Federal regulators on Friday unexpectedly announced an end to hopes that Pfizer’s COVID-19 vaccine could be approved for children under 5 by the end of the month.
The Food and Drug Administration (FDA) had been expected to start formally debating next week the emergency use authorization request for a two-shot dose for children 6 months through 4 years.
But on Friday, the agency announced that the initial studies proved the need for more testing to see if young kids would need a third shot, too.
Pfizer and its partner, BioNTech, had hoped to race through approval and have the shots ready for use by the end of this month.
The setback means the necessary data to again seek approval will not be available “in early April” at the earliest, companies said.
The FDA’s vaccine chief, Dr. Peter Marks, said that he “empathized” with parents who feel “urgency” in getting their kids protected, especially amid fears of possible future variants emerging.
“We take our responsibility for reviewing these vaccines very seriously because we’re parents as well,” he told reporters during a teleconference.
He also suggested that the unexpected delay should increase confidence once a shot is approved.
“I think parents can feel reassured that we have set a standard by which we feel that if something does not meet that standard, we can’t proceed forward,” he said.
“I hope that reassures people that the process has a standard that … we follow.
“And we follow the science in 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.”
The initial rush to get emergency approval for the shots — which are one-tenth the strength of the adult ones — was itself a surprise. Early data had suggested the two-shot plan did not increase immunity enough.
Marks said Friday that the federal agency decided to evaluate the data still because of the need to “act with urgency” due to the “Omicron surge and the notable increase in hospitalizations in the youngest children to their highest level during the pandemic so far.”
He insisted that Friday’s surprise delay to rushing the timeline “was not based on the dropping number of cases” recorded across the US.
“It’s still a staggering number of cases each day that we’re having,” he insisted of the ongoing spread.
“Since the early days of the pandemic, we’ve always followed the science in this ever-changing situation.”
Pfizer and BioNTech noted that the plan had initially always been to evaluate three shots for kids.
“Given that the study is advancing at a rapid pace, the companies will wait for the three-dose data as Pfizer and BioNTech continue to believe it may provide a higher level of protection in this age group,” the companies said in a statement.
The nation’s 18 million children under 5 years old are the only age group not yet eligible for vaccination.
SOURCE: NY Post