The coronavirus vaccine for children under 5 years of age prepared by the consortium of companies made up of Pfizer and BioNtech could be available at the end of February, according to The Washington Post published on Tuesday.
According to the newspaper, which cites sources familiar with the investigation, both pharmaceutical companies are expected to present today to the US Food and Drug Administration (FDA) an emergency use authorization request for this new version of the COVID-19 vaccine.
The drug can be administered to , which would make it the first to go on the market for that age group.
The FDA urged the companies to apply so that regulators could begin reviewing the data obtained by the companies after administering two doses of the vaccine, the newspaper reported.
In recent months, the pharmaceutical consortium has also been testing a third dose among this group, after the results obtained in terms of immunization when applying
Even so, according to the Post, the company has verified that the two doses of the vaccine in minors are safe and they are now analyzing the results with a booster injection, although they will not be available until at least the end of March.
Once that information is submitted to the FDA, regulators are expected to authorize a third dose of the pediatric vaccine as well.
“We know that two doses are not enough and we understand it”, said one of the sources consulted by the newspaper. “The idea is that we go ahead and start the review (by the FDA) with two doses,” so that the vaccination of minors begins before knowing who provides the third dose, he added.
Outside FDA advisers are expected to meet on the two-dose request in mid-February. It also appears that outside experts, members of the Advisory Committee on Immunization Practices, will study the issue this month.
In December, Pfizer and BioNTech announced that two doses of the vaccine in children aged 2, 3, and 4 years would be generated in adolescents and adults.
But the two-injection regimen created a protective immune response in children aged 6 months to 2 years. That’s when drugmakers added a third injection to the trial to try to boost the immune response.
In the trial, children aged 6 months to 5 years received two doses of 3-microgram injections, a tenth of the dose given to adults, three weeks apart.