The US Food and Drug Administration will make it harder to approve vaccines, after it said COVID-19 shots were linked to at least 10 children’s deaths.
The alleged connection, reportedly made in an internal FDA memo, said that the deaths were caused by heart muscle inflammation, but no evidence has been released. The FDA’s vaccine regulatory chief said the new rules would make it much harder to authorize vaccines for pregnant women, and that trials would have to show a reduction in disease rather than biological responses such as generating antibodies. The US administration is highly vaccine-skeptical. Perhaps not unrelatedly, measles, previously considered eradicated, has returned to the country, although it is also on the rise elsewhere in the Americas.