FDA Wants Pfizer, Moderna To Expand Vaccine Safety Trials For Kids
Wider testing -- spurred by rare cases of heart inflammation in teens -- could delay approval for the covid shot to be administered to children 11 and under.
The Washington Post:
FDA Asks Pfizer, Moderna To Test Their Vaccines In More Children To Help Rule Out Safety Issues
Federal regulators have requested that vaccine companies expand their trials to test coronavirus shots in several thousand school-aged children before seeking authorization — a move intended to assess whether a rare inflammation of the heart muscle that has been seen in young adults shortly after vaccination is more common in younger age groups. The changes to ongoing pediatric trials run by Moderna and Pfizer and its German partner, BioNTech, could delay the availability of the vaccines to children between 5 and 11 beyond the hoped-for timeline of early fall, although it is unclear by how much. As the country faces a surge fueled largely by cases in unvaccinated people and the school year approaches, pediatricians and families have impatiently awaited shots of protection. (McGinley, Johnson and Abutaleb, 7/26)
Bloomberg:
Moderna Expands Child Vaccine Trial to Get More Safety Data
Moderna Inc. said it would expand an ongoing trial of its coronavirus vaccine in children under 12 years old to gather more safety data amid worries that messenger RNA shots may trigger rare heart side effects. “The objective is to enroll a larger safety database which increases the likelihood of detecting rarer events,” a Moderna spokeswoman said in a statement. Clinical trial timelines are regularly re-evaluated based on regulatory agency discussions and requests, she said, and Moderna expects to have data that would support authorization in late 2021 or early 2022. The Cambridge, Massachusetts-based company is discussing a proposal for a bigger trial with the U.S. Food and Drug Administration, she said. (Langreth and Griffin, 7/26)
Fox News:
Moderna Seeks To Expand COVID-19 Vaccine Trial For Kids
Moderna intends to expand a COVID-19 vaccine trial among kids under 12 to better monitor for potential rare side effects, a spokesperson confirmed to Fox News. "It is our intent to expand the trial and we are actively discussing a proposal with the FDA," a Moderna spokesperson wrote to Fox News in an email. "The objective is to enroll a larger safety database which increases the likelihood of detecting rarer events." "At this point we expect to have a package that supports authorization in winter 2021/early 2022, should the FDA choose to use the authorization avenue," the statement continues in part. (Rivas, 7/26)
The New York Times:
Vaccine Makers Are Asked To Expand Safety Studies On Children
At the urging of federal regulators, two coronavirus vaccine makers are expanding the size of their studies in children ages 5 to 11 — a precautionary measure intended to detect rare side effects including heart inflammation problems that turned up in vaccinated people younger than 30. Appearing at a televised town-hall-style meeting in Ohio last week, President Biden said that emergency clearance for pediatric vaccines would come “soon.” The White House has declined to be more specific on the timeline, and it was unclear how much of an impact, if any, expanding the studies would have on when vaccines could be authorized for young children. (Stolberg, LaFraniere and Weiland, 7/26)
