The Pfizer corporation said on Thursday that they are now asking the US Food and Drug Administration to issue an emergency use authorization of their Covid-19 vaccine for children aged 5 to 11.
The move comes after a months-long surge of the Delta variant of Covid-19 all around the US and the rest of the world, causing an enormous spike in hospitalizations and deaths in unvaccinated people.
If and when the FDA grants the authorization, the Pfizer product would be the very first Covid-19 vaccine to become available to younger children; the vaccine already has full approval for all those 16 and over and was granted an emergency use authorization for all those between 12 and 15.
In September, Pfizer publicized its findings from Phase Two of its three trials, showing that the product was not only safe but activated a “robust” antibody response in those aged 5 to 11.
A total of 2,268 volunteer subjects, aged 5 to 11 received a two-dose regimen of the Pfizer inoculation, administered 21 days apart, accord to a report from CNN. Unlike the adult doses, however, the trial geared to much younger children used 10-microgram doses, one-third of the amount of vaccine given to all those 12 and up.
Pfizer officials say that they measured the immune responses as seen in the amounts of neutralizing antibodies in participants’ blood, contrasting those levels to what had already been seen in a control group comprised of 16- to 25-year-olds who had received the larger 30-microgram shot series.
The company says that the immunity levels detected in the youngest children were comparable to those seen in the other group, making for a “strong immune response in this cohort of children one month after the second dose.”
Although the company, which was the first to produce a coronavirus vaccine, along with the German firm BioNTech, began to send its data for younger children to the FDA in September, no formal authorization had been requested until Thursday.
Earlier, FDA officials had stated that it could authorize emergency use of the vaccine in a matter of weeks, rather than months, as soon as they had enough information, but emphasized that the timeline would be dependent on the timeliness and the quality of the data it had to consider.
The month of October will be a busy one as the FDA will be tasked with not only verifying whether or not the vaccine can be used for those 5 and older but whether or not boosters of the Johnson & Johnson and Moderna inoculations are needed for certain populations under various conditions — and whether or not it is prudent to mix and match vaccine products.
Knowing that Pfizer would soon ask for the EUA, last week the FDA arranged for a meeting on October 26 of its Related Biological Products Advisory Committee to discuss the safety and efficacy of the vaccine for those aged 5 to 11.
Upon the FDA’s issuance of the EUA, a panel of vaccine advisers at the CDC vaccine will meet to rule on whether or not to recommend its use for that age cohort.
Acting FDA Commissioner Dr. Janet Woodcock told the press regarding the upcoming meeting “We know from our vast experience with other pediatric vaccines that children are not small adults, and we will conduct a comprehensive evaluation of clinical trial data submitted in support of the safety and effectiveness of the vaccine used in a younger pediatric population, which may need a different dosage or formulation from that used in an older pediatric population or adults.”
The Pfizer company posted on Twitter saying “With new cases in children in the U.S. continuing to be at a high level, this submission is an important step in our ongoing effort against #COVID19.”
Pfizer and BioNTech had earlier announced that the results of trials involving even younger children, from six months to under five years, will expected by the end of the fourth quarter of this year.
Today’s news comes after children in the US have suffered increasing rates of Covid-19 after their return to school while the Delta variant rages on.
Those aged 5-11 suffered one of the highest rates of coronavirus per 100,000 population, at 202.9 as of September 25, according to federal figures.
Children as a rule do not suffer as severely from the coronavirus as do older people; the humber of hospital admissions for those aged 0-17 declined from a record high in early September, representing 0.50 per 100,000, down to a rate of 0.34 by the end of the month.