US regulators OK new COVID-19 shot option from Novavax

Gaithersburg, July 14 (BUS): The United States will get another COVID-19 vaccine, as the Food and Drug Administration on Wednesday cleared Novavax shots for adults.

Novavax makes a more conventional type of vaccine than the three other COVID-19 vaccines available for use in the United States — and it’s already available in Europe and many other countries, according to the Associated Press.

Nearly a quarter of American adults did not receive their initial vaccines until late in the pandemic, and experts expect at least some of them to roll up their sleeves for a more traditional option — a protein-based vaccine.

The Maryland company also hopes that its shots will become one of the best supporting options in the United States and abroad. Tens of millions of Americans still need boosters that experts say are necessary to provide the best possible protection as the coronavirus continues to mutate.

Currently, the Food and Drug Administration has authorized the initial dose series of Novavax for people 18 years of age or older.

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

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

Stanley Erk, chief executive of Novavax, said he expects the United States to expand use of the vaccine beyond unvaccinated adults fairly quickly.

Erk said the Food and Drug Administration is already evaluating it for those as young as 12. Novavax also provided data on booster doses, including the use of “mix and match” in people who previously received the Pfizer or Moderna vaccines.

The Biden administration has purchased 3.2 million doses of Novavax so far, and Erk said vaccinations should begin later this month.

Sharon Bentley of Argyll, Texas, is one of the strongholds. Bentley was hesitant about the first COVID-19 vaccines, but then her husband volunteered to try Novavax, receiving two doses and then a booster dose later.

Bentley said her husband’s positive experience with a more realistic, tried-and-true technique “convinced me,” adding that she plans to tell some unvaccinated friends the option as well.

The Novavax vaccine is made from copies of the spiky protein that coats the coronavirus, packaged in nanoparticles that resemble the virus in the immune system. An immune-boosting agent, or adjuvant, made from the bark of a South American tree is then added that acts as a red flag to ensure these particles look suspicious enough to elicit a strong immune response.

Protein vaccines have been used for years to prevent hepatitis B, shingles, and other diseases. It’s a completely different technology than the mainstream Pfizer and Moderna COVID-19 vaccines that provide genetic instructions for the body to produce its own versions of the Spike protein. Johnson & Johnson’s less frequently used option uses harmless cold viruses to communicate spike-making instructions.

Like other vaccines used in the United States, Novavax vaccines have been shown to be highly effective in preventing the most severe outcomes of COVID-19. Typical vaccine reactions were mild, including arm pain and fatigue. But the FDA has already warned of the possibility of a rare risk, inflammation of the heart, which has also been observed with the Pfizer and Modern vaccines.

The Novavax vaccine was tested long before the omicron variant appeared. But last month, the company released data showing that a booster dose promises a robust immune response even against omicron’s newest relative — preliminary evidence that several FDA scientific advisors have described as compelling.

However, US regulators are planning an enhanced fall campaign with Pfizer and Moderna shots that better target omicron subspecies – and Novavax has also begun testing the updated shots. Erk said the company could have updated the available doses late in the year.

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

Previous manufacturing difficulties hampered the vaccine, though Erk said those issues have been resolved and Novavax can meet global demand. Much of the company’s vaccines, including those for the United States, are produced by the Serum Institute of India, the world’s largest vaccine manufacturer.

MI