Alert — Pfizer Vaccine receives full FDA approval…
Posted by Kane on August 23, 2021 11:35 am

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UPDATE — Full Approval Granted

The Food and Drug Administration issued full approval to the Pfizer COVID vaccine on Monday morning. The vaccine, which was granted FDA emergency use authorization in December, will now be marketed under the name Comirnaty for Americans 16-years-old or older.

“The FDA’s approval of this vaccine is a milestone as we continue to battle the COVID-19 pandemic. While this and other vaccines have met the FDA’s rigorous, scientific standards for emergency use authorization, as the first FDA-approved COVID-19 vaccine, the public can be very confident that this vaccine meets the high standards for safety, effectiveness, and manufacturing quality the FDA requires of an approved product,” said Acting FDA Commissioner Janet Woodcock in a statement.

“While millions of people have already safely received COVID-19 vaccines, we recognize that for some, the FDA approval of a vaccine may now instill additional confidence to get vaccinated. Today’s milestone puts us one step closer to altering the course of this pandemic in the U.S.,” she said.

Surgeon General expects more Vaccine mandates now that FDA approval has been granted.

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https://citizenfreepress.com/breaking/al...oval-on-monday/

Military & Blue States Announce Vaccine Mandates MINUTES After FDA Approves Injection
The usual hysterical fake newsers like Jennifer Rubin and Max Boot celebrating the medical tyranny.
By Jamie White
INFOWARS.COM
Monday, August 23, 2021

The establishment is wasting no time announcing vaccine mandates in the military and in New York and California minutes after the Food and Drug Administration’s (FDA) approval of the COVID mRNA injection.

Just minutes after the FDA’s announcement, Pentagon spokesperson John Kirby announced Monday that the military is now requiring soldiers to get the jab under threat of court martial.

“Now that the Pfizer vaccine has been approved, the Defense Department is prepared to issue new guidance requiring all service members to be vaccinated,” Kirby told reporters.

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y Jamie White | INFOWARS.COM Monday, August 23, 2021
The establishment is wasting no time announcing vaccine mandates in the military and in New York and California minutes after the Food and Drug Administration’s (FDA) approval of the COVID mRNA injection.

Just minutes after the FDA’s announcement, Pentagon spokesperson John Kirby announced Monday that the military is now requiring soldiers to get the jab under threat of court martial.

“Now that the Pfizer vaccine has been approved, the Defense Department is prepared to issue new guidance requiring all service members to be vaccinated,” Kirby told reporters.


New York announced the state’s Department of Education is also requiring it’s nearly 150,000 employees and all students to get the shot with no opt-out option.

New York City Mayor Bill de Blasio announced a similar mandate for city workers.

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Los Angeles announced vaccine mandates for its 60,000 city workers, including police and firefighters.

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https://www.newswars.com/military-blue-s...oves-injection/

US Drug Regulators Approve Pfizer’s COVID-19 Vaccine
By Zachary Stieber
August 23, 2021 Updated: August 23, 2021

U.S. drug regulators on Aug. 23 approved the COVID-19 vaccine from Pfizer and BioNTech for people 16 and older, making it the first such shot to receive approval in the country.

The Food and Drug Administration (FDA) said the vaccine, which will be known as Comirnaty, proved effective in a clinical trial of approximately 44,000 people.

The shot was 91 percent effective in preventing COVID-19 infection, regulators said, and was also effective in preventing severe disease and hospitalization.

The trial is ongoing in centers in six different countries, including the United States, and the data cited was accrued through March 13. Participants received either two doses of Pfizer’s jab or a placebo.

FDA officials said they also reviewed safety data and determined that the vaccine’s known and potential benefits outweigh its known and potential risks, including side effects.

“As the first FDA-approved COVID-19 vaccine, the public can be very confident that this vaccine meets the high standards for safety, effectiveness, and manufacturing quality the FDA requires of an approved product,” Dr. Janet Woodcock, the FDA’s acting commissioner, said in a statement.

“While millions of people have already safely received COVID-19 vaccines, we recognize that for some, the FDA approval of a vaccine may now instill additional confidence to get vaccinated. Today’s milestone puts us one step closer to altering the course of this pandemic in the U.S.”

The FDA issued emergency use authorization to the Pfizer shot and a COVID-19 vaccine from Moderna in December 2020. Several months later, regulators authorized a shot from Johnson & Johnson. But none until Aug. 23 had received approval, which has a higher bar than authorization.

COVID-19 is the disease caused by the CCP (Chinese Communist Party) virus.

The approval “affirms the efficacy and safety profile of our vaccine at a time when it is urgently needed,” Pfizer CEO Albert Bourla said in an emailed statement. “I am hopeful this approval will help increase confidence in our vaccine, as vaccination remains the best tool we have to help protect lives and achieve herd immunity.”

The decision will likely lead to new vaccine mandates, as some officials have held off imposing vaccine requirements due to the lack of an approved vaccine.

Approximately 201.4 million Americans have received at least one COVID-19 vaccine dose as of Aug. 22, according to federal data. More than 204 million Pfizer doses have been administered.

The approval comes as studies show that the efficacy of vaccines in preventing CCP virus infection is waning. That prompted a host of officials, including the FDA’s Woodcock, to announce last week that they plan, starting next month, to recommend booster shots, pending FDA authorization. Still, for now, those who get two Moderna or Pfizer shots are considered fully vaccinated.

The approval drew both support and criticism.

“With six months of safety data, the vaccine is still safe, still effective,” Dr. Alok Patel, a pediatric hospitalist in San Francisco, said on ABC News.

President Joe Biden said in a statement that the approval “should give added confidence that this vaccine is safe and effective.”

However, Peter Doshi, senior editor of the British Medical Journal, said on Aug. 23 that the FDA should have demanded “controlled studies with long term follow up” before granting the approval.

While the Delta variant of the CCP virus has been blamed for the vaccine’s waning effectiveness, he wrote, it may not be the true cause, since there hasn’t been enough time yet to properly study the data.

Adverse Reactions

While the FDA approved Pfizer’s jab, regulators also said they determined that there are “increased risks” of myocarditis and pericarditis, or heart inflammation, following administration of the shot, particularly within the seven days following the second dose of the two-dose regimen.

“The observed risk is higher among males under 40 years of age compared to females and older males. The observed risk is highest in males 12 through 17 years of age. Available data from short-term follow-up suggest that most individuals have had resolution of symptoms. However, some individuals required intensive care support. Information is not yet available about potential long-term health outcomes. The Comirnaty Prescribing Information (pdf) includes a warning about these risks,” the agency said.

The FDA previously added a warning about the heart inflammation to both the Pfizer and Moderna vaccines, which both utilize messenger RNA technology, but maintains that teenagers should still get vaccinated.

In the clinical trial that the FDA reviewed, approximately 58 percent of the participants were monitored for four or more months following their second dose. About a third of those who received the vaccine from that subset reported adverse events.

The most common side effect was pain at the injection site, followed by fatigue and headache. Some participants, 108 who got the vaccine and 151 who got a single vaccine dose or the placebo, reported that serious adverse events occurred, including Bell’s palsy (facial paralysis).

“In the analysis of blinded, placebo-controlled follow-up, there were no notable patterns between treatment groups for specific categories of serious adverse events (including neurologic, neuro-inflammatory, and thrombotic events) that would suggest a causal relationship to Comirnaty,” the FDA said in an approval document (pdf).

Approximately 3,079 people have died after receiving the Pfizer jab, according to the Vaccine Adverse Event Reporting System (VAERS), a passive reporting system run jointly by the FDA and the Centers for Disease Control and Prevention.

Some 15,268 people have been hospitalized after getting a Pfizer shot, according to VAERS reports. Nearly 3,900 have reportedly suffered a permanent disability.

The system is “not designed to determine if a vaccine caused a health problem, but is especially useful for detecting unusual or unexpected patterns of adverse event reporting that might indicate a possible safety problem with a vaccine,” according to its website.

Anybody can submit reports to the system. Health care providers are encouraged to submit reports, and vaccine manufacturers are required to report certain adverse events. Federal health officials then review the submissions.

https://www.theepochtimes.com/us-drug-re...s0HKbi6mQ%3D%3D



Here's the prescribing information insert:

The Comirnaty Prescribing Information (pdf)

Approved under the name of Comirnaty as a vaccine for those 16 and older; still under EUA for those 12 - 16.

FDA NEWS RELEASE

FDA Approves First COVID-19 Vaccine
Approval Signifies Key Achievement for Public Health

For Immediate Release:
August 23, 2021

Today, the U.S. Food and Drug Administration approved the first COVID-19 vaccine. The vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine, and will now be marketed as Comirnaty (koe-mir’-na-tee), for the prevention of COVID-19 disease in individuals 16 years of age and older. The vaccine also continues to be available under emergency use authorization (EUA), including for individuals 12 through 15 years of age and for the administration of a third dose in certain immunocompromised individuals.

“The FDA’s approval of this vaccine is a milestone as we continue to battle the COVID-19 pandemic. While this and other vaccines have met the FDA’s rigorous, scientific standards for emergency use authorization, as the first FDA-approved COVID-19 vaccine, the public can be very confident that this vaccine meets the high standards for safety, effectiveness, and manufacturing quality the FDA requires of an approved product,” said Acting FDA Commissioner Janet Woodcock, M.D. “While millions of people have already safely received COVID-19 vaccines, we recognize that for some, the FDA approval of a vaccine may now instill additional confidence to get vaccinated. Today’s milestone puts us one step closer to altering the course of this pandemic in the U.S.”

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https://www.fda.gov/news-events/press-an...ovid-19-vaccine