The Novavax logo is reflected in a drop on a syringe needle. Photo: Reuters/Dado Ruvic/Illustration.
New Delhi: The Serum Institute of India (SII), the world’s biggest vaccine maker, has applied to local authorities to conduct a small domestic trial of Novavax Inc’s COVID-19 vaccine, which was found to be 89.3% effective in a UK trial.
Serum Institute expected a decision on an Indian trial of Novavax’s vaccine soon, CEO Adar Poonawalla told Reuters on Friday, hours after the US company reported early efficacy data.
“We have already applied to the drug controller’s office for the bridging trial, a few days ago,” Poonawalla said. “So they should also give that approval soon now.”
Novavax’s UK trial, which enrolled 15,000 people aged 18 to 84, is expected to be used to apply for use in Britain, the European Union and other countries.
However, a mid-stage trial of the vaccine in South Africa, where a troubling new variant of the virus is common, showed 60% efficacy among people who did not have HIV.
Novavax shares surged 34% in after hours trading following release of the trial results on the same day the US reported its first cases of the South African variant.
The company is already stockpiling vaccine doses at six operating manufacturing locations, and said it expects a total of eight plants in seven countries to produce at the rate of two billion doses per year, including from SII.
SII is already bulk producing a vaccine created by the University of Oxford researchers and AstraZeneca, and Poonawalla told Reuters earlier this month that his company would manufacture “upwards of 40-50 million doses per month” of the Novavax vaccine from around April.
Indian health officials say they generally ask for bridging trials to determine if a vaccine is safe and generates an immune response in its citizens whose genetic makeup can be different from people in western nations.
There are, however, provisions under rules introduced in 2019 to waive such trials in certain conditions. Pfizer Inc. requested an exception while seeking an emergency-use authorisation for its vaccine developed with German partner BioNTech SE, a request the government has turned down.
The Pfizer vaccine has not been approved in India, whose immunisation campaign is using a homegrown one developed by Bharat Biotech and the Indian Council of Medical Research, and the AstraZeneca/Oxford University vaccine.
Novavax’s UK study took place as the more highly transmissible UK variant was circulating. A preliminary analysis suggests the vaccine is 85.6% effective against this mutation, the US company said in a news release. It did not provide detailed data.
John Moore, a professor of microbiology and immunology at Weill Cornell Medical College in New York, said the Novavax UK data is essentially the same as results from Pfizer and Moderna.
“It’s not statistically different. The vaccine basically works well in the predominant strain circulating in the UK, which means it’s likely to be equally effective in the United States,” he said.
Amesh Adalja, an infectious disease expert at the Johns Hopkins Center for Health Security, said the results were in line with hopes, and that he was concerned people would focus too much on the weaker effectiveness shown in South Africa.
“We’ve gotten spoiled because we’ve seen the Moderna and Pfizer numbers. I know people are going to be alarmed, but 60% efficacy against the new variant is acceptable,” he said, noting that the FDA initially said it would approve a vaccine that was at least 50% effective.
The South African variant has been shown to evade antibody protection in lab studies by Moderna and Pfizer/BioNTech.
Novavax said it started making new versions of its vaccine to protect against emerging virus variants in early January and expects to select ideal candidates for a booster in the coming days. The company said it plans to initiate clinical testing of these new vaccines in the second quarter of this year.
A 30,000-person trial in the US and Mexico that began in December also is underway. The company has received $1.6 billion from the US government in funding for the vaccine trial and for 100 million doses.
It also has received at least $388 million in backing from the Coalition for Epidemic Preparedness Innovation (CEPI), a Norway-based group backed by 14 governments, the Bill and Melinda Gates Foundation, and Britain’s Wellcome Trust.
Authorised vaccines so far have been based on newer technology platforms, such as the messenger RNA technology used by Moderna and Pfizer/BioNTech, or inactivated cold virus platforms used by Oxford University/AstraZeneca and CanSino Biologics.
Novavax’s is a more conventional protein-based vaccine, an approach similar to that used by Sanofi to make its Flublok seasonal flu vaccine. The Novavax vaccine works with the company’s proprietary Matrix-M adjuvant used to boost its efficacy.
(Reuters – reporting by Krishna N. Das, Caroline Humer, Julie Steenhuysen and Vishwadha Chander; editing by Shri Navaratnam, Jane Wardell, Peter Henderson and Bill Berkrot)