NBC News
Food and Drug Administration Officials (FDA) will present next week that, they say, relate to COVID-19 vaccines with the death of 25 children, confirmed a source to NBC News, Telemundo News sister chain.
The report, which The Washington Post first reported, will be presented at an expected meeting with the Federal Agency on Vaccines Advisory Committee.
The Advisory Committee on Vaccination Practices (ACIP) of the Centers for Disease Control and Prevention (CDC) plans to meet Thursday and Friday to review and formulate recommendations on several vaccines, including those used against COVID-19, updated for this fall.
The FDA bases its statement on deaths on a data analysis of the notification system of adverse reactions to vaccines (VAers), a public access base that carry the FDA and CDC, according to three sources familiar with discussions.
However, according to two of the sources, the agency is making improper use of the database, which allows any person – including doctors, patients and caregivers – to record reports on adverse events that they consider related to vaccines. Those reports are not verifiedbut health agencies use the database as a guide for issues that require more thoroughly investigate.
Dorit Reiss, an expert in vaccination policy of the Law School of the University of California in San Francisco, said that the data base reports cannot demonstrate a relationship between vaccination and the death of children.
“To identify the causality of a vaccine it is necessary to demonstrate that the cause of death was somewhat caused by the vaccine and, on its own, a VAers report would not prove it; broader studies are needed that compare the incidents of damage with and without the vaccine,” he said in an email.
In a statement, Andrew Nixon, spokesman for the Department of Health and Human Services, said: “FDA staff and CDC periodically analyze the VAERS data and other security control data, and those reviews are shared publicly through the process established by the ACIP.”
Last week, the FDA Commissioner Marty Makary told CNN chain that the agency was investigating the deaths of healthy children after receiving vaccines against the Coronavirus.
“We have been investigating the VAers reports of reports that indicate that there have been children who have died because of the COVID-19 vaccine,” Makary said. “We are going to publish a report in the coming weeks and we will make it known to people. We are carrying out an exhaustive investigation.”
The Vaers website warns that reports They can contain inaccurate, incomplete or biased information. “As a result, there are limitations regarding the scientific use of the data. VAers report data should always be interpreted taking into account these limitations.”
The Washington Post reported that Makary’s special advisor, Dr. Tracy Beth Høeg, a sports medicine specialist who criticized vaccines against COVID-19 for children during the pandemic, present the new findings at the meeting of the vaccine committee next week.
An former FDA official, who asked to remain in anonymity to be able to speak freely, rejected the findings.
“I can tell you with all certainty that we review all autopsies reports and we found nothing,” said the official in a text message. “Unless someone has hidden them, I don’t know what they mean.”
Research on vaccines
Numerous studies have shown that vaccines against COVID-19 are safe in children and also reduce the risk of hospitalization and death.
An analysis of 2023 published in Jama Pediatrics reviewed 17 studies, which included more than 10 million children between 5 and 11 years old who were vaccinated with Pfizer and Modern HRNM vaccines. It was shown that vaccines reduce the risk of infection and hospitalization in vaccinated children, compared to those who were not vaccinated.
Another study, published in Nature Communications in 2024, did not find a greater risk of adverse effects on young children who received vaccines against COVID-19, including those of Pfizer and Modern. A small increase in myocarditis risk, an inflammation of the heart, in male adolescents after the first two doses, was observed.
At a meeting of the FDA Advisory Committee held in May, Pfizer presented real data on his Vaccine against COVID-19, including tens of thousands of children 6 months or more, and concluded that the vaccine was safe and reduced the risk of hospitalization and death. The pharmaceutical company also noted that there are around a dozen studies after approval that evaluate vaccines in more than 60 million people worldwide.
Pfizer and Modern did not respond immediately to a request for comments.
Anti -Vacunas activists have been pointing out the VAers data as proof that vaccines are dangerous, but definitive conclusions cannot be drawn only from the Vaers reports.
The Secretary of Health and Human Services (HHS), Robert F. Kennedy Jr., anti -vaccine activist for a long time, made reference to the database during an audience of the Senate Finance Committee last week.
“There were more reports to Vaers, which is the only surveillance system that we have of injuries and deaths from that vaccine, than all vaccines together in history,” Kennedy said, referring to the Vaccine against COVID-19.
During the summer, Kennedy dismissed all the members of the ACIP and replaced them by members chosen by himself, some of whom are known anti -vacuum activists. The American Pediatrics Academy described Kennedy’s new members as a “radical deviation” of the mission of the Committee to protect children.
One of the new panel members, Resef Levi, has been designated to direct the working group on the Vaccine against COVID-19 of the panel. Levi is a professor at the Massachusetts Technology Institute and is not a doctor. He has affirmed that vaccines against coronavirus cause serious damage and death.
Any recommendation that is made during the ACIP meeting could influence who can receive the COVID-19 vaccine.
Kennedy has already taken measures to limit access to this year’s vaccine: last month, he announced that the FDA had approved vaccines against updated COVID-19 for autumn for people 65 years of age or older and those with underlying medical conditions. Limited approval has left some confused patients and pharmacies, and some patients reported that they have not been able to receive vaccines.
In an opinion article published last week in The Wall Street Journal, Makary said that approval equals the United States with other similar countries, such as France, which recommends vaccines against COVID-19 for people over 80 years, and the United Kingdom, which does so for people over 75 years.
“The FDA can only approve products if we believe that there is a substantial certainty that the benefits exceed the risks,” Makary wrote, questioning whether the benefits of a “seventh vaccine against COVID-19″ currently exceed the risks for a “12-year-old healthy girl who has recently recovered from the crown.”
