Pune's Serum Institute of India (SII) will have 200 million doses of the AstraZeneca-Oxford University vaccine for the coronavirus ready by January, ramping up its capacity to make 100 million doses of the inoculation monthly..
Sources said the company has recruited over 1,600 participants in India for phase 3 trials of Covishield (the AstraZeneca vaccine candidate).All participants have received the first shot of the vaccine and by the end of November, the second shot would be completed. Data analysis would begin after the second shot, sources said.
"SII has started stock-piling the vaccine and now has roughly 40 million doses ready. It is using some of the capacities it had for under development products for the Covid-19 vaccine and by January we will have a capacity to make 100 million doses per month and a stockpile of 200 million doses," said a source.
About 50 per cent of its capacity will be for India, it said.
SII has committed supplying 200 mn doses to Gavi, the Vaccine Alliance and Bill and Melinda Gates Foundation, at Rs 250 per dose or $3 per dose for 2021 for low and medium income countries. It has also received around $300 million risk funding for the same.
Around 50 percent of SII's Covid-19 vaccine production in 2021 would be for global requirements.
"The data from AstraZeneca's large scale UK trials (on 30,000 volunteers) would be ready in the next three weeks or so. Post that it can be submitted to the Indian regulator. SII would also submit interim data from the Indian arm of the trial in December. The regulator can take a call whether to allow emergency use authorisation of the vaccine based on the data," the source added.
The company said that based on phase 2 and 3 trial results, SII will help ICMR to "pursue early availability of this product for India".
Covishield has been developed at the SII Pune laboratory with a master seed from Oxford University-Astra Zeneca. The vaccine made in UK is currently being tested in large efficacy trials in UK, Brazil, South Africa and the US.
As such, the data from these trials would primarily reflect immunogenicity (whether the vaccine candidate triggers an immune response) and safety (whether it causes unwanted side effects or organ damage etc) of the vaccine candidate.
Efficacy data (whether the vaccine works to protect against Covid19 infection if exposed to the virus) would take time until a certain number of people in the placebo arm of the studies have infection.
The Indian regulator thus may allow emergency use authorisation of the vaccine if the Indian government wants to start the vaccination drive from January, as has been already indicated.
In another important development, the country's apex health research institute the Indian Council of Medical Research (ICMR) has partnered with SII to conduct phase 2 and 3 clinical trials of Covovax, the vaccine candidate from Novavax.
ICMR would be funding the clinical trials in India. It is also working closely with SII for the Covishield vaccine trials across 15 centers in India.
US-based Novavax has initiated its late phase trials in South Africa and in UK and will soon commence the same in the USA. SII has received the bulk vaccine and Matrix-M adjuvant from Novavax and will soon fill and finish them in vials. This vaccine formulated at SII (Covovax) will be tested in a Phase 3 trial in India and an application for the same to regulatory authorities will be made soon by ICMR and SII.
Adar Poonawalla, CEO of Serum Institute of India, said, “ICMR has played a huge role in coming forward and strengthening India’s fight against COVID-19. The collaboration will further aid us in putting India at the forefront of developing an immunogenic and efficacious vaccine.”
ICMR upbeat about the collaboration. Dr. Balram Bhargava, Director General of ICMR, said, “At present, India plays a prominent role in vaccine development and manufacturing globally. Buoyed by the latest technology and well-equipped facilities, SII has continually proven its research and manufacturing prowess. The partnership is our contribution to lending our expertise and support to bolster our fight against the global pandemic.”
"The partnership will see the scientists of both the entities facilitate the advancement of regulatory approvals for Covishield and Covovax while ensuring strict adherence to all the requisite scientific, ethical and regulatory standards," the statement read.