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Future access could be limited by stricter FDA policy for COVID vaccines

Do we really need a booster of COVID-19? Comment on FDA’s new guidelines on vaccines for people with a weak immune system

“For some Americans, we don’t know if they should be getting a seventh or eighth or ninth or tenth COVID-19 booster.” he says.

The rate of covid-related hospital stays was reported to the HHS by hospitals, but not since May of last year. Vaccines are an important safeguard for people with a weakened immune system. The FDA’s new directive raises questions about whether people considered healthy will be able to get vaccinated if they want to protect someone close to them who’s at greater risk.

The changes may mean that annual boosters aren’t always recommended for everyone. Instead, they would be aimed at older people and younger people with health risks. If additional studies show the benefits of vaccinations, then other adults and children would be willing to take the risks.

We launched down this multiyear campaign of distrust and booster after booster of the American public. The FDA does not have gold-standard science to support the new policy, according to a new director of the Center for Biologics Evaluation and Research.

The federal health officials say the steps will bring the U.S. in line with the approach that other high-income countries take towards the vaccines and are necessary to restore trust in the vaccines.

According to a journal article, up to 200 million Americans would be eligible for the COVID vaccine under the new approach. That’s a change from the current approach, which recommends vaccines for almost everyone.

Rick Bright, a former federal vaccine official, finds the clarity of the guidelines refreshing. “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. Not everyone is at equal risk and public policy should reflect that reality.”

The new requirements do not require any assistance from independent advisers and are unnecessary due to the evidence that the vaccine works, according to critics.

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 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 people with weak immune systems may want to be protected from other people, says Hotez.

It is not ethical to give a placebo in a clinical study for a vaccine given the fact that the virus can be a major threat to everyone and the fact that COVID vaccines have shown to be effective.

A comment on the CDC secretary of vaccine policy, Dr. Paul Offit, told The Associated Press: “Vaccines are available and insurable” if you are a woman and you are likely to get a

I am a senior science reporter and have been for more than a decade. She is also the host of Hell or High Water: When Disaster Hits Home , a podcast from Vox Media and Audible Originals.

“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.

The commentary said that they don’t know whether a woman who has had three Covid-19 shots will benefit from the seventh dose.

But previous CDC studies have shown that getting a booster can help prevent mild to moderate cases of covid up to six months after getting the shot regardless of whether a person is at higher risk or not, Offit tells The Associated Press. Even if a person does get sick, it is possible to be vaccine free and get less severe illness, according to the CDC.

“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.

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