Preliminary data suggested the three-dose series is 80% effective in preventing symptomatic COVID-19 for children younger than 5.
Preliminary data suggested the three-dose series is 80% effective in preventing symptomatic COVID-19, the companies said, but they cautioned the calculation is based on just 10 cases diagnosed among study participants by the end of April. The study rules state that at least 21 cases are needed to formally determine effectiveness, and Pfizer promised an update as soon as more data is available.
Pfizer’s conclusion that the tots produce antibodies similar to levels that protect young adults was encouraging, said Dr. Jesse Goodman of Georgetown University, a former FDA vaccine chief. What’s next? FDA vaccine chief Dr. Peter Marks has pledged the agency will “move quickly without sacrificing our standards” in evaluating tot-sized doses from both Pfizer and Moderna.
The FDA had set tentative dates in June for its scientific advisers to publicly debate Moderna’s and Pfizer’s data. The latest target: June 14 to consider whether to allow Moderna vaccine for older kids and June 15 to debate vaccinations for tots under 5, from either or both companies depending on the status of the applications.