In a move hailed by those who do not believe it necessary or healthy to vaccinate children as young as six months old, U.S. Government and Pfizer officials have agreed to delay their planned new vaccine rollout.
Pfizer’s CEO announced the agreement on Sunday.
“We all agreed it’s better if we wait for the three doses to come out,” CEO Albert Bourla said on CBS’ “Face the Nation.”
According to the Epoch Times, “Pfizer and its partner BioNTech have been testing their vaccine on children aged six months to four years.”
In November they announced they were “expanding the clinical trial to three doses because the two-dose of the primary regimen didn’t trigger a sufficient immune response in some of the kids.”
Translation: Research shows that children, who are naturally highly resistant to testing positive for COVID, do not benefit from two doses of a drug purported to minimize the risk of contracting COVID, so we will now begin testing to see how children respond to receiving three doses of the vaccine.
Officials appeared ready to grant emergency expanded use authorization last month, but at the last moment announced a postponement.
“The data that we saw made us realize that we needed to see data from a third dose, as in the ongoing trial, in order to make a determination that we could proceed with doing an authorization,” Dr. Peter Marks, the director of the FDA’s Center for Biologics Evaluation and Research, told reporters on a call, according to the Epoch Times.
Marks also said he hoped the decision to delay the rollout would “reassure” people that the FDA was “making sure that anything that we authorize has the safety and efficacy that people have come to expect from our regulatory review of medical products.”
FDA officials declined to provide additional details. However, Dr. Scott Gottlieb, a former FDA chief and current Pfizer’s board member, said the decision stemmed from a “low number of cases overall in the clinical trial.”
Pfizer CEO Albert Bourla said: “It’s one thing to have a vaccine out there, it’s another thing to have a clear picture for the parents that all scientists, that they all agree—CDC, FDA, the industry, academia—that this is the right thing to do for the kids.”
Bourla continued, saying that he believes three doses “will likely provide a very strong set of evidence where everybody will agree.”
Bourla added that the data regarding how a three-dose regimen impacts children as young as six months will likely be available in April, and that authorization could come in May, “if it works.”
Bourla concluded the interview by saying that “Regulators, I’m sure, will do their utmost to review them fast, And we will be ready with manufacturing.”
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