Is a New and Better Vaccine Coming Soon?
A new player in the field of COVID vaccines could be arriving soon. The trials so far are encouraging for both safety and efficacy. It even has some advantages over the Pfizer, Moderna, and J&J vaccines that have become so familiar to us.
Novavax, headquartered in Maryland, has enrolled over 30,000 volunteer individuals in the US and Mexico in their Phase 3 clinical trials of their new COVID-19 vaccine. This vaccine is both innovative and “old school” in that it uses viral protein (antigen) rather than mRNA.
Here are the characteristics of this upcoming vaccine:
- Clinical trials so far, show 90% effectivity against Covid-19 overall, and 100% protection from moderate to severe disease.
- In people at high risk of developing complications from COVID-19 (people 65 years or older and people under age 65 with certain comorbidities or with likely regular exposure to COVID-19), the vaccine showed 91% efficacy in preventing symptomatic COVID-19 disease.
- It is a protein based vaccine engineered from the first strain of SARS-CoV-2 virus. It uses recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein. This antigen can neither replicate nor cause COVID-19 infection.
- The vaccine is created using a genetically modified baculovirus which infects a culture of Sf9 moth cells, which create the spike protein and display it on their cell membranes. The spike proteins are then harvested and assembled onto a synthetic lipid nanoparticle about 50 nanometers across, each displaying up to 14 spike proteins. This complicated manufacturing process takes weeks rather than days as with the mRNA vaccines.
- The adjuvant used is Novavax’s patented saponin-based Matrix-M™ to enhance the immune response and stimulate high levels of neutralizing antibodies.
- It demonstrated efficacy of 96.4% against the original virus strain, 86.3% against the Alpha (B.1.1.7) variant and 89.7% efficacy overall.
- It is stored and stable at refrigerator temperature (2 to 8 deg. C), so it can use existing supply chain modalities.
- It requires two injections, 21 days apart, and possibly followed by a booster six months later.
- Analysis of sera from primary vaccination series showed cross-reactive functional antibodies to Alpha, Beta and Delta variants, all of which increased 6- to 10-fold with the secondary booster injection.
- Early human trials showed strong antibody responses, was well tolerated with no serious adverse events and few side effects. Injection-site tenderness and pain, fatigue, headache, and muscle pain were the most reported side events.
- Novavax was originally backed by $388 million from the Coalition for Epidemic Preparedness and Innovation (CEPI), a non-profit founded by Bill Gates in 2015.
Novavax has previous experience with recombinant and nanotechnology for the development of novel vaccines. NanoFlu™, its quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults and will soon be advanced for regulatory submission.
This new COVID-19 vaccine may find its greatest use as a booster (known as a heterologous booster) to the previously released vaccines, which have shown rare but concerning adverse effects, such as blood clots and myocarditis (heart inflammation). Due to the low rate of side effects and adverse events shown so far, the Novavax may be the preferred booster vaccine of choice as our immunity eventually wanes with the Pfizer, Moderna, and J&J vaccines.