FDA Authorizes COVID-19 Vaccine From Novavax
TThe Food and Drug Administration cleared Novavax for adult use on Wednesday in the United States.
Novavax makes a more traditional type of shot than the three other COVID-19 vaccines available for use in the U.S.—and one that’s already available in Europe and multiple other countries.
Nearly a quarter of American adults still haven’t gotten their primary vaccinations even this late in the pandemic, and experts expect at least some of them to roll up their sleeves for a more conventional option—a protein-based vaccine.
Maryland’s company hopes to be the top choice of boosters in the U.S. Experts say boosters are still needed by millions to provide the highest protection against the coronavirus, which is continuing its mutation.
For now, the FDA authorized Novavax’s initial two-dose series for people 18 and older.
“I encourage anyone who is eligible for, but has not yet received, a COVID-19 vaccine to consider doing so,” FDA Commissioner Dr. Robert Califf said in a statement.
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The Centers for Disease Control and Prevention have to recommend the best way for shots to be taken. This decision is expected next week.
Stanley Erck, CEO of Novavax, told The Associated Press that he expects the U.S. will expand the use of the vaccine to include unvaccinated adults very quickly.
It is being evaluated by the FDA for children as young as 12 years old, Erck explained. Novavax also has submitted data on booster doses, including “mix-and-match” use in people who’d earlier received Pfizer or Moderna vaccinations.
Biden has purchased 3.2 Million Novavax doses to date. Erck stated that vaccinations should start later in the month.
Sharon Bentley, Argyle (Texas), is among the remaining holdouts. Bentley hesitated to receive the COVID-19 vaccines at first, but her husband agreed and she was given two Novavax doses as well as a booster.
Her husband’s positive experience with a more tried-and-true technology, “that convinced me,” Bentley said, adding that she planned to tell some unvaccinated friends about the option, too.
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Novavax vaccine contains copies of the spike protein which coats coronavirus. These are then packaged into nanoparticles, making it look almost like a virus to the immune system. Then an immune-boosting ingredient, or adjuvant, that’s made from the bark of a South American tree is added that acts as a red flag to ensure those particles look suspicious enough to spark a strong immune response.
Since years, protein vaccines have been used to protect against hepatitis B and other diseases such as shingles. It’s a very different technology than the dominant Pfizer and Moderna COVID-19 vaccines that deliver genetic instructions for the body to produce its own copies of the spike protein. The lesser-used Johnson & Johnson option uses a harmless cold virus to deliver spike-making instructions.
Like the other vaccines used in the U.S., the Novavax shots have proved highly effective at preventing COVID-19’s most severe outcomes. The most common reactions to vaccines were arm pain, fatigue and mild swelling. FDA warned about a possible risk of heart inflammation with Moderna and Pfizer vaccines.
Novavax had been tested well before the introduction of the new omicron strain. But last month, the company released data showing a booster dose promised a strong immune response even against omicron’s newest relatives—preliminary evidence that several of the FDA’s scientific advisers called compelling.
Still, U.S. regulators are planning for a fall booster campaign using Pfizer and Moderna shots that better target omicron subtypes—and Novavax also has begun testing updated shots. Erck stated that the company may have the updated doses ready by the end of the year.
European regulators have approved the Novavax vaccine for use as early as 12 years old. Several countries also allow booster doses.
Erck explained that earlier manufacturing issues were a problem with the vaccine. However, these problems have since been fixed and Novavax will be able to fulfill global demand. Much of the company’s vaccine, including doses for the U.S., are being produced by the Serum Institute of India, the world’s largest vaccine manufacturer.
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