Three doses of Pfizer’s COVID-19 vaccine provide strong protection for children under 5, the company announced Monday. Pfizer plans to provide the data to US regulators later this week to allow little ones to get vaccinated.
The news comes after months of anxious waiting by desperate parents to get their babies, toddlers and preschoolers vaccinated, especially as COVID-19 cases rise again. The 18 million children under age 5 are the only group in the United States not yet eligible for the COVID-19 vaccination.
The Food and Drug Administration has begun evaluating data from rival Moderna, which hopes to start offering two injections for children by the summer.
Pfizer had a harder time understanding his approach. He aims to give toddlers an even lower dose – just a tenth of the amount adults get – but found during his trial that two shots didn’t seem strong enough for preschoolers. The researchers therefore gave a third injection to more than 1,600 youngsters – aged between 6 months and 4 years – during the winter surge of the omicron variant.
In a press release, Pfizer and partner BioNTech said the extra dose did the trick, boosting anti-virus antibody levels enough to meet FDA criteria for safe emergency use of the vaccine. of security.
Preliminary data suggests 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 at the end of April. Study rules state that at least 21 cases are needed to formally determine efficacy, and Pfizer has promised an update as soon as more data becomes available.
The companies had already submitted data on the first two doses to the FDA, and BioNTech CEO Dr. Ugur Sahin said final data from the third shot would be submitted this week.
“The study suggests that a low dose of 3 micrograms of our vaccine, carefully selected based on safety data, provides young children with a high level of protection against recent strains of COVID-19,” he said. he said in a statement.
And after? FDA Vaccine Chief Dr. Peter Marks has pledged the agency “will act quickly without sacrificing our standards” in assessing Pfizer and Moderna’s early doses.
The agency has set tentative dates next month for its science advisers to publicly debate each company’s data.
Moderna seeks to be the first to vaccinate the little ones. He submitted data to the FDA indicating that toddlers develop high levels of anti-virus antibodies after two injections containing a quarter of the adult dose. The Moderna study found efficacy against symptomatic COVID-19 to be 40% to 50% during the omicon surge, much like adults who received only two doses of the vaccine.
Complicating Moderna’s progress, the FDA has so far licensed its vaccine for use only in adults.
The FDA is expected to review Moderna’s data on the youngest age group, as well as its study on adolescents and elementary-aged children. Other countries have already extended the shooting of Moderna to children as young as 6 years old.
Although COVID-19 is generally not as dangerous for young people as it is for adults, some children become seriously ill or even die. And the omicron variant has particularly affected children, with those under 5 being hospitalized at higher rates than at the height of the previous delta surge.
It is not known how many requests there will be to vaccinate the youngest children. Pfizer vaccines for ages 5 to 11 opened in November, but only about 30% of that age group received the recommended initial two doses. Last week, U.S. health officials said elementary-aged children should get a booster shot like everyone 12 and older is supposed to get, for the best protection against the latest coronavirus variants.
The Associated Press Health and Science Department is supported by the Howard Hughes Medical Institute Department of Science Education. The AP is solely responsible for all content.