Pfizer, BioNTech delay FDA request for vaccines for children under 5

[mystery-ak]

Pfizer, BioNTech delay FDA request for vaccines for children under 5
By Nathaniel Weixel - 02/11/22 01:46 PM EST

Pfizer and BioNTech on Friday said they are delaying their request for the Food and Drug Administration (FDA) to authorize their coronavirus vaccine for children under five years old, because there's not enough data on the efficacy of a third dose.

An FDA advisory panel meeting scheduled for next week has been postponed, the FDA said.

"Based on the agency’s preliminary assessment, and to allow more time to evaluate additional data, we believe additional information regarding the ongoing evaluation of a third dose should be considered as part of our decision-making for potential authorization," the agency said in a statement.

The decision to extend the data submission and delay the advisory panel meeting pushes back the timeline for authorizing COVID-19 shots for kids under five, a major blow to parents of young kids.

The companies said they don't expect to have three-dose protection data available until early April.

"Cases continue to accumulate according to the study protocol and more data are being generated because rates of infection and illness remain high in children of this age, especially due to the recent Omicron surge," Pfizer said in a statement.

Pfizer earlier this month began applying for emergency use authorization of its vaccine in kids ages six months to four years old. But though the company said three doses will eventually be needed, the application was only for two doses.

more
https://thehill.com/policy/healthcare/593897-pfizer-biontech-to-delay-fda-request-for-vaccines-for-children-under-5

[mystery-ak]

Why..what's the real reason,  are you killing little kids like you have been with unborn babies?

[Kamaji]

That's not a "major blow to parents of young kids", it's a lifesaver because it staves off fascist mandatory vaccinations for young children who are not at risk from covid-19 anyways.

[jmyrlefuller]

Why..what's the real reason,  are you killing little kids like you have been with unborn babies?

Because Anthony Fauci told them to.

[Fishrrman]

"Pfizer, BioNTech delay FDA request for vaccines for children under 5"

Somebody blinked.
I'm guessin' it was the FDA, who passed the word to the drug companies that this one wasn't gonna fly...

[mystery-ak]

FDA Postpones Meeting On Authorizing Baby Pfizer Vaccine After 'New Data' Emerges From Clinical Trial

Patrick Howley  February 13, 2022 at 7:14am
The Food and Drug Administration (FDA) is postponing its advisory committee meeting on potential authorization for the Pfizer-BioNTech Coronavirus vaccine for babies as young as six months old. The FDA said that “new data” emerged in clinical trials, according to Pfizer, and so the FDA has postponed the meeting, which would have discussed emergency use authorization for the injection for children between the ages of six months and four years old. Obviously, this could be a massive setback for Pfizer-BioNTech’s efforts to inject children. As NATIONAL FILE reported days ago, the University of Pennsylvania — which hosts and directly funds Joe Biden’s think tank — profits off Pfizer-BioNTech vaccine sales and even profits off the Biden FDA’s approval of the vaccines, which represents a massive conflict of interest for Joe Biden. The FDA is still experiencing backlash after one of its advisory committee members, Eric Rubin, stated, “But we’re never going to learn about how safe the vaccine is unless we start giving it. That’s just the way it goes.” The FDA knew about numerous adverse events for children in past clinical trials but approved the injection anyway for ages 5 to 11. The FDA advisory committee that authorized the jab for 5-year olds was filled with Pfizer cronies. Not surprisingly, Pfizer’s fourth quarter earnings report discusses the possibility of unfavorable safety data for the vaccine and the risk of “serious” adverse reactions.

more
https://nationalfile.com/fda-postpones-meeting-authorizing-baby-pfizer-vaccine-new-data-emerges-clinical-trial/

[Kamaji]

FDA Postpones Meeting On Authorizing Baby Pfizer Vaccine After 'New Data' Emerges From Clinical Trial

Patrick Howley  February 13, 2022 at 7:14am
The Food and Drug Administration (FDA) is postponing its advisory committee meeting on potential authorization for the Pfizer-BioNTech Coronavirus vaccine for babies as young as six months old. The FDA said that “new data” emerged in clinical trials, according to Pfizer, and so the FDA has postponed the meeting, which would have discussed emergency use authorization for the injection for children between the ages of six months and four years old. Obviously, this could be a massive setback for Pfizer-BioNTech’s efforts to inject children. As NATIONAL FILE reported days ago, the University of Pennsylvania — which hosts and directly funds Joe Biden’s think tank — profits off Pfizer-BioNTech vaccine sales and even profits off the Biden FDA’s approval of the vaccines, which represents a massive conflict of interest for Joe Biden. The FDA is still experiencing backlash after one of its advisory committee members, Eric Rubin, stated, “But we’re never going to learn about how safe the vaccine is unless we start giving it. That’s just the way it goes.” The FDA knew about numerous adverse events for children in past clinical trials but approved the injection anyway for ages 5 to 11. The FDA advisory committee that authorized the jab for 5-year olds was filled with Pfizer cronies. Not surprisingly, Pfizer’s fourth quarter earnings report discusses the possibility of unfavorable safety data for the vaccine and the risk of “serious” adverse reactions.

more
https://nationalfile.com/fda-postpones-meeting-authorizing-baby-pfizer-vaccine-new-data-emerges-clinical-trial/

What, exactly, is this "new data"?