While many Americans have put the COVID pandemic in their rearview mirror, Pfizer and BioNTech, the makers of one of the most widely used dosing regimens during the crisis, have plowed ahead with their trials on children between six-months-old and five-years-old to meet the criteria set low through the continuation of the Emergency Use Authorization (EUA).
In a joint statement issued Monday, the companies explained their findings were part of a clinical trial on nearly 1,700 children within the age demographic. The results of the trial presented a “robust immune response…deemed safe” and allows the completion of the application for the EUA from federal regulators.
“We are pleased that our formulation for the youngest children, which we carefully selected to be one-tenth of the dose strength for adults, was well tolerated and produced a strong immune response,” Pfizer CEO Albert Bourla stated in the release.
The reported efficacy was 80.3 percent “based on 10 symptomatic COVID-19 cases identified from seven days after the third dose and accrued as of April 29, 2022. The trial protocol specifies a formal analysis will be performed when at least 21 cases have accrued from seven days after the third dose. Final vaccine efficacy data will be shared once available.”
These data will be shared and submitted to the @US_FDA this week and other global regulators shortly, with the hope of providing this vaccine to our youngest children 6 mo to <5yrs as soon as possible, pending regulatory authorization.
— Pfizer Inc. (@pfizer) May 23, 2022
Bourla went on to state, “These topline safety, immunogenicity and efficacy data are encouraging, and we look forward to soon completing our submissions to regulators globally with the hope of making this vaccine available to younger children as quickly as possible, subject to regulatory authorization.”
BioNTech founder Prof. Ugur Sahin explained, “The study suggests that a low 3-ug dose of our vaccine, carefully selected based on tolerability data, provides young children with a high level of protection against the recent COVID-19 strains.” He also anticipated the submission to the Food and Drug Administration would be completed this week and the European Medicines Agency and other such bodies would receive submissions as soon as possible.
What is not clear from the efficacy claims reported by Pfizer is whether the clinical trials accounted for protection from symptomatic contagion from antibodies already present in the immune systems of the children. According to the Centers for Disease Control and Prevention, “As of February 2022, approximately 75% of children and adolescents had serologic evidence of previous infection…with approximately one third becoming newly seropositive since December 2021.”
The demographics considered account for children 11-years-old and younger. With children already at the lowest risk from the virus and evidence to suggest the vast majority have already been exposed to and have recovered from COVID, it’s no wonder that the number of parents prepared to wait on a vaccine outweighs those eager to sign their child up for a first dose in the currently three dose regimen.
According to one poll, less than 20 percent of parents want to promptly get their child under five-years-old a Pfizer shot when they hit the market and almost 40 percent want to wait. Meanwhile, nearly a third are adamantly opposed to the measure with another group of over 10 percent saying they’ll do it if required.
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