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FDA approval for COVID-19 vaccine

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On Aug. 23, 2021, the U.S. Food and Drug Administration (FDA) approved the first COVID-19 vaccine. What does this mean for you?

On Aug. 23, 2021, the U.S. Food and Drug Administration (FDA) approved the first COVID-19 vaccine.

Pfizer-BioNTech COVID-19 vaccine, now known as COMIRNATY (koe-mir’-na-tee), can be used to prevent COVID-19 disease in individuals 16 years of age and older. Comirnaty also continues to be available under emergency use authorization (EUA) for individuals 12 through 15 years of age and for an additional (third) dose in certain immunocompromised individuals.

What is required for FDA approval?

FDA conducted a thorough evaluation of the data and information submitted in the Biologics License Application (BLA) for Comirnaty before making a determination that the vaccine is safe and effective in preventing COVID-19 in individuals 16 years of age and older.

BLA is FDA’s standard “full approval” mechanism for biological products, including therapeutics and vaccines. A company seeking a BLA for its product must demonstrate that the product is “safe, pure, and potent,” which generally means completing robust, well-controlled clinical trials.

“A licensed vaccine means that FDA has reviewed and approved all the steps in vaccine production, including inspection of manufacturing facilities,” said Dr. Edward Belongia, director of the Center for Clinical Epidemiology and Population Health at Marshfield Clinic Research Foundation. “A licensed vaccine has at least six months of follow-up data demonstrating both safety and efficacy.”

A company receiving a BLA for their product can introduce the product into interstate commerce and market it for its approved uses. A BLA also has no defined end date, assuming no significant problems emerge; the product can stay on the market indefinitely.

Why select a new name?

Pfizer announced the brand name Comirnaty in a statement for the European Union in December 2020. The name represents a combination of the terms COVID-19, mRNA, community and immunity. The announcement stated that the name was “to highlight the first authorization of a messenger RNA (mRNA) vaccine, as well as the joint global efforts that made this achievement possible with unprecedented rigor and efficiency – and with safety at the forefront – during this global pandemic.”

FDA approval allows companies like Pfizer-BioNTech to manufacturer and sell their vaccines. Thus, the opportunity to sell a product allows them to call it something different and market to the general public.

What does this FDA approval mean for you?

The name isn’t the only change with FDA approval. This approval allows Pfizer-BioNTech the ability to charge health care facilities and other organizations for their product. However, Dr. Belongia explained that United States government has purchased enough COVID-19 doses to vaccinate the entire U.S. population at no cost to the individual.

A U.S. survey found that 32% of unvaccinated adults say they would be more likely to get a vaccine that had full FDA approval. Reducing vaccine hesitancy is a positive benefit for Comirnaty.

Additionally, EUAs only last as long as the public health emergency; therefore full FDA approval will allow manufacturers to continue marketing the COVID-19 vaccine after the emergency ends.

How safe and effective is Comirnaty (COVID-19 Vaccine mRNA)?

According to FDA, the overall vaccine was 91% effective in preventing COVID-19 disease.

“The clinical trial and post-authorization studies have shown that two doses of Comirnaty provide a high level of protection against COVID-19 hospitalization, including serious illness caused by the delta variant,” Belongia said.

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 pain, chills, joint pain and fever.

Rare cases of myocarditis (heart inflammation) have occurred after Comirnaty. The FDA and Centers for Disease Control and Prevention (CDC) conducted a rigorous evaluation of the post-authorization safety surveillance data and determined that risk is increased after receipt of Comirnaty, particularly within seven days following the second dose. Most cases have occurred in males under 40 years old, but the absolute risk is very low in this age group – about three to eight cases per million doses.

Short-term follow-up indicates that most cases of myocarditis have been mild with complete resolution of symptoms. However, some individuals had more serious illness requiring ICU admission. Information is not yet available about potential long-term health outcomes. The Comirnaty Prescribing Information includes a warning about these risks.

Will FDA still research the Comirnaty COVID-19 vaccine?

Belongia said people who were enrolled in the clinical trial will be followed for two years to evaluate long term safety and efficacy. The FDA and CDC have monitoring systems in place to ensure that any safety concerns continue to be identified and evaluated in a timely manner.

In addition, the FDA is requiring Pfizer-BioNTech to conduct post marketing studies to assess vaccine effectiveness and the risks of myocarditis/pericarditis following vaccination with Comirnaty. These studies will include an evaluation of long-term outcomes after myocarditis. The company has committed to additional post-marketing safety studies, including a study to assess safety of Comirnaty in pregnant women and infant outcomes.

What about the other COVID-19 vaccines?

Moderna and Janssen (Johnson & Johnson) are still being used under Emergency Use Authorization. Moderna has submitted a BLA and is awaiting a licensing decision from FDA. Janseen has not yet submitted a BLA. The Moderna COVID-19 vaccine has received conditional marketing authorization for use in Europe with the trade name Spikevax.

Marshfield Clinic Health System will continue to offer Comirnaty and other vaccines based on CDC recommendations. Talk to your provider if you have additional questions.

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