US Regulators OK Novavax’s New Covid-19 Withdrawal Option – Times of India


WASHINGTON: The US gets another Covid-19 vaccine choice as the Food and Drug Administration approved on Wednesday Novavax adult recordings.
Novavax makes a more traditional type of shot than the other three COVID-19 vaccines available for use in the US – and one already available in Europe and multiple other countries.
Nearly a quarter of American adults still haven’t received 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 one. vaccine.
The Maryland company also hopes its shots can become a top pick in the US and beyond. Tens of millions of Americans still need boosters that experts call critical for the best possible protection as the coronavirus continues to mutate.
For now, the FDA has approved the initial two-dose series of Novavax for people ages 18 and older.
“I encourage anyone who is eligible for a Covid-19 vaccine, but has not yet received it, to consider it,” said FDA Commissioner Dr. Robert Califf in a statement.
Before shootings begin, the Centers for Disease Control and Prevention must recommend how to use them, a decision expected next week.
Novavax CEO Stanley Erck told The Associated Press that he expected the US to expand vaccine use to more than unvaccinated adults quite quickly.
The FDA is already evaluating it for people as young as 12, Erck said. Novavax has also submitted data on booster doses, including ‘mix-and-match’ use in people who had previously received Pfizer or Moderna vaccinations.
The Biden administration has so far purchased 3.2 million doses of Novavax, and Erck said vaccinations should begin later this month.
Sharon Bentley of Argyle, Texas, is one of the stragglers. Bentley was hesitant about the first Covid-19 vaccines, but then her husband volunteered for a Novavax trial, where he received two doses and later a booster.
Her husband’s positive experience with a more tried-and-true technology “convinced me,” Bentley said, adding that she planned to tell some unvaccinated friends about the option as well.
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 that acts as a red flag to make 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 the dominant Pfizer and Moderna Covid-19 vaccines that give genetic instructions to the body to produce its own copies of the spike protein. The lesser-used Johnson and Johnson option uses a harmless cold virus to provide spike making instructions.
Like the other vaccines used in the US, the Novavax injections have proven to be highly effective in preventing the most serious effects of Covid-19.
Typical vaccine reactions were mild, including arm pain and fatigue. But the FDA did warn of the possibility of a rare risk, heart inflammation, which has also been seen with the Pfizer and Moderna vaccines.
The Novavax vaccine was tested long before the omicron variant hit. But last month, the company released data showing that a booster dose promised a strong immune response, even against omicron’s newest relatives — preliminary evidence that several FDA scientific advisors called compelling.
Still, US regulators are planning a fall booster campaign with Pfizer and Moderna shots that better target omicron subtypes — and Novavax has begun testing updated shots, too. Erck said the company may have updated doses available late in the year.
European regulators recently approved the Novavax vaccine for use from the age of 12, and several countries have approved booster doses of the original vaccine.
Previous manufacturing issues have held back the vaccine, although Erck said those have been resolved and Novavax can meet global demand.
Much of the company’s vaccine, including doses for the US, is produced by the Serum Institute of India, the world’s largest vaccine manufacturer.

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