For the past year, we have ignored the Novavax COVID-19 vaccine while focusing on the ones from AstraZeneca, Moderna, Pfizer, and JNJ. However, Novavax will soon be requesting an Emergency Use Authorization (EUA) in the USA for its vaccine, known as Nuvaxovid or Covovax, bringing another weapon in the war against COVID-19. The vaccine received an emergency use authorization in the EU in December 2021.
The Novavax COVID-19 vaccine is completely different than the mRNA vaccines from Moderna and Pfizer and the adenovirus vector vaccines from JNJ and AstraZeneca. It uses a technology that is similar to what is used with other common vaccines.
Unfortunately, Novavax ran into several manufacturing issues which delayed its availability across the world. But over the past few months, they fixed those issues with their contractors and now appear to be ready to launch the vaccine widely across the world.
I just wanted to make sure that we remain aware of it, and I wanted to toss out some ideas that I have about the vaccine. I think it might be much more important than the other vaccines in fighting against the variants that keep hitting us.
What is the Novavax COVID-19 vaccine technology?
The Novavax vaccine utilizes a recombinant spike protein subunit antigen that is produced before being placed in the vaccine. It does not use mRNA, which all of the other vaccines use either directly or indirectly with the adenovirus vector, the vaccine contains the key S-protein antigen. Pertussis, hepatitis B, and pneumococcus have utilized similar technology for many years.
The vaccine is produced by creating an engineered baculovirus containing a gene for a modified SARS-CoV-2 spike protein. The baculovirus infects a culture of Sf9 moth cells, which then create the spike protein and display it on their cell membranes. The spike proteins are harvested and assembled onto a synthetic lipid nanoparticle about 50 nanometers across, each displaying up to 14 spike proteins that form the antigenic surface to induce an immune response.
The vaccine requires two doses, 21 days apart, and is stable at 2 to 8 °C (36 to 46 °F) or refrigerator temperatures.
The Novavax COVID-19 vaccine underwent clinical trials in several countries across the world.
The UK study included 14,039 people randomized into the vaccine and placebo groups. The reported results were:
- the vaccine had an overall efficacy of 83.4% two weeks after the first dose and 89.7% one week after the second dose.
- there was no difference in serious adverse effects between the vaccine and placebo groups (more evidence of the nocebo effect).
Novavax reported that their vaccine showed a 50-60% effectiveness in a South Africa study.
Novavax also reported an overall 90.4% efficacy in the Phase 3 USA and Mexico trial that involved nearly 30,000 people ages 18 years and older.
Because of the dates of their clinical trial, there are no published results for the effectiveness of the Novavax vaccine against the Delta and Omicron variants of SARS-CoV-2.
Why this new vaccine might be important?
From my perspective, there could be four good reasons that this vaccine could be very important going forward.
First, because it uses a different technology for producing an antigen, it may provide a different immune response than the current vaccines. It might train the immune system to better recognize new variants. To be fair, I don’t have evidence of this, because the spike protein that is used in this vaccine is similar to the ones produced by the mRNA vaccines, but it’s possible that the vaccine plus adjuvant does a better job. It could also be an alternative booster vaccine.
Second, the initial reports show lower severe adverse effects from the vaccine. For example, there were no reports of myocarditis events that have been shown to be possibly linked to the mRNA and adenovirus vaccines. This could reduce vaccine hesitancy in some groups that have resisted the current vaccines because of the extremely rare adverse events.
Third, because it can be stored in a normal refrigerator, this vaccine can be distributed more easily. Plus, physicians’ offices can have the vaccine on hand to give after they consult with a patient.
Finally, because it is not an mRNA vaccine (and the adenovirus vaccines also use mRNA, they just deliver it in a different manner) which has garnered some negative PR for debunked reasons, it could also be more acceptable to vaccine-hesitant individuals.
Of course, none of this matters to the crackpot anti-vaxxers who won’t listen to reason about these vaccines. But it could make this type of COVID-19 vaccine much more acceptable to those who are sitting on the fence, especially for their children.
Once the Novavax COVID-19 vaccine is widely available, I might consider getting another booster with it, just to be safe.
Update 1 February 2022
Novavax submitted an application for an Emergency Use Authorization to the Food and Drug Administration. The application will be reviewed by the Vaccines and Related Biological Products Advisory Committee (VRBPAC) before a recommendation is made to the FDA Commissioner, who has the authority to accept or reject the EUA. This could take several weeks, and I’ll update everyone once the EUA is approved.
- Heath PT, Galiza EP, Baxter DN, Boffito M, Browne D, Burns F, Chadwick DR, Clark R, Cosgrove C, Galloway J, Goodman AL, Heer A, Higham A, Iyengar S, Jamal A, Jeanes C, Kalra PA, Kyriakidou C, McAuley DF, Meyrick A, Minassian AM, Minton J, Moore P, Munsoor I, Nicholls H, Osanlou O, Packham J, Pretswell CH, San Francisco Ramos A, Saralaya D, Sheridan RP, Smith R, Soiza RL, Swift PA, Thomson EC, Turner J, Viljoen ME, Albert G, Cho I, Dubovsky F, Glenn G, Rivers J, Robertson A, Smith K, Toback S; 2019nCoV-302 Study Group. Safety and Efficacy of NVX-CoV2373 Covid-19 Vaccine. N Engl J Med. 2021 Sep 23;385(13):1172-1183. doi: 10.1056/NEJMoa2107659. Epub 2021 Jun 30. PMID: 34192426; PMCID: PMC8262625.
- Wadman M. Novavax launches pivotal U.S. trial of dark horse COVID-19 vaccine after manufacturing delays. Science. doi:10.1126/science.abg3441. S2CID 234411557.
- Wadman M, Jon C. Novavax vaccine delivers 89% efficacy against COVID-19 in UK – but is less potent in South Africa. Science. doi:10.1126/science.abg8101
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