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US drug regulator postpones meeting on infant Covid vaccines
NYSE - LSE
US drug regulator postpones meeting on infant Covid vaccines
The US Food and Drug Administration (FDA) on Friday announced it was pushing back a meeting scheduled for next week where a panel of experts would have decided whether to endorse the Pfizer-BioNTech Covid vaccine for infants.
The meeting would have evaluated whether two doses of the shot should be authorized for children aged six months through four years, even though clinical trials are still evaluating whether three shots are needed.
Interim results in fact had shown that a low dose of three micrograms given across this age group to stave off side effects did not elicit an immune response comparable to older age groups given a higher dose.
"Given that the study is advancing at a rapid pace, the companies will wait for the three-dose data as Pfizer and BioNTech continue to believe it may provide a higher level of protection in this age group," the US and German firms said in a statement.
"We will provide an update on timing for the advisory committee meeting once we receive additional data on a third dose in this age group from the company’s ongoing clinical trial and have an opportunity to complete an updated evaluation," added the FDA.
A. Lefebvre--BTZ
