- Three doses of Pfizer’s COVID-19 vaccine offer strong protection for children under 5, the company announced Monday.
- Pfizer plans to turn over the data to US regulators later this week in a move to allow younger children to receive the vaccines.
- The news comes after months of anxious waiting by parents desperate to vaccinate their infants, toddlers and preschoolers.
Three doses of the vaccine COVID-19 from Pfizer offer strong protection for children under 5, the company announced Monday.
Pfizer plans to hand over data from its vaccine to regulators from the US later this week in a move to allow younger children to receive the vaccines.
The news comes after months of anxious waiting by parents desperate to vaccinate their babies, toddlers and preschoolers, especially as COVID-19 cases are on the rise again. The 18 million children under the age of 5 are the only group in the US not yet eligible for COVID-19 vaccination.
The Food and Drug Administration has begun evaluating data from rival Moderna, which hopes to start offering two shots for children by the summer.
Pfizer has had a harder time figuring out its approach
His goal is to give children an even lower dose, just a tenth of the amount adults get, but he found during his trial that two injections didn’t seem strong enough for preschoolers. So, researchers gave a third injection to more than 1,600 childrenfrom 6 months to 4 years, during the winter increase of the omicron variant.
In a press release, Pfizer and its partner BioNTech said the additional injection worked, boosting the children’s antibody levels against the virus enough to meet FDA criteria for emergency use of the vaccine without issue. of security.
Preliminary data suggested that the three-dose series is 80% effective in preventing symptomatic COVID-19, the companies said, but cautioned that the estimate is based on just 10 cases diagnosed among study participants in late April. 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 had already submitted data on the first two doses to the FDA, and BioNTech CEO Dr. Ugur Sahin said final data on the third dose 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 recent strains of COVID-19,” it said in a statement.
The FDA’s vaccine chief, Dr. Peter Marks, promised that the agency “will move quickly without sacrificing our standards” when evaluating the small doses of Pfizer and Moderna.
The agency has set tentative dates next month for its scientific advisers to publicly discuss each company’s data.
Moderna seeks to be the first to vaccinate the smallest. It sent data to the FDA saying that children develop high levels of antibodies that fight the virus after two injections containing a quarter of the dose given to adults. Moderna study found effectiveness against symptomatic COVID-19 was 40% to 50% during omicron surgeas for adults who only received two doses of the vaccine.
To complicate Moderna’s progress, the FDA has so far allowed its vaccine to be used only in adults.
FDA expected to review Moderna’s data on younger age group, in addition to his study of adolescents and elementary school children. Other countries have already extended the Moderna opportunity to children up to 6 years old.
Although COVID-19 is generally not as dangerous for young people as it is for adults, some children do get very sick or even die. And the omicron variant hit children especially hard, with higher hospitalization rates for children under 5 than at the peak of the previous delta surge.
It is unclear how much demand there will be to vaccinate younger children. Pfizer’s injections for children ages 5 to 11 opened in November, but only about 30% of that age group have received the two recommended starting doses.
Last week, US health officials said primary school children should get a booster shot like everyone over 12 is supposed to gets, to get the best protection against the latest variants of the coronavirus.
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