On Monday, the biotechnology company Novavax declared that it has formally requested an emergency use permission (EUA) from the Food and Drug Administration for its COVID-19 vaccine. The announcement was made on the same day that the FDA fully approved the Moderna COVID-19 vaccine and more than five months after the Pfizer-BioNTech COVID-19 vaccine received full FDA approval.
In a press statement, Novavax requests that its protein-based NVX-CoV2373 vaccine be approved for use in adults aged 18 and older. The company notes that clinical trials have shown the vaccine to have a 90% efficacy rate and a “reassuring” safety profile.
In a statement, Stanley C. Erck, president and chief executive officer of Novavax, said, “We believe our vaccine offers a differentiated option built on a well-understood protein-based vaccine platform that can be a substitute to the portfolio of available vaccines to help fight the COVID-19 pandemic.
Some have questioned the need for a new COVID-19 vaccination at this time, however infectious disease specialists claim that this vaccine fills a gap. What you should know is as follows.
How does the vaccine Novavax function?
The original SARS-CoV-2, the virus that causes COVID-19, was used as the genetic basis for the protein-based Novavax vaccine. The baculovirus, an insect virus, has the SARS-CoV-2 spike protein gene. Infected insect cells release the spike protein after contracting that virus. William Schaffner, M.D., an infectious disease expert and professor at the Vanderbilt University School of Medicine, adds that when the spike proteins are harvested, they are coupled with an adjuvant (a substance that boosts your body’s immune reaction).
The vaccination “takes a more conventional approach,” according to Dr. Schaffner. “The vaccine was created using the crucial portion of the spike protein. The body produces antibodies in response to that portion of the spike protein.
The vaccine is intended to be administered twice in 0.5 millilitre doses, separated by 21 days.
The Novavax vaccine works slightly differently from other vaccines. Those include:
- mRNA vaccines: These vaccines encode a part of the spike protein that’s found on the surface of SARS-CoV-2, the Centers for Disease Control and Prevention (CDC) explains. The mRNA vaccines use pieces of that encoded protein to spark an immune response from your body and develop antibodies. Your body eventually eliminates the protein and the mRNA, but the antibodies stick around.
- Vector vaccines: These vaccines use an inactivated virus as a carrier to deliver proteins that your body recognizes as a threat. As a result, your body makes antibodies against those proteins. The Johnson & Johnson COVID-19 vaccine is an adenovirus vaccine, which means it uses an inactivated common cold virus.
- Whole killed vaccines: These vaccines use a killed version of the germ that causes a disease, the U.S. Department of Health and Human Services (HHS) explains. These also prompt an immune response in your body but they don’t usually create as much immunity as those that use live viruses. As a result, you may need several doses over time to have ongoing immunity. Common inactivated vaccines include the flu shot, hepatitis A shot, polio vaccine, and rabies vaccine.
What does the data say about the Novavax vaccine?
The PREVENT-19 experiment, which included around 30,000 individuals in the United States and Mexico, and another trial with almost 15,000 participants in the United Kingdom, were both Phase 3 clinical trials conducted by Novavax.
There were 56 COVID-19 cases in the placebo group and six instances in the vaccine group in the U.K. trial, yielding an effectiveness rate of 89.3%. In the PREVENT-19 experiment, 14 of the vaccinated individuals contracted the virus while 63 placebo recipients developed COVID-19, giving the vaccine a 90.4% effectiveness rate.
The most common side effects from the trials included:
- Nausea or vomiting
- Muscle aches and pains
- Joint stiffness
- Injection site pain and tenderness
- Malaise, aka a general feeling of discomfort
Why is the Novavax vaccine needed now?
Modera and Pfizer-BioNTech are two COVID-19 vaccines that have previously received full FDA approval for usage, while Johnson & Johnson is another that is currently using an EUA. Why then is a second COVID-19 vaccine required?
At the University at Buffalo in New York, Thomas Russo, M.D., professor and director of infectious diseases, acknowledges that “we now have enough COVID-19 vaccine to vaccinate everyone we want.” The mRNA vaccines, he claims, are “experimental,” but “Novavax has a chance to be a niche vaccine for those patients.”
According to Dr. Russo, Novavax’s more conventional immunization strategy “may be more tolerable to some.” We may be able to change the dial with these people as a result, he continues.
Amesh A. Adalja, M.D., a specialist on infectious diseases and a senior scholar at the Johns Hopkins Center for Health Security, adds that having more options is just a good thing. The more COVID vaccinations available, the better, he asserts.
According to Dr. Schaffner, “the extremely small minority” of persons who are allergic to components of mRNA vaccines may find the Novavax vaccine to be a useful alternative. And more strategies for combating COVID-19 are always preferable, he adds.
In general, especially during pandemics, “we always desire to have more vaccine makers,” he claims. When a new variety will appear and more options will be required, who knows?
The FDA has received the clinical trial data and EUA application from Novavax. It’s uncertain whether or when it will be approved.