New Delhi: Serum Institute of India (SII) and Indian Council of Medical Research (ICMR) has announced the completion of the enrolment of phase III clinical trials of Covishield. In an exclusive interview with ETV Bharat, Dr Suneela Garg, Director Professor and Head Community at Maulana Azad Medical College, said on Thursday that Covidshied will probably be one of the first vaccines which will see the light of the day.
"We have successfully completed the phase III individuals," she said.
"Now we are exactly going to know the prevalence of antibodies and probably it will be one of the first vaccines," Dr Garg said.
Interestingly, SII, the world's largest vaccine manufacturer by volume has already manufactured 40 million doses of the vaccine, under the at-risk manufacturing and stockpiling license from the DCGI.
"Manufacturing of 40 million doses only shows the confidence in this vaccine, but we have to wait till this phase completed," she said.
The ICMR has funded the clinical trial site fees while SII has funded other expenses for Covishield. At present, SII and ICMR are conducting Phase 2/3 clinical trial of Covishield at 15 different centres and already completed enrolment of all 1600 participants recently.
Covishield has been developed at the SII Pune laboratory with a master seed from Oxford University and Astra Zeneca, a Cambridge based pharmaceutical company. The vaccine made in the UK is currently being tested in large efficacy trials in UK, Brazil, South Africa and the USA.
"At present, India played 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," said Dr Balaram Bhargava, director general of ICMR.
He said that the partnership will see the scientists of both the entities facilitate the advancement of regulatory approval for Covishield and Covovax while ensuring strict adherence to all the requisite scientific, ethical and regulatory standards.
It may also be worth noticing that India has also been conducting human clinical trials of two more indigenous Covid-19 vaccines produced by Bharat Biotech and Zydas Cadila.
If we look at all the vaccines, we have to look into the completion of all phases. It should be very safe, we need to prepare supply chain management as well," said Dr Garg.
When asked about the availability of the vaccine, Dr Garg said, "by the time we look into all factors, the vaccine should be made available by mid-2021 or end of 2921."
Referring to the vaccine manufactured by Pfizer, Dr Garg said that the storage of this vaccine couldn't be a critical issue for India.
"Pfizer vaccine should be stored at a minimum temperature of minus 80°C and that is where we need to look into our complete supply chain. India, will, of course, prepare it over a period of time," said Dr Garg.
