US regulators fix new Covid-19 shot option from Novavax – Times of India

Washington: America is getting another Kovid-19 Vaccination The choice was approved on Wednesday as the Food and Drug Administration novavax Shots for adults.
Novavax makes a more traditional type of shot 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 still haven’t received their primary vaccinations late in the pandemic, and experts expect at least some of them to roll up their sleeves for a more traditional alternative — a protein-based vaccine.
The Maryland company also hopes its shots could become a top booster option in the US and beyond. Millions of Americans still need boosters, which experts say are vital for the best possible protection as the coronavirus continues to mutate.
for now, FDA The initial two-dose series of Novavax is authorized for people 18 years of age and older.
“I encourage anyone who is eligible, but has not yet received a COVID-19 vaccine,” FDA Commissioner Dr Robert Califf said in a statement.
Before the shots begin, the Centers for Disease Control and Prevention should make recommendations on how they should be used, with a decision expected next week.
Novavax CEO Stanley Erk told The Associated Press that he expects the US to expand the use of the vaccine to unvaccinated adults much sooner.
Already the FDA is evaluating it for people under the age of 12, Erck said. Novavax has also accumulated data on booster doses, including “mix-and-match” use in people who have previously received a Pfizer or Moderna vaccination.
The Biden administration has purchased 3.2 million Novavax doses so far, and Erk said vaccination should begin later this month.
Sharon Bentley of Argyle, Texas, is one of the holdouts. Bentley was hesitant about COVID-19 vaccines at first, but then her husband volunteered for the Novavax trial to receive two doses and a booster later.
Bentley said her husband’s positive experiences with a more tried-and-true technique, “which reassured me,” said she also planned to tell some unaffiliated 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 in the immune system.
Then there’s an immune-boosting ingredient, or adjuvant, made from the bark of a South American tree, which acts as a red flag to make sure those particles are there to spark a strong immune response. Looks suspicious enough.
Protein vaccines have been used for years to prevent hepatitis B, shingles, and other diseases.
It is a very different technology than the flagship Pfizer and modern COVID-19 vaccines that give the body genetic instructions to make its own copies of the spike protein. The lesser-used Johnson & Johnson alternative uses a harmless cold virus to deliver spike-making instructions.
Like other vaccines used in the US, Novavax shots have proven highly effective in preventing the most severe consequences of Covid-19.
Typical vaccine reactions were mild, including arm pain and fatigue. But the FDA warned about the potential for a rare risk, heart inflammation, that has also been seen with Pfizer and Moderna vaccines.
The Novavax vaccine was tested long before the Omron version came out. But last month, the company released data showing a booster dose promised a strong immune response even against Omicron’s newest relatives — preliminary evidence that many of the FDA’s scientific advisers called compelling.
Still, U.S. regulators Pfizer and Moderna are planning a decline-enhancing campaign using shots that target better Omicron subtypes — and Novavax has begun testing the updated shots, too. Erck said the company could update available dosages at the end of the year.
European regulators recently approved the Novavax vaccine for use at age 12, and several countries have authorized booster doses of its original vaccine.
Manufacturing difficulties previously halted the vaccine, although Erck said they have been resolved and that Novavax can meet global demand.
Most of the company’s vaccines, including doses for the US, are being manufactured by Serum Institute of India, the world’s largest vaccine manufacturer.