The Food and Drug Administration adopts a new approach to assess and approve COVID vaccines.
Deb Cohn-Orbach / Universal Images Group Editorial / Getty Images
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Deb Cohn-Orbach / Universal Images Group Editorial / Getty Images
The Food and Drug Administration is adopting a new approach to COVVI-19 vaccines that would favor vaccinations for those most at risk of serious complications of the disease, but could make more difficult for many other people to get the gunshots.
The new strategy would continue the current approval of the vaccine for people aged 65 and over and the youngest with health problems that put them at high risk, according to a Article published Tuesday in The New England Journal of Medicine. But the FDA will now require vaccine manufacturers to put additional additional studies to assess the safety and efficiency of vaccines for healthy children and young adults.
“We have launched this multi -year campaign to booster after Booster after Booster and Mistrust towards the American public. And we do not have a standard golden science to support this for the Americans at medium and low risk,” said Dr. Vinay Prasad, the new director of the new FDA policy.
Federal health officials claim that the stages will put the United States according to the approach that other high-income countries adopt towards vaccines and are necessary to restore confidence in vaccines.
For consumers, changes may mean that annual boosters would not be automatically recommended for everyone. Instead, they would target the elderly and young people with health risks. For other adults and children, additional studies should show that the benefits of vaccination prevail over risks.
From 100 million to 200 million Americans would be eligible for vaccines treated as part of the new approach, according to an estimate cited in the journal article. This is a change from the current approach, which recommends vaccines for almost everyone.
The FDA says that the new approach balances flexibility and rigor
“The new COVVI-19 philosophy of the FDA represents a balance of regulatory flexibility and a commitment to the standard sciences,” wrote PRASAD and the FDA commissioner, Dr. Martin Makary, in the journal article. “The FDA will approve vaccines for high -risk people and, at the same time, will require robust and standard data on low -risk people.”
This decision was greeted by certain 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 signals a major gap in relation to the unique approach which is largely defined the American vaccination policy so far. Not everyone is at an equal risk and public policy should reflect this reality.”
But criticisms say that the new requirements are bypassing the usual contributions of independent external advisers and are not necessary given the overwhelming evidence that ceremonial vaccines are safe and effective.
They also fear that the regulatory move sends the misleading message that the vaccines have not been properly evaluated and that this would limit the availability of vaccines because insurers would no longer pay for fire for everyone.
Insurers may no longer pay for certain vaccinations
“Secretary Kennedy had clearly indicated that he would never move away from vaccines,” said Michael Osterholm, director of the Center for Infectious Disease Research and Policy at the University of Minnesota, in an NPR interview, referring to the Secretary of Health and Social Services Robert F. Kennedy Jr., who survives the FDA. “This violates this in any possible way” because if the insurance companies will not pay for the vaccine, many people simply cannot afford it. “”
Others also note that the new approach does not take into account other problems, such as the fact that even younger and healthier people can become long and that vaccination can reduce this risk.
“It is very important because Long Covid performs in all age groups and even children and, therefore, I think that COVIVS vaccines should be made available to all age groups,” said Dr. Peter Hooz, dean of the National School of Tropical Medicine at the Baylor College of Medicine.
Others at low risk themselves may want to be vaccinated to protect other people, such as older family members and those who have a low immune system, says Hooz.
Many experts also argue that it would be contrary to the ethics of carrying out a clinical study which involves giving some people a placebo instead of a vaccine, since the virus can be a major threat for anyone and that vaccines are comfortable have proven to be effective.
“I do not think that it is ethical, since we have a vaccine that works, since we know that Sars-Cov2 continues to circulate and cause hospitalizations and death, and there is no group that has no risk,” explains Dr. Paul Offit, director of the Vaccines Education Center of the University of Pennsylvania.
But Prasad argues that more evidence is necessary to prove that additional vaccinations would offer an advantage to most young and healthy.
“The truth is that for many Americans, we just don’t know if where they should get a seventh or eighth or ninth or 10th Booster COVID-19,” said PRASAD.
Later this week, an independent FDA advisory committee will meet to discuss the composition of new boosters wearing for fall and winter next.
