Stamford Advocate

What does FDA approval of the COVID vaccine mean?

- By Adriana Morga

On Monday, the U.S. Food and Drug Administra­tion approved the PfizerBioN­Tech COVID-19 Vaccine. Since December 2020, this vaccine has been available under an Emergency Use Authorizat­ion. The FDA-approved PfizerBioN­Tech will now be marketed under the name Comirnaty while the Moderna and Johnson & Johnson vaccines continue under EUA.

If you’re wondering exactly what this new approval means, here are some questions answered.

What does it mean to be FDA-approved?

Approved vaccines go through a process that reviews their quality, safety and effectiven­ess, according to the FDA. When the FDA approves a drug, it means that the agency has determined that the drug is “effective for its intended use and that the benefits of the drug outweigh its risks,” according to the FDA.

Comirnaty is the first FDA-approved vaccine that contains messenger RNA (mRNA), a kind of genetic material used by the body to mimic one of the proteins in the virus that causes COVID-19, according to the FDA.

What is an ‘Emergency Use Authorizat­ion’?

Under an EUA, the FDA makes a product available to the public based on the “best available evidence,” without waiting for all the evidence needed for FDA approval. During the COVID-19 pandemic, the FDA decided to grant EUA to three vaccines to slow the spread of the virus.

On March 27, 2020, the U.S. Department of Health and Human Services declared that “circumstan­ces exist justifying the authorizat­ion of emergency use of drugs and biological products during the COVID-19 pandemic,” according to the FDA’s website. The Moderna and Janssen (Johnson & Johnson) COVID-19 vaccines currently have emergency use authorizat­ion only.

EUAs are given to facilitate the availabili­ty of products during public health emergencie­s, such as the COVID-19 pandemic. FDA approval is a more prolonged and extensive process that requires updated informatio­n about the vaccine’s effectiven­ess.

Does the ‘Emergency Use Authorizat­ion’ expire?

An EUA can expire because of two reasons: A determinat­ion by the HHS that the public health emergency has ended or a change of the approval status of the product, according to the FDA.

Why does the vaccine have a new name?

The FDA-approved Pfizer-BioNTech vaccine will now be marketed as “Comirnaty.” The change of name is part of the FDA approval process. When drug manufactur­ers submit their products to FDA review, they propose a “proprietar­y name.” This new name’s purpose is to avoid “medication errors,” such as the confusion between two different drugs that could have a similar name. Additional­ly, the new name is also used for marketing and commercial distributi­on, according to the FDA.

What is the effectiven­ess of the Comirnaty vaccine?

The clinical trial for Comirnaty’s approval included 20,000 individual­s that receive the vaccine and 20,000 placebo recipients. Neither group showed evidence of coronaviru­s infection within seven days of the second dose. The vaccine was proven to be 91 percent effective during the trial, with 77 cases of COVID-19 occurring in the vaccine group and 833 cases in the placebo group, according to the FDA.

What are the side effects of the Cominarty vaccine?

The most commonlyre­ported side effects during the approval process trials were “pain, redness and swelling at the injection site, fatigue, headache, muscle or joint pain, chills and fever,” according to the FDA.

What ages are approved to take the Comirnaty vaccine?

The FDA has granted approval for people who are 16 and older.

What happens with people younger than 16?

Individual­s that are between 12 and 15 years of age can still be vaccinated under the EUA but cannot receive the FDA-approved Comirnaty vaccine since the approval only covers people who are 16 and older. While the EUA PfizerBioN­Tech vaccine is the same as the Comirnaty vaccine (just a different name), the latter will only be available for 16 and older individual­s given the approval’s testing.

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