What does FDA approval of the COVID vaccine mean?
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.