Officials of Food and Drug Administration are planning to present data they claim the COVID vaccine to 25 deaths in children at which is expected to view a closely viewed vaccine advice committee next week, a source confirmed to NBC News.
The Washington Post First reported the expected data.
The Advisation Practices of Acip of the Centers for Disease Control and Prevention is planned to meet on Thursday and Friday to assess and make recommendations about various vaccines, including the updated COVID recordings of this fall.
The FDA bases its claim on an analysis of data from the vaccine side operating event reporting system, or VAERS, a publicly available database that is maintained by the FDA and the CDC, according to three sources that are familiar with the plan.
But, two of the sources, said that the agency abuses the database with which everyone – including doctors, patients and caregivers – can submit reports to Vaers about side effects that they believe are linked to vaccines. The reports have not been verified, but the health agencies use the database as a manual for topics to investigate further.
Dorit Reiss, an expert in vaccine policy at the University of California Law, San Francisco, said that the database reports could not prove a connection between vaccination and killing children.
The Centers for Disease Control and Prevention have issued a new warning in which travelers encourage not to fly unless they are vaccinated against measles.
“To identify the connection for a vaccine, you must prove that the cause of death was something that caused the vaccine, and in itself a VAERS report would not show that you need larger studies in which incidents of the damage with or without the vaccine are compared,” she said in an e -mail.
In a statement, Andrew Nixon, a spokesperson for the Ministry of Health and Human Services, said,
Last week, FDA commissioner Marty Makary told CNN That the agency investigated the death of healthy children from the shots of the Covid.
“We looked at the VAERS database with self-reports that there have been children who died of the Covid vaccine,” Makary said. “We will release a report in the coming weeks and we will let people know. We are doing an intense investigation.”
The Vaers -website Warnings that reports may contain incorrect, incomplete or favored information. “As a result, there are limitations to how the data can be used scientifically. Data from VAERS reports must always be interpreted with these limitations in mind.”
The Washington Post reported The special adviser of Die Makary Dr. Tracy Beth HøegA doctor for sports medicine who criticized Covid shots for children during the pandemic is expected to present the new findings during the vaccine Committee meeting of next week.
A former FDA officer, who asked an anonymity to speak freely, pushed back on the findings.
“I can tell you in a pile of Bibles that we have looked through all autopsy reports and that we have not found anything,” said the official in an SMS. “Unless someone hid for us, I don’t know what to refer to.”
Research into Covid -vaccines and side effects
Numerous studies have shown that the COVID recordings are safe in children and also reduce their risk of hospitalization and death.
An analysis of 2023 Published in Jama Pediatrics Assessed 17 studies, including more than 10 million children aged 5 to 11 who were vaccinated with the MRNA recordings of Pfizer and Moderna. The shots were found to reduce the risk of infection and hospitalization in vaccinated children, compared to children who have not been vaccinated.
Another study, Published in Nature Communications In 2024 there was no increased risk of side effects in young children who received COVID recordings, also from Pfizer and Moderna. It found a small increased risk of myocarditis, a heart infection, in male teenagers after the first two doses.
During an FDA Advisory Committee meeting in May, Pfizer Practical data presented On the Covid vaccine, including tens of thousands of children aged 6 months and older, it discovered that the shot was safe and reduced the risk of hospitalization and death. The medicine maker also noted that there are about a dozen studies after approval that evaluate the safety of the shots among more than 60 million people worldwide.
Pfizer and Moderna did not immediately respond to a request for comments.
Anti-vaccin activists have long pointed to VAERS data as proof that vaccines are dangerous, but definitive conclusions can not only be drawn from VAERS reports.
Health and Human Services Secretary Robert F. Kennedy. Jr., an old anti-vaccin activist, referred to the database during a hearing of the Senate Finance Committee last week.
“There were more reports to Vaers, the only security system we have about injuries and deaths because of that vaccine than all vaccines in history,” said Kennedy, referring to the Covid vaccine.
In the summer, Kennedy All members of Acip fired And they replace them with his own chosen members, some of whom are known anti-vaccin activists. The American Academy of Pediatrics called the new members of Kennedy a ‘Stadical Departer’From the committee’s mission to protect children.
One of the new panel members, RETTEF LEVI, has been tapped to lead the working group of the panel. Levi is a professor of the Massachusetts Institute of Technology and is not a doctor. He has claimed that Covid -vaccines cause serious damage and death.
All recommendations made during the ACIP meeting can influence who can get a Covid shot.
Kennedy has already taken steps to limit access to this year’s vaccine: last month he announced that the FDA had approved updated Covid shots for the fall for people 65 and higher and people with underlying medical conditions. The limited approval has confused some patients and pharmacies and some patients report that they have not been able to get the recordings.
In A Wall Street Journal Op-ED published Last week Makary said that approval brings the US in line with peer countries, including France, who recommends Covid shots for people over 80, and the UK, which recommends the shots for people over 75.
“The FDA can only approve products if we believe that there is a substantial certainty that the benefits outweigh the risks,” Makary wrote, wondering whether the benefits of a “seventh shot” are currently outweighing the risks for a “healthy 12-year-old girl recently recovered from Covid.”
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