Pfizer to Ask for Vaccine Authorization for Children Under 5

The Pfizer corporation, the first pharmaceutical firm to have a vaccine against the coronavirus, is expected to ask the United States Food and Drug Administration to authorize its inoculation for children under the age of 5.

At a time when Pfizer already has produced a vaccine targeted specifically against the Omicron variant of the coronavirus, with plans to put it before the FDA in March, the  under-5 cohort is still without an authorized or approved vaccine.

However, Pfizer and its partnering firm, BioNTech, are expected to ask the FDA to authorize its original coronavirus vaccine for this age group — which includes all children as young as 6 months — as a two-dose regimen.

Vaccine for children under 5 is eagerly awaited 13 months after inoculations began for adults

Meanwhile, they are studying the efficacy of administering three doses of the shot to this age group as well.

The New York Times reports that individuals familiar with the process say that federal regulators are chomping at the bit to review the scientists’ findings so that the shots can be authorized on an emergency basis as soon as the end of this month.

Time is of course of the essence while this youngest age cohort awaits the vaccine — fully thirteen months after the first adults began receiving the Pfizer product in December of 2020.

If the company waited for results from a study on how well a three-dose course of the vaccines worked in this age group, the necessary data would not even be submitted to the FDA until late March, fifteen months after the beginning of the vaccination process for adults.

With over 19 million Americans under the age of five, the pressure has been on for some time to make the shot available to the youngest of all in society; health officials and Pfizer executives had both been hinting recently that an emergency authorization was on the way.

Children have been contracting the Omicron variant at a rate not terribly different from other age groups, with hospitalizations rising even for the youngest Americans.

Scott Gottlieb, a board member of Pfizer who is also a former commissioner of the FDA, told CBS News on Sunday that the vaccine could possibly be authorized as soon as March for this age cohort.

While day care facilities close on a regular basis as a result of workers and children testing positive for the virus, parents are complaining they are at their wits’ end trying to juggle child care as they await the authorization of a shot for their youngest children.

The Times reports that people who have been made aware of the Pfizer/BioNTech studies for under 5 children say that the testing indeed indicated that two doses of the vaccine afforded significant protection against the coronavirus. There were also no safety concerns whatsoever associated with the administration of the vaccine to this youngest group of children.

Eventually, after the studies on a third, booster shot, are concluded, a third shot will be added to the regimen for the under-5s, according to officials familiar with the studies.

While the companies announced a month and a half ago that children aged from 6 months to two years who were given two vaccine doses of the vaccine having one tenth of the strength of adult shots produced immunity comparable to that found in young people ages 16 to 25, the response was less resounding in those between the ages of 2 to 4.

This led the companies to undertake the testing of a third shot, also at this lowered strength, in young children. However, federal regulators, who are eager to authorize the use of the vaccine for the youngest children, urged Pfizer to ask for authorization for a two-dose regimen so that children can be protected from the Omicron variant and any other mutations that may pop up.

Although young children do not as a rule suffer as severely from the coronavirus, the American Academy of Pediatrics has stated that Omicron has now stepped up the threat of the virus in the youngest children.

Dr. Rochelle Walensky, the director of the US Centers for Disease Control and Prevention, told reporters in January “Sadly, we are seeing the rates of hospitalizations increasing for children 0 to 4, children who are not yet currently eligible for Covid-19 vaccination,”  blaming the lightning-fast transmission of the Omicron variant.

Still, hospitals across the United States are already reporting decreases in the numbers of hospitalized patients, with many leaders — including White House adviser Dr. Anthony Fauci — saying that it is time to learn how to live with the virus.

Federal regulators granted their full approval to the Moderna vaccine, which is the second-most widely used inoculation in the US, on Monday.

If and when the Pfizer/BioNTech shot is authorized, this youngest cohort will receive their second inocuiation three weeks after their first; if a third dose is authorized, they will be eligible to receive their third shot two months after the second one.

The C.D.C. now considers three doses of the vaccine to be an “up-to-date” regimen for those eligible for extra shots, including those 12 and up. Regulators have authorized booster doses given five months after second injections. Children as young as 5 who have weakened immune systems are also eligible for extra shots.

Many health authorities have expressed alarm over the pace of inoculation for the 28 million American children who are between the ages of 5 and 11.At this point, only  approximately 30 percent of these children have received at least one dose, according to the CDC.

Health officials say that as of now there are a range of factors playing into this, including the misinformation some parents have received, the belief that overall, the virus is not as severe in children to begin with; and a purported lack of time to get their children the shots.

The Times reports, however, that a study of hundreds of children who had been hospitalized in six different American cities in the Summer of 2021, released by the CDC, showed that almost all of the youngsters who were seriously ill had not been fully vaccinated.