In this video, Dr. Seheult of MedCram details how the newly approved, under emergency use authorization (EUA), vaccine from Novavax works. Novavax is the name of the company that has developed the latest Covid-19 vaccine called NVX-CoV2373. Novovax has gotten EUA from the FDA and the CDC has approved it. An anticipated rollout of Novavax should be coming shortly.
Novovax Production
The Novovax manufacturing process is very different compared to the mRNA vaccines. It is considered to be a traditional vaccine in the way it was produced. This includes involving a protein that is embedded in a nanoparticle. For Novovax production, it started with sequencing the original SARS-CoV-2 virus known as the Wuhan-Hu- 1. The RNA was then taken and transcribed into DNA using DNA nucleic acids. The sequence for the spike protein was then taken and specifically put into a virus (Baculovirus) that only infects moth cells and not human cells. This Baculovirus then infects a moth cell. The DNA goes into the cytoplasm of the moth cell and gets taken up into the nucleus and then DNA is transcribed into RNA which is translated into spike proteins. The moth cell essentially becomes a factory for spike proteins. The manufacturing process then collects these spike proteins and puts them into a nanoparticle. An adjuvant substance called Matrix M is then added to the nanoparticle so that it can cause the immune system to basically wake and notice things more. The adjuvant for the Novavax comes from a tree called Quillaja Saponaria, which has a substance that is irritating to the body. In the final step, this nanoparticle with the DNA and adjuvant is injected into the human body to get an immune response.
mRNA Vaccine Production
In contrast, mRNA vaccine production has fewer steps. The mRNA virus spike protein is isolated. The mRNA is put into a nanoparticle and then injected directly into the human cell. It interacts with the ribosomes in the cytoplasm to make spike proteins that project on the human cells without anything further needed.
DNA vaccine production
The vaccine from Johnson and Johnson uses an adenovirus vector that infects the cells and the material is DNA and not RNA in origin.
Novovax Phase 3 Trial
The study that tested Novovax was the phase 3 trial (Prevent-19) and it enrolled about 30,000 people that had never had an infection with Sars-CoV-2 in the U.S. and Mexico. There were initial delays in the trial as it was getting started around the time the mRNA vaccines had become available. There was debate as to whether it was ethical to keep people in a placebo trial when there were proven vaccines at that time. To get around this, the trial offered a crossover option around the 2-month mark so that someone in the placebo arm could get a vaccine. The overall efficacy of the vaccine was 90.4% and was statistically significant. In terms of prevention of moderate and severe symptoms, it had 100% prevention.
Limitations of Trial
Limitations included in this trial were that the virus used was the original alpha variant and not one of the more recent subvariants. There were not enough 65+-year-old subjects enrolled due to other EUA vaccines (namely Pfizer and Moderna) being available and a strong push that this age group gets vaccinated as soon as possible.
Side effects
Side effects of the vaccine included pain and tenderness at the injection site. Systemic symptoms consisted of headache, muscle pain, fatigue, malaise, and joint pain. There were also 6 cases of myocarditis/pericarditis in the vaccine arm that occurred after vaccine administration and were felt to be a causal association. The Novovax study did note that in the mRNA trials during pre-authorization, those mRNA trials did not have any vaccine-associated myocarditis until it was discovered post-authorization. However, in Novavax, they were already finding myocarditis/pericarditis in the pre-authorization state. They are anticipating there might be a higher incidence of cases post-authorization per the authors of the study.
The vaccine is anticipated to have about 3.2 million doses shipped shortly. About 22% of people in the U.S. still have not received a single Covid vaccine per the CDC. This may be a good alternative for those who have been hesitant to use mRNA vaccines. Even though the spike protein may have changed, the underlying T cell response has still been good. It is important to continue to monitor the risks for myocarditis/pericarditis post-vaccination and to work to improve your immune system.
LINKS / REFERENCES:
Efficacy and Safety of NVX-CoV2373 in Adults in the United States and Mexico (NEJM) | https://www.nejm.org/doi/full/10.1056…
Novavax Is the Latest Approved COVID Vaccine—Here’s What to Know About It (Parade) | https://parade.com/health/novavax-vac…
Adjuvant effects of saponins on animal immune responses (PMC) | https://www.ncbi.nlm.nih.gov/pmc/arti…
U.S. clinical trial results show Novavax vaccine is safe and prevents COVID-19 (NIH) | https://www.nih.gov/news-events/news-…
Novavax’s COVID-19 Vaccine: Your Questions Answered (Yale) | https://www.yalemedicine.org/news/nov…
Vaccines and Related Biological Products Advisory Committee Meeting June 7, 2022 (FDA) | https://www.fda.gov/media/158912/down…
Novavax adds blinded crossover arms to COVID-19 vaccine trials (Fierce) |
https://www.fiercebiotech.com/biotech…
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