The FDA is signaling a significant departure from the one-size-fits-all approach to vaccine development in the U.S.

“The truth is that for many Americans we simply do not know the answer to whether or they should be getting a seventh or eighth or ninth or 10th COVID-19 booster,” Prasad says.

The FDA says it will require more data from additional clinical trials before approvals can be granted for covid-19 vaccines being developed for people not considered to be at heightened risk from severe sickness. 100 to 200 million Americans will still have annual access to covid vaccines after the policy change. That would be less than 60 percent of the US population.

The new strategy would continue the current vaccine approval process for people ages 65 and older and younger people with health problems that put them at high risk, according to an article published Tuesday in The New England Journal of Medicine. Vaccine manufacturers will have to conduct more large studies to evaluate the safety and effectiveness of vaccines for children and younger healthy adults.

We have launched down a multiyear campaign of distrust of the American public. The new director of the FDA’s Center for Biologics Evaluation and Research explained that they have no “gold standard science” to support the new policy.

The steps taken by the federal health officials will make the U.S. a better place to live, and will help reestablish trust in the vaccines.

In the NEJM article, the FDA notes that covid booster uptake has been low in the US, with less than a quarter of people getting the shot each year. Public trust in vaccinations has weakened, and that may even be a result of this.

The clarity of the guidelines is refreshing according to Rick Bright, a former federal vaccine official. “The FDA is signaling a major departure from the one-size-fits-all approach that’s largely defined the U.S. vaccination policy until now. Public policy should reflect the reality that not everyone is at equal risk.

Proponents say that the new requirements are unnecessary and that the overwhelmingly positive evidence that the COVID vaccine is safe and effective is irrelevant.

They also worry the regulatory move 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 the shots for everyone.

Others note that the new approach doesn’t take into account the fact that even younger people can get long COVID and that immunization can reduce that risk.

Others at low risk themselves may want to get vaccinated to protect other people, such as older family members and those with weak immune systems, Hotez says.

Many experts also argue that it would be unethical to perform a clinical study that involves giving some people a placebo instead of a vaccine, given that the virus can be a major threat to anyone and COVID vaccines have been shown to be effective.

Reply to the Secretary of the FDA on Covid-19 Vaccines and Implications for Prevention and Epidemic Prevention, and an Associated Press Comment on Offit

is a senior science reporter covering energy and the environment with more than a decade of experience. She is the host of Hell or High Water: When Disasterhits Home, which is in addition to her other work.

Paul Offit, a vaccine scientist, assistant professor of pediatrics, and professor of vaccine research at the Children’s Hospital of Philadelphia, told The Associated Press that the only thing this will do is make vaccines less insurable and less available.

“We simply don’t know whether a healthy 52-year-old woman with a normal BMI who has had Covid-19 three times and has received six previous doses of a Covid-19 vaccine will benefit from the seventh dose,” the NEJM commentary says.

The CDC has shown that a booster shot can prevent some mild tomoderate cases of covidence for up to six months even if a person is not at higher risk. And even if someone does get sick, being vaccinated can make the illness shorter and less severe and reduce the risk of developing long covid, according to the Centers for Disease Control and Prevention.

“It has become clear that truth and transparency are not desired by the Secretary, but rather he wishes subservient confirmation of his misinformation and lies,” Peter Marks, former director of the FDA’s Center for Biologics Evaluation and Research (CBER) that regulates vaccines, wrote in a resignation letter in March.