Pfizer Postpones Application For FDA Approval of Vaccine For Kids Under 5

 Sun 10:58 am +01:00, 13 Feb 2022  1

posted by Weaver

Pfizer has pulled their application for emergency use authorisation to enable them to inject children under the age of five years old. Although both Pfizer and the FDA claim that they were “waiting for more data” which was to be available in early April, it now looks like this is not true.

According to a report in the NY Times this morning we learned the real reason why Pfizer withdrew its EUA — The clinical trial had failed, again.

The NY Times reported that the turnabout came as the Centers for Disease Control and Prevention released data on Friday showing that booster shots of the Pfizer and Moderna vaccines lose some of their effectiveness against emergency room visits and hospitalizations by the four-month point.

The agency said the data was some of the earliest evidence on the durability of boosters. While it showed three doses offered better protection than two, it raised sobering questions about how long that protection lasts against severe disease. (source)

Together, the two developments dampened some earlier optimism about vaccines. They also presented at least a temporary setback for the Biden administration’s vaccination campaign (source)

The Jab Failed Back in December 2021

Back in December 2021, Pfizer said that the clinical trial of its mRNA jab for children under age 5 had failed. However, they did not withdraw the product, instead Pfizer “amended” its clinical trial to add a third dose and kept the original trial going meaning the children had to take another dose of the gene therapy mRNA.

Pfizer kept the clinical trial going for another 55 days from December 17 to the announcement that came yesterday which meant they had collected another 55 days’ worth of data.

“The F.D.A. began pressing Pfizer-BioNTech to seek authorization for a two-shot regimen weeks ago, despite disappointing results from the trial that were announced in December. Children ages 2 through 4 produced only 60 percent of the antibody levels that older teens and young adults did.”

The data showed that the jab did not work, according to the New York Times

Pfizer alerted the F.D.A.late on Thursday [Feb. 10 that it had more recent data, from mid-January on, showing a more discouraging picture as the Omicron variant bore down. The new data revealed that two doses were not sufficiently effective in preventing symptomatic infection.

Is This The Bad News Pfizer Was Expecting?

The Expose reported yesterday that Pfizer had added warnings to their financial review that safety data “May Impact Business” and said that it would appear that Pfizer is anticipating some bad news.

This was a result of several redline changes in their fourth-quarter and full-year 2021 earnings release on February 8, 2022. These changes seem to be centered around disclosures of unfavourable safety data.

“We could assume they are aware that the ordered release of their COVID vaccine Clinical trial data may cause them a few issues,” we reported. This could well have been a big cause of those issues and the millions of children under 5 that will be spared will equate to losses in Pfizers wallet.

Also the uptake of the vaccine in children — including in those 5 to 11, who began receiving Pfizer-BioNTech shots in early November — has been strikingly low.

Only about a third of the 28 million children from the U.S. in that age group have received at least one dose so far, according to C.D.C. data! (source). Let’s hope this is the same worldwide as parents get wiser to Pfizer.

Great news all round!