A fourth vaccine against COVID-19 may be authorized in the near future in the US. Meet: Novavax!
What is Novavax?
Novavax is a little different than the other COVID-19 vaccines available in the US. The SARS-CoV2 spike protein is the little piece of the virus that allows it to enter cells where it can make copies of itself and ultimately get you sick. Vaccines teach the body to make antibodies against the spike protein and prevent you from getting ill. The other vaccines use a modified virus or mRNA to get your cells to make the spike protein for your body to train up on and make antibodies against. Novavax cuts out the middleman. It is a protein subunit vaccine. It is made up of the spike protein itself and an adjuvant. An adjuvant is an ingredient added to a vaccine to increase the immune response to make more antibodies. The spike protein by itself cannot make you sick or give you COVID-19.
Is Novavax safe and effective?
In a study including about 30,000 adults, the vaccine efficacy to protect against symptomatic COVID-19 was 90.4%, which is great! This study was done before Omicron, so we don’t yet know how effective this vaccine will be against that variant.
Novavax is less reactogenic than the mRNA vaccines. This means there are fewer symptoms of the immune system kicking in (think headache, muscle soreness, fatigue, fever). Even without those symptoms, the vaccine is still doing its thing and working.
There is a theoretical concern for myocarditis, or inflammation of the heart muscle, from this vaccine. Six cases of myocarditis occurred in the study group and five of those were reported within 2 weeks of vaccination. All individuals recovered well. This number is too small to know for sure if the myocarditis was caused by the vaccine and more time and studies are needed to answer this question. We do know that the risk of myocarditis from COVID-19 is much higher than the risk of myocarditis from the other COVID-19 vaccines.
When will it be authorized?
The Vaccines and Related Biological Products Advisory Committee (a group that advises the FDA about vaccines) met to hear information about Novavax on June 7th and voted overwhelmingly to recommend that the FDA grant emergency authorization to Novavax. The Committee also felt that the risk posed by the possibility of heart inflammation was significantly outweighed by the benefits of vaccination.
The FDA still needs to decide if they will accept the Committee’s recommendation (they usually do) and then the CDC would need to recommend the vaccine before it would become available. The FDA is looking at manufacturing processes before it will decide whether or not to authorize Novavax.
Notably, Novavax has already been authorized in more than 40 countries and has emergency authorizations from the European Union and the World Health Organization.
We Nerdy Girls will keep you up to date as more info becomes available!
Stay safe. Stay well.
Those Nerdy Girls