A new report states that the Biden administration’s Food and Drug Administration is pushing Pfizer and its partner, BioNTech to request emergency-use authorization for a vaccine for children as young as six months.
“Pfizer and its partner, BioNTech, the manufacturers of the vaccine, are expected to submit to the Food and Drug Administration as early as Tuesday a request for emergency-use authorization for the vaccine for children 6 months to 5 years old, which would make it the first vaccine available for that age group. Older children already can receive the shot,” The Washington Post reported, adding, “The FDA urged the companies to submit the application so that regulators could begin reviewing the two-shot data, according to the knowledgeable individuals, who spoke on the condition of anonymity because they were not authorized to speak publicly.”
Pfizer spokeswoman Jerica Pitts stated, “At this time, we have not filed a submission and we’re continuing to collect and analyze data from both two and three doses in our younger age cohort.”
“As part of our ongoing commitment, we will share new updates as they become available,” she added.
Testing for a two-shot regiment yielded results that were found unsatisfactory in stimulating a strong immune response. The Post quoted a person “familiar with the situation” insisting, “We know that two doses isn’t enough, and we get that….The idea is, let’s go ahead and start the review of two doses. If the data holds up in the submission, you could start kids on their primary baseline months earlier than if you don’t do anything until the third-dose data comes in.”
“Pfizer and BioNTech in mid-December announced that children 6 months to two years old who were given two doses of the vaccine at a tenth of the strength of adult doses produced an immune response comparable to that of young people ages 16 to 25. But among children ages 2 to 4, the response was less robust,” The New York Times noted.
Last Friday, Pfizer discussed updated trial data with Dr. Anthony Fauci, among other government officials. One administration official told the Post of a “robust conversation” that three doses were likely more effective than two shots, adding, “But to get to three, you have to get two shots first. … There’s interest in seeing this move forward.”
A trial was conducted in which children between six months and five years old received two doses of three-microgram shots. That amount represents one-tenth of the adult dose.
The American Academy of Pediatrics’ chief executive Mark Del Monte declared, “We understand the urgent need for a safe and effective vaccine for that age group.” He continued, “We are eager to see the data and will continue to follow the science.”
According to the COVKID Project, the number of deaths from COVID-19 per million population among young children in the first year of life was tiny; between 1/1/2020 and 12/11/2021 it was 43.1, it was 8.9 between the ages of one and two, 3.1 between two and three years of age, 3.3 between three and four years of age, and 3.5 between the ages of four and five.