US-based Novavax Inc has signed a supply and license agreement with the Serum Institute of India for the development and commercialization of its COVID19 vaccine candidate.
As per the deal, Serum Institute will have exclusive rights for the vaccine in India during the term of the deal and non-exclusive rights during the “Pandemic Period” in all countries other than those designated by the World Bank as upper-middle or high-income countries.
On Tuesday, Novavax reported that its experimental COVID-19 vaccine produced high levels of antibodies against the novel coronavirus in a small, early-stage clinical trial, and that it could start a large pivotal Phase III trial as soon as late September.
No serious adverse events were reported and safety follow-up continues, Novavax said on Tuesday, while releasing the results of the study about its Covid-19 vaccine, NVX-CoV2373.
The trial evaluated two doses of the vaccine across two dose levels — 5 and 25 microgram — in 131 healthy adults ages 18-59 years.
“The Phase 1 data demonstrate that NVX-CoV2373 with our Matrix-M adjuvant is a well-tolerated COVID-19 vaccine with a robust immunogenicity profile,” Gregory Glenn, President, Research and Development at Novavax, said in a statement.
Novavax’s vaccine is one of more than two dozen products to have entered the first round of safety tests in people.
Novavax has become the third US company to release Phase-1 data of Covid-19 vaccines after Moderna and Pfizer.
Formula used by Novavax is different from all the other vaccines that have produced results in humans so far.
Its vaccines contain a coronavirus protein that prompts a response from the immune system. Protein-based vaccines have a longer track record than some of the newer approaches used by competing coronavirus vaccines, such as those based on viral genes or so-called adenoviruses.
Protein-based vaccines are licensed for diseases such as hepatitis B and shingles. Novavax successfully completed a Phase 3 trial for a protein-based vaccine for influenza earlier this year and has done research on other diseases, such as Middle East respiratory syndrome.
Novavax’s technology turns moth cells into factories for a coronavirus protein called spike, which studs the surface of coronaviruses. Its vaccine combines several of the spike proteins in a nanoparticle.
Novavax was awarded $1.6 billion by the US government as part of Operation Warp Speed (OWS), a program to deliver millions of doses of a safe, effective vaccine for Covid-19 to the US population.