Pfizer/BioNTech say three Covid shots generate good response in under-5s
24/05/2022
Washington, may 23: 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 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 are rising. 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 Administration has begun evaluating data from rival Moderna, which hopes to begin offering 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 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 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 third-shot data would be submitted this week.
The study suggests that a low, 3-microgram dose of our vaccine, carefully selected based on tolerability data, provides young children with a high level of protection against the recent COVID-19 strains, he said in a statement.
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 agency has set tentative dates next month for its scientific advisers to publicly debate data from each company.
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.
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