants could emerge. The more vulnerable people who are vaccinated and boosted, the sooner the pandemic will be over. The FDA should act expeditiously to authorize an important tool we need in our armamentarium against Covid.

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Dr. Siegel is a clinical professor of medicine at NYU Langone Health and a Fox News medical correspondent.

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