'We do not have data on the proper dose, nor do we have the full data on the safety in children younger than what is in the EUA, and so that would be a great concern that people would vaccinate children,' FDA commissioner Janet Woodcock said.
Out of more than 26 million doses given to young people, the CDC has so far confirmed 323 cases of heart inflammation, called myocarditis or pericarditis, and is still monitoring more cases. Of the confirmed cases, the vast majority were temporary and resolved with monitoring and treatment.
No cases of COVID occurred in the 1,005 adolescents that received the vaccine, while there were 16 cases of COVID among the 978 kids who received the placebo, "thus indicating the vaccine was 100% effective in preventing COVID-19 In this trial," said Marks. Ashton noted that while there has been anecdotal discussion of the emotional event of finally receiving the, the idea of the cause being from the vaccine itself "defies science and biology."
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