NEW DELHI: The Serum Institute of India has started the production of Covovax, its own version of US-based Novavax’s Covid vaccine, which has shown the efficacy of over 90% in a recently concluded phase 3 trial.
In India, this vaccine -- whose 20 crore doses have been projected to be available between August and December -- is undergoing a bridging trial and is set to also be tested on kids starting next month.
“A new milestone has been reached; this week we began our first batch of Covovax (a Covid vaccine developed by Novavax) at our facility, here in Pune,” said SII in a tweet on Friday. Its CEO Adar Poonawalla had earlier said that a ban on raw materials required for the vaccines by the US was set to impact vaccine manufacturing.
The Joe Biden administration in the US, however, had subsequently lifted the ban.
Meanwhile, as part of phase 2 and 3, observer-blind, randomized, controlled bridging study on 1,600 adults across 20 sites including AIIMS, Delhi, and Gorakhpur, studies are underway to determine the safety and immunogenicity of this protein-based vaccine in the Indian population.
Earlier this month, Novavax had said that the vaccine has an efficacy of 90.4% in preventing infection and 100% efficacy against moderate to severe disease while announcing results from its late-stage trials. The company had said in a statement that its recombinant nanoparticle protein-based vaccine was tested in nearly 30,000 volunteers between January-April in the US and Mexico and significantly, also included nearly 44%, non-white participants.
The two doses of the vaccine are administered 21 days apart and its efficacy results have since been compared to the coronavirus vaccines by Pfizer and Moderna, like the phase 3 trials of this vaccine conducted later meant that it was pitted against more aggressive variants of Covid virus.
Following the declaration of the phase 3 trials, senior authorities in the Indian government had said that the vaccine data in a large trial are "promising", adding that the bridging trials in the country are also in an advanced stage of completion.
"What we're learning from data available in the public domain is that this vaccine is very safe and highly effective. It'll be produced in India," VK Paul, member, health, Niti Aayog, and chairman of the national Covid19 task force had said.
Sources in the company, meanwhile, told The New Indian Express that it is looking at a September timeline to launch the vaccine in India to aid the country’s ongoing Covid vaccination drive.
“Also, since a need has been felt to prepare Covid vaccines for kids in case of major outbreaks in future, we are keen to study whether the vaccine is equally safe and effective for the children,” a senior executive said, adding that a trial design is being worked out which will then be submitted to the Central Drugs Standard Control Organisation for approval.