Pfizer and BioNTech seek authorization of second coronavirus booster shot for people 65 and older

[dirtybenny]

Pharmaceutical giant Pfizer and its partner, BioNTech, filed Tuesday for emergency authorization of a second booster shot of their coronavirus vaccine for people 65 and older, an effort to bolster waning immunity that occurs several months after the first booster, the companies announced.

The submission to the Food and Drug Administration includes “real world data” collected in Israel, one of the few countries that has authorized a second booster for older people. The decision from the FDA could come relatively quickly, especially if officials conclude the data is straightforward and does not have to be reviewed by a panel of outside vaccine experts.

In a separate move aimed at answering longer-term questions about booster strategies, the FDA plans to hold a meeting of its outside advisers in early April to consider whether there should be an effort in October or November, perhaps in conjunction with the annual influenza vaccine campaign, to encourage some or all adults to get additional boosters. The panel could also discuss whether the shots should be the same formula as current vaccines or retooled to counter new variants, according to a federal official who spoke on the condition of anonymity to discuss the plans.

Officials in the Biden administration and the public health community are keeping a close eye on a rise in coronavirus cases in Europe and the proliferation of the omicron variant BA.2. Some experts are worried cases could increase in the United States following the relaxation of mask requirements as BA.2, which is more transmissible than the original version of omicron, becomes dominant.

https://www.washingtonpost.com/health/2 ... ster-shot/

Keeping a close eye, eh? Another AI-generated term for psychic driving........one to keep an eye on...one to watch .eye of horus


Well, eye am keeping a close I on the A Eye....

Reminds me of when the AI came up with the vaccine being the "light at the end of the tunnel"

[fakeologist]

This story is a reuseable, recyclable template.
I'm numb to the words now

[rachel]

Well pointed out regarding the 'Emergency Use Authorisation'.

[rachel]

Children’s Health Defense Sues FDA Over Approval of Pfizer Comirnaty Vaccine

Children’s Health Defense (CHD) on Aug. 31 filed suit in U.S. District Court, Eastern District of Tennessee against the U.S. Food and Drug Administration (FDA) and its acting director, Dr. Janet Woodcock, for their allegedly deceptive, rushed licensure of Pfizer’s Comirnaty vaccine.

CHD argues that the licensure was a classic “bait and switch,” allowing Pfizer, the Biden administration, the U.S. military and employers to exhort people to take “licensed” vaccines when in fact the vaccines available and being administered continued to be the Pfizer-BioNTech Emergency Use Authorization (EUA) vaccines.

According to the lawsuit, the FDA violated federal law when it simultaneously licensed Pfizer’s “Comirnaty” vaccine and extended Pfizer’s EUA for its vaccine that has the “same formulation” and that “can be used interchangeably,” according to the FDA.

The law (21 U.S. Code § 360bbb-3-(3)) on “authorization for medical products for use in emergencies” requires the EUA designation be used only when “there is no adequate, approved and available alternative to the product for diagnosing, preventing or treating such disease or condition.”

The lawsuit alleges once the FDA approved and licensed Pfizer’s Comirnaty vaccine, there was no further basis for the FDA to preserve the EUA status for the Pfizer-BioNTech vaccine that Pfizer acknowledges has the “same formulation” and is “interchangeable.”

[rachel]

Pfizer, FDA Documents Contradict Official COVID Vaccine Safety Narrative — Is This Fraud?

How do we get information about the vaccines we take?

We get it from our doctors, our friends and the media. We hear experts like Dr. Anthony Fauci and Dr. Rochelle Walensky talk about them.

We see advertisements for the COVID-19 vaccines. And we see COVID vaccines in the news, day in and day out.

On the other hand, there exist official, legal documents that lay out precisely what the evidence showed when decisions were made to issue an Emergency Use Authorization (EUA) for the Pfizer-BioNTech vaccine, and a license for Pfizer’s Comirnaty vaccine.

These documents tell us what information Pfizer and the U.S. Food and Drug Administration (FDA) are willing to stand by.

The documents also establish the legal requirements for issuing the EUA and license for Pfizer’s vaccines.

It may come as a shock, but what the FDA said when it issued both the EUA and the license for Pfizer’s vaccines was very different from what you heard from the Centers for Disease Control and Prevention (CDC), the media and other sources.

For example, the CDC strongly encourages vaccination during pregnancy, although as late as December 2021, the FDA and Pfizer claimed the information available was inadequate to determine risk in pregnancy.

Here is the precise language on the Comirnaty label:

“Available data on Comirnaty administered to pregnant women are insufficient to inform vaccine-associated risks in pregnancy.”

That is a pretty clear “We don’t know.”

Yet here is CDC Director Walensky assuring us the vaccine poses no health risks with regard to pregnancy or fertility: