WASHINGTON — Two of the Food and Drug Administration’s top vaccine regulators will leave the agency this fall, a development that could disrupt its work on deciding whether to recommend coronavirus vaccines for children under 12 and booster shots for the general population.Dr. Marion Gruber, the director of the F.D.A.’s vaccines office, will retire at the end of October, and her deputy, Dr. Philip Krause, will leave in November, according to an email that Dr. Peter Marks, the agency’s top vaccine regulator, sent to staff members on Tuesday morning. One reason is that Dr. Gruber and Dr. Krause were upset about the Biden administration’s recent announcement that adults should get a coronavirus booster vaccination eight months after they received their second shot, according to people familiar with their thinking.Neither believed there was enough data to justify offering booster shots yet, the people said, and both viewed the announcement, amplified by President Biden, as pressure on the F.D.A. to quickly authorize them.Dr. Marks said he would serve as the acting director of the vaccines office while the agency searched for its next leader. Stephanie Caccomo, a spokeswoman for the agency, said it was “confident in the expertise and ability of our staff to continue our critical public health work.”Some public health experts have said the administration’s booster shot announcement, which did include a caveat that the F.D.A. would first have to authorize such shots, undermined the agency’s responsibility to make that assessment on its own schedule, led by career scientists. Since Mr. Biden took office in January, the White House has made a point of saying it would not influence the F.D.A.’s work.Some outside experts have also challenged the booster plan as premature, saying the available data shows that the Pfizer-BioNTech and Moderna vaccines are holding up well against severe disease and hospitalization, including against the Delta variant. Extra shots would be warranted only if the vaccines failed to meet that standard, some have said.White House officials have stressed that the plan for Americans to start receiving boosters next month was uniformly endorsed by the most senior federal health officials, including Dr. Janet Woodcock, the acting F.D.A. commissioner. They have described the need to develop a booster plan as urgent in light of growing evidence that the vaccines lose potency over time — a trend that they fear suggests the vaccines’ protection against severe disease and hospitalization will also soon weaken..css-1xzcza9{list-style-type:disc;padding-inline-start:1em;}.css-3btd0c{font-family:nyt-franklin,helvetica,arial,sans-serif;font-size:1rem;line-height:1.375rem;color:#333;margin-bottom:0.78125rem;}@media (min-width:740px){.css-3btd0c{font-size:1.0625rem;line-height:1.5rem;margin-bottom:0.9375rem;}}.css-3btd0c strong{font-weight:600;}.css-3btd0c em{font-style:italic;}.css-w739ur{margin:0 auto 5px;font-family:nyt-franklin,helvetica,arial,sans-serif;font-weight:700;font-size:1.125rem;line-height:1.3125rem;color:#121212;}#NYT_BELOW_MAIN_CONTENT_REGION .css-w739ur{font-family:nyt-cheltenham,georgia,'times new roman',times,serif;font-weight:700;font-size:1.375rem;line-height:1.625rem;}@media (min-width:740px){#NYT_BELOW_MAIN_CONTENT_REGION .css-w739ur{font-size:1.6875rem;line-height:1.875rem;}}@media (min-width:740px){.css-w739ur{font-size:1.25rem;line-height:1.4375rem;}}.css-9s9ecg{margin-bottom:15px;}.css-uf1ume{display:-webkit-box;display:-webkit-flex;display:-ms-flexbox;display:flex;-webkit-box-pack:justify;-webkit-justify-content:space-between;-ms-flex-pack:justify;justify-content:space-between;}.css-wxi1cx{display:-webkit-box;display:-webkit-flex;display:-ms-flexbox;display:flex;-webkit-flex-direction:column;-ms-flex-direction:column;flex-direction:column;-webkit-align-self:flex-end;-ms-flex-item-align:end;align-self:flex-end;}.css-12vbvwq{background-color:white;border:1px solid #e2e2e2;width:calc(100% - 40px);max-width:600px;margin:1.5rem auto 1.9rem;padding:15px;box-sizing:border-box;}@media (min-width:740px){.css-12vbvwq{padding:20px;width:100%;}}.css-12vbvwq:focus{outline:1px solid #e2e2e2;}#NYT_BELOW_MAIN_CONTENT_REGION .css-12vbvwq{border:none;padding:10px 0 0;border-top:2px solid #121212;}.css-12vbvwq[data-truncated] .css-rdoyk0{-webkit-transform:rotate(0deg);-ms-transform:rotate(0deg);transform:rotate(0deg);}.css-12vbvwq[data-truncated] .css-eb027h{max-height:300px;overflow:hidden;-webkit-transition:none;transition:none;}.css-12vbvwq[data-truncated] .css-5gimkt:after{content:'See more';}.css-12vbvwq[data-truncated] .css-6mllg9{opacity:1;}.css-qjk116{margin:0 auto;overflow:hidden;}.css-qjk116 strong{font-weight:700;}.css-qjk116 em{font-style:italic;}.css-qjk116By: Noah Weiland and Sharon LaFraniere
Title: Two Top F.D.A. Vaccine Regulators Are Set to Depart During a Crucial Period
Sourced From: www.nytimes.com/2021/08/31/us/politics/fda-vaccine-regulators.html
Published Date: Tue, 31 Aug 2021 22:51:21 +0000
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