Pfizer Jab Receives Full Approval From FDA, Pentagon Mandates Vaccinations For All Troops
23 August, 2021
TACOMA, WA — The U.S. Food and Drug Administration has given the Pfizer COVID-19 vaccine it’s full approval for patients 16 and older. Now, Washington’s leaders are hoping the news may help address lingering vaccine hesitancy.
“The Food and Drug Administration’s full authorization of the Pfizer-BioNTech vaccine today is a great milestone in our fight against this deadly pandemic,” said Gov. Jay Inslee in a written statement. “People who get vaccinated should be more confident than ever in the safety and effectiveness of this vaccine. It does not just save the lives of individuals; it can save entire communities from further devastation.”
With the FDA’s approval, the U.S. has become the first country to fully approve the shot, according to Pfizer. Previously, the vaccine had only been granted for emergency use. Emergency use authorization requires just two months of study. Full approval requires six months of research, which Pfizer pursued, and which the FDA has now reviewed as part of its approval process. The FDA also reviewed real-world evidence, looking at data of the millions of Americans who have received the Pfizer vaccine already.
“More than half of American adults have been fully vaccinated against COVID, either through the Pfizer, Moderna or Johnson & Johnson vaccines,” Inslee said. “The result is that at least 170 million Americans, and more than 4 million Washingtonians, have robust protection from this virus. We can already see this in the fact that 95% of COVID hospitalizations in our state are among the unvaccinated.”
The approval is also being celebrated by the Washington State Department of Health.
“Great news!” the department tweeted. “After a rigorous review of safety/effectiveness data, FDA has granted full approval to the Pfizer COVID-19 vaccine for ages 16+.”
According to the DOH, a CDC committee is set to meet next Monday to review the FDA’s approval and update vaccine recommendations. As the Associated Press reports, those updated recommendations may make it easier for businesses and government agencies to mandate vaccines.
“There’s the precedent in the past – if you look at public and private organizations mandating vaccines or requiring vaccination for things that are fully approved, there’s precedent,” said Dr. Joshua Liao, an Internal Medicine Physician with UW Medicine. “I think there’s less precedent, because there’s less precedent in general, about emergency authorization for vaccines. And so, I do think this milestone will provide a rationale for different organizations and institutions to begin that mandating vaccination.”
Washington state has already issued some vaccine mandates, requiring state employees, health care workers, and school staff to be vaccinated by mid-October. When announcing those mandates, the governor argued they were necessary to boost the state’s flagging vaccination rate, and combat the rising tide of new COVID-19 infections driven by the spread of the delta variant.
Washington’s vaccination rate has lulled to an average of just over 11,000 vaccine doses administered per day, according to the latest DOH data. At the same time, case counts are also spiking, up to a seven-day rolling average of 2,819 new COVID-19 cases per day the second week of August. Nearly 95 percent of COVID-19 cases, hospitalizations and deaths in Washington have been among the unvaccinated.
Now that the Pfizer vaccine has received full approval, doctors say they’re cautiously optimistic that vaccination rates may pick up again.
“This full approval, I’m hoping, will increase the confidence from some people who have yet to get the vaccine, to get vaccinated,” Liao said. “But we also have to, at the same time, realize that this is a continual process. And so, this marks a milestone in our journey in understanding, in this case, a particular vaccine. But that journey doesn’t stop today or tomorrow. It continues forward.”
To those who are still hesitant even with the FDA’s full approval, Inslee says to talk to your doctor about vaccination.
“Washingtonians can make informed decisions about getting this preventative treatment,” Inslee said. “Talk to your health provider about whether this is the right decision for you.”
21 August, 2021
Update (1100ET): The Pentagon’s press secretary has just confirmed that – as expected – the DoD will now require all troops across the armed services to get the vaccine.
Troops who refuse the vaccine could face “disciplinary” measures, including being dragged in front of a military tribunal that would mete out punishment. Commanders have several options for dealing with troops who refuse mandatory COVID-19 vaccines including issuing them a letter of reprimand or taking other administrative action; using nonjudicial punishment to push them to get vaccinated; referring troops to an administrative separation board for failure to obey an order, or even referring service members to courts-martial, which has already happened in the past when some troops refused to get vaccinated for Anthrax.
“We have every expectation that once the vaccines are made mandatory the troops are going to do the right thing,” Kirby told reporters at a Pentagon news conference a few weeks ago. “But, without speaking to the future, it’s treated, certainly, like any lawful order, and there could be administrative and disciplinary repercussions for failing to obey that order.”
The DoD also make sure that service members who have reservations about getting a COVID-19 vaccine are “properly counseled” about the risks to their personal health and their unit’s readiness that could arise from them refusing the jab, and that commanders have a “range of tools” to pressure troops to comply.
“Commanders have a range of tools, short of 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 expected in the private sector as well, with companies like Wal-Mart, along with thousands of smaller businesses, expected to require proof of vaccination for all workers.
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Roughly 8 months after the Pfizer-BioNTech jab was first approved for public use after receiving an unprecedented emergency authorization, the jab has officially become the first to receive full approval by the FDA on Monday, the Washington Post reports.
The news, which was telegraphed days in advance, sent shares of Pfizer and BioNTech surging shortly after the open on Monday.
As the mainstream media immediately pointed out, the approval might prompt some skeptical adults to take the vaccine, while giving businesses the last piece of ammunition they needed to require workers to get the jab, or be fired. According to the CDC, 204MM Pfizer jabs (which will henceforth be known as Comirnaty, the official brand name of the jab) have been doled out since the emergency authorization was first handed down last December.
The vaccine is officially approved for Americans over the age of 16, while the emergency authorization remains in effect for patients between 12 and 15. Notably, the FDA is requiring Pfizer to conduct more research on the risks of myocarditis and pericarditis and other potential side effects. Pfizer will also develop a registry to help monitor outcomes for infants after vaccinated women give birth.
CNBC reports that a survey from the Kaiser Family Foundation found 3 in 10 unvaccinated adults said they would be more likely to get vaccinated if one of the vaccines receives full approval. Full approval is “more psychological than anything else,” said Dr. Paul Offit, a voting member of the agency’s Vaccines and Related Biological Products Advisory Committee. “I mean you already have more than 320MM doses administered. The vaccines already have an enormous safety and efficacy profile.”
“The FDA will do what it thinks it needs to do to make sure that the American public is safe,” he said.
Initially, full authorization was expected to arrive in September, but the Biden Administration has ramped up the pressure in recent days. Full approval opens the door to several activities that were barred under the emergency authorization: Pfizer can now advertise the jab, and it can now continue to vaccinate people even after the COVID “emergency” is deemed over. Pfizer can also now raise the price of the vaccine. They have already raised the price of the jab in the EU.
Pfizer and BioNTech have both said they intend to generate billions of dollars in revenues (and likely profits) from sales of the jab.
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’s the full press release from the FDA:
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.”
Since Dec. 11, 2020, the Pfizer-BioNTech COVID-19 Vaccine has been available under EUA in individuals 16 years of age and older, and the authorization was expanded to include those 12 through 15 years of age on May 10, 2021. EUAs can be used by the FDA during public health emergencies to provide access to medical products that may be effective in preventing, diagnosing, or treating a disease, provided that the FDA determines that the known and potential benefits of a product, when used to prevent, diagnose, or treat the disease, outweigh the known and potential risks of the product.
FDA-approved vaccines undergo the agency’s standard process for reviewing the quality, safety and effectiveness of medical products. For all vaccines, the FDA evaluates data and information included in the manufacturer’s submission of a biologics license application (BLA). A BLA is a comprehensive document that is submitted to the agency providing very specific requirements. For Comirnaty, the BLA builds on the extensive data and information previously submitted that supported the EUA, such as preclinical and clinical data and information, as well as details of the manufacturing process, vaccine testing results to ensure vaccine quality, and inspections of the sites where the vaccine is made. The agency conducts its own analyses of the information in the BLA to make sure the vaccine is safe and effective and meets the FDA’s standards for approval.
Comirnaty contains messenger RNA (mRNA), a kind of genetic material. The mRNA is used by the body to make a mimic of one of the proteins in the virus that causes COVID-19. The result of a person receiving this vaccine is that their immune system will ultimately 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 – nor does it alter – an individual’s genetic material. Comirnaty has the same formulation as the EUA vaccine and is administered as a series of two doses, three weeks apart.
“Our scientific and medical experts conducted an incredibly thorough and thoughtful evaluation of this vaccine. We evaluated scientific data and information included in hundreds of thousands of pages, conducted our own analyses of Comirnaty’s safety and effectiveness, and performed a detailed assessment of the manufacturing processes, including inspections of the manufacturing facilities,” said Peter Marks, M.D., Ph.D., director of FDA’s Center for Biologics Evaluation and Research. “We have not lost sight that the COVID-19 public health crisis continues in the U.S. and that the public is counting on safe and effective vaccines. The public and medical community can be confident that although we approved this vaccine expeditiously, it was fully in keeping with our existing high standards for vaccines in the U.S.”
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While this is definitely a ‘win’ for Pfizer, BioNTech and their shareholders, it’s not the end of the road as far as the approval process is concerned: The FDA is now expected to weigh approval of a booster dose, which the Biden Administration is pushing for before Sept. 20, when it expects to start doling out jabs to the most vulnerable patients.