FDA grants Pfizer COVID-19 vaccine full approval

[keehah]

Turkish 'dream team' couple behind Pfizer's Covid-19 vaccine
The global success of a scientific couple has left Germany's Turkish community with a deep sense of pride. The pair, Ozlem Tureci and Ugur Sahin, hit the world's headlines this week with the news that they'd found a vaccine that could combat the coronavirus. Their research company BioNTech is now worth billions of dollars. TRT World's Sibel Karkus is in Berlin with more on the couple whose Turkish parents came to Germany as migrant workers.
Nov 11, 2020

2:52

nbcnews.com: Pfizer is testing a third Covid vaccine dose in young kids, delaying trial results

Dec. 17, 2021
Pfizer and BioNTech are testing a third dose of their Covid-19 vaccine in an ongoing trial of children ages 6 months to under 5 years after the companies found that the two-dose regimen didn’t generate a strong enough immune response in some children, the companies announced Friday.

The change to the trial protocol means that the companies won't have data to submit to regulators until the first half of 2022. That's a change from earlier this month, when Pfizer CEO Albert Bourla said the company could have data on young kids by the end of this year...

[W]we have decided to modify each of the pediatric studies to incorporate a third dose to the series and seek licensure for a three-dose series rather than a two-dose series as originally anticipated," Jansen said.

[ziero0]

It is not hard to achieve a cure for something that doesn't exist.

The infection rate for the newest variety of flu is 500 per 100,000. Or .5 percent.

FDA approval exists for those things authorized to engage in INTERSTATE COMMERCE. Has nothng to do with whether it works.

[keehah]

usatoday.com: Fact check: Pfizer's FDA-approved vaccine is available in US

Daniel FunkeUSA TODAY
Oct. 20, 2021
The claim: Pfizer's FDA-approved coronavirus vaccine is not yet available in the United States...

Comirnaty is the brand name for Pfizer's coronavirus vaccine. The FDA approved the shot in late August for Americans ages 16 and older.

But posts claiming Comirnaty is not yet available in the U.S. have racked up thousands of interactions on Facebook and Instagram over the past month, according to CrowdTangle, a social media insights tool...

"I can confirm that our vaccine has been granted FDA approval and that Comirnaty is available," Kit Longley, a spokesperson for Pfizer, said in an email...

Our rating: False

Based on our research, we rate FALSE the claim that Pfizer's FDA-approved coronavirus vaccine is not yet available in the U.S.

nationalfile.com: CDC Confirms Comirnaty NOT Available In USA, Meaning No FDA-Approved COVID Vax Is Available To Americans

December 23, 2021
Previously, the Pfizer vaccine and all other COVID-19 vaccines were being used under an Emergency Use Authorization (EUA), and this is what was granted to the Pfizer vaccine as it was originally manufactured and labeled.

News reports, including “fact checks” from USA Today, claim that the Comirnaty vaccine is simply the rebranded name of the original Pfizer-BioNTech vaccine that initially received the EUA.

Therefore, the news reports argue, a full FDA-approved COVID-19 vaccine is available to Americans. “The authorization changed, but the vaccine didn’t,” USA Today claims.

However, this is not the case...

It has now been confirmed, through the CDC’s own website, that “Comirnaty products are not orderable at this time.”
The CDC notes that Pfizer “does not plan to produce any product [under the Comirnaty label] with EUA authorized product [the original vaccine] is still available and being made available for U.S. distribution.”...

This would seem to confirm previous reports from National File and Star News reporter Peter D’Abrosca, which included statements from Pfizer that refused to plainly state whether the Comirnaty vaccine was available to people living in the United States or its territories...

With Comirnaty not being available anywhere in the United States, it would seem impossible for any entity within the state to legally mandate a COVID-19 vaccine.

fda.gov: FDA NEWS RELEASECoronavirus (COVID-19) Update: FDA Authorizes Moderna and Pfizer-BioNTech COVID-19 Vaccines for Children Down to 6 Months of Age

June 17, 2022
Today, the U.S. Food and Drug Administration authorized emergency use of the Moderna COVID-19 Vaccine and the Pfizer-BioNTech COVID-19 Vaccine for the prevention of COVID-19 to include use in children down to 6 months of age...

The Moderna COVID-19 Vaccine is administered as a primary series of two doses, one month apart, to individuals 6 months through 17 years of age. The vaccine is also authorized to provide a third primary series dose at least one month following the second dose for individuals in this age group who have been determined to have certain kinds of immunocompromise.

The Pfizer-BioNTech COVID-19 Vaccine is administered as a primary series of three doses in which the initial two doses are administered three weeks apart followed by a third dose administered at least eight weeks after the second dose in individuals 6 months through 4 years of age.

[keehah]

pfizer.com: Statement from Pfizer Chairman and CEO Albert Bourla on Testing Positive for COVID-19

AUGUST 15, 2022 – Pfizer Inc. (NYSE: PFE)
I would like to inform the public that I have tested positive for COVID-19. I am grateful to have received four doses of the Pfizer-BioNTech vaccine... I have started a course of PAXLOVID™ (nirmatrelvir [PF-07321332] tablets and ritonavir tablets), I am isolating in place as well as following all public health precautions.

We have come so far in the past two years in our efforts to battle this disease..

About PAXLOVID™ (nirmatrelvir [PF-07321332] tablets and ritonavir tablets)
PAXLOVID is a SARS-CoV-2 main protease (Mpro) inhibitor (also known as SARS-CoV-2 3CL protease inhibitor) therapy. It was developed to be administered orally so that it can be prescribed early after infection, potentially helping patients avoid severe illness (which can lead to hospitalization and death). Nirmatrelvir [PF-07321332], which originated in Pfizer laboratories, is designed to block the activity of the Mpro, an enzyme that the coronavirus needs to replicate. Co-administration with a low dose of ritonavir helps slow the metabolism, or breakdown, of nirmatrelvir in order for it to remain active in the body for longer periods of time at higher concentrations to help combat the virus.

U.S. FDA Emergency Use Authorization Statement
PAXLOVID has not been approved but has been authorized for emergency use by FDA under an EUA, for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg)...

is not approved for any use, including for use for the treatment of COVID-19...

IMPORTANT SAFETY INFORMATION

[several pages warning why not to take the PAXLOVID experimental drug]

[keehah]

Have the Feds even approved this vaccine yet? Probably not if this authorization still requires Trump's and Biden's "emergency use."

The August 2021 approval of "COMIRNATY™" was a legally different and not being distributed vaccine rather than the "Pfizer-BioNTech COVID-19 Vaccine" being used.


fda.gov: Coronavirus (COVID-19) Update: FDA Authorizes Bivalent Pfizer-BioNTech COVID-19 Vaccine as Booster Dose for Certain Children 6 Months through 4 Years of Age

March 14, 2023
Today, the U.S. Food and Drug Administration amended the emergency use authorization (EUA) of the Pfizer-BioNTech COVID-19 Vaccine, Bivalent to provide for a single booster dose of the vaccine in children 6 months through 4 years of age at least 2 months after completion of primary vaccination with three doses of the monovalent (single strain) Pfizer-BioNTech COVID-19 Vaccine...

“Today’s authorization provides parents and caregivers of children 6 months through 4 years of age who received the three-dose primary series with the monovalent Pfizer-BioNTech COVID-19 Vaccine an opportunity to update their children’s protection by receiving a booster dose with the Pfizer-BioNTech COVID-19 Vaccine, Bivalent,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. “Currently available data show that vaccination remains the best defense against severe disease, hospitalization and death caused by COVID-19 across all age groups, and we encourage all eligible individuals to make sure that their vaccinations are up to date with a bivalent COVID-19 vaccine.”

wikipedia.org/wiki/Democide

[keehah]

fda.gov: FDA NEWS RELEASECoronavirus (COVID-19) Update: FDA Authorizes Changes to Simplify Use of Bivalent mRNA COVID-19 Vaccines

April 18, 2023

Today, the U.S. Food and Drug Administration amended the emergency use authorizations (EUAs) of the Moderna and Pfizer-BioNTech COVID-19 bivalent mRNA vaccines to simplify the vaccination schedule for most individuals. This action includes authorizing the current bivalent vaccines (original and omicron BA.4/BA.5 strains) to be used for all doses administered to individuals 6 months of age and older, including for an additional dose or doses for certain populations. The monovalent Moderna and Pfizer-BioNTech COVID-19 vaccines are no longer authorized for use in the United States...

The safety and effectiveness of Moderna COVID-19 Vaccine, Bivalent is based on FDA’s previous analyses of clinical trials data of monovalent Moderna COVID-19 Vaccine in individuals 6 months of age and older and an investigational bivalent Moderna COVID-19 vaccine (original and omicron BA.1) in individuals 18 years of age and older. ...

The data accrued with the investigational bivalent Moderna COVID-19 vaccine (original and omicron BA.1) and with the monovalent Moderna COVID-19 Vaccine are relevant to the Moderna COVID-19 Vaccine, Bivalent because these vaccines are manufactured using the same process...

With today’s authorizations, the fact sheets have been updated and consolidated for the Moderna COVID-19 Vaccine, Bivalent and the Pfizer-BioNTech COVID-19 Vaccine, Bivalent. Each vaccine now has one fact sheet for healthcare providers and one fact sheet for recipients and caregivers, rather than different fact sheets for the various authorized age groups.

Vaccines and Related Biological Products Advisory Committee

Today’s authorizations follow discussions that occurred during a meeting with the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Jan. 26. At that time, by a unanimous vote, the committee recommended harmonizing the strain composition of COVID-19 vaccines used in the U.S. There was also support for simplifying the vaccine dosing schedule.

In June, the FDA will hold a meeting of its VRBPAC to discuss the strain composition of the COVID-19 vaccines for fall of 2023. Much like the FDA does yearly with the influenza vaccines, the agency will seek input from the committee on which SARS-CoV-2 variants and lineages are most likely to circulate in the upcoming year. Once the specific strains are selected for the COVID-19 vaccines, the FDA expects manufacturers to make updated formulations of the vaccines for availability this fall.

The amendments to the EUAs were issued to ModernaTX Inc. and Pfizer Inc.

reuters.com: Fact check: The COVID-19 vaccine is not an operating system designed to program humans

By Reuters Staff FEBRUARY 9, 2021
“DID YOU EVER WONDER WHY BILL GATES, A SOFTWARE DEVELOPER, BECAME THE EXPERT ON COVID-19?”, the post reads (here). “BECAUSE THE COVID-19 VACCINES ARE AN “OPERATING SYSTEM” DESIGNED TO PROGRAM HUMANS AND HACK THEIR BIOLOGICAL FUNCTIONS.”..

On its website, the pharmaceutical company Moderna, which has developed a COVID-19 vaccine, compares the mRNA science in its vaccine to an “operating system” (here)...

According to Moderna, mRNA science is comparable to an operating system because it can be used to tackle multiple different diseases.

“Recognizing the broad potential of mRNA science, we set out to create an mRNA technology platform that functions very much like an operating system on a computer.

“It is designed so that it can plug and play interchangeably with different programs. In our case, the “program” or “app” is our mRNA drug - the unique mRNA sequence that codes for a protein.”

This is possible, Moderna explains, because the only thing that changes from one potential mRNA medicine to another is the genetic code that instructs ribosomes to make protein...

VERDICT
False. COVID-19 vaccines are designed to provoke an immune response against the SARS-CoV-2 virus.