The U.S. Food and Drug Administration (FDA) says it will make vaccine rules stricter after reports connected some child deaths to COVID-19 shots.
A recent FDA memo shows that between 2021 and 2024, 96 deaths of children were reported after getting COVID-19 vaccines. The memo says that at least 10 of these deaths were linked to the shots. Most of these cases involved heart inflammation, also called myocarditis, which is a serious condition.
Vinay Prasad, a top FDA vaccine official, said the agency needs to change how it approves vaccines. He wants bigger and more detailed safety studies before a vaccine is approved. The FDA also plans to look again at giving multiple vaccines at the same time to children. Vaccines for pregnant women will be checked more carefully as well.
The memo has raised strong reactions. Some experts say that the reports come from VAERS, the vaccine safety reporting system. They warn that just because a death is reported after vaccination, it does not mean the vaccine caused it. Some researchers say serious side effects are very rare, given that hundreds of millions of COVID-19 vaccine doses have been given.
Prasad said the FDA must admit that COVID-19 vaccines have caused deaths in children. He also asked any staff who do not agree with the new approach to leave the agency.
Many worry that the stricter rules could slow down new vaccines, like flu or pneumonia shots. Some experts fear it could also reduce public trust in vaccines.
The FDA says the changes are necessary to protect children, pregnant women, and other vulnerable groups. The agency wants to make sure future vaccines are safe and effective before being approved.
This move shows the FDA is taking safety seriously and wants to prevent serious problems in the future. It also signals that vaccine approval in the U.S. may become more cautious, especially for children.
