Pfizer seeks US approval for COVID vaccine for children under 5

If the Food and Drug Administration (FDA) authorizes the two-shot regimen, it would become the first COVID vaccine available for this age group in the United States.

The companies said Tuesday that they have begun submitting their formal applications “after a request” from the FDA, which appears to want the process to proceed quickly.

In a tweet soon after the announcement, FDA said it would hold a meeting in two weeks on February 15 to consider the request.

“Providing a safe and effective vaccine for children in this age group is a priority for the agency,” said FDA interim chief Janet Woodcock.

Pfizer CEO Albert Boerla said in a statement that the companies are seeking authorization for only two doses of their vaccine, but are confident that one is “to achieve a high level of protection against current and potential future variants”. A third will be required.

“If two doses are authorized, parents will have the opportunity to start covid-19 vaccination while awaiting the possible authorization of the third dose series for their children,” he added.

To limit side effects for this young age group, Pfizer chose to reduce its vaccine dosage significantly, to just three micrograms per jab versus 30 for people over the age of 12, and from 10 to five. For 11 years old.

The company’s researchers concluded last fall that the low dose of the vaccine provided protection in children up to two years of age but not two to five years of age, and announced in December that they would be adding a third dose to their trials.

Pfizer and BioNTech said in the statement that data on the three-dose regimen “is expected in the coming months and will be presented to the FDA to support potential expansion”.

If the FDA authorizes emergency use of the vaccine, an advisory committee for the Centers for Disease Control and Prevention (CDC) will meet to decide whether or not to recommend its use.

– slow movement in minors –

There are nearly 23 million children under the age of five in the United States, and two years after the pandemic began, many parents are eagerly waiting to get their young children vaccinated against the coronavirus.

The Pfizer-BioEntech vaccine was approved three months ago for emergency use in children ages five to 11, but uptake has been relatively slow.

In that age group, only 30 percent have received at least one dose and about 22 percent have been fully vaccinated, according to the Centers for Disease Control and Prevention (CDC).

Young children are less likely to become seriously ill from COVID-19, but some still end up hospitalized due to the virus.

New pediatric COVID hospitalizations in the United States reached a record high in December as the Omicron strain spread rapidly.

Some cases of the deadly disease MIS-C (Multi-System Inflammatory Syndrome in Children) have also been reported in young children with COVID.

CDC data shows that nearly 400 children aged four and younger have died from COVID-19 in the United States since the pandemic began.

This story has been published without modification in text from a wire agency feed. Only the title has been changed.