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A third pediatric dose of the Pfizer-BioNTech COVID-19 vaccine in children aged 6 months to less than 5 years gave a strong immune response, with a safety profile similar to placebo, the companies said.
Pfizer’s pediatric COVID-19 vaccine has an efficacy of 80.3%, according to a preliminary analysis, and meets “all immunoassay criteria required for authorization for emergency use,” the company said Monday. The results are based on clinical studies in which children from six months to 5 years received three doses of the company’s vaccine.
Pfizer and its partner, BioNTech, plan to submit the new data to the Food and Drug Administration this week, bringing families with young children one step closer to a long-awaited vaccine.
Also on Monday, the FDA updated the schedule for its vaccine advisory committee, saying it will meet to discuss pediatric COVID-19 vaccines on June 15.
The course has three doses
The size of Pfizer’s pediatric dose is one tenth of the adult dose. The company had originally tested a two-dose regimen, but mixed results led Pfizer to test a three-dose regimen.
The third dose was “well tolerated among 1678 children under the age of 5 with a safety profile similar to placebo,” Pfzier said when announcing the news.
Children in the trial received the third shot at least two months after their second dose, the company said, adding that at the time of the vaccine trial, omicron had become the dominant COVID-19 variant in the United States.
So when could young children get the vaccine?
Pfizer announced its findings two weeks before what had been the FDA’s earliest date to begin the review process for vaccines for young children. The agency had set three dates in June for its independent advisory panel to meet and discuss pediatric vaccines: June 8, 21 and 22.
But the FDA updated the plan on Monday, saying that the influential advisory committee on vaccines and related biological products, or VRBPAC, now plans to meet on June 15 to discuss vaccinations for children as young as 6 months.
VRBPAC will consider applications from both manufacturers of the most common COVID-19 vaccines in the United States: Moderna asked the FDA last month to approve a low-dose form of the vaccine for younger children.
Children from 5 to 11 years have been eligible for the covid-19 vaccine since November last year. For tips on when younger children may be able to receive the vaccines, here is a look at how the previous process unfolded:
October 7: Pfizer formally asked the FDA for authorization for emergency use of its vaccine for children ages 5 to 11, after saying it was found to be safe and effective;
October 22: The FDA released the companies’ briefing documents, as well as its own analysis;
October 26: The FDA’s advisory panel recommended the Pfizer vaccine for children aged 5 to 11
November 2: The CDC recommended Pfizer’s vaccine for the age group; it will be widely available within a week thereafter.
If VRBPAC agrees with Pfizer’s findings and that the time frame is repeated, it is possible that toddlers, preschoolers and new kindergartens may be eligible to receive the vaccine during the first weeks of summer.