US health officials are reportedly planning to release data on child deaths and serious side effects they would attribute to Covid-19 vaccines, raising alarm among public health experts who say the publicly available data does not support these claims and the report may lead to increased anti-vaccine sentiment.
Independent advisers for the US Centers for Disease Control and Prevention (CDC) later this week plan to revisit recommendations for Covid shots as well as vaccines for measles and hepatitis B.
The move is part of a larger effort to cast doubt on vaccines and reduce access to them, said David Gorski, a professor of surgery and oncology at Wayne State University who has tracked anti-vaccine activism for decades.
Robert F Kennedy Jr, secretary of the US Department of Health and Human Services (HHS), is a longtime anti-vaxxer who continues to make sweeping, controversial changes to the US vaccine program, Gorski said.
“RFK Jr wants to take away your vaccines,” he said.
Officials are looking at 25 reports of pediatric deaths following Covid vaccination, apparently stemming from the crowdsourced database known as the Vaccine Adverse Event Reporting System (VAERS), according to reporting by the Washington Post.
Yet years of data and research show that Covid vaccinations are safe and effective.
“Covid vaccination involved much larger numbers of people receiving vaccines than we’ve had for anything in history,” said Anne Schuchat, a former principal deputy director of the CDC.
Using VAERS to cast doubt on the safety of vaccines is a decades-long anti-vax tactic, and research has shown a spike in reports related to litigation, Gorski said.
While the system can help discover red flags, Schuchat noted it can’t be used to demonstrate causality.
“Anybody can report into it,” she said – including patients, family members, lawyers, friends and people on social media. One doctor successfully submitted a report on his transformation into the Incredible Hulk.
The child deaths report is expected to be presented at the meeting of the CDC’s Advisory Committee on Immunization Practices (ACIP) later this week.
Staff at the CDC and the US Food and Drug Administration (FDA) “routinely analyze VAERS and other safety monitoring data, and those reviews are being shared publicly through the established ACIP process”, said Andrew Nixon, HHS spokesperson, in a statement to the Guardian.
“Until that is shared publicly, any of this should be considered pure speculation.”
ACIP will vote on three shots – the measles, mumps, rubella, and varicella (MMRV) vaccine, the hepatitis B vaccine given at birth, and Covid vaccines – and it will also hold votes for the Vaccines for Children program, which provides shots to nearly half of children in the US.
It’s not clear what the ACIP votes will entail, but experts believe some of the shots may be restricted and others may lose their recommendation, which would affect insurance coverage – especially from Medicaid and Medicare.
“If it’s not on the CDC recommended schedule, then insurance companies don’t have to pay for it,” Gorski said. “Federal government programs like Medicare and Medicaid will not pay for it, the Vaccines for Children program will not pay for it. Now, insurance companies might decide to pay for it anyway, at least within the FDA guidelines, but there’s no guarantee that they all will.”
On Monday, days before the ACIP meeting is set to begin, HHS announced five more advisers, some of whom have a history of troubling statements on vaccines and infectious disease.
There are other safety systems to flag side effects, like the Vaccine Safety Datalink, that are confirmed by medical records and also provide comparisons to understand if an unanticipated adverse event is linked to vaccines, Schuchat said. It’s not clear if the report will pull from these sources.
“We are getting the data that was never made available before, including adverse event data,” Marty Makary, head of the FDA , told CNN earlier this month.
Those possible adverse events include “young people who have died from the Covid vaccine”, he added. “And we’re going to make that available to the medical community in full transparency, because this is the question that Americans are asking.”
Kennedy’s team at HHS reportedly requested full access to VAERS, including the ability to modify the database.
“We allowed them to have read access but would not give them write access,” said Peter Marks, the former vaccines chief at FDA.
Reports of death, especially among children, would be “the top priority” for health officials, said Gorski.
Any reports of serious side effects are investigated by officials at the CDC and FDA, said Schuchat.
“There is a deep look into the death of a child or particularly worrisome reports,” she said.
Now, the FDA seems to be reopening these reports. It’s not clear whether the FDA is doing anything differently with these investigations now, or how they would reclassify deaths as vaccine-related.
“Anything’s possible,” Schuchat said. “We’re in new territory right now.”
FDA could also temporarily pull the licenses of Covid vaccines while it investigates potential events, or it could add a black-box warning about the purported risks of the vaccine.
Yet the FDA recently granted full licensure to Covid vaccines without raising concerns about credible safety issues.
Changes to the CDC’s recommendations could instead limit the vaccines until most people can’t access them, Gorski said. “My fear is that within a year, the Covid vaccines will be gone, for all intents and purposes.”
Anti-vax officials seem to view the Covid shots as a “test case” or a template for restricting access to other vaccines, Gorski said, before adding that the hepatitis B vaccine currently given at birth may lose its recommendation as soon as this week.
More than 1,000 current and former HHS employees have called for Kennedy’s resignation because of moves like this – including Schuchat.
“It’s really scary, the actions he’s taking and the people he seems to be trusting,” she said of Kennedy. “This person has so much authority right now.”
