Three doses of Pfizer’s COVID-19 vaccine offer the strongest protection for children younger than 5, the company announced Monday, another step toward shots for the littlest kids possibly beginning in early summer. Pfizer plans to submit the findings to U.S. regulators later this week. The Food and Drug Administration (FDA) already is evaluating an application by rival Moderna to offer two-dose vaccinations to infants and toddlers, and set June 15th as a tentative date for its independent scientific advisers to publicly debate the data from one or both companies.
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 youngsters under 5 are the only group in the U.S. not yet eligible for COVID-19 vaccination.
Pfizer’s competitor Moderna asked FDA to authorize two shots, each containing a quarter of the dose given to adults. While that showed good levels of virus-fighting antibodies, Moderna’s study found effectiveness against symptomatic COVID-19 was just 40% to 50% during the omicron surge, much like for adults who’ve only had two vaccine doses.
Moderna said it asked U.S. regulators to authorize its COVID vaccine for children under the age of 6, which would make it the first shot against the coronavirus available for those under 5-years-old https://t.co/tE5aCHHDaB pic.twitter.com/oMqwC24Pjt
— Reuters (@Reuters) April 28, 2022
Pfizer has had a tough time figuring out its exact approach to getting the dosage correct. It aims to give the youngest kids an extra low 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 omicron variant. Pfizer and its partner BioNTech said the extra shot did the trick, revving up the children’s levels of virus-fighting antibodies enough to meet FDA criteria for emergency use of the vaccine with no safety problems.
Pfizer-BioNTech's Covid-19 vaccine succeeds in children ages 6 months to 5 years.
It’s time to vaccinate our under-fives and now we've got options.
Here's what we know so far and how things stack up against Moderna:https://t.co/6Aymp28kQl
— Jeremy Faust MD MS (ER physician) (@jeremyfaust) May 23, 2022