Future access to COVID vaccines may be limited by a stricter FDA policy

Why should American children get their COVID-19 booster? Critics of the new NEJM and OSHA director, Dr. Prasad,

“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.

In the new NEJM, FDA officials say that they will approve vaccines for high-risk persons and also demand robust,gold-standard data on persons at low risk.

The dean of the National School of Tropical Medicine at the Baylor College of Medicine believes that the vaccine should be available to all age groups.

“We have launched down this multiyear campaign of booster after booster after booster and distrust of the American public. “We don’t have good science to support the new policy for average-risk Americans,” said Dr. Prasad, the FDA’s Center for Biologics Evaluation and Research director.

The federal health officials say the steps will bring the United States in line with other high income countries that use a different approach to the vaccines.

In an article published in the NEJM, the FDA noted that only 25% of the US population get the shot each year. “There may even be a ripple effect: public trust in vaccination in general has declined,” it says.

“Secretary Kennedy had made it clear that he would never take vaccines away from anyone,”  Michael Osterholm, director of the Center for Infectious Disease Research and Policy at the University of Minnesota, said in an interview with NPR, referring to Health and Human Services Secretary Robert F. Kennedy Jr., who oversees the FDA. “This violates that in every way possible” because if insurance companies won’t pay for the vaccine many people simply won’t be able to afford it.”

But critics say the new requirements bypass the usual input from independent outside advisers and are unnecessary given the overwhelming evidence that COVID vaccines are safe and effective.

They worry that the regulatory move sends a misleading message that the vaccines have not been adequately evaluated and that insurers will no longer pay for the shots for everyone, so there will be less access to them.

Others also note that the new approach doesn’t take other issues into account, such as the fact that even younger, healthier people can get long COVID and that immunization can reduce that risk.

Older family members and weak immune systems could be at risk if others at low risk weren’t given vaccines, Hotez says.

It would be unethical to give some people a placebo instead of a vaccine, given that the viruses can be a major threat to anyone and COVID vaccines have been shown to be effective, according to many experts.

Marks Resigned from the CDC in December 2015 after a 15-year War on Covid-19, a Commentary on Offit

is a senior science reporter covering energy and the environment with more than a decade of experience. She is a host of Hell or High Water: When Disaster hits home as well as a radio show.

“The only thing that can come of this will make vaccines less insurable and less available,” Paul Offit, a vaccine scientist, virologist, and professor of pediatrics at the Children’s Hospital of Philadelphia, told The Associated Press.

“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.

In the past, studies have shown that a booster shot can help prevent some types of covidies up to six months after getting it, even if you aren’t 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.

Peter Marks, the director of the FDAs Center for Biologics Evaluation and Research, resigned because he said that truth and transparency were not desired by the Secretary.