Less than two weeks after Frontline News highlighted serious issues with Pfizer’s initial request to the FDA for use of its mRNA vaccine in 6-month-old infants and small children up to 4-years-old, NBC News reports the pharmaceutical giant has pulled its request for emergency use authorization in that age group.
Pfizer’s play on words
Dr. John Tores, NBC News senior medical correspondent, notes Pfizer avoided terms like, “delay,” or “pull,” opting to issue a press release describing its action as merely a move to “extend” the submission it announced just 10 days earlier:
“Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced plans to extend their rolling submission to the U.S. Food and Drug Administration (FDA) seeking to amend the Emergency Use Authorization of the Pfizer-BioNTech COVID-19 Vaccine to include children 6 months through 4 years of age, which had been requested by FDA.”
Keeping results from the public eye
Pfizer’s “extension” of its rolling submission pushes off the FDA’s publication of its analysis of Pfizer’s data to date on infants and children. NBC News says this move came amid experts’ opposition to initial FDA plans to approve 2 doses of the vaccine while Pfizer continued to gather data on a third dose:
“The FDA was expected to publish an analysis of the Pfizer data Friday, ahead of an advisory committee meeting next week. The FDA said Friday the meeting has been postponed.
“Two people familiar with the FDA’s plans said there had already been a lot of pushback on the agency from outside experts who had concerns that Pfizer’s data wasn’t sufficient. The experts felt, one of the people said, that their concerns were ‘falling on deaf ears’ within the agency.” [Emphases added].
Pfizer’s unusual request
In an article entitled, “Pfizer vaccine for infants and children under five: 5 facts you need to know - Pharma giant pushes vaccine for small children despite failure in clinical trials,” AFLDS shined a spotlight on Pfizer’s highly unusual strategy. For perhaps the first time in FDA history, the company planned to push through approval of a failed vaccine on the assumption that it will later obtain positive results with a higher dosage, which would then be incorporated into the approval.
“Pfizer's request for authorization for two doses was an unusual request, given that the first two shots didn't work and there is no guarantee that adding a third dose will be sufficient.”
Casting light on Pfizer's strategy
AFLDS’ first fact you need to know about the vaccine’s extension to small children warned,
“1. Pfizer and the FDA are moving forward DESPITE the failure of its drug trials on children under 5.”
AFLDS pointed out that Pfizer was already forced to concede its failure to demonstrate efficacy in this age group in a December report, “… two doses of the pediatric vaccine failed in 2-, 3- and 4-year-olds to trigger an immune response comparable to what was generated in teens and older adults.”
AFLDS’ second fact you need to know revealed,
“2. A third dose is already planned.”
AFLDS explained then that, “Due to the disappointing results from the trials of the two-shot regimen in children under 5, Pfizer immediately began testing a third dose on those children, amending its study to provide for a third injection.”
FDA approval based on assumptions?
AFLDS highlighted the degree to which conjecture was incorporated into Pfizer’s request with a Washington Post quote of an anonymous administration official stating that Pfizer’s briefing of Dr. Anthony Fauci and other public health officials included, “a ‘robust conversation’ that three doses were likely to be much better than two shots [in children under 5] … But to get to three, you have to get two shots first … There’s interest in seeing this move forward.” [Emphases added].
That is, an interest based on conjecture (“likely to be much better”) in the face of failed experiments (“failed in 2-, 3- and 4-year-olds to trigger …”).
Using emergency use authorization to expand an experiment to all small children?
“3. The third dose may already be added to the scheduled dosing of infants and young children by April.”
AFLDS explained that, despite the fact that Pfizer itself would not obtain data on its third shot in children until April, “knowledgeable individuals” informed the Washington Post that, “Once that information is submitted, regulators are expected to authorize a third dose of the pediatric vaccine. ‘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.’” [Emphases added].
In pulling its request for emergency use authorization on children under 5, Pfizer and the FDA may have tacitly agreed that an informed American public will not accept experimentation on small children.
The company and the government will now wait for data to justify the use of the mRNA vaccine in small children before asking parents to enlist infants as young as 6 months in the vaccination program. ABC News quoted Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research:
“We realized now, in data that came in very rapidly because of the large number of cases of Omicron, that at this time, it makes sense for us to wait until we have the data from the evaluation of a third dose before taking action."