Three doses of Pfizer’s COVID-19 vaccine offer strong protection for children younger than 5, the company announced Monday. Pfizer will provide the data to the U.S. regulators this week as a first step towards allowing the youngest children to get shots.
After months of anxiety and waiting, parents are finally able to give their baby, toddler, or preschooler a vaccine. This is especially important as COVID-19 rates continue to rise. Only the 18 million infants below 5 years of age are currently eligible for COVID-19.
Moderna is a rival to the Food and Drug Administration. The agency hopes to offer two child-sized shots this summer.
Pfizer’s approach has been more difficult to figure out. 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.
The companies stated that preliminary data suggests the three-dose regimen is effective at preventing symptoms of COVID-19. However, they warned that the calculations are based only on 10 cases among the study participants as of the April end. Pfizer has promised to update the information as soon as it is possible. According to study regulations, 21 cases must be present in order for effectiveness to be formally determined.
Continue reading: How parents can protect their children from COVID-19 hazards.
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.
For its scientific advisers, tentative dates have been set for next month to debate publicly data from companies.
Moderna wants to become the first company to immunize the youngest children. The FDA received data from Moderna indicating that infants have high levels of antiviral antibodies following two doses of vaccine that are only 25% of what is given to adults. The Moderna study found effectiveness against symptomatic COVID-19 was 40% to 50% during the Omicron surge, much like for adults who’ve only had two vaccine doses.
Complicating Moderna’s progress, the FDA so far has allowed its vaccine to be used only in adults.
The FDA is expected to review Moderna’s data on both the youngest age group, plus its study of teens and elementary-age children. Other countries already have expanded Moderna’s shot to kids as young as 6.
While COVID-19 generally isn’t as dangerous to youngsters as to adults, some children do become severely ill or even die. Children under five years old were hospitalized more often than those over 5 at the height of the delta surge.
It’s not clear how much demand there will be to vaccinate the youngest kids. The Pfizer vaccines for children aged 5 to 11 years old were available in November. However, only 30% of those who received the two recommended doses have received them. U.S. authorities recommended that elementary-aged children receive a booster shot, just as everyone older than 12 should, to protect them against new coronavirus variants.
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