Food and Drug Administration (FDA) Commissioner Marty Makary said the agency is conducting an investigation into whether the COVID-19 jab caused deaths in children. According to The Epoch Times reporter Zachary Stieber, a report is expected within a few weeks. New: FDA investigating deaths among children from COVID-19 vaccines, will publish a report within a few weeks, commissioner says. https://t.co/xI5j0bH4W8 — Zachary Stieber (@ZackStieber) September 5, 2025 More from STAT News: In an interview with CNN’s Jake Tapper, Makary said his staff is looking into deaths of young healthy children from the Covid vaccine. He did not share specific data linking pediatric deaths to the vaccine, instead pointing to self reports in the FDA’s vaccine safety database. Self-reported adverse events in the FDA’s vaccine database do not definitively prove that the person’s symptoms were caused by the vaccines. Makary’s comments, however, indicated that he thinks the reports are evidence enough. “The American people deserve to see the data on children who died from the Covid vaccine,” Makary said. Watch part of the interview with CNN’s Jake Tapper: The American people deserve to see the data on children who died from the Covid vaccine. pic.twitter.com/TqG2ZLdo9E — Dr. Marty Makary (@DrMakaryFDA) September 5, 2025 “A lot of people report vaccine injury,” Makary told told “Elizabeth Vargas Reports,” according to NewsNation. “A lot of people report complications, including children who have died from the vaccine. So we can’t just be blind,” he added. FDA Commissioner Marty Makary says new COVID-19 vaccine guidelines will follow a science-based approach, and that his agency is “encouraging an open dialogue.” MORE: https://t.co/OXqMcf0tRM pic.twitter.com/nhGI5ePFzJ — NewsNation (@NewsNation) September 3, 2025 NewsNation provided further info: Access to a COVID-19 vaccine is now more limited than it was four years ago. The FDA also recently narrowed its criteria for who qualifies for the vaccine and Makary wrote an op-ed explaining why the administration doesn’t support COVID-19 boosters forever. Makary told NewsNation that it all comes down to two crucial questions. “The American people want to know, are we supposed to keep going like this?” he said. “[And] do the benefits outweigh the risks? That is the question.” Makary said, “we have an agreement … with the large vaccine makers that make the COVID vaccine that they will conduct a randomized control placebo trial and have those results back to us by May.” The new study, which will begin this winter, will hopefully provide answers to whether the benefits outweigh the risks of the vaccine moving forward. Watch additional coverage from NewsNation: