Three doses of Pfizer’s COVID-19 vaccine offer strong protection for children under the age of 5, the company announced Monday. Pfizer plans to release the data to US regulators later this week to give the youngest children a chance to get the shots.
The news comes after months of anxiously waiting by parents desperate to get their babies, toddlers and preschoolers vaccinated, especially as COVID-19 cases rise again. The 18 million infants under the age of 5 are the only group in the US not yet eligible for a COVID-19 vaccine.
The Food and Drug Administration has begun evaluating data from rival Moderna, which hopes to offer two kid-sized shots by the summer.
Pfizer had a bumpy time figuring out its approach. It aims to give toddlers an even lower dose — just a tenth the amount adults get — but found during its trial that two shots didn’t seem strong enough for preschoolers. So the researchers gave more than 1,600 youngsters — aged 6 months to 4 years — a third shot of the Omicron variant during the winter tide.
In a press release, Pfizer and its partner BioNTech said the extra shot did the trick, raising the little ones’ virus-fighting antibody levels enough to meet FDA criteria for emergency use of the vaccine without safety concerns.
Preliminary data suggests the three-dose regimen is 80% effective in preventing symptomatic COVID-19, the companies said, but cautioned that the calculation is based on just 10 cases reported by the end of April among the study participants were diagnosed. Study rules state that at least 21 cases are needed to formally determine efficacy, and Pfizer promised an update once more data becomes available.
The companies had already submitted data to the FDA on the first two doses, and BioNTech CEO Dr. Ugur Sahin said final data for the third dose would be submitted this week.
“The study suggests that a low 3 microgram dose of our vaccine, carefully selected based on safety data, provides young children with a high level of protection against the recent strains of COVID-19,” he said in a statement.
What’s next? FDA vaccine chief Dr. Peter Marks has promised that the agency will “move quickly without sacrificing our standards” to evaluate large doses of Pfizer and Moderna.
The agency has hired Tentative Dates next month for its scientific advisors to publicly discuss data from each company.
Moderna wants to be the first to vaccinate the youngest children. It transmitted data According to the FDA, after two injections containing a quarter of the dose given to adults, young children develop high levels of virus-fighting antibodies. The Moderna study found that efficacy against symptomatic COVID-19 was 40% to 50% during the Omicon surge, similar to adults who only received two doses of vaccine.
To complicate Moderna’s progress, the FDA has so far only approved its vaccine for use in adults.
The FDA is expected to review Moderna’s data on both the youngest age group and its study on teens and elementary school children. Other countries have already expanded Moderna’s shot to children ages 6 and up.
While COVID-19 is generally not as dangerous for youth as it is for adults, some children become seriously ill or even die. And the Omicron variant hit children particularly hard, with those under the age of 5 being hospitalized more frequently than at the peak of the previous delta surge.
It is not clear what the demand will be to vaccinate the youngest children. Pfizer shots for 5- to 11-year-olds opened in November, but only about 30% of that age group got the recommended first two doses. Last week, US health officials said elementary school-age children should get one booster vaccination As intended for everyone aged 12 and over, for the best protection against the latest coronavirus variants.
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