India, Russia in talks over Covid vaccine production
Govt says Moscow has shared some info on its vaccine Sputnik V
NEWDELHI/PUNE: India and Russia are in discussion for the potential production of a Covid-19 vaccine developed by Moscow’s Gamaleya institute, according to Union health secretary Rajesh Bhushan who said New Delhi has received some information about the candidate but detailed data is awaited.
The Russian vaccine, called Sputnik V, was the first to be approved for use anywhere in the world even though it is yet to undergo safety and efficacy trials large groups of human volunteers – one of the most crucial steps before a vaccine candidate can be approved. Russian president Vladimir Putin said the shot is safe and effective.
“As far as Sputnik V is concerned, both the countries (India and Russia) are in communication,” said Bhushan during the briefing on Covid-19 on Friday. “Some initial information has already been shared with us (by the Russian government), while some detailed information is awaited by us (from the Russian government),” he added.
India currently has three vaccine candidates against Covid-19 under various stages of human trials, and there are three vaccine candidates in pre-clinical stages, said director general of the Indian Council of Medical Research (ICMR), Dr Balram Bhargava.
Of the three vaccine manufacturers approved to conduct human trials in India, two are working on an indigenously developed candidate, while the third has been developed by Oxford University and British pharma firm Astrazeneca, which has struck a trials and production deal with Pune’s Serum Institute of India (SII).
“SII has begun phase 2/3 trials on 1,700 adult participants; Bharat Biotech’s vaccine candidate has completed phase 1 on about 375 participants, and Zydus Cadila’s phase I trial has also taken place in about 50 participants. The vaccine is given in two doses, and the second shot is usually given on either the 14th or 28th day after the first dose. After two-four weeks antibodies response is checked in blood,” said Dr Bhargava.
Around the world, there are 31 potential vaccine in human trials and the Oxford-astrazeneca candidate is largely considered as the front runner along with the one by United States’s Moderna.
In India, SII has begun the phase II/III clinical trials at Bharati Vidyapeeth Deemed University Medical College and Hospital, Pune. “We have asked for about 300-350 vials of the Covishield vaccine being manufactured by Pune based Serum Institute of India,” said Dr Sanjay Lalwani, medical director, Bharati Vidyapeeth.
The vials arrived on Tuesday evening at the hospital at its Katraj campus, and the candidates will be administered the dose between 12 noon to 2 pm on Wednesday.
“Once the vials arrive, we will check the temperature logs of the vaccine. We have also called about 10 volunteers who will be tested for Covid and presence of antibodies on Wednesday morning. The eligibility criteria is that the person must be aged between 18-99 years without any comorbidities. Also, he or she has to be tested negative for the SARSCOV-2 virus which causes Covid19 and test negative for the antibodies of the virus. So the person must not be currently or previously infected with Covid. Out of the 10 volunteers, whoever is deemed fit for the vaccination process will be vaccinated. They will be kept under a close check and after a week the next batch of volunteers will be vaccinated,” said Lalwani.
The hospital was earlier also part of Serum Institute’s research to determine if the recombinant Bacille Calmetteguerian (BCG) vaccine can boost immunity to fight against the Covid19 virus which was a six months study.
SII is world’s largest vaccine manufacturer by number of doses produced and sold globally. On August 3, India’s drugs controller gave SII approval for phase II and III clinical trials.
The first make in India vaccine candidate by Bharat Biotech, Covaxin, received central drugs controller’s approval for phase I/II human trials on June 29. The vaccine candidate has been developed in collaboration with ICMR as its National Institute of Virology in Pune had isolated the SARS-COV-2 strain that causes Covid-19, and transferred to Bharat Biotech in May.
Pharma major Zydus Cadila has also started phase 2 clinical trials to establish efficacy of its indigenously developed vaccine candidate, Zycov-d. The phase 2 trial began on August 6.