Pfizer Requests US Authorization to Own COVID for Children Under 5 | Coronavirus pandemic News

U.S. pharmaceutical company Pfizer has asked the U.S. to allow low doses of COVID-19 vaccine for children under the age of five, and may pave the way for younger Americans to start receiving shots before March.

In a separate move, the U.S. Food and Drug Administration (FDA) asked Pfizer and its partner BioNTech to place an order earlier than expected by the companies.

The nation’s 19 million children under the age of five are the only group in the U.S. not eligible for the coronavirus vaccine, and many parents are pushing for the spread of shots to children and preschoolers, especially when Omicron sent waves. record number of young people to the hospital.

If approved by the FDA, Pfizer jabs, which are only a tenth of the dose given to adults, can be given to six-month-olds.

Pfizer said Tuesday it had begun shipping its data to the FDA and expects the process to be completed in a few days.

The open question is how much will young people need to own. Pfizer is testing three shots after two very low-dose babies but not quite strong ones for preschoolers, and the latest data from the study is not expected until the end of March.

This means that the FDA may consider whether to allow two shots for now, perhaps a third shot will be cleared later if the test allows it.

The FDA said Tuesday it will hold a panel of independent researchers and doctors in mid-February to help review Pfizer’s data. The agency should not follow the advice of panel members, but their contribution is a key step in publicly examining the safety and effectiveness of the vaccine.

The FDA’s final decision may come within a month, but that’s not the only hurdle. It must also be signed by the U.S. Centers for Disease Control and Prevention (CDC).

The Biden administration is trying to speed up the COVID-19 shooting permit for children by competing vaccines are essential for keeping schools and kindergartens open and open, and for parents to release their childcare obligations so that they can return to work.

However, vaccination rates have been lower among children than in other age groups.

As of last week, 20 percent of five- to 11-year-olds and just over half of those between the ages of 12 and 17 were vaccinated, according to the American Academy of Pediatrics (AAP). Nearly three-quarters of adults are fully vaccinated in the United States.

It is possible for young children to become seriously ill with coronavirus, which is much less likely than adults, and pediatric COVID-19 infections are more prevalent than at any other point. pandemic.

“What we’re seeing right now is still a lot of hospitalizations and unfortunately some deaths in this age group,” said Dr. Sean O’Leary of the University of Colorado, who is on the AAP’s Infectious Diseases Committee.

If the FDA clears vaccines for these young people, “it will be very important because all of these hospitalizations and deaths can be fundamentally prevented,” he said.

For children under the age of five, Pfizer’s research provides participants with two shots for three weeks, and a third dose at least two months later. The company is testing whether young people produce antibody levels similar to those that support teenagers and young adults.

In December, Pfizer announced that children under the age of two were protected but that the antibody response was too low in two- and four-year-olds. It’s not clear why, but one option is to have a very low dose that is too low for preschoolers.

Preliminary results showed that the shots were safe, so Pfizer added a third dose to improve the protection of the tests.

Given how well Booster works for older age groups, it “makes sense” that younger children can benefit from a third benefit, O’Leary said. “I can certainly understand where both the company and the FDA are coming from when they want to take this forward, with a third dose expected in the future.”