India could be on the threshold of manufacturing the candidate Covid-19 vaccine, Sputnik V, but West Bengal may already have missed its date with its trials on account of government delays in grant of approvals.
Experts say the setback could lead to loss of invaluable trial data from the state which has seen significant surges in Covid-19 cases in recent times, besides registering uncomfortable mortality rates.
Bengal’s state-run College of Medicine and Sagar Dutta Hospital (CMSDH) in North 24 Parganas district, adjacent to Kolkata, was chosen as one of the sites for the Phase II trials of Sputnik V alongside six other institutes from different parts of the country.
The hospital is now on the verge of losing the opportunity to host the trials with about 12-14 volunteers since time is of essence in the ongoing vaccine race between global pharmaceutical giants and the state failed to respond in time.
“We had approached the state health department for necessary approvals for both Phase II and Phase III trials on 4 November this year. Normally, for clinical trials of vaccines, approvals come from authorities of the hospital concerned. But since this is a Covid-19 vaccine, the technical advisory committee and ethics committee of the hospital wanted us to get a No Objection Certificate from the health department first. We are yet to get that response,” said Snehendu Konar, head of business development of the site management organisation, CliniMed LifeSciences.
Since it takes about 30 days to start the trial before obtaining necessary clearances from the multiple committees of the hospitals which could not be approached yet for want of the initial government clearance, it is evident that Bengal may already have missed the bus.
Except Bengal, necessary trial approvals have already come from the remaining sites and trials are about to start soon, Konar said.
On Tuesday, developers of the Sputnik V – Gamaleya Research Centre and Russian Direct Investment Fund (RDIF) – announced that the vaccine showed 95 per cent efficacy after second interim analysis of clinical trial data and that the double dose vaccine would cost a little over Rs 700 a piece outside Russia.
In India, RDIF has tied up with pharma major Dr Reddy’s Laboratories for clinical trials and has offered 100 million doses for distribution in the country. Industry insiders confirmed that the pharma company has already moved out of Bengal and chosen a different trial site in eastern India.
The Bengal government, however, does not agree with the alleged delay. “The proposal for trial comes from the hospital concerned and our committee has to go through the required process to grant approval. Those who say there has been a delay, only they can best answer why they think that way,” said Dr Debasish Bhattacharya, state Director of Medical Education, before declining any further comment on the matter.
Although Bengal has recently managed to bring down active COVID cases to just under 25,000 and enhanced its recovery rate to about 93 per cent, there are still concerns about its mortality rate which stands at about 1.75 per cent and insufficient test numbers that have been hovering around the 45,000-mark a day for some time now.
The implications of the trial loss seem to be a deeper than what meets the eye. “Ideally, Sputnik V should have started clinical trials from Phase III in India since it had already completed Phase II trials in Russia. But the Drug Control General of India forbade Phase III bypassing Phase II since patient safety concerns were raised about the vaccine. Clinical trials are a race against time because of global competition and the Indian partner of the RDIF has a stiff deadline to meet for completing Phase II trials. The chosen sites were, hence competitively selected. The company would not wait for approvals to come and would naturally move on to another site with easier access and approvals. Because, in any case, this is extra work for them,” said Dr Subhrojyoti Bhowmick, senior pharmacologist and patient safety expert.
“The advantage of hosting trials in a state where COVID-19 figures are not encouraging is that some of our frontline warriors could have been protected right now. Given that no other international companies in the vaccine race have opted for Bengal so far, we have lost that opportunity,” he added.
Besides the missed opportunity, there are clinical implications of forgoing the trial. “Bengalis have a different genetic make-up compared to communities in other parts of the country and the data generated from Phase II trials of the vaccine elsewhere would not have any state implications. We would never know whether the adverse effect profile shown by Indians outside Bengal applies to people within the state as well,” Dr Bhowmick said.
Although the state government has now reportedly pulled up its socks to grant the approval for Phase III trials of the vaccine which is likely to start in January next year, there is scepticism on whether Bengal would receive a second chance. The mindset at work could be that of ‘once bitten, twice shy’.
“There would be even more urgency for Phase III trials because that is the final stage before the vaccine is cleared for manufacture and mass inoculation. The Phase II sites which do well would automatically be selected for Phase III and it is only natural for companies to not return to sites which have previously taken time to process approvals. So we cannot take it for granted that the hospital would be selected for the final phase which involves having a lot more volunteers than the current stage and the other sites would have an upper hand in this,” said a pharmaceutical executive in Kolkata, requesting anonymity.
The site management company is, however, not ready to give up just yet. “The government is likely to grant approval anytime now and we are hopeful that we will be able to rope in Sagar Dutta Hospital for the final phase where we need to have 1400 volunteers from the site,” said Konar, while keeping fingers crossed.
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