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Pfizer Jab gets full FDA approval, Pentagon authorizes vaccinations for all troops

by Tyler Durden

As expected, the Pentagon press secretary confirmed that the Department of Defense will now require all forces across the armed forces to receive the vaccine.

Soldiers who refuse the vaccine may face “disciplinary” measures, including being dragged before a military court that would impose the punishment. Commanders have several options for dealing with forces that refuse mandatory COVID-19 vaccines including issuing them a letter of reprimand or taking other administrative actions; the use of non-judicial punishment to induce them to inoculate; Refer troops to an administrative board for dismissal for not obeying the order, or even refer service members to military courts, which has already happened in the past when some troops refused to inoculate with anthrax.

“We have every expectation that once vaccines are made mandatory, the troops will do the right thing,” Kirby told reporters at a Pentagon briefing a few weeks ago. “But, without talking to the future, it is, of course, treated like any legal order, and there could be administrative and disciplinary ramifications for not complying with that order.”

The Department of Defense also makes sure that service members who have reservations about getting the COVID-19 vaccine are “properly counseled” about the risks to their personal health and preparedness and unit that might arise from their refusal of vaccine cakes, and that commanders have a “broad range” of tools “To pressure troops to comply.

“Leaders have a set of tools, less than using the UCMJ [Uniform Code of Military Justice] available to them to try to help individuals make the right decisions,” Kirby added.

Similar mandates are also expected in the private sector, where companies like Walmart, along with thousands of small businesses, are expected to require proof of vaccination for all workers.

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Nearly 8 months after the Pfizer-BioNTech syringe was approved for general use after receiving an unprecedented emergency authorization, the vaccine officially became the first to gain full approval by the Food and Drug Administration on Monday, Washington Post reports.

The news, which was Telegraph days ago, sent shares of Pfizer and BioNTech up shortly after the opening on Monday.

As mainstream media immediately pointed out, approval may prompt some skeptical adults to take the vaccine, while giving companies the last bit of ammunition they need to ask workers to get vaccinated, or shot. According to the CDC, 204MM Pfizer jabs (which will henceforth be known as Comirnaty, the official brand name for the cover) since the emergency permission was first handed over last December.

The vaccine is officially approved for Americans over 16, while the emergency permit remains in place for patients 12 to 15 years old. Myocarditis and pericarditis And other possible side effects. Pfizer will also develop a registry to help monitor infant outcomes after vaccinated women are born.

CNBC reports that a survey from the Kaiser Family Foundation found that 3 in 10 unvaccinated adults said they would be more likely to be vaccinated if one of the vaccines received full approval. The full approval is “more psychological than anything else,” said Dr. Paul Offit, a voting member of the agency’s Advisory Committee on Vaccines and Biological Related Products. “I mean you already have over 320 million doses given. Vaccines really have a massive profile in terms of safety and efficacy.”

“The FDA is going to do what it thinks it needs to do to make sure the American public is safe,” he said.

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Initially, the full mandate was expected to arrive in September, but the Biden administration has increased the pressure in recent days. Full approval opens the door to many activities that have been blocked under the emergency permit: Pfizer can now announce a vaccine, and it can now continue to vaccinate people even after the COVID “emergency” is over. Pfizer can now raise the price of the vaccine. that they Already raised the price of the vaccine in the European Union.

Both Pfizer and BioNTech have said they intend to generate billions of dollars in revenue (and potential profits) from sales of punches.

As vaccine proponents celebrate the news, Alex Berenson, a prominent skeptic, has a question: How can a vaccine be fully approved when we don’t even know the optimal number of doses?

Here The full press release From the FDA:

Today, the US Food and Drug Administration approved the first vaccine for the COVID-19 virus. The vaccine is known as the Pfizer-BioNTech COVID-19 vaccine, and will now be marketed as Comirnaty (koe-mir’-na-tee), to prevent COVID-19 disease in individuals 16 years of age or older. The vaccine is also still available under an Emergency Use Authorization (EUA), including for individuals 12 to 15 years of age and for administration of a third dose in certain immunocompromised individuals.

The FDA approval of this vaccine is a milestone as we continue to fight the COVID-19 pandemic. While this and other vaccines have met the FDA’s stringent scientific criteria for emergency use authorization, as the first FDA-approved COVID-19 vaccine, the public can be very confident that this vaccine meets high standards for safety. Efficacy and manufacturing quality Janet Woodcock, the FDA’s acting commissioner, said the FDA requires an approved product “While millions of people have already received COVID-19 vaccines safely, we recognize that for some, FDA approval of a vaccine may now be instilled.” Extra confidence to get vaccinated. Today’s mark puts us one step closer to changing the course of this pandemic in the United States.”

Since December 11, 2020, the Pfizer-BioNTech COVID-19 vaccine has been available under the EUA to individuals 16 years of age and older, and authorization has been expanded to those 12 to 15 years of age on May 10, 2021. EUAs can be used by the Food Administration and FDA during public health emergencies to provide access to medicinal products that may be effective in preventing, diagnosing, or treating disease, provided the Food and Drug Administration determines that the known and potential benefits of the product, when used for prevention, outweigh the disease diagnosis or treatment risks known and potential for the product.

FDA-approved vaccines are subject to the agency’s standard process for reviewing the quality, safety, and efficacy of medicinal products. For all vaccines, the U.S. Food and Drug Administration evaluates the data and information contained in the manufacturer’s Biological Materials Authorization Application (BLA) submission. The BLA is a comprehensive document submitted to the agency that provides very specific requirements. For Comirnaty, the BLA relies on comprehensive data and information previously provided that support the EUA, such as preclinical and clinical data and information, as well as details of the manufacturing process, vaccine test results to ensure vaccine quality, and site inspections where the vaccine is made. The agency conducts its own analyzes of the information contained in the Drug Control Act (BLA) to ensure that the vaccine is safe, effective, and meets Food and Drug Administration (FDA) standards for approval.

Comirnaty contains messenger RNA (mRNA), which is a type of genetic material. The body uses mRNA to mimic one of the proteins in the virus that causes COVID-19. The consequence of a person receiving this vaccine is that their immune system will eventually react defensively to the virus that causes COVID-19. The mRNA in Comirnaty is only present in the body for a short time and is not incorporated into – and does not alter – the genetic material of the individual. Comirnaty has the same formula as the EUA vaccine and is given as a series of two doses, three weeks apart.

“Our scientific and medical experts have conducted an incredibly comprehensive and thoughtful evaluation of this vaccine. We have evaluated the scientific data and information included in hundreds of thousands of pages, conducted our own analyzes of Comirnaty’s safety and efficacy, and conducted a detailed evaluation of manufacturing processes, including inspections of manufacturing facilities. Director of the Food and Drug Administration’s Center for Biological Evaluation and Research. “We have not forgotten that the COVID-19 public health crisis continues in the United States and that the public is dependent on safe and effective vaccines. The general community and medicine can be confident that while we have this vaccine approved quickly, it is fully in line with the current high standards for vaccines in the United States.”

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While this is certainly a ‘win’ for Pfizer, BioNTech, and its shareholders, it’s not the end of the road in terms of the approval process: The Food and Drug Administration is now expected to weigh approval for a booster dose, which the Biden administration is doing before Sept. 20 , when you expect to start handing punches to the most vulnerable patients.

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