The Pfizer COVID Vaccine's Full Approval: What NJ Needs To Know

NEW JERSEY — The Pfizer-BioNTech COVID-19 vaccine is the first to be fully approved by the U.S. Food and Drug Administration beyond its emergency use authorization. With this approval made on Monday, state and federal officials are hoping it will give more residents the confidence to get vaccinated.

"We hope today's news will persuade those who have been hesitant to get vaccinated," New Jersey Health Commissioner Judith Persichilli said during Monday's COVID-19 briefing. "We know from our COVID community corps volunteers that lack of full FDA approval has been cited by some as the reason they have not received the vaccination."

Acting FDA Commissioner Janet Woodcock noted that the approval of the vaccine is a milestone in the fight against the pandemic.

"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," Woodcock said.

Here are some key facts to know about the Pfizer COVID vaccine approval:

When was the Pfizer-BioNTech COVID-19 Vaccine first made available?

Since Dec. 11, 2020 under emergency use authorization (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.

What is the new name for the Pfizer vaccine?

The vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine, and will now be marketed as Comirnaty which is pronounced koe-mir’-na-tee.

What criteria and testing did the Pfizer vaccine undergo to get FDA approval?

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.

How many people were tested in the FDA approval process?

Specifically, in the FDA’s review for approval, the agency analyzed effectiveness data from about 20,000 vaccine and 20,000 placebo recipients ages 16 and older who did not have evidence of the COVID-19 virus infection within a week of receiving the second dose. The safety of Comirnaty was evaluated in about 22,000 people who received the vaccine and 22,000 people who received a placebo 16 years of age and older.

How long were trial participants followed for?

More than half of the clinical trial participants were followed for safety outcomes for at least four months after the second dose. Overall, about 12,000 recipients have been followed for at least 6 months.

Any side effects reported during the clinical trial?

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

How effective is the Pfizer vaccine?

Based on results from the clinical trial, the vaccine was 91 percent effective in preventing COVID-19 disease. The vaccine is effective in preventing COVID-19 and potentially serious outcomes including hospitalization and death.

How does Comirnaty fight against COVID-19?

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.

Who is the Pfizer vaccine FDA approval for?

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.

How many people are vaccinated in New Jersey?

In New Jersey as of Monday, 5.4 million people have been fully vaccinated. Of those people, 3.2 million people have received the first dose of the Pfizer COVID vaccine and 2.9 million people have received the second or both doses of Pfizer's COVID vaccine.

For his part, Governor Phil Murphy said as he has repeatedly for months, that vaccinations were crucial in beating the pandemic.

"What is most important right now is for everyone to get vaccinated. That number continues to grow," he said. "Do your part. Get vaccinated."

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