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The director of the Food and Drug Administration’s vaccine division told agency staff in a memo that an internal review found that at least 10 children died “after and because of receiving” the Covid vaccine. The 3,000-word memo, obtained by NBC News, was written by Dr. Vinay Prasad, director of the FDA’s Center for Biologics Evaluation and Research. In it, Prasad claims that agency staff determined that “no fewer than 10” of 96 child deaths reported to the Vaccine Adverse Event Reporting System, or VAERS, between 2021 and 2024 were “related” to Covid vaccination. He said the true numbers could be higher, accusing the agency of ignoring the safety concerns for years. The memo, sent Friday, did not include the children’s ages or medical histories, timelines or documentation for the deaths he references and does not identify the manufacturer of the vaccine. The FDA’s findings have not been published in a peer-reviewed journal. Experts push back Experts who reviewed the memo say it is misusing information from VAERS, an unverified reporting system that allows anyone, including doctors, patients and caregivers, to submit entriesabout adverse events they believe are linked to vaccines. The system’s own website warns that submissions can contain inaccurate, incomplete or biased information. “This is sort of science by press release,” said Dr. Paul Offit, a pediatrician and the director of the Vaccine Education Center at the Children’s Hospital of Philadelphia, calling the memo “irresponsible” and “dangerous.” “This is a profound revelation,” Prasad wrote in the memo. “For the first time, the U.S. FDA will acknowledge that COVID-19 vaccines have killed American children.” Prasad suggests that the child deaths were tied to myocarditis, an inflammation of the heart muscle, but doesn’t include evidence to support the claim. The FDA directed all media inquiries to the Department of Health and Human Services. An HHS spokesperson did not immediately respond to a request for comment. Dr. Peter Marks, the FDA’s former vaccine chief who was ousted by Health Secretary Robert F. Kennedy Jr. earlier this year, said the agency is misusing the database and the claims are right out of what he calls the “anti-vaccine playbook.” The FDA uses the database to look for early “signals” — patterns that might suggest a possible safety issue, Marks told NBC News. It was one of the tools the agency used to identify a rare blood clotting condition linked to Johnson & Johnson’s Covid vaccine, he said. The mRNA Covid vaccines, from Pfizer and Moderna, have also been linked to a small but increased risk of myocarditis in young men. Most cases have been found to be mild and resolve within a few days. Marks said the FDA is not reviewing new safety reports but instead re-examining older ones and appears to be classifying some of them as vaccine-related. He added that Covid infection is also associated with myocarditis — and is often more severe than cases seen after vaccination. “This memo conveys a very troubling mixture of misrepresentation and lies,” Marks said. “The climate within the agency is incredibly toxic right now.” Health & Science Nov 20 Without evidence, CDC changes messaging on vaccines and autism Vaccines Oct 25 Is it time for your flu shot? What to know about effectiveness and how long it lasts Proposed changes The memo uses highly ideological language, repeatedly characterizing Covid vaccine requirements for schools and employers as “coercive,” calling past agency decisions “dishonest,” and arguing that vaccine regulation “may have harmed more children than we saved.” At one point, Prasad instructs staff who disagree with his conclusions to resign. He outlined a series of proposed changes to how the FDA evaluates vaccines. He said the agency would revisit how annual flu shots are evaluated, calling the current process an “evidence-based catastrophe of low quality evidence.” He also said pneumonia vaccine makers “will have to show their products…

A mass shooting at a birthday party left four people dead and several hospitalized Saturday evening, the San Joaquin County Sheriff’s Office said. Deputies responded to the 900 block of Lucile Avenue shortly before 6 p.m. regarding reports of a shooting, according to the sheriff’s office. Officials said 14 people were shot, and four of them are dead. The victims were found at the banquet hall, according to authorities. The Vice Mayor of Stockton, Jason Lee, said the shooting happened during a child’s birthday party. The victims are juveniles and adults, according to officials. “Tonight, my heart is heavy in a way that’s hard to put into words. As Vice Mayor of Stockton — and as someone who grew up in this community — I am devastated and angry to learn about the mass shooting at a child’s birthday party. An ice cream shop should never be a place where families fear for their lives,” Lee wrote. The sheriff’s office said the suspect or suspects involved in the incident have not been identified and added that this might have been a targeted incident. This story uses functionality that may not work in our app. Click here to open the story in your web browser.

Both the House and Senate have started inquiries into a reported second strike on an alleged drug boat in the Caribbean last September which killed the survivors of an initial strike. According to reporting from The Washington Post, which cited “two people with direct knowledge of the operation,” Defense Secretary Pete Hegseth allegedly gave a spoken order to kill everyone on board a vessel suspected of carrying drugs on Sept. 2 — the first strike of nearly two dozen on other vessels in the region since that day. Additionally, The Post said its reporting “is based on interviews with and accounts from seven people with knowledge of the Sept. 2 strike and the overall operation.” The Post reported that after an initial strike showed two survivors, the commander overseeing the attack reportedly ordered a second strike to kill them. NBC News has not independently confirmed The Washington Post’s reporting. The top Republican and Democrat on the GOP-led Senate Armed Services Committee said in a statement Friday that the committee was aware of recent reports. “The Committee has directed inquiries to the [Department of Defense], and we will be conducting vigorous oversight to determine the facts related to these circumstances,” Sens. Roger Wicker, R-Miss., and Jack Reed, D-R.I., said in the statement. The Republican-led House Armed Services Committee followed suit Saturday, with Reps. Mike Rogers, R-Ala., and Adam Smith, D-Wash., issuing a joint statement in which they said the House Committee is “committed to providing rigorous oversight of the Department of Defense’s military operations in the Caribbean.” Trump Administration Nov 2 U.S. military strikes alleged drug boat in the Caribbean killing 3, Pete Hegseth says United Kingdom Nov 12 U.K. withholds intelligence on alleged drug boats over U.S. strikes, sources say “We take seriously the reports of follow-on strikes on boats alleged to be ferrying narcotics in the SOUTHCOM region and are taking bipartisan action to gather a full accounting of the operation in question,” Rogers and Smith wrote. The Pentagon did not immediately respond to NBC News’ request for comment Saturday night on the committees’ statements or on The Post’s reporting. However, chief Pentagon spokesperson Sean Parnell told The Post in a statement that “this entire narrative is completely false.” He told the newspaper that the “ongoing operations to dismantle narcoterrorism and to protect the Homeland from deadly drugs have been a resounding success.” Hegseth posted on X Friday evening that the strikes were intended to be “lethal, kinetic strikes.” “The declared intent is to stop lethal drugs, destroy narco-boats, and kill the narco-terrorists who are poisoning the American people. Every trafficker we kill is affiliated with a Designated Terrorist Organization,” Hegseth wrote. “Our current operations in the Caribbean are lawful under both U.S. and international law, with all actions in compliance with the law of armed conflict—and approved by the best military and civilian lawyers, up and down the chain of command,” he added. The committees’ statements come amid President Donald Trump’s administration mounting pressure on Venezuela, as Trump weighs military action against the country following nearly two dozen known strikes on vessels in the region, which have killed at least 82 people. Trump on Saturday morning said Venezuela’s airspace should be considered “closed.” The strikes have raised concerns in Congress about a lack of information from administration officials. Trump last month indicated that his administration will not seek congressional approval for targeting drug traffickers, saying, “I think we’re just gonna kill people that are bringing drugs into our country.” “We’re going to kill them. They’re going to be, like, dead,” Trump added. Brennan Leach and Kyle Stewart contributed.

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