Pfizer Offers Update on Shots for Kids Under 5

Preliminary data suggest 3 shots offer strong protection for the youngest patients
By Newser Editors and Wire Services
Posted May 23, 2022 8:31 AM CDT
Pfizer: Early Data Suggest 3 Shots Best for Kids Under 5
A nurse holds a vial of the Pfizer COVID-19 vaccine for children ages 5 to 11, right, and a vial of the vaccine for adults, which has a different colored label, at a vaccination station in Jackson, Miss., on Feb. 8, 2022.   (AP Photo/Rogelio V. Solis, File)

(Newser) – Three doses of Pfizer's COVID-19 vaccine offer strong protection for children younger than 5, the company announced Monday. Pfizer plans to give the data to US 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 are rising. The 18 million tots under 5 are the only group in the US not yet eligible for COVID-19 vaccination. The FDA has begun evaluating data from rival Moderna, which hopes to begin offering two kid-size shots by summer, per the AP. Pfizer has had a bumpier time figuring out its approach. It aims to give tots an even lower dose—just 1/10th of the amount adults receive—but discovered during its trial that two shots didn't seem quite strong enough for younger kids.

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 omicron 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 suggest the three-dose series is 80% effective in preventing symptomatic COVID-19, the companies said, but they cautioned that the calculation is based on just 10 cases diagnosed among study participants by the end of April. Study rules state that at least 21 cases are needed to formally determine effectiveness, and Pfizer has promised an update as soon as more data is available.

Moderna is seeking to be the first to vaccinate the littlest kids. It submitted data to the FDA saying tots develop high levels of virus-fighting antibodies after two shots that contain a quarter of the dose given to adults. The Moderna study found effectiveness against symptomatic COVID-19 was 40% to 50% during the omicon surge, much like for adults who've only had two vaccine doses. It's not clear how much demand there will be to vaccinate the littlest ones. Pfizer shots for 5- to 11-year-olds opened in November, but only about 30% of that group have gotten the recommended initial two doses. What's next? FDA vaccine chief Dr. Peter Marks has pledged the agency will "move quickly without sacrificing our standards" in evaluating tot-size doses from both firms. The agency has set tentative dates next month for its scientific advisers to publicly debate data from each company.

(Read more Pfizer stories.)

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