Biotech company Novavax has announced it will be initially prioritizing regulatory submissions for its promising COVID-19 vaccine in countries with urgent needs such as India, Indonesia and the Philippines. The long-anticipated vaccine is also being trialed as a third booster in people initially administered other vaccines.
Novavax’s COVID-19 vaccine is what's known as a protein subunit vaccine. Currently available COVID-19 vaccines are designed to coax cells into producing a part of the SARS-CoV-2 virus which then trigger the immune system to recognize it. Novavax’s candidate is a little different. It directly delivers lab-grown coronavirus spike proteins into the body in the form of nanoparticles created to mimic the structure of the virus.
So far, Phase 3 trials have demonstrated incredibly promising efficacy, but the company has been facing some challenging manufacturing hurdles. Most recently the company revealed its manufacturing facilities in the United States were struggling to pass the US Food and Drug Administration’s regulatory requirements, delaying its local approval until the end of 2021.
A recent announcement from Novavax reveals it is moving forward with manufacturing in India as part of a massive production deal with the Serum Institute of India. Regulatory submissions have now reportedly been filed with India, Indonesia and the Philippines.
The plan is to soon sort regulatory approval with the World Health Organization in order to allow low-income countries to access the vaccine. Over one billion doses are promised to these regions through a WHO scheme named COVAX.
"Today's submission of our recombinant nanoparticle COVID-19 vaccine, the first protein-based option filed with any regulatory agency, represents a major milestone in Novavax's transformation into a commercial global vaccine company," says Novavax CEO Stanley Erck. "This important step toward access to millions of doses of a safe and effective vaccine for countries with an urgent need to control the pandemic was made possible through our strategic partnership with Serum Institute of India, and it demonstrates the power of global collaboration."
With current vaccine supplies not a problem in countries such as the US, it is unsurprising Novavax is shifting its current focus toward those parts of the world in great immediate need. Looking forward to 2022, Novavax is positioning its vaccine to be the booster of choice for countries with populations initially immunized with other vaccines.
Early data from an ongoing booster study indicate very effective antibody responses are generated by a third dose against new virus variants such as Delta. While that data is from trials investigating individuals vaccinated solely with Novavax’s candidate, a large mix-and-match booster trial in the United Kingdom is set to deliver valuable insights into the efficacy of different vaccines given as a third dose.
The study is called COV-Boost, and it's studying immune responses in people given a third dose of a COVID-19 vaccine at least three months after initial vaccination with either Pfizer or AstraZeneca vaccines.
Almost 3,000 subjects have been recruited for the booster study, with each participant randomly administered a booster of one of seven different COVID-19 vaccines. Initial data will evaluate immune biomarkers such as antibody responses, but subjects will be followed for a year, with subsequent infection data collected over the longer follow-up.
No data has been officially released from the COV-Boost trial so far, but Erck has suggested Novavax’s vaccine is being positioned as the, “universal booster of choice and the preferred vaccine for annual re-vaccination.”