US Government, Pfizer ‘All Agreed’ to Delay Decision on Company’s COVID-19 Vaccine for Young Children: Bourla

Contact Your Elected Officials
The Epoch Times Header

The U.S. government and Pfizer reached an agreement to delay the U.S. regulatory decision on the company’s COVID-19 vaccine for children as young as 6 months old, Pfizer’s CEO said on March 13.

“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.”

Pfizer and its partner BioNTech have been testing their vaccine on children aged 6 months to 4 years but announced in late 2021 that they were expanding the clinical trial to three doses because the two-dose primary regimen didn’t trigger a sufficient immune response in some of the kids.

Instead of waiting for the expanded trial to be completed, the U.S. Food and Drug Administration (FDA) soon after asked Pfizer for data on the vaccine. Because of the spike in COVID-19 cases and hospitalizations from the Omicron virus variant, regulators were considering expanding emergency use authorization for the shot to the young population.

Officials appeared poised to grant the expanded authorization in February, but days before a scheduled vaccine advisory panel meeting, they announced they were postponing the decision.

“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. He said he hoped the move 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 more insight into the reason for the postponement. Dr. Scott Gottlieb, a former FDA chief who sits on Pfizer’s board, said it stemmed from a “low number of cases overall in the clinical trial.”

“Most kids are not getting symptomatic COVID,” he said.

By Zachary Stieber

Read Full Article on TheEpochTimes.com

The Epoch Times
The Epoch Timeshttps://www.theepochtimes.com/
Tired of biased news? The Epoch Times is truthful, factual news that other media outlets don't report. No spin. No agenda. Just honest journalism like it used to be.

Trump’s Proposal For NATO To Stop Buying Russian Oil & Start Tariffing China Is Unrealistic

Trump proposed on social media that NATO stop buying Russian oil and start tariffing China 50-100% as part of his plan for ending the Ukrainian Conflict.

The Choices We Make

Death and disagreement are inevitable. Love and hate are choices. We will all die. Before we do, what choices will we make?

Elon Musk Speaks at Unite the Kingdom Rally

Tommy Robinson held rally, with Elon Musk appearing virtually, calling attention to leftist politicians who allow foreign immigrants to invade England.

Doxed Democrats Are Getting Fired Left and Left

Not a misprint because a title of “left and...

Hold Up, Feds, Without Federalism, There Is No USA

Federalism is essential to governing the U.S., yet the federal government is undermining it by bribing states to implement unnecessary federal programs.

Driver Rams Car Into FBI Pittsburgh Gate in Potential Act of Terror, Official Says

Driver crashes car into FBI Pittsburgh office gate in a suspected targeted attack the agency says may be an act of terror against the bureau.

Poland Open to Hosting French Nuclear Arms on Its Soil, President Says

Poland does not rule out possibility of hosting French nuclear weapons on its territory, country’s president, Nawrocki, said in remarks to French media.

RFK Jr. Plans to Change Childhood Vaccine Schedule, Ousted CDC Director Says

Health Secretary Robert F. Kennedy Jr. plans to change the immunization schedule for children, Susan Monare, fired director of the CDC testified.

Rubio Says US Visa Revocations Underway After Charlie Kirk Death Celebrations

SoS Marco Rubio said foreign nationals who made celebratory comments over Charlie Kirk’s assassination will have their U.S. visas revoked.

Trump Supports Designating Antifa a Terrorist Organization

President Trump said he would support designating the antifa movement a terrorist organization in the wake of Charlie Kirk’s assassination last week.

US Conducts Strike on Another Drug Boat From Venezuela: Trump

Three people were killed in a U.S. strike on a Venezuelan drug boat, President Donald Trump announced on Sept. 15.

Trump Signs Memo Targeting Direct-to-Consumer Pharmaceutical Advertising

President Trump signed a memo to ensure drug ads give fair, balanced, and complete information to protect and inform American consumers.
spot_img

Related Articles

Popular Categories

MAGA Business Central