FDA Grants Full Approval, Changes Name of Pfizer Vaccine

Today, in a long-awaited move, the FDA has finally granted full approval to Pfizer’s COVID vaccine, making it the first FDA-approved vaccine for COVID-19. The FDA’s official statement reads: 

“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.” 

In a statement about the vaccine’s approval, the FDA also noted that there has been a name change to the vaccine: formerly known as the Pfizer-BioNTech COVID-19 vaccine, the vaccine will now be called Comirnaty (koe-mir’-na-tee). According to a joint press release from Pfizer and BioNTech, the name is a combination of the terms COVID-19, mRNA, community, and immunity. 

Details about the Vaccine

The newly-named Comirnaty vaccine (given in 2 doses, 3 weeks apart) is fully approved for people ages 16 and up, while emergency authorization (EUA) will continue for anyone 12-15 and for a third booster shot in immunocompromised people who qualify. 

Like the Moderna vaccine, the Comirnaty vaccine is an mRNA vaccine--which means the vaccine contains mRNA that will create a protein similar to the one in the virus that causes COVID-19. However, the FDA noted in their approval that the mRNA is only in the body for a short amount of time and is not incorporated into or alters a person’s genes. 

If you’re curious about what’s in the vaccine, the package insert also lists all of the ingredients of the Comirnaty vaccine (formerly known as Pfizer’s vaccine):

◉ lipids: (0.43 mg ((4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate), 0.05 mg 2-(polyethylene glycol 2000)-N,N-ditetradecylacetamide, 0.09 mg 1,2-distearoyl-sn-glycero-3-phosphocholine, and 0.2 mg cholesterol)

◉ 0.01 mg potassium chloride

◉ 0.01 mg monobasic potassium phosphate

◉ 0.36 mg sodium chloride

◉ 0.07 mg dibasic sodium phosphate dihydrate

◉ 6 mg sucrose

◉ The diluent (0.9% Sodium Chloride Injection, USP) contributes an additional 2.16 mg sodium chloride per dose.

◉ COMIRNATY does not contain preservatives

What Took So Long?

If you’re wondering what exactly took so long to get this vaccine officially approved by the FDA, you’re not alone--but the FDA did address what exactly goes into the approval process. (And for the record, historically, vaccine approvals have taken several years, so even though many people felt like the vaccine should have been approved months ago, this was still a relatively speedy process.)

The FDA explained that the approval for any vaccines follows a “standard process” that reviews the quality, safety, and effectiveness of a medical product. Vaccine approval also involves:

◉ Evaluating data and information from the manufacturer’s biologics license application (BLA)

◉ Additional information from both the EUA data and ongoing data

◉ Manufacturing process review

◉ Vaccine testing results for vaccine quality

◉ Site inspections where the vaccine is made

◉ An FDA-specific analysis to ensure the vaccine meets FDA standards

They also listed some detailed information about the specifics of the safety and efficacy results of Pfizer’s vaccine that led to the full approval. 

Effectiveness

◉ Data from approximately 20,000 vaccine and 20,000 placebo recipients ages 16 and older (with no evidence of the COVID-19 virus infection within a week of receiving the second dose) was used

◉ Based on results from the clinical trial, the vaccine was 91% effective in preventing COVID-19 disease. 

Safety

◉ Data from approximately 22,000 people aged 16+ who got the vaccine and 22,000 people who had a placebo was used.

◉ Over half of the clinical trial participants were followed 4 months after the second dose and overall, 12,000 people who had the vaccine were followed for at least 6 months.

◉ The most common side effects were: pain, redness and swelling at the injection site, fatigue, headache, muscle or joint pain, chills, and fever.

◉ According to post-EUA safety data, the FDA concluded there is an increased risk of myocarditis and pericarditis, especially within 7 days of the second dose. The risk is higher in males under age 50, with the highest risk in men 12-17. The FDA noted that “available” data shows most people’s symptoms resolved on their own, while others required intensive care support.

◉ Syncope (fainting) upon administration also received a special address in the Comirnaty’s packet insert, as some people have experienced syncope with the vaccine, although according to the company, it’s not clear why. 

“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,” Peter Marks, M.D., Ph.D., director of FDA’s Center for Biologics Evaluation and Research said in the FDA’s statement. “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 the 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."

What Happens Next?

There is hope from both political leaders and healthcare officials that the full FDA approval will help encourage vaccine-hesitant individuals to get vaccinated. In an address from the White House, President Joe Biden called on Americans who had been waiting for the vaccine’s full approval to get vaccinated as soon as possible. 

"If you are one of the millions of Americans who said they will not get the shot until it has full and final approval of the FDA, it has now happened. The moment you've been waiting for is here, it's time for you to go get your vaccination, and get it today. Today,” he said. 

The American Medical Association, the American Hospital Association and the American Nurses Association also released a statement applauding the FDA's full approval of the Pfizer COVID-19 vaccine.

“According to recent polling, 30 percent of unvaccinated people said they were waiting for vaccines to receive full approval before getting vaccinated. We are there now; this vaccine is fully approved. If uncertainty was holding you back, now is the time to act. And if you still have questions about the vaccines or about COVID-19, please consult your health care professional,” the statement reads. 

“With millions of data points on the vaccine’s safety and efficacy over nearly nine months of vaccinations, every ‘i’ is dotted and every ‘t’ is crossed. This vaccine is safe, it prevents severe COVID-19, hospitalization, and deaths, and it will save your life. Science, data, and thorough research have given us the tools to defeat COVID-19. With the delta variant surging, there has never been a better time to get vaccinated.”

Source: nurse.org