American biotechnology company Novavax on Monday announced that its Covid-19 vaccine, NVX-CoV2373, showed 100% protection against moderate and severe infections with 90.4% efficacy overall in phase three trials.
“The study enrolled 29,960 participants across 119 sites in the US and Mexico to evaluate efficacy, safety and immunogenicity, with an emphasis on recruiting a representative population of communities and demographic groups most impacted by the disease,” the company said in a statement.
The Maryland-headquartered company said it plans to file for regulatory authorisations in the third quarter of the year – between July and September. It added that it would seek approvals for the vaccine’s use after completion of the final processes.
“Novavax continues to work with a sense of urgency to complete our regulatory submissions and deliver this vaccine, built on a well understood and proven platform, to a world that is still in great need of vaccines,” the statement said.
Novavax’s President of Research and Development Gregory M Glenn said the data showed “consistent, high levels of efficacy” and reaffirms the ability of the company’s vaccine to prevent Covid-19 “amid ongoing genetic evolution of the virus”.
The company will hold a press briefing on Monday at 6 pm Indian Standard Time.
The news assumes significance for India as the Serum Institute and the Indian Council of Medical Research have collaborated to manufacture Covovax, which is developed by United States vaccine company Novavax.
On January 30, Serum Institute of India Chief Executive Officer Adar Poonawalla had announced that his company had applied to begin trials in India. Poonawalla had then said that he was expecting to launch Covovax in June.
The bridging trial will determine if the vaccine is safe and generates an immune response among Indian citizens, whose genetic structure can be different from people in western countries. However, there are provisions under rules to waive such trials in certain conditions.
The Serum Institute of India in Pune is the world’s largest vaccine manufacturer. In July 2020, Novavax had signed a deal with the Serum Institute to produce 2 billion (200 crore) doses of coronavirus vaccines. Poonawalla had then said that his company would manufacture the Novavax vaccine “upwards of 40-50 million [4-5 crore] doses per month” from around April this year.
India, which launched its vaccination drive on January 16, has been inoculating its population with two Covid-19 vaccines. One is Serum Institute’s Covishield, developed in collaboration with the Oxford University and drug company AstraZeneca. The other is Covaxin, created in partnership of Indian drug company Bharat Biotech and the Union government’s Indian Council of Medical Research.
However, as India opened up its vaccination programme to the entire adult population from May, it began to face hurdles due to lack of sufficient stock for everyone above 18 years. Following this, the Narendra Modi government announced a change in its vaccination policy on June 7.