pfizer shot :: Article CreatorRFK Jr. Rolls Back Covid Vaccine Recommendations For Healthy Children, Pregnant People
Health secretary Robert F. Kennedy Jr. Announced Tuesday that he has unilaterally struck the recommendation that healthy children and healthy pregnant people get Covid-19 booster shots — a move that experts say is unprecedented.
Kennedy made the announcement on the social media site X, flanked by Jay Bhattacharya, director of the National Institutes of Health, and Marty Makary, the commissioner of the Food and Drug Administration.
"It's common sense, and it's good science," said Bhattacharya, whose agency has no involvement in the regulation of vaccines, or in decisions on who should get them.
Absent from the video was anyone from the Centers for Disease Control and Prevention, which sets policy for who should get approved vaccines based on the advice of its expert panel, the Advisory Committee on Immunization Practices. The CDC is currently without an acting director.
Several sources have told STAT neither the CDC nor the ACIP was consulted on or alerted to the announcement before the video announcement was posted to Kennedy's X account.
As of Tuesday afternoon, the CDC's website still listed Covid vaccines in the pediatric vaccination schedule, the instructions for health care providers of which vaccines children and pregnant people ought to get, and at which time.
The CDC hasn't published any information on RFK Jr.'s changes, including what conditions would make a pregnant person or child healthy or unhealthy. It's also not clear how the move affects the primary series of Covid shots, given to babies as young as six months, a point at which they may have no immunity to Covid.
It is extraordinary that a health secretary would remove vaccines from a CDC vaccination schedule without undergoing a consultation process, and without asking the advice of the ACIP, said Dorit Reiss, a law professor at UC Law San Francisco who follows vaccination policy closely. "There is a process, and it hasn't been followed," Reiss told STAT in an interview. She suggested the lack of process could make the decision vulnerable to being overturned, if it is challenged in court. A court would demand that such a change in policy was the result of a deliberative process, she said. "Administrative decisions actually have to be made on the basis of something, not just because the agency feels like it," Reiss said. "A one-minute video on Twitter is not a thorough explanation." Kathryn Edwards, a vaccines expert who is a former member of the ACIP and a professor emeritus at Vanderbilt University, was also critical of Kennedy's move. "He's overstepped his bounds," she said. Reiss noted that in a New England Journal of Medicine article last week announcing a new approach to use of Covid booster shots, Makary and Vinay Prasad, who oversees the FDA's Center for Biologics Evaluation and Research, listed pregnancy as one of the medical conditions that warrants Covid vaccination. The American College of Obstetricians and Gynecologists expressed dismay about the policy announcement, saying it will put pregnant people and their babies at increased risk from Covid. "It is very clear that Covid infection during pregnancy can be catastrophic and lead to major disability, and it can cause devastating consequences for families," the organization said in a statement. "The Covid vaccine is safe during pregnancy, and vaccination can protect our patients and their infants." The organization cited CDC data that showed in 2022-2023 and 2023-2024, the vast majority of babies who were hospitalized for Covid infection had been born to unvaccinated mothers. "Following this announcement, we are worried about our patients in the future, who may be less likely to choose vaccination during pregnancy despite the clear and definitive evidence demonstrating its benefit," ACOG said. "We are concerned about access implications, and what this recommendation will mean for insurance coverage of the Covid vaccine for those who do choose to get vaccinated during pregnancy." Kennedy's decision to remove booster shots from the schedule of recommended vaccines does not make them entirely unavailable, but it could affect whether insurers cover them. Under the Affordable Care Act, most health plans have to cover vaccines recommended by ACIP at no cost to patients. This included the Covid vaccines. Some insurers may decide not to cover Covid vaccines for pregnant women and children, Reiss said, suggesting the result will likely be a patchwork, with some insurance companies retaining coverage and others dropping it. If a person has to pay out of pocket for a Covid booster, the price tag is steep, especially for young children. The pharmacy chain CVS charges $198.99 per dose. When young children who have never been vaccinated against Covid get their primary series, they must get two doses, if they are getting the Moderna vaccine, and three doses, if they are getting the Pfizer shot. Reiss also said that even for parents who want to vaccinate their children, and pregnant people who want to get boosters, there may be confusion on the part of health professionals who give vaccines as to whether vaccination is permitted. Beyond politics, even U.S. Vaccine experts may envision fewer Covid shots in the future
Michael Osterholm, director of the University of Minnesota's Center for Infectious Disease Research and Policy, noted that Kennedy's decision is in contradiction to a promise he made during his Senate confirmation process that he would not take vaccines away from people who want them.
The decision comes at a time when the ACIP has been in the process of reviewing who should get Covid vaccines. A subcommittee of the group that focuses on Covid vaccination policy indicated last month that it intends to recommend that the current universal vaccination recommendation be replaced with one that urges people at high risk of severe illness if they contract Covid to continue to be vaccinated. The full committee is expected to vote on the proposed change when it meets in late June.
"It seems like an end run around the normal process, around the normal transparency where you get outside expert input, and perhaps also around the scientists and the agency as we don't hear anything of what the reasoning was for this decision," said Jesse Goodman, a former FDA chief scientist who is now director of Georgetown University's Center on Medical Product Access, Safety and Stewardship. "All the existing data shows that these vaccines can help protect children and they can help protect pregnant women and they can help protect even infants after they're born if pregnant women are vaccinated. So I'm pretty taken aback by this."
A vaccine researcher who has served on ACIP but who asked not to be named said Kennedy's move to pre-empt the committee's vote on the issue was a violation of the pledge he made during his Senate confirmation hearing not to interfere with the ACIP.
"Kennedy promised that ACIP would be left alone. Updating the schedule of recommended vaccines without ACIP advice breaks the pledge completely. RFK is making a fool out of Senator [Bill] Cassidy," the individual said, referring to the Republican senator — a pro-vaccines physician — who extracted a series of promises from Kennedy in exchange for supporting his nomination.
In a break from precedent, The American Academy of Pediatrics was not consulted on the decision, according to Sean O'Leary, who chairs its committee on infectious diseases. Normally the AAP aligns its recommendations with ACIP, but "now that HHS has made this decision, we may have to rethink how we harmonize with the federal government," he said.
He added: "ACIP goes through all the data, makes evidence-based decisions based on the data they use, what's called the evidence to recommendations framework. This recommendation essentially completely ignores that."
Though final details of the recommendation the ACIP will vote on haven't yet been made public, it appears the Covid vaccine subcommittee will suggest that people over age 65; people at high risk because of medical conditions — including pregnant people; and very young children should still be urged to be vaccinated. It is likely the new recommendation — if approved by the full committee and the CDC director — would stipulate that other people could be vaccinated against Covid if they wish.
Anil Oza and Bob Herman contributed reporting.
Pfizer Scientist Claimed COVID Vax Results Being Delayed Until After 2020 Election 'wasn't A Coincidence': House GOP Panel
WASHINGTON — The release of COVID-19 vaccine results after the 2020 election may have not been a "coincidence" — and could have been part of an effort by senior Pfizer executives to "deliberately slow down" the testing, according to bombshell allegations from a Republican-led congressional panel.
The House Judiciary Committee revealed Thursday that Pfizer's former Global Head of Vaccines Research and Development, Dr. Philip Dormitzer, may have "conspired to withhold public health information to influence" the presidential contest between Donald Trump and Joe Biden.
The London-based drugmaker GSK in an April 16 letter to Judiciary Chairman Jim Jordan (R-Ohio) disclosed that Dormitzer "approached a representative from the GSK human resources team to speak about a potential relocation abroad" in November 2024.
he release of COVID-19 vaccine results days after the 2020 election may have not been a "coincidence" — and could have been part of an effort by senior Pfizer executives to "deliberately slow down" the testing, a House panel alleged. Frank – stock.Adobe.Com
According to the HR rep, the ex-Pfizer vaccine scientist was "visibly upset" in the meeting and asked to be moved to Canada "due to concerns that he could be investigated by the incoming Trump Administration over his role in developing Pfizer's COVID-19 vaccine."
When the GSK employee asked what his reasons were for requesting the relocation, Dormitzer apparently responded: "Let's just say it wasn't a coincidence, the timing of the vaccine."
Pfizer used independent experts to review the effectiveness and safety of its vaccines and broadcast the results being shared by its scientists just five days after polls closed for the 2020 election on Nov. 3.
GSK also divulged in the letter that some of its employees heard from the scientist "in late 2020, the three most senior people in Pfizer R&D were involved in a decision to deliberately slow down clinical testing so that it would not be complete prior to the results of the presidential election that year."
But the drugmaker, in its letter, also denied that Dormitzer was copping to "delaying disclosure of completed results," characterizing his statements as being part of "a situation of slowing down results before disclosure became necessary."
The Judiciary panel still fired off a pair of letters to Dormitzer and Pfizer's chairman and CEO, Dr. Albert Bourla, on Thursday demanding all records — including emails, texts, meeting notes and other documents — showing data from the clinical trials or communications with federal public health agencies.
"My Pfizer colleagues and I did everything we could to get the FDA's Emergency Use Authorization at the very first possible moment," Dormitzer said in March in response to the allegations. Bloomberg via Getty Images
"This new information appears to suggest that you and other senior Pfizer executives conspired to withhold public health information to influence the 2020 presidential election," Jordan wrote to Dormitzer.
"Due to the seriousness of these allegations, the Committee is compelled to request additional information to inform our oversight."
The responsive files are supposed to cover the period between March 2020 and the present, per the letters.
Jordan's panel has also demanded Dormitzer — schedule a transcribed interview no later than May 29.
The House Judiciary Committee alleged that the former head of Global Head of Vaccines Research and Development may have "conspired to withhold public health information to influence" the 2020 election. AP
Dormitzer has only contributed to Democratic campaigns, federal election campaign filings show, forking over hundreds of dollars in the 2010s to congressional candidates while working in vaccine development at Novartis.
His comments to GSK employees were first made in the course of a federal probe by Manhattan prosecutors, which, along with the Judiciary letters, was first reported by The Wall Street Journal.
The scientist has denied that he or anyone at Pfizer tried to delay the vaccine, and said his comments to his colleagues at GSK were misinterpreted.
Dormitzer's comments to GSK employees were first made in the course of a federal probe by Manhattan prosecutors, which, along with the Judiciary letters, was first reported by The Wall Street Journal. LightRocket via Getty Images
"My Pfizer colleagues and I did everything we could to get the FDA's Emergency Use Authorization at the very first possible moment," Dormitzer previously told Reuters in a statement amid the investigation by the US Attorneys' Office for the Southern District of New York.
"Any other interpretation of my comments about the pace of the vaccine's development would be incorrect."
"Pfizer is in receipt of the letter asking about allegations made in a Wall Street Journal story, and we will respond directly to the Committee," a rep for the pharmaceutical company said in a statement.
President Trump has touted how "proud" he was of "Operation Warp Speed" being able to get Americans vaccinated against COVID. Getty Images
"The COVID-19 vaccine development process was driven by science and guided by the U.S. FDA back in 2020," the rep added.
"We have consistently and transparently reiterated the facts and the timeline of the tireless work of scientists, regulators, and thousands of clinical trial volunteers who made the vaccine possible. Theories to the contrary are simply untrue and being manufactured."
Reps for GSK did not immediately respond to a request for comment.
President Trump has touted how "proud" he was of "Operation Warp Speed" being able to get Americans vaccinated from COVID, with the purchase of 200 million doses of Pfizer's vaccine and 200 million doses of the Moderna shot.
US Drops COVID Vaccine Recommendations For Healthy Children, Pregnant Women
By Manas Mishra and Michael Erman
(Reuters) -The U.S. Has stopped recommending routine COVID-19 vaccinations for pregnant women and healthy children, Health Secretary Robert F. Kennedy Jr announced in a social media post on Tuesday, circumventing the CDC's traditional recommendation process.
Kennedy, FDA commissioner Marty Makary and National Institutes of Health director Jay Bhattacharya said in a video that the shots have been removed from the Centers for Disease Control and Prevention's recommended immunization schedule.
The changes come a week after they unveiled tighter requirements for COVID shots, effectively limiting them to older adults and those at risk of developing severe illness.
Traditionally, the CDC's Advisory Committee for Immunization Practices would meet and vote on changes to the immunization schedule or recommendations on who should get vaccines before the director of the CDC made a final call. The committee has not voted on these changes.
Kennedy, a long-time vaccine skeptic whose department oversees the CDC, has been remaking the U.S. Health system to align with President Donald Trump's goal of dramatically shrinking the federal government.
"Last year, the Biden Administration urged healthy children to get yet another COVID shot despite the lack of clinical data to support repeat booster strategy in children," Kennedy said in the video.
The CDC, following its panel of outside experts, previously recommended updated COVID vaccines for everyone aged six months and older.
Insurers said they are reviewing the regulatory guidance to determine their policies, which typically follow the ACIP recommendations.
A spokesperson for CVS Health said the company is determining whether changes in health insurance coverage are required as the federal government reassesses COVID-19 vaccine eligibility, while a Blue Cross Blue Shield Association spokesperson said preventative health benefits, including COVID vaccines, are essential in keeping patients healthy.
'TURNED UPSIDE DOWN'
"The recommendation is coming down from the secretary, so the process has just been turned upside down," said William Schaffner, professor of infectious diseases at Vanderbilt University Medical Center and a consultant to the ACIP.
Schaffner said the CDC's panel was to vote on these issues at a June meeting, where he had expected them to favor more targeted shots instead of a universal vaccine recommendation. "But this seems to be a bit preemptory," he said.
Dorit Reiss, professor of law at UC Law San Francisco, said in a Facebook post that going around the advisory committee might hurt the agency in the case of potential litigation.
Studies with hundreds of thousands of people around the world show that COVID-19 vaccination before and during pregnancy is safe, effective, and beneficial to both the pregnant woman and the baby, according to the CDC's website.
But Makary said in the video that there was no evidence that healthy children need routine COVID shots. Most countries have stopped recommending it for children, he added.
COVID vaccine makers Moderna and Pfizer did not respond to requests for comment.
Dr. Cody Meissner, professor of pediatrics at Dartmouth who co-wrote an editorial with Makary during the COVID pandemic against masks for children, said he agreed with the decision.
He said he felt the U.S. Had been overemphasizing the importance of the COVID vaccine for young children and pregnant women, and that previous recommendations were based on politics, adding that the severity of the illness generated by the virus seems to have lessened over time in young children.
(Reporting by Manas Mishra in Bengaluru and Michael Erman in New York; Editing by Arun Koyyur, Maju Samuel and Bill Berkrot)
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