内容摘要：He has occasionally endorsed the measles, mumps and rubella vaccine as “effective,” but also continues to raise safety concerns about the shots in other statements. In a CBS interview last week, he claimed the vaccines were “not safety tested.”

He has occasionally endorsed the measles, mumps and rubella vaccine as “effective,” but also continues to raise safety concerns about the shots in other statements. In a CBS interview last week, he claimed the vaccines were “not safety tested.”

Hoeg — along with Makary and Prasad — spent much of the COVID-19 pandemic criticizing the FDA’s handling of booster shots, particularly in children and young adults. All three were co-authors of a 2022 paper stating that requiring booster shots in young people would cause more harm than benefit.Novavax isn’t the only vaccine manufacturer already affected by changing attitudes at FDA. Earlier this month, Moderna pushed back the target date for its new COVID-and-flu combination vaccine to next year after the FDA requested additional effectiveness data.

As the FDA’s top official overseeing vaccines, Prasad is now in position to reverse what he recently called “a number of missteps” in how the FDA assessed the benefits and risks of COVID-19 boosters.He questioned how much benefit yearly vaccinations continue to offer. In a podcast shortly before assuming his FDA job, Prasad suggested companies could study about 20,000 older adults in August or September to show if an updated vaccine prevented COVID-related hospitalizations.There is “legitimate debate about who should be boosted, how frequently they should be boosted and the value of boosting low-risk individuals,” said Hopkins’ Adalja. But he stressed that CDC’s Advisory Committee on Immunization Practices has the proper expertise to be making those decisions.

And other experts say simply updating the strain that a COVID-19 vaccine targets doesn’t make it a new product — and real-world data shows each fall’s update has offered benefit.“The data are clear and compelling” that vaccination reduces seniors’ risk of hospitalization and serious illness for four to six months, said Michael Osterholm, a University of Minnesota infectious disease researcher.

Nor could that kind of study be accomplished quickly enough to get millions of people vaccinated before the yearly winter surge, said Dr. Jesse Goodman of Georgetown University, a former FDA vaccine chief.

“You’d always be doing clinical trials and you’d never have a vaccine that was up to date,” he said.— were short-lived. But the fifth xenotransplant recipient,

as prior patients, boosted the field — thriving for now 2½ months after a pig kidney transplant at NYU Langone Health in November.Doctors are moving from those one-off experiments to more formal studies. As they monitor Andrews’ recovery, doctors at Mass General Brigham have Food and Drug Administration permission to perform two additional transplants in their pilot study, using gene-edited pig kidneys supplied by biotech eGenesis.

And United Therapeutics, another developer of gene-edited pig organs, just won FDA approval for the world’s first clinical trial of xenotransplantation. Initially, six patients will receive pig kidneys — and if they fare well over six months, up to 50 additional patients will receive transplants.“This is uncharted territory,” said Mass General’s Dr. Tatsuo Kawai, who led both Andrews’ surgery and the world’s first pig kidney transplant last year. But with lessons from animal research and the prior human attempts, he said, “I’m very optimistic. And hopefully we can get to survival, kidney survival, for over two years.”