The US health authority (FDA) said the Covid-19 vaccine developed by Pfizer and BioNTech met the agency’s criteria for immune response in a study of children aged 5 to 11.
In a report released Friday (22), the agency indicated the risk of heart disease, including vaccine-associated myocarditis, but said the overall benefit in preventing Covid-19 disease and hospitalization would outweigh the risk of heart disease.
The FDA’s assessment may support the agency’s authorization of the vaccine in children over the next few days or weeks, but the risk of myocarditis will likely be a matter of debate among agency advisers.
The FDA confirmed data the companies released earlier in the day showing that the vaccine was 90.7% effective at preventing symptomatic Covid-19 in a study of children aged 5 to 11, reported health officials. likely to be considered before authorizing use by
The vaccine was deemed safe and tolerable, the companies said in a document sent to the FDA. In early October, Pfizer and BioNTech asked the agency to authorize the vaccine for children ages 5-11.
The documents were published ahead of Tuesday’s meeting of the Expert Advisory Committee on Vaccines and Related Biologics to advise the FDA. The committee will meet to review the evidence for the safety and efficacy of vaccination in children and vote to recommend whether the FDA should authorize its use. If the vote is favourable, FDA authorization could be made in a few days.