The Food and Drug Administration (FDA) took the unusual step of requesting data from Pfizer and BioNTech on how its vaccine has been doing in a clinical trial because of the surge in pediatric COVID-19 hospitalizations and wanting to prepare for the next “twist” in the pandemic, an FDA official said on Feb. 4.
“As reports of pediatric hospitalizations increased in association with the Omicron-variant surge in late December, FDA requested Pfizer to provide more detailed data for our review as data became available,” Dr. Dorian Fink, the official, told a Centers for Disease Control and Prevention (CDC) vaccine advisory panel during a virtual meeting on a different subject.
COVID-19-associated hospitalizations rose to record-highs for children younger than 5 years old, according to COVID-NET, a surveillance system that is the CDC’s source for hospitalization rates linked to COVID-19.
However, a significant portion of COVID-19 hospitalizations are actually cases where people are hospitalized for other reasons and test positive for COVID-19 upon admission, according to state, hospital, and CDC officials.
“In some hospitals that we’ve talked to, up to 40 percent of the patients who are coming in with COVID-19 are coming in not because they’re sick with COVID, but because they’re coming in with something else and have had COVID, or the Omicron variant, detected,” Dr. Rochelle Walensky, the CDC’s director, said in January.
COVID-19 is the disease caused by the CCP (Chinese Communist Party) virus.
The FDA asked for data from Pfizer and its partner BioNTech because it may grant emergency use authorization for a two-dose regimen for young children, the only population that can’t currently get a COVID-19 vaccine.
Besides the rise in hospitalizations, Fink said agency officials were also motivated by the amount of inquiries that came in from health care providers, advocacy groups, and the general public expressing “intense interest” about the potential clearance for COVID-19 vaccines for the youngest children.
Pfizer and its partner BioNTech on Feb. 1 said they had submitted data to the FDA and asked for authorization for their shot for children as young as six months old.
The companies about 45 days prior had announced their vaccine didn’t produce an adequate immune response in children 2 to 5.
The FDA will review the data, Fink said, adding that while the Omicron variant-driven surge is declining “it is imperative not only to react to the present situation, but also to be prepared for when we are confronted with the next unexpected twist.”
Several experts have told The Epoch Times that parents of children under 5, an age group at little risk from COVID-19, should be cautious about getting their kids vaccinated.
“Think twice before you vaccinate your kids. Because if something bad happens, you can’t go back and say, ‘whoops, I want a do-over,’” Dr. Robert Malone, a virologist and immunologist, said in a recent interview.
The FDA, meanwhile, has been dealing with pushback for a number of vaccine-related decisions during the pandemic, including clearing booster shots for teenagers despite some experts saying much of that population was sufficiently protected with a primary series and that an additional shot wasn’t worth the risk of side effects such as heart inflammation.
Two FDA officials resigned in 2021 due to disagreements over how the agency handled boosters.
The FDA also pulled a document offline this week after being questioned about certain portions, including a newly revealed meta-analysis from the agency that revealed a higher-than-ever estimated rate of post-vaccination heart inflammation events in youth who received a Moderna vaccine, drawing criticism.
Fink said the choice to convene the Vaccines and Related Biological Products Advisory Committee on Feb. 15 to go over data concerning Pfizer’s shot for young children was done to be transparent.
“FDA intends to conduct an open, transparent discussion of the available data, to listen carefully to the assessment of our expert committee members, and to end the meeting better prepared to build upon our response to COVID-19, whether this follows from a clear recommendation for an authorization, or from recommendations for additional data to support authorization in the near future,” he said.