Pfizer: 3 COVID-19 shots will protect children under 5

Trio of doses proves 80% effective to stop symptomatic cases.

Three doses of Pfizer’s COVID-19 vaccine offer strong protection for chil- dren younger than 5, the company announced Monday. Pfizer plans to give the data to U.S. regulators later this week in a step toward letting the littlest kids get the shots.

The news comes after months of anxious waiting by parents desperate to vaccinate their babies, toddlers and preschoolers, especially as COVID-19 cases once again arerising. The 18 million tots under 5 are the only group in the U.S. not yet eligible for COVID-19 vaccination.

The Food and Drug Admin- istration has begun evaluat- ing data from rival Moderna, which hopes to begin offer- ing two kid-sized shots by summer.

Pfizer has had a bumpier time figuring out its approach. It aims to give tots an even lower dose — just one-tenth of the amount adults receive — but discovered during its trial that two shots didn’t seem quite strong enough for preschoolers. So researchers gave a third shot to more than 1,600 youngsters — from age 6 months to 4 years — during the winter surge of the omi- cron variant.

In a press release, Pfizer and its partner Biontech said the extra shot did the trick, revving up tots’ levels of virus-fighting antibodies enough to meet FDA criteria for emergency use of the vaccine with no safety problems.

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.

The companies already had submitted data on the first two doses to the FDA, and Biontech’s CEO, Dr. Ugur Sahin, said the final thirdshot data would be submitted this week.

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.

AP 2022 Pfizer said its third shot boosts tots’ levels of antibodies enough to meet FDA emergency use standards.