US delays decision on COVID vaccine for children under 5
Al JazeeraUS FDA postpones decision to approve shot for young children by at least two months, seeking more data. A United States decision on Pfizer and BioNTech’s COVID-19 vaccine for children six months through four years of age has been postponed for at least two months after the Food and Drug Administration said it needed more data. On Friday, the agency said it had reviewed new trial information that had come in since Pfizer and BioNTech’s request for emergency authorisation and decided it needed more data before moving forward. It makes sense to wait for the safety and efficacy data on all three doses to be available before we make a decision about this vaccine,” said Dr Paul Offit from Children’s Hospital of Philadelphia. Still, Dr Amesh Adalja, an infectious disease expert at the Johns Hopkins Center for Health Security, said there was considerable pushback about the FDA’s decision to pursue authorisation so quickly, “as this age group is very low risk for severe disease and vaccine uptake in the five-11 has been very suboptimal”.