Pfizer Postpones Request To Give COVID Vaccines To Kids Under 5


Pfizer-BioNTech has postponed its request that the Food and Drug Administration approve its COVID-19 vaccine for kids underneath 5, saying it needs to attend for knowledge on a 3rd dose in that age group earlier than continuing.

Data has shown that the company’s two-dose routine triggers a robust immune response in youngsters underneath 2, however that the consequences aren’t as sturdy in youngsters between the ages of two and 5. Pfizer-BioNTech initially stated it could search approval for the two-dose routine whereas it continued to analysis whether or not a 3rd shot may assist youngsters older than 2.

But the company stated Friday that it’s extra sensible to request approval for all three doses directly.

“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 company stated, including that it expects the info on a 3rd dose in early April.

The vaccine maker believes a three-dose routine will show be the simplest for kids within the proposed age group, which might begin at 6 months of age.

“This is also supported by recent observations of three dose booster data in several other age groups that seems to meaningfully augment neutralizing antibody levels and real world vaccine protection for omicron compared to the two-dose regimen,” Pfizer-BioNTech stated in its assertion.

FDA leaders stated they supported the choice, writing in a statement on Friday that they “believe additional information regarding the ongoing evaluation of a third dose should be considered as part of our decision-making for potential authorization.”

The FDA committee that will have taken on the approval course of was initially scheduled to satisfy subsequent week.