A stricter FDA policy for Covid -vaccines can limit future access

The Food and Drug Administration uses a new approach to COVID-19 vaccines that would give priority to immunisations for people with the highest risk of serious complications of the disease, but could make it more difficult for many other people to make the recordings.

The new strategy would continue the current vaccine inspection process for people aged 65 and older and younger people with health problems who bring them with a high risk, according to a article Published in Tuesday The New England Journal of Medicine. But the FDA now requires that vaccine manufacturers carry out additional large studies to evaluate the safety and effectiveness of the vaccines for children and younger healthy adults.

“We have launched this multi -year campaign from Booster na Booster after Booster and distrust of the American public. And we have no gold standard science to support this for Americans with an average risk,” Dr. Vinay Prasadsaid the new director of the FDAs Center for Biologics Evaluation and Research, during a briefing to explain the new policy.

The federal health officials say that the steps will bring the US to the approach that other countries with a high income follow to the vaccines and are necessary to restore trust in the vaccines.

For consumers, the changes can mean that annual boosters are not automatically recommended for everyone. Instead, they would be aimed at the elderly and younger people with health risks. For other adults and children, additional studies should show that the benefits of vaccination outweigh the risks.

From 100 million to 200 million Americans would be eligible for COVID vaccins under the new approach, according to an estimate that is cited in the Journal article. That is a change compared to the current approach, which recommends vaccines for almost everyone.

FDA says that the new approach balances flexibility and strictness

“The new COVID-19 philosophy of the FDA represents a balance between legal flexibility and a dedication to gold standard science,” wrote Prasad and FDA commissioner Dr. Martin MakaryIn the Journal article. “The FDA will approve vaccines for people with a high risk and at the same time demand robust, gold standard data on people with a low risk.”

The move was welcomed by some independent experts in the field of public health.

“I find it refreshing to see the clarity in these guidelines,” says Rick Bright, a former federal vaccine official. “The FDA indicates an important deviation from the One-Size-Fits-All approach that has so far largely defined the American vaccination policy. Not everyone has an equal risk and public policy should reflect that reality.”

But critics say that the new requirements circumvent the usual input of independent external advisers and are not necessary given the overwhelming evidence that Covid vaccines are safe and effective.

They are also concerned that the regulatory movement sends the misleading message that the vaccines have not been adequately evaluated and that it would limit the availability of the vaccines because insurers would no longer pay for everyone for the shots.

Insurers can no longer pay for some vaccinations

“Secretary Kennedy had made it clear that he would never remove vaccines from anyone,” Michael OsterholmDirector of the Center for Infectious Disease Research and Policy at the University of Minnesota, said in an interview with NPR, referring to the secretary Robert F. Kennedy Jr., who supervises the FDA. “This violates that in all possible ways,” because if insurance companies will not pay for the vaccine, many people simply cannot afford it. “

Others also note that the new approach does not take other issues into account, such as the fact that even younger, healthier people can become Covid and that immunization can reduce that risk.

“That is very important because Long Covid takes place in all age groups and even children and that is why I think COVID vaccines should be made available to all age groups,” says Dr. Peter HotezDean of the National School of Tropical Medicine to Baylor College of Medicine.

Others with a low risk themselves may want to be vaccinated to protect other people, such as older family members and people with a weak immune system, says Hotez.

Many experts also claim that it would be unethical to perform a clinical examination in which some people give a placebo instead of a vaccine, since the virus can pose a major threat to everyone and that COVID vaccines can be effective.

“I don’t think it’s ethical, given that we have a vaccine that works, given that we know it SARS-COV-2 Keep circulating and causing hospital admissions and death, and there is no group that has no risk, “says Dr. Paul OffitDirector of the Vaccine Education Center at the University of Pennsylvania.

But Prasad argues that more evidence is needed to prove that extra vaccinations would offer an advantage for most young, healthy people.

“The truth is that for many Americans we just don’t know the answer whether they should get a seventh or eighth or ninth or 10th COVID-19 booster,” says Prasad.

Later this week an independent The FDA consultancy will meet to discuss The composition of new Covid boosters for next fall and winter.