Katelynn Singleton, news editor
On Monday, Aug. 23, the U.S. Food and Drug Administration (FDA) approved the first COVID-19 vaccine. The Pfizer-BioNTech COVID-19 Vaccine will be marketed as “Comirnaty” following its approval, and it is available for individuals 16 years and older. Comirnaty had previously been authorized for emergency use for said individuals. Emergency use authorization of the Comirnaty vaccine is still in place for individuals ages 12 through 15.
Prior to approval by the FDA, the vaccine was administered under an Emergency Use Authorization (EUA). According to the FDA, an EUA is used to provide medical products that help treat a disease during a public health emergency.
The general timeline for the creation of the COVID-19 vaccine was sped up due to the severity of the COVID-19 pandemic. Christopher Hall, an associate biology professor at Berry, said that the vaccine for the SARS virus was being experimented with starting in 2004. SARS and COVID-19 are related viruses, which allowed for a faster development of the COVID-19 vaccine. Additionally, the clinical trials that a vaccine must go through were combined.
There are typically three phases that clinical trials go through, with the first being administered to a group of around 20 to 100 people to determine safety and reactions. The second is a larger group of people and studies the correlation between the doses received and the immune response. The third phase sees the vaccine being administered to thousands of people and generates information on the effectiveness of the vaccine. During development of the COVID-19 vaccine specifically, the first two phases were combined.
“The reason they could do this so fast was because of all the resources they suddenly pumped into it,” said Hall, “We suddenly had this real need, we had all these people getting COVID, and all resources got shoved into that.”
In order to gain FDA approval, the manufacturer of a vaccine must submit a biologics license application (BLA). The BLA for the Comirnaty vaccine includes preclinical and clinical data and information. It also includes testing results that ensure the quality of the vaccine, details of the manufacturing process and inspections of the vaccine manufacturing sites.
Following submission, a team evaluates the BLA and makes the determination to approve a vaccine. According to the FDA, this team is typically comprised of physicians, chemists, statisticians, pharmacologists/toxiciologists, microbiologists, experts in postmarketing safety, clinical study site inspectors, manufacturing and facility inspectors, and labeling and communications experts. They analyze the benefits and risks involved for the population who will receive the vaccine, as well as the disease it is targeting. When a vaccine is approved, it means that it is licensed for use in the United States.
After approval, the vaccine continues to be monitored to ensure effectiveness and identify any long-term complications that may occur. According to Johns Hopkins medicine, the FDA also sets strict guidelines for the manufacturers of the vaccine to guarantee that the quality and effectiveness of the vaccine stays consistent.
In a statement by FDA Commissioner Dr. Janet Woodcock, she says that the vaccine meets the high standards the FDA requires of an approved product, and that the public can be confident in its safety, effectiveness, and quality.
Hall says that the discussion on social media regarding the vaccine can be frustrating, especially the false information that people are spreading as truth. He hopes the approval of the vaccine by the FDA will encourage people to get vaccinated.
“It’s well documented that if you get the vaccine, there’s no harm,” Hall said, “I really hope people just go out and get the vaccine so that we can get past this.”
Berry has yet to release a statement regarding the requirement of a COVID-19 vaccine in students, staff or faculty members at the time of publication. The vaccine is currently strongly recommended among the Berry