HomeTechnologyUS Regulators Approve New Novavax COVID-19 Vaccine Option

US Regulators Approve New Novavax COVID-19 Vaccine Option


By LAURAN NEERGAARD, AP Medical Writer

The US is getting another COVID-19 vaccine option as the Food and Drug Administration (FDA) approved Novavax injections for adults on Wednesday.

Novavax makes a more traditional type of injection than the other three COVID-19 vaccines available for use in the US, and one that is already available in Europe and many other countries.

Nearly a quarter of American adults have yet to receive their primary vaccines even at this late stage of the pandemic, and experts hope at least some of them will roll up their sleeves to opt for a more conventional option: a protein-based vaccine.

The Maryland company also hopes its injections could become one of the best booster options in the US and beyond. Tens of millions of Americans still need backups that experts say are critical to getting the best possible protection as the coronavirus continues to mutate.

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For now, the FDA cleared the initial two-dose series of Novavax for people 18 and older.

“I encourage anyone who is eligible for a COVID-19 vaccine, but has not yet received one, to consider doing so,” FDA Commissioner Dr. Robert Califf said in a statement.

Before the injections begin, the Centers for Disease Control and Prevention must recommend how they should be used, a decision expected next week.

Novavax CEO Stanley Erck told The Associated Press that he expected the United States to expand use of the vaccine beyond unvaccinated adults fairly quickly.

The FDA is already evaluating it for children up to 12 years old, Erck said. Novavax has also submitted data on booster doses, including the use of “mix and match” in people who previously received Pfizer or Moderna vaccines.

The Biden administration has purchased 3.2 million doses of Novavax so far, and Erck said the shots should start later this month.

Sharon Bentley of Argyle, Texas, is one of the holdouts. Bentley was hesitant about the first COVID-19 shots, but then her husband volunteered for a Novavax trial, she got two doses and then a booster.

Her husband’s positive experience with more tried-and-true technology, “that sold me,” Bentley said, adding that she also planned to tell some unvaccinated friends about the option.

The Novavax vaccine is made from copies of the spike protein that coats the coronavirus, packaged in nanoparticles that resemble a virus to the immune system. Then an immune-boosting ingredient, or adjuvant, made from the bark of a South American tree, is added, acting as a red flag to ensure those particles look suspicious enough to trigger a strong immune response.

Protein vaccines have been used for years to prevent hepatitis B, shingles, and other diseases. It’s a very different technology from Pfizer’s and Moderna’s dominant COVID-19 vaccines that deliver genetic instructions for the body to make its own copies of the spike protein. Johnson & Johnson’s lesser-used option uses a harmless cold virus to give pickaxe instructions.

Like the other vaccines used in the US, Novavax injections have been shown to be very effective in preventing the most serious outcomes of COVID-19. Typical reactions to the vaccine were mild, including arm pain and fatigue. But the FDA has warned of the possibility of a rare risk, inflammation of the heart, which has also been seen with vaccines from Pfizer and Moderna.

The Novavax vaccine was tested long before the omicron variant arrived. But last month, the company published data showing that 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, US regulators are planning a fall booster campaign using injections from Pfizer and Moderna that better target omicron subtypes, and Novavax has also started testing updated injections. Erck said the company could have updated doses available by the end of the year.

European regulators recently approved the Novavax vaccine for use from the age of 12, and several countries have authorized booster doses of its original vaccine.

Previous manufacturing difficulties delayed the vaccine, although Erck said they have been resolved and Novavax can meet global demand. Much of the company’s vaccine, including doses for the US, is being produced by the Serum Institute of India, the world’s largest vaccine maker.

The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content.

Copyright 2022 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.



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