Three doses of Pfizer-BioNTech’s COVID-19 vaccine offer strong protection to children under five, companies announced Monday. Pfizer plans to hand over the data to U.S. regulators later this week in a move to allow younger children to have the photos.
The news comes after months of anxiously waiting for parents desperate to vaccinate their babies, toddlers and preschoolers, especially as the number of COVID-19 cases in the United States rises again. The 18 million children under the age of five are the only group in the U.S. that is not yet eligible for COVID-19 vaccination.
Health Canada has not yet approved COVID-19 mRNA vaccines for children under five.
Pfizer told CBC News on Monday morning that they are in talks with Health Canada about a vaccine for children under five, but cannot comment on the timelines.
The U.S. Food and Drug Administration has begun evaluating data from Pfizer’s rival, Moderna, which hopes to begin offering two child-sized injections in the summer.
A young boy prepares to receive a dose of the Pfizer pediatric vaccine at the Scotiabank Arena in Toronto. In Canada, 41% of the population between the ages of 5 and 11 are considered fully vaccinated. (Mike Cole / CBC)
Pfizer has gone to great lengths to discover his approach. It aims to give children under five only a tenth of the amount adults receive, an even lower dose than children aged five to 12. However, the company discovered during its trial that two injections with this dose did not appear at all. strong enough for preschoolers. Thus, the researchers gave a third injection to more than 1,600 young people (from six months to four years) during the winter increase of the Omicron variant.
In a press release, Pfizer and its partner BioNTech said the extra shot did the trick, raising children’s anti-virus antibody levels enough to meet FDA criteria for use. Vaccine Emergency Without Safety Issues
Preliminary data suggested that the three-dose series is 80% effective in preventing symptomatic COVID-19, the companies said, but warned that the calculation is based on only 10 cases diagnosed among study participants at end of April. The rules of the study 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 sent data on the first two doses to the FDA, and BioNTech CEO Dr. Ugur Sahin said the final data for the third injection will be released this week.
“The study suggests that a low dose of 3 micrograms of our vaccine, carefully selected based on tolerability data, provides young children with a high level of protection against recent strains of COVID-19,” he said in a statement. press release.
Regulatory approvals are still needed
What’s next? FDA Vaccine Chief Dr. Peter Marks has promised that the agency will “move quickly without sacrificing our standards” when assessing the dose size for children under five. both Pfizer and Moderna.
The agency has set provisional dates for next month for its scientific advisers to publicly discuss each company’s data.
Katrina Taormina removes the Pfizer-BioNTech COVID-19 vaccine in a syringe at Lehman High School on Tuesday, July 27, 2021, in New York City. Pfizer’s rival, Moderna, wants to be the first to vaccinate younger children. (Mark Lennihan / The Associated Press)
Modern wants to be the first to vaccinate the little ones. He presented data to the FDA saying that young children develop high levels of antibodies against the virus after two injections containing a quarter of the dose given to adults. Moderna’s study found that the effectiveness of symptomatic COVID-19 was 40 to 50 percent during the increase in Omicron, as were adults who had only received two doses of the vaccine.
Complicating Moderna’s progress, the FDA has so far allowed its vaccine to be used only in adults.
Last month, the company told CBC News that it hoped to complete the application for regulatory approval of its COVID-19 vaccine in children five years of age or younger soon.
The FDA is expected to review Moderna’s data on both the younger age group and its study of adolescents and primary children. Health Canada authorized Moderna injections for children between the ages of six and 11 in March. Last fall, it expanded the Pfizer Dam to children ages five to 11.
Although COVID-19 is generally not as dangerous for young people as it is for adults, some children get seriously ill or even die. And the Omicron variant especially affected children, with children under five hospitalized at higher rates than at the peak of the previous Delta rise.
It is unclear what demand there will be for vaccinating the little ones. Pfizer injections for children ages five to 11 were opened in November, but only about 30% of this age group have received the two recommended starting doses. In Canada, 41% of the population between the ages of five and 11 are considered fully vaccinated.
Last week, U.S. health officials said primary school children should receive a booster vaccine as everyone should be given 12 years of age or older to get the best protection against it. the latest coronavirus variants.