The Food and Drug Administration is adopting a new approach to new vaccines for the 199 vaccine, which will prioritize immunization at the highest risk of severe complications of the disease, but may make it harder for many others to get shots.

Under a new strategy, the new strategy will continue the current vaccine approval process for young people aged 65 and under with health problems, putting them at high risk. article Published on Tuesday New England Journal of Medicine. However, the FDA will now require vaccine manufacturers to conduct other large studies to evaluate the safety and effectiveness of vaccines for children and young healthy adults.

"We have started years of booster movements with boosters and boosters that don't trust the American public. And we don't have the science of the golden standard to support average risk, low risk Americans," Dr. Vinay PrasadThe new director of the FDA Center for Biosystem Assessment and Research said in a briefing that the new policy was explained.

Federal health officials said the steps would align the approach taken by the U.S. with the vaccines taken by other high-income countries and would be necessary to restore trust in the vaccine.

For consumers, the change may mean that everyone’s annual booster will not be automatically recommended. Instead, they will target older and younger people at health risks. For other adults and children, other studies must show that the benefits of vaccination outweigh the risks.

According to estimates cited in the magazine article, from the new approach, between 100 million and 200 million Americans are eligible for a common vaccine. This is a change with the current approach, which suggests vaccines to almost everyone.

The new approach balances flexibility and rigor, FDA says

"The FDA's new Covid-19 philosophy is a balance of regulatory flexibility and commitment to the science of gold standard," wrote Prasad and FDA Commissioner. Martin Makaryin journal articles. “The FDA will approve vaccines for those with high risk while requiring strong gold standard data for those with low risk.”

The move was welcomed by some independent public health experts.

"I find it refreshing to see the clarity of these guidelines," said Rick Bright, a former federal vaccine official. "The FDA shows that this defines the U.S. vaccination policy in comparison to a certain level of approach. U.S. vaccination policy so far. Not everyone is at the same risk, and public policy should reflect that reality."

But critics say the new demand bypasses routine input from independent external consultants and given the lot of evidence that the vaccine is safe and effective.

They also fear that regulatory actions convey a misleading message that vaccines have not been fully evaluated and will limit vaccine availability because insurers will no longer pay for footage for everyone.

Insurance companies may no longer pay for certain vaccinations

“Secretary Kennedy has made it clear that he will never take the vaccine from anyone.” Michael OsterholmIn an interview with NPR, the director of the Center for Infectious Disease Research and Policy at the University of Minnesota said that it was referring to Secretary of Health and Human Services Robert F. Kennedy Jr., who oversees the FDA. "This violates all possible violations" because if the insurance company does not pay for the vaccine, it will simply not be affordable for many people. ”

Others also pointed out that the new approach does not consider other issues, such as even younger and healthier people who can interact with each other for a long time, and immunization can reduce this risk.

"This is very important because it happens for a long time in all ages and even children, so I think vaccines should be provided to all ages," the doctor said. Peter Hotelzdean of the National School of Tropical Medicine at Baylor Medical College.

Others at low risk may themselves want to get vaccinated to protect others, such as older family members and people with weak immune systems, Hotelz said.

Many experts also believe that it is unethical to conduct a clinical study involving giving some people a placebo instead of a vaccine, because the virus may be a major threat to anyone and that the Covid vaccine has been proven to be effective.

“Given we know we know, I think it’s a valid vaccine, I think it’s immoral SARS-CoV-2 Continued circulation and resulted in hospitalization and death, no group had no risks. ” Paul OffitDirector of the Center for Vaccine Education at the University of Pennsylvania.

But Prasad believes more evidence is needed to prove that other vaccinations will benefit most young, healthy people.

"The truth is, for many Americans, we simply don't know if we should get the answer to the seventh, eighth or ninth or twelfth one booster," Prasad said.

An independent FDA advisory committee will meet later this week to discuss the composition of new Covid boosters next fall and winter.