A US decision on Pfizer and BioNTech's Covid-19 vaccine for infants and children six months through four years of age has been postponed for at least two months after the Food and Drug Administration (FDA) said it needed more data.
The FDA had planned to decide on the vaccine based on early trial data as soon as next week with the government planning to roll it out on Feb 21. It had asked Pfizer to speed up its application as the Omicron variant of the coronavirus caused a surge of infections, including among children.
On Friday, the agency said it had reviewed new trial information that arrived after Pfizer and BioNTech's request for emergency authorisation and decided it needed more data before weighing in on the authorisation, Reuters reported.
