The company has decided to add the third dose for all children and babies aged 6 months to 5 years after its independent external advisers have reviewed the data so far.
It showed that two child-sized doses of the Pfizer / BioNtech vaccine did not produce the immunity expected in children 2 to 5 years old, although they did for babies up to the age of. 2 years.
So the company said it would “modify” the trial to add a third dose.
“The study will now include the evaluation of a third dose of 3 micrograms at least two months after the second dose of the two-dose series to provide high levels of protection in this young age group,” he said. -he declares.
Pfizer had reduced the dose for the children. For ages 12 and over, the dose is 30 micrograms of vaccine. Pfizer and BioNTech reduced this dose to 10 micrograms for children aged 5 to 11 and reduced it further, to 3 micrograms per dose, for younger children.
The first tests had indicated that this small dose would produce a strong immune response in children and minimize the risk of side effects.
But interim data – which the Independent Data and Safety Oversight Council can see without giving the company or investigators details – indicates that this low-dose regimen did not produce the immune response expected in children of 2 to 5 years.
“No safety concerns have been identified and the 3 microgram dose has demonstrated a favorable safety profile in children 6 months to less than 5 years of age,” Pfizer said in a statement.
“The decision to evaluate a third dose of 3 micrograms for children 6 months to less than 5 years old reflects the companies’ commitment to carefully select the right dose to maximize the risk-benefit profile,” he added. .
If the three-dose study is successful, Pfizer and BioNTech plan to submit data to regulators to support an Emergency Use Authorization (EUA) for children 6 months to less than 5 years of age in the first half of 2022 . “
The company will also test third doses in older children, who do not yet have authorization for booster doses of the vaccine. Children aged 5 to 11 and 12 to 15 will receive a third full dose during the trials.
The changes likely mean a delay in authorizing vaccines for young children, Dr Anthony Fauci said.
“I think out of necessity, Erica, it’s going to take time when we get emergency use authorization for children this young, it probably won’t be until the second quarter of 2022, and we were hoping that would be in. the first trimester, âFauci, director of the National Institute of Allergy and Infectious Diseases, told CNN’s Erica Hill.
“But at least according to what Pfizer is saying, by the time they get all the necessary data and go through the whole procedure for obtaining emergency use authorization, unfortunately it won’t be until the second one. quarter, “he added.
âBut you really want to get the right dose and the right diet for the kids. So even if you don’t like it being late, you want to get it right, and that’s what they’re talking about. . “