FDA requirements for future COVID vaccines could affect access: recordings

The Food and Drug Administration is pursuing a new approach for COVID-19 vaccines that prioritize vaccinations for people with the highest risk of serious complications from the disease, but could make it more difficult for many other people to get the recordings.

The new strategy would continue the current vaccination agreement for people aged 65 and younger people with health problems, which they expose a high risk according to A Article Published on Tuesday in The New England Journal of Medicine. The FDA now requires the vaccine manufacturer to carry out additional large studies in order to evaluate the safety and effectiveness of vaccines for children and younger healthy adults.

“We started this multi-year campaign from Booster to Booster to Booster and distrust of the American public. And we have no gold standard science to support this for average risk-risk Americans,” Dr. Dr. Vinay PrasadThe new director of the FDA Center for Biological Assessment and Research said during a briefing to explain the new directive.

The federal health officers say that the steps will bring the USA in line with the approach that other countries with high incomes are necessary in the vaccines and to restore trust in the vaccines.

For consumers, the changes could mean that annual boosters are not automatically recommended for everyone. Instead, they are aimed at older people and younger people with health risks. For other adults and children, additional studies would have to demonstrate the advantages of vaccination.

From 100 million to 200 million Americans, according to an estimate, which was listed in the article of the Journal article, would be considered for Covid vaccines as part of the new approach. This is a change compared to the current approach that vaccines recommends for almost everyone.

FDA says that the new approach compensates for flexibility and strict

“The FDA’s new COVID-19 philosophy is a balance of regulatory flexibility and commitment to gold standard science,” wrote Prasad and FDA Commissioner Dr. Martin Makaryin the journal article. “The FDA approves vaccines for high -risk opera and at the same time demands robust, gold standard data on people with little risk.”

The move was welcomed by some independent public health experts.

“I find it refreshing to recognize the clarity in these guidelines,” says Rick Bright, a former official of the federal vaccine. “The FDA signals a great departure from the uniform approach that has largely defined the previous vaccination policy of the US vaccines. Not everyone is the same risk and public order should reflect this reality.”

However, critics say that the new requirements deal with the usual input from independent external consultants and, given the overwhelming evidence that Covid vaccines are safe and effective, are unnecessary.

They also fear that the regulatory move sends the misleading message that the vaccines were not adequately evaluated and that the availability of the vaccines would not restrict the availability, since the insurers would no longer pay for the recordings for everyone.

Insurers may no longer pay for vaccinations

“Secretary Kennedy had made it clear that he would never take away 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 and referred to the secretary for health and human services, Robert F. Kennedy Jr., who monitors the FDA. “This violates this in every respect”, because if insurance companies do not pay the vaccine, many people simply cannot afford it. “

Others also find that the new approach does not take any other problems into account, such as the fact that younger, healthier people become long covid and that immunization can reduce this risk.

“This is very important because long covid occurs in all age groups and even children and I think that Covid vaccines should be made available to all age groups,” says Dr. Peter HodezDean of the National School of Tropical Medicine at the Baylor College of Medicine.

Others with little risk themselves may want to vaccinate to protect other people, such as: B. older family members and people with a weak immune system, says Hotez.

Many experts also argue that it would be unethical to carry out a clinical study in which some people would give placebo instead of a vaccine, since the virus can be a major threat to everyone and covid vaccines.

“I don’t think it’s ethical because we have a vaccine that works because we know that SARS-CoV-2 Circulates and causes hospitalization and death, and there is no group that has no risk, ”says Dr. Paul OffitDirector of the vaccination training center at the University of Pennsylvania.

However, Prasad argues that further evidence is necessary to prove that additional vaccinations would benefit most young, healthy people.

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

Later this week an independent one The FDA advisory committee will meet to discuss The composition of new Covid booster for next autumn and winter.