On Aug. 30, 2024, the Food and Drug Administration amended the emergency use authorization of the Novavax COVID-19 Vaccine, which includes a single component that corresponds to the Omicron variant JN. One strain of SARS-CoV-2. The Novavax COVID-19 Vaccine is no longer authorized for use in the United States. This was the first COVID-19 vaccine for FDA action since the second Trump administration took office in January.
On March 11, 2020, the entire world shut down after COVID-19 caused 4,291 deaths with 118,000 cases in 114 countries — the World Health Organization, or WHO, declared COVID-19 a pandemic.
The FDA is a United States federal agency within the Department of Health and Human Services responsible for protecting public health by ensuring the safety, efficacy, security of human and veterinary drugs, vaccines, medical devices, the Nations’s food supply, cosmetics and products that emit radiation.
The Pfizer vaccine is an mRNA vaccine that helps protect against the COVID-19 infection. It was developed by Pfizer and BioNTech and was one of the first vaccines approved for use in the U.S. in December of 2020.
Founded in 2008, BioNTech is a German multinational biotechnology company headquartered in Mainz that develops immunotherapies and vaccines, particularly for cancer and infectious diseases. This company utilizes technology platforms, including mRNA-based therapies, targeted therapies and immunomodulators, to develop its treatments.
The Novavax shot is already available for emergency use. Still, full FDA approval would allow the vaccine to be used more widely and could offer more reassurance to people looking for alternatives to existing vaccines.
“I had to [get vaccinated] as a requirement for going out of the country,” said Camille Tobey, a sophomore mass communication major.
The Novavax vaccine is a traditional vaccine compared to the other vaccines. Its technology has been used before to prevent such conditions as shingles, human papillomavirus, or HPV and others.
“It contains the coronavirus spike protein, but it’s engineered as a nanoparticle that cannot cause disease,” said Chloe Butts, a junior theatre major.
Unlike other vaccines, Novavax directly injects a version of the spike protein, along with another ingredient that also stimulates the immune system into the body, leading to the production of antibodies and T-cells.
T-cells are part of the immune system and develop from stem cells in the bone marrow. They help protect the body from infection and may also help fight cancer.
“I have personally had the Pfizer version of the vaccine since it came out,” said Will Evans, dean of the College of Health Sciences at GCSU. “While I cannot officially say I have ever been diagnosed with the virus that causes COVID-19, the messenger RNA vaccines are very effective and have been found to have limited adverse effects, all things considered.”
Evans says that all vaccines undergo four phases of testing. Phase one is the initial trial of a vaccine in humans for safety, dosing, and early efficacy information in a two-digit number of healthy volunteers. Phase two is the subsequent trial on a drug’s efficacy and safety in a larger population of over 100 people in particular disease settings.
Phase three is the larger clinical study, with more than 1,000 people, often spanning regions or countries, to confirm efficacy and safety by monitoring adverse reactions. The vaccine is compared against a placebo or standard treatment. Phase four a trial is conducted after FDA approval and after the vaccine is on the market to gain additional information about the vaccine’s risks and benefits. This also established effectiveness in a real-world setting vs tightly controlled scientific settings.
“This vaccine would work similarly to other vaccines but would not apply messenger RNA technology,” Evans said. “Rather, components from the spike protein found in one the virus are used. It still aims at producing an immune response in people so we can better recognize and fight the virus if exposed.”
Many await to see what it would take for the FDA to approve this vaccine in the future.