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US regulators OK New COVID firing option from Novavax

The United States gets another choice of vaccine against COVID-19 as the Food and Drug Administration cleared Novavax shots for adults on Wednesday.

Novavax produces a more conventional type of shotgun than the other three COVID-19 vaccines available for use in the United States – and one that is already available in Europe and many other countries.

Nearly a quarter of American adults have not yet received basic vaccinations even so late in the pandemic, and experts expect that at least some of them will roll up their sleeves for a more traditional option – a protein-based vaccine.

The Maryland company also hopes that its shot can become a top booster in the United States and beyond. Tens of millions of Americans still need stimulation, which experts call important for the best possible protection as the coronary virus continues to mutate.

For now, the FDA approved the first two-dose series of Novavax for people 18 years and older.

“I urge anyone who is entitled to, but has not yet received, a COVID-19 vaccine to consider doing so,” FDA Director Robert Califf said in a statement.

Before the shots start, the Centers for Disease Control and Prevention must recommend how to use them, a decision is expected next week.

Stanley Erck, CEO of Novavax, told the Associated Press that he expected the United States to increase its use of the vaccine more rapidly than unvaccinated adults.

The FDA is already estimating it for those down to 12 years old, Erck said. Novavax has also provided data on booster doses, including “mixed-and-match” use in people who have previously received Pfizer or Moderna vaccinations.

The Biden government has bought 3.2 million Novavax doses so far and Erck said vaccinations should begin later this month.

Skeptic convinced

Sharon Bentley from Argyle, Texas, is one of the stops. Bentley was hesitant about the first COVID-19 vaccines, but then her husband volunteered for a Novavax trial, received two doses and later stimulants.

Her husband’s positive experience with proven technology “convinced me,” Bentley said, adding that she was going to tell some unvaccinated friends about the benefits.

The Novavax vaccine is made from copies of the spiked protein that envelops the coronavirus, packaged in nanoparticles that resemble the virus for the immune system. Then an immunosuppressive ingredient, or excipient, made from the bark of a South American tree is added and acts as a red flag to ensure that these particles look suspicious enough to elicit a strong immune response.

Protein vaccines have been used for many years to prevent hepatitis B, colon and other diseases. This is a completely different technology than the prevailing Pfizer and Moderna COVID-19 vaccines, which provide genetic instructions for the body to produce its own copies of the top protein. Less used Johnson & Johnson option uses harmless cold virus to deliver top type instructions.

Like other vaccines used in the United States, Novavax shots have been shown to be very effective in preventing the most serious consequences of COVID-19. Typical vaccine reactions were mild, including arm pain and fatigue. But the FDA warned 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 became effective. But last month, the company released data showing that a booster dose promised a strong immune response, even against omicron’s latest relatives – preliminary evidence that some FDA scientific advisers said convincingly.

However, US regulators are planning a campaign to promote Pfizer and Moderna bullets that target omicron sub-models better, and Novavax has also started testing updated bullets. Erck said the company may have updated the dose available later in the year.

European regulators recently approved the Novavax vaccine for use up to the age of 12, and several countries have allowed booster doses of the original vaccine.

Previous production difficulties sustained the vaccine, although Erck said it had been resolved and that Novavax could meet international demand. Much of the company’s vaccine, including doses for the United States, is manufactured by the Serum Institute of India, the world’s largest vaccine manufacturer.

US regulators OK New COVID firing option from Novavax

Source link US regulators OK New COVID firing option from Novavax

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