Three doses of Pfizer-BioNTech’s COVID-19 vaccine offer strong protection for children under five, the companies said Monday. Pfizer plans to provide the data to US regulators later this week in a step towards allowing the youngest children to receive photos.
The news comes after months of anxious waiting by parents desperate to vaccinate their babies, young children 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 United States not yet eligible for COVID-19 vaccination.
Health Canada has not yet approved mRNA vaccines against COVID-19 for children under five.
Pfizer told CBC News on Monday morning that they were in talks with Health Canada about a vaccine for children under five, but could not comment on the deadlines.
The US Food and Drug Administration has begun evaluating data from Pfizer Moderna’s competitor, which hopes to start offering two children’s photos by summer.
A young child is preparing to receive a dose of the Pfizer pediatric vaccine at the Scotiabank Arena in Toronto. In Canada, 41% of the population aged 5 to 11 is considered fully vaccinated. (Mike Cole / CBC)
Pfizer had a harder time figuring out his approach. It aims to give children under the age of five only one tenth of the amount that adults receive – even a lower dose than for children aged 5 to 12. However, the company found during its study that two injections at this dose did not seem quite strong enough for preschoolers. Thus, the researchers gave a third opportunity to more than 1,600 young people – aged six months to four years – during the winter jump of the Omicron variant.
In a press release, Pfizer and its partner BioNTech said the supplemental injection had worked, raising levels of anti-virus antibodies in children enough to meet FDA criteria for emergency use of the vaccine without safety concerns.
Preliminary data suggest that the three-dose series is 80% effective in preventing symptomatic COVID-19, the companies said, but warned that the calculation was based on only 10 cases diagnosed among study participants by the end of April. The rules of the study state that at least 21 cases are needed to formally determine effectiveness, and Pfizer has promised an update as soon as more data becomes available.
The companies have already provided data on the first two doses to the FDA, and BioNTech’s chief executive, Dr. Ugur Shahin, said final data on the third dose will be provided 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 the latest strains of COVID-19,” he said in a statement.
Regulatory approvals are still required
What next? FDA vaccine chief Dr. Peter Marx has promised that the agency “will move fast without sacrificing our standards” in assessing dose levels for children under five from Pfizer and Moderna.
The agency has set preliminary dates next month for its research advisers to publicly discuss data from each company.
Katrina Taormina withdrew the Pfizer-BioNTech COVID-19 vaccine in a syringe at Lehman High School on Tuesday, July 27, 2021, in New York City. Pfizer Moderna’s rival aims to be the first to vaccinate young children. (Mark Lenihan / Associated Press)
Moderna aims to be the first to vaccinate young children. He sent data to the FDA, according to which young children develop high levels of antibodies to fight viruses after two injections, which contain a quarter of the dose given to adults. The Moderna study found that the effectiveness against symptomatic COVID-19 was 40 to 50 percent during the Omicron jump, similar to adults who had only two doses of the vaccine.
Complicating Moderna’s progress, the FDA has so far allowed the vaccine to be used only in adults.
Last month, the company told CBC News that it hopes to complete the application for regulatory approval of its COVID-19 vaccine for children under five soon.
The FDA is expected to review Moderna data for both the youngest age group and the study of teenagers and young children. Health Canada approved Moderna photos for children between the ages of six and 11 in March. Last fall, he expanded Pfizer’s photo for children between the ages of five and 11.
While 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 hit children particularly hard, with those under five being hospitalized at higher rates than at the peak of Delta’s previous jump.
It is unclear how much demand there will be for vaccinating young children. Pfizer injections for children 5 to 11 years of age began in November, but only about 30% of this age group received the recommended initial two doses. In Canada, 41% of the population aged 5 to 11 is considered fully vaccinated.
Last week, U.S. health officials said young children should receive a booster vaccine, just as everyone 12 years and older is expected to receive, for the best protection against the latest coronavirus variants.
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