FDA Advisor Supports Novavax COVID Shot as US Fourth Option

American adults who have not been vaccinated with COVID-19 may soon have another option, as an advisor to the Food and Drug Administration on Tuesday endorsed a more traditional type of shot.

Next, the FDA needs to decide whether to license the late Novavax-produced protein vaccine as the fourth in the country. coronavirus Taken for adults.It’s made with more traditional techniques than today’s major Pfizer and Moderna shots and the lesser-used Johnson. & Johnson option.

N ovavax Shot is already available as the first vaccination or mix and match booster in Australia, Canada, parts of Europe, and several other countries. However, US approval is an important hurdle for Maryland-based companies.

Dr. Peter Markes, FDA’s head of vaccines, said another option in the United States could seduce at least some vaccines to hold up for whatever reason.

“There are very serious problems with vaccination in the United States. I feel we have to do what we can to make people more comfortable accepting these potentially life-saving products. That’s what it is. “

The FDA has finished scrutinizing the data, so the FDA’s final decision is not expected immediately.

Also, at least soon, it’s not clear how widely the Novavax vaccine will be used. According to the Centers for Disease Control and Prevention, only about 27 million US adults remain unvaccinated. Ultimately, Novavax also wants to be an option for millions of people who haven’t yet been affected by today’s booster effects. vaccinationNo matter which shot people took first.

The FDA’s advisory board voted that the benefits of the two major Novavax doses outweighed the risks, but there were many questions about Shot’s role at this point in the pandemic.

“This vaccine certainly meets some unmet needs, such as options for people who are allergic to competing shots,” said Dr. Michael Nelson of the University of Virginia.

However, he said the FDA is currently considering two adult doses when other COVID-19 vaccines require a third dose.

“This vaccine has incredible potential,” but there is still no clear evidence of how well it works against the more contagious Omicron mutants and their siblings, the Rockefeller Foundation said. Dr. Bruce Gerin, a fellow adviser, added.

Large studies in the United States, Mexico, and the United Kingdom have found that two doses of the Novavax vaccine are safe and about 90% effective in preventing symptomatic COVID-19. One complication: These studies were conducted much earlier in the pandemic.

Dr. Philip Dubovsky, Chief Medical Officer of Novavax, said the booster dose test has revived antibodies that fight viruses that may address the Omicron variant. This data will need to be reviewed by the FDA later.

“We believe that this type of vaccine produces a wide range of immune responses against a variety of mutants,” he told the FDA Advisory Board.

Although study participants generally experienced only mild reactions such as injection site pain and malaise, the FDA highlighted possible concerns: myocarditis found in 40,000 vaccinated people in the study. Six cases of heart inflammation known as.

The COVID-19 vaccine has been scrutinized for possible cardiac inflammation after Pfizer and Moderna injections were associated with its rare risk.

Novavax argued that the report had other potential causes. Other infections, including COVID-19, can also cause heart inflammation. To date, more than 744,000 vaccinations in other countries have supported shot safety, the company said.

Some FDA advisers said the Novavax vaccine should be accompanied by warnings until more is known, but be careful when comparing it to the estimated rates of rare side effects of Pfizer and Moderna shots. I’m paying.

“I don’t want to improperly stigmatize this vaccine,” said Dr. Cody Meissner of Tufts University.

The Novavax vaccine is made of a copy of the peplomer that coats the coronavirus and is packaged into virus-like nanoparticles for the immune system. Next, an immunopotentiating ingredient or adjuvant made from the bark of South American trees is added. This acts as a danger signal to make the particles look suspicious enough to provoke a strong immune response.

Protein vaccines have been used for years to prevent hepatitis B, shingles and other illnesses.

This is very different from the vaccines currently used in the United States. The most widely used Pfizer and Moderna vaccines provide the body with genetic instructions to produce a unique copy of the spike protein. J& J uses a cold virus to deliver these instructions.

Manufacturing issues prevented the Novavax vaccine, but the company said it had been resolved. Novavax, a small biotechnology company, created a vaccine in the laboratory. However, the Serum Institute of India, the world’s largest vaccine maker, produces most shots, including shots for the United States.

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The Associated Press’s Department of Health Sciences is supported by the Science Education Department of the Howard Hughes Medical Institute. AP is solely responsible for all content.