Trump administration health officials are reportedly planning to link the Covid vaccines and the deaths of over two dozen children.
The FDA said Friday it is examining the rare deaths of 25 young people after they received their Pfizer or Moderna Covid vaccines and is seeking data on the safety of the shots for pregnant women.
According to anonymous sources close to the situation, health officials under the Trump administration plan to include claims about pediatric deaths in a presentation next week to a panel of CDC advisors that is currently evaluating Covid vaccine recommendations.
Four anonymous sources who spoke to The Washington Post on the condition of anonymity said the findings appear to be based on information submitted to the Vaccine Adverse Event Reporting System (VAERS), a voluntary database for reporting vaccine side effects.
Patients, doctors, pharmacists and people who see a report on social media are all able to submit a VAERS report and they are unverified.
The CDC has emphasized that the database is not designed to assess if a shot was directly responsible for a death or other adverse side effect, as this requires more thorough investigation.
VAERS has received 1,600 reports particularly about myocarditis, inflammation around the heart muscle, being linked to the shots, but federal figures show the side effect is extremely rare and only occurs in one in 125,000 shots.
However, they told the Post that the presentation to the CDC's Advisory Committee on Immunization Practices (ACIP) is not final, and the full methodology for the analysis was not immediately clear.
The FDA said Friday it is examining the rare deaths of 25 young people after they received their Pfizer or Moderna Covid vaccines and is seeking data on the safety of the shots for pregnant women (stock photo)
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The plans to investigate pediatric deaths come amid a period of nationwide division on Covid vaccine recommendations. While states like Florida have banned all mandates, a handful of democratic states have issued their own guidelines allowing anyone to get the shot.
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Current recommendations state the vaccine is available to anyone over 65 or younger people with an underlying condition that would make them more vulnerable to Covid infections, such as asthma or being immunocompromised.
Department of Health and Human Services (HHS) Secretary Robert F Kennedy Jr, a longtime vaccine skeptic who has criticized the US's approach to Covid shots, told health officials in May to stop recommending the shots for healthy children.
However, the American Academy of Pediatrics recommends annual Covid shots for children ages six to 23 months and older children if their parents choose.
And scientists have said the vaccines are safe and effective in children and a Covid infection may pose a higher health risk.
FDA Commissioner Dr Marty Makary told CNN last week that officials were investigating reports of possible childhood deaths linked to the vaccine, including reviewing autopsy reports and interviewing patients' families.
The move comes as Robert F Kennedy Jr (pictured here with President Donald Trump) has called for the Covid shot to no longer be recommended for healthy children
HHS spokesperson Andrew Nixon told the Washington Post in an email: 'FDA and CDC staff routinely analyze VAERS and other safety monitoring data, and those reviews are being shared publicly through the established ACIP process.
'Any recommendations on updated COVID-19 vaccines will be based on gold standard science and deliberated transparently at ACIP next week.'
The panel's integrity has recently been in question, however, after Kennedy fired its members and appointed his own picks, many of whom are also vaccine skeptics.
The CDC has acknowledged that myocarditis and pericarditis, inflammation of the sac-like lining surrounding the heart, are known Covid vaccine complications, but has emphasized they are rare and has not provided an exact number of cases.
A recent FDA analysis estimated the conditions occur in one in 125,000 doses of the 2023-2024 shots for children and adults under 65. But for young men under 25, the risk was 19 per 500,000, or the equivalent of one in 250.
The FDA estimates myocarditis and pericarditis occurred in one in 125,000 doses of the 2023-2024 Covid shots. Past studies, as shown above, have estimated a risk of between one in 50,000 and one in 200,000
With myocarditis, it's thought that the immune system may register mRNA in Covid vaccines as a threat, leading the immune system to attack itself and cause inflammation of the myocardium, the heart's muscle.
This same mechanism has been linked to pericarditis, which leads to inflammation of the pericardium, the sac surrounding the heart.
Both conditions have been linked to viruses like the common cold and hepatitis, as well as Covid.
While most cases are mild, in rare instances, myocarditis can damage the heart and make it difficult for it to pump blood, eventually leading to heart failure, heart attack, and stroke.
Currently, there is no conclusive evidence of deaths in the US directly caused by myocarditis from Covid vaccines.