A vaccination site in March in Los Angeles.Credit…Alisha Jucevic for The New York TimesOutside advisers to the Food and Drug Administration on Wednesday are discussing the applications from Moderna and Pfizer to vaccinate the youngest American children against the coronavirus, a much-anticipated review that could clear the way for regulators to grant emergency authorization this week for one or both vaccines.The F.D.A. has said that clinical trial data from the companies shows that each vaccine met the criteria for safety and effectiveness in the age group. The agency has sent 230 pages of documents to the advisers to review. Votes on whether to recommend authorization of Pfizer’s vaccine for children 6 months through 4 years old, and Moderna’s for children 6 months through 5 years old, are expected by the end of Wednesday. (Watch the meeting live here.)More than two years into the pandemic, no vaccine has been authorized for children younger than 5 in the United States, an unmet need that has dismayed many parents. If the panel recommends one or both vaccines, the F.D.A. is poised to clear them as early as Friday.A similar panel for the Centers for Disease Control and Prevention is scheduled to meet on Friday and Saturday to issue its own recommendation, which could lead to children starting to get vaccinated next week.Some difficult questions remain. Perhaps most important is that neither vaccine has been tested against the subvariants now pervading the United States. The clinical trials were largely conducted when the Omicron variant prevailed, before the emergence of subvariants. Two of them, BA.4 and BA.5, could become dominant within a month.“We’re really trying to predict the future,” said Dr. Paul Offit, a vaccine expert with Children’s Hospital of Philadelphia …
Latest Covid-19 News: Vaccines, Travel and More – The New York Times
