None of the children in the trial had any serious side effects, the release said.
“These safety, immunogenic and efficacy data are encouraging, and we look forward to completing our applications to regulators around the world soon, hoping to make this vaccine available to young children as soon as possible, subject to regulatory approval,” said Albert Burla. Pfizer’s CEO, the statement said.
Background: Pfizer and BioNTech initially asked the FDA to authorize their two strikes Covid-19 regimen for children 6 months to 5 years in February. Agency delayed a meeting of the advisory committee that will discuss the vaccine for this population, deciding to wait for additional data on the third dose. Pfizer tested a dose for children of about one-tenth of what adults received. Two infant doses in children 6 to 24 months of age developed immunity comparable to that in young adults who received two full doses. The same two pediatric doses did not create similar immunity in children 2 to 5 years of age.
The companies collected data on three doses of their vaccine in 1,678 children who received the third vaccine at least two months after they received the second, the release said. Omicron was the dominant variant of Covid-19 that was circulating at the time.
In late April, Asked Modern FDA to allow a two-dose Covid-19 vaccine for the same age group. Late-stage clinical trials have shown that pediatric doses of vaccines have created comparable immunity in the youngest children as well as two full doses in young adults.
However, the Moderna vaccine reduced the incidence of Covid-19 symptoms by 43.7 percent among children aged 6 to 24 months and by 51 percent of cases detected by PCR tests. In children aged 2 to 6 years, this reduced the incidence of symptoms by 35.7 per cent and the cases detected by PCR by 37 per cent.
What’s next: According to the release, Pfizer expects to complete the filing with the FDA this week. The FDA will schedule a meeting of the advisory committee to discuss the companies ’application when they complete the data submission.