\n<\/p>\n
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.<\/p>\n
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.<\/p>\n
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.<\/p>\n
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.<\/p>\n
\u201cRFK Jr wants to take away your vaccines,\u201d he said.<\/p>\n
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.<\/p>\n
Yet years of data and research show that Covid vaccinations are safe and effective.<\/p>\n
\u201cCovid vaccination involved much larger numbers of people receiving vaccines than we\u2019ve had for anything in history,\u201d said Anne Schuchat, a former principal deputy director of the CDC.<\/p>\n
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.<\/p>\n
While the system can help discover red flags, Schuchat noted it can\u2019t be used to demonstrate causality.<\/p>\n
\u201cAnybody can report into it,\u201d she said \u2013 including patients, family members, lawyers, friends and people on social media. One doctor successfully submitted a report on his transformation into the Incredible Hulk.<\/p>\n
The child deaths report is expected to be presented at the meeting of the CDC\u2019s Advisory Committee on Immunization Practices (ACIP) later this week.<\/p>\n
Staff at the CDC and the US Food and Drug Administration (FDA) \u201croutinely analyze VAERS and other safety monitoring data, and those reviews are being shared publicly through the established ACIP process\u201d, said Andrew Nixon, HHS spokesperson, in a statement to the Guardian.<\/p>\n
\u201cUntil that is shared publicly, any of this should be considered pure speculation.\u201d<\/p>\n
ACIP will vote on three shots \u2013 the measles, mumps, rubella, and varicella (MMRV) vaccine, the hepatitis B vaccine given at birth, and Covid vaccines \u2013 and it will also hold votes for the Vaccines for Children program, which provides shots to nearly half of children in the US.<\/p>\n
It\u2019s 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 \u2013 especially from Medicaid and Medicare.<\/p>\n
\u201cIf it\u2019s not on the CDC recommended schedule, then insurance companies don\u2019t have to pay for it,\u201d Gorski said. \u201cFederal 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\u2019s no guarantee that they all will.\u201d<\/p>\n
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.<\/p>\n
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\u2019s not clear if the report will pull from these sources.<\/p>\n
\u201cWe are getting the data that was never made available before, including adverse event data,\u201d Marty Makary, head of the FDA , told CNN earlier this month.<\/p>\n
Those possible adverse events include \u201cyoung people who have died from the Covid vaccine\u201d, he added. \u201cAnd we\u2019re going to make that available to the medical community in full transparency, because this is the question that Americans are asking.\u201d<\/p>\n
Kennedy\u2019s team at HHS reportedly requested full access to VAERS, including the ability to modify the database.<\/p>\n
\u201cWe allowed them to have read access but would not give them write access,\u201d said Peter Marks, the former vaccines chief at FDA.<\/p>\n
Reports of death, especially among children, would be \u201cthe top priority\u201d for health officials, said Gorski.<\/p>\n
Any reports of serious side effects are investigated by officials at the CDC and FDA, said Schuchat.<\/p>\n
\u201cThere is a deep look into the death of a child or particularly worrisome reports,\u201d she said.<\/p>\n
Now, the FDA seems to be reopening these reports. It\u2019s not clear whether the FDA is doing anything differently with these investigations now, or how they would reclassify deaths as vaccine-related.<\/p>\n
\u201cAnything\u2019s possible,\u201d Schuchat said. \u201cWe\u2019re in new territory right now.\u201d<\/p>\n
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.<\/p>\n
Yet the FDA recently granted full licensure to Covid vaccines without raising concerns about credible safety issues.<\/p>\n
Changes to the CDC\u2019s recommendations could instead limit the vaccines until most people can\u2019t access them, Gorski said. \u201cMy fear is that within a year, the Covid vaccines will be gone, for all intents and purposes.\u201d<\/p>\n
Anti-vax officials seem to view the Covid shots as a \u201ctest case\u201d 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.<\/p>\n
More than 1,000 current and former HHS employees have called for Kennedy\u2019s resignation because of moves like this \u2013 including Schuchat.<\/p>\n
\u201cIt\u2019s really scary, the actions he\u2019s taking and the people he seems to be trusting,\u201d she said of Kennedy. \u201cThis person has so much authority right now.\u201d<\/p>\n","protected":false},"excerpt":{"rendered":"
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