The Serum Institute of India, the world’s biggest vaccine maker, has applied to local authorities to conduct a small domestic trial of American vaccine developer Novavax’s COVID-19 jab, which was found to be 89.3 per cent effective in a UK trial. It was also found to be highly effective against a variant first identified in the UK. But the positive Phase 3 clinical trial data was partly offset by other results that showed it offered significantly less protection against a highly transmissible variant of the coronavirus first identified in South Africa, which is spreading rapidly around the world.
Serum Institute expected a decision on an Indian trial of Novavax’s vaccine soon, Chief Executive Adar Poonawalla told news agency Reuters on Friday, hours after the US company reported the efficacy data.
“We have already applied to the drug controller’s office for the bridging trial, a few days ago. So they should also give that approval soon now,” Mr Poonawalla said.
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.
Serum Institute is already bulk producing a vaccine created by Oxford University and AstraZeneca, and Mr Poonawalla said 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 so-called bridging trials to figure out if a vaccine is safe and generates an immune response in its citizens whose genetic makeup can be different from people in western nations.
The efficacy of the Novavax vaccine was calculated at 95.6 per cent against the original coronavirus strain, and 85.6 per cent against the UK variant. But the level of protection was lower in a smaller, mid-stage trial conducted in South Africa.
Novavax said it began working on new shots against emerging strains in early January and expects to select ideal candidates in the coming days, then begin clinical testing in the second quarter of the year.
The Novavax vaccine was one of six candidates backed by a US government project formerly known as Operation Warp Speed, which has provided the company $1.75 billion. It’s also being tested in a trial in the US and Mexico, which has recruited 16,000 of 30,000 participants.
Unlike the Pfizer, Moderna and AstraZeneca vaccines, which deliver the genetic instructions that make human cells create a key protein of the virus, the Novavax shot injects the proteins directly into the body to evoke an immune response.
Over 29 lakh healthcare and frontline workers so far since India began its COVID-19 vaccination drive two weeks ago using two locally-made shots – the AstraZeneca one from Serum Institute and another developed by Bharat Biotech and India’s top clinical research body.
(With inputs from Reuters, AFP)