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| Photo: frederic j. brown/Agence France-Presse/Getty Images |
HHS to Stop Recommending Routine Covid Shots for Children, Pregnant Women
The Trump administration is planning to drop recommendations that pregnant women, teenagers and children get Covid-19 vaccines as a matter of routine, according to people familiar with the matter.
The Department of Health and Human Services, led by Secretary Robert F. Kennedy Jr., is expected to remove the Centers for Disease Control and Prevention’s recommendations for those groups around the same time it launches a new framework for approving vaccines, the people said.
The exact timing of the announcement wasn’t clear, the people said, though it was expected in the coming days.
The CDC currently recommends that everyone six months and older, including pregnant women, should receive Covid-19 vaccines. It wasn’t clear if the department is planning to remove the recommendation for Covid-19 shots entirely for those groups, or just suggest that patients talk with their doctors about risks and benefits.
Spokespeople for HHS, CDC and the White House didn’t immediately respond to requests for comment.
Kennedy has long been a foe of the Covid-19 vaccines and petitioned the Food and Drug Administration in 2021 to revoke their emergency-use authorizations. Trump appointees working closely with him have also been critics of the shots, especially those that use messenger-RNA technology or are authorized for use in children.
“Separate from my role as a regulator at the FDA, I am not encouraging or insisting young, healthy children to get a Covid shot unless there is new evidence that emerges that suggests there is a clear benefit,” FDA Commissioner Dr. Marty Makary said Thursday. --->READ MORE HERE (or HERE)
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| Michel Euler/AP |
FDA Commissioner Marty Makary said his agency plans to release a new framework for vaccine approvals in “coming days.”
The head of the Food and Drug Administration said the agency will soon unveil a new framework detailing what companies must do to seek approval of vaccines, a move that comes as the Trump administration has introduced uncertainty into the annual process for green-lighting updated coronavirus shots traditionally offered in the fall.
“We want to be very transparent,” FDA Commissioner Marty Makary said Thursday during a conference of the Food and Drug Law Institute, a nonprofit organization. “We want to create a framework for vaccine makers that they can use so they have a predictable FDA where they don’t have to worry how is this going to be received.”
The FDA is a massive agency charged with regulating a vast array of products, including reviewing the safety and efficacy of vaccines and approving the shots. Makary said the framework will probably be introduced in the “coming days” and suggested that it would take the form of a guidance to companies so that they know the agency’s approach to vaccine approvals.
When asked by reporters, Makary did not offer more details about the framework or what it would mean for updates to the coronavirus shot. The agency’s expert advisers are set to meet next week to make recommendations on selecting the formula vaccine makers should use to update their shots to target the strain of the virus currently circulating in the country.
Robert F. Kennedy Jr., the secretary of the Department of Health and Human Services, has said he intends to shift the way vaccines are tested.
Earlier this month, HHS told The Washington Post that all new vaccines will be required to undergo placebo testing, a process where some people receive the vaccines while others receive an inert substance, such as a saline shot, to compare results. Kennedy, who has a long history of disparaging vaccines and seeking placebo-controlled studies for shots that are already approved for use in the United States, has argued that he is simply seeking good data about vaccines. --->READ MORE HEREFollow links below to relevant/related stories and resources:
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