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NJ Governor Phil Murphy and his wife Tammy get their first doses of the Pfizer COVID-19 vaccination at the Atlantic City mega site. NorthJersey.com

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Eight months after first authorizing the Pfizer-BioNTech COVID-19 vaccine for emergency use in the United States, the Food and Drug Administration on Monday issued full approval.

Now that the companies' in-depth application has been granted, many businesses, schools and other entities are expected to require vaccination of employees and students. 

The FDA decision also clears the way for the companies to market their vaccine, which is not permitted without full approval. And it could launch a race for booster shots, allowing doctors to prescribe extra Pfizer-BioNTech shots "off label" to anyone they think should get one. 

“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 Janet Woodcock, the acting FDA commissioner. “Today’s milestone puts us one step closer to altering the course of this pandemic in the U.S.” 

What's different now that the Pfizer vaccine has FDA full approval?

The federal Food and Drug Administration says the Pfizer-BioNTech vaccine meets its high standards for safety and effectiveness. It has reviewed additional, updated data about the safety of the vaccine in a larger group of clinical-trial participants for six months, compared with two months for the earlier emergency authorization.

The agency also performed a detailed assessment of the manufacturing processes, including inspections of the manufacturing facilities, said Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research.

The vaccine was authorized for use in adults on Dec. 10, under an emergency use authorization. That authorization is allowed during public health emergencies when the FDA finds that the “known and potential benefits of a product … outweigh the known and potential risks of the product.”

How effective is the Pfizer COVID-19 vaccine?

The vaccine was 91% effective in preventing COVID-19 disease, based on the updated clinical trial results, the FDA said in its announcement. The vaccine is effective in preventing COVID-19 and potentially serious outcomes including hospitalization and death.

How long does it take to get full approval for a vaccine?

The first emergency use authorization for the Pfizer-BioNTech vaccine in people age 16 and older was issued on Dec. 11. An additional authorization extending its use to those ages 12 to 15 was given on May 10. The application for approval was fast-tracked, meaning that follow-up data on safety was submitted on a rolling basis to speed the FDA’s review.  

Is the Pfizer vaccine FDA approved for everyone now?

The FDA approved the Pfizer vaccine for people 16 years old and older. It continues to be available under an emergency use authorization for children ages 12 through 15 and as a booster shot or third dose for people with certain conditions that compromise their immune systems.

What is Comirnaty?

That is the brand name that Pfizer-BioNTech has given to its vaccine for prevention of COVID-19. It is pronounced koe-mir’-na-tee. Previously, it was simply called the Pfizer-BioNTech COVID-19 vaccine. 

Booster shots: NJ is preparing for a COVID booster shot rollout. Will it go more smoothly this time?

How many people have been vaccinated?

In the United States, 204 million doses of the Pfizer vaccine have been administered. More than 92 million people have received the full two-dose regimen.

In New Jersey, 6.2 million doses of the Pfizer vaccine have been administered, and 2.9 million people have received both doses.

Will more people get the COVID vaccine now?

Three in 10 unvaccinated people have said they would be more likely to get vaccinated if the vaccines have full approval, rather than an emergency use authorization, according to the Kaiser Family Foundation’s vaccine monitor surveys. Worries about safety and the fact that the vaccines were still considered experimental contributed to vaccine hesitancy. This step should increase confidence in the vaccines.

What will full approval mean for vaccine mandates by businesses and universities?

More businesses and universities are likely to go ahead now with plans to require employees and students to get a COVID vaccine. They previously had legal authority to require vaccines for their employees, under a ruling from the federal Equal Employment Opportunity Commission. But with full federal approval of the vaccine, there may be more protection from legal challenges to those requirements.

For example, Holy Name Medical Center in Teaneck was waiting for full approval before requiring that all of its staff get vaccinated. Louisiana’s governor and the city of San Francisco also had announced they would wait for full FDA approval before any requirement for vaccination.

How will this affect a booster shot for COVID?

Third doses — or booster shots — of the Pfizer and Moderna vaccines have been authorized by the FDA for people with organ transplants and conditions that cause them to have weaker immune systems. The White House last week announced a plan to make booster shots available to others who received Pfizer or Moderna vaccines eight months after their second dose. Pending regulatory approval, that would start on Sept. 20.

Now  that the Pfizer vaccine has received full approval, physicians can prescribe it “off label,” or for uses not specified by the FDA. Although physicians are discouraged from doing so, that could make it easier for some people to jump the line to get a third dose ahead of the eligibility guidelines set by the federal government.   

What does full approval mean for Pfizer-BioNTech?

The company can now advertise and market the vaccine for the prevention of COVID-19 in people 16 and older. What has been known as the Pfizer-BioNTech COVID-19 vaccine will now be marketed as Comirnaty, according to the FDA.

Can children can get the COVID vaccine now?

No COVID vaccine has been authorized yet for children younger than 12. Clinical trials are underway in children as young as 6 months old, and data is expected to be submitted this fall. An emergency use authorization for those ages 5 to 11 is likely to come first and may occur before the end of the year.

What are the side effects of Pfizer's COVID-19 vaccine?

The most common side effects reported by clinical trial participants were pain, redness and swelling at the injection site, fatigue, headache, muscle or joint pain, chills and fever.

Can the COVID-19 vaccine cause heart myocarditis and pericarditis? Should I be worried?

The FDA said that data from people given the Pfizer-BioNTech vaccine showed rare cases of inflammation of the heart muscle, known as myocarditis, and of the lining outside the heart, known as pericarditis, particularly within seven days after the second dose. The risk appeared higher among males younger than 40, and highest among young men ages 12 through 17, compared with females and older men. Most recovered quickly, although some required intensive care. Information is not yet available about potential long-term outcomes.

The federal Centers for Disease Control and Prevention says these side effects are rare, and that the known and potential benefits of COVID-19 vaccination outweigh the known and potential risks, including the possible risk of myocarditis or pericarditis. 

What is the Moderna vaccine FDA approval timeline?

Moderna announced in June that it had started submitting its material for full approval, called a Biologics License Application, on a rolling basis to the FDA. It requested an expedited review by the FDA. It currently is available to those age 18 and older under an emergency use authorization.

Is the Johnson & Johnson COVID vaccine FDA-approved?

Johnson & Johnson has said it expects to apply for approval of its single-dose Janssen vaccine before the end of the year. it is also available under an emergency use authorization for those age 18 and older. 

Lindy Washburn is a senior health care reporter for NorthJersey.com. To keep up-to-date about how changes in the medical world affect the health of you and your family, please subscribe or activate your digital account today.

Email: washburn@northjersey.com 

Twitter: @lindywa 

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