How Bharat Biotech found itself in front of Covid vaccine queue

New Delhi | Mumbai: The Indian Council of Medical Research (ICMR), India’s apex medical research body, appears to have set August 15 as the launch date for the country's first Covid-19 vaccine being developed by Bharat Biotech, and has instructed a dozen hospitals and medical institutes to fast-track clinical trials. In a letter written to these organisations, which have been enlisted as clinical trial sites for this vaccine candidate, ICMR director general Balram Bhargava said this was a top priority project which was being monitored at the highest level of the government."ICMR has partnered with Bharat Biotech International to fast-track clinical trials of the indigenous Covid-19 vaccine. It is envisaged to launch the vaccine for public health use latest by August 15, 2020 after completion of all clinical trials," stated the letter. It further instructed all the clinical trial sites to enrol participants for the trial by July 7, and added that non-compliance would be taken very seriously. Bhargava’s missive has created quite a stir among medical professionals and healthcare experts. Typically, a vaccine takes several years for commercial launch and while this time frame is being severely compressed for developing a Covid-19 vaccine, a 40-45 day schedule for undertaking and completing all three phases of clinical trials is unheard of.ET spoke to six of the 12 principal investigators who are listed for the ICMR-Bharat Biotech trials and none of them said it was possible to develop a vaccine by August this year. Later during the day, news agency ANI reported that ICMR has said that the purpose of the letter was to expedite trials so that results could be available by August 15. The vaccine would need more time for public use. But ET could not independently verify this and queries sent to ICMR went unanswered.When contacted, Bharat Biotech declined comment. “At this moment we do not have any information to share. We will come back once we have the details,” the company said in response to a query on the possible launch on August 15. Public health experts have raised several questions on the accelerated approach, ranging from getting mandatory approval from ethics committees, starting enrolment of participants within a week to predetermining the trial result in less than 45 days. These issues will have a bearing on the safety and efficacy of the vaccine, they said. “A vaccine trial completed in a little over a month with its efficacy pre-decided raises ethical questions,” said Anant Bhan, a Punebased researcher in global health and bioethics.As per data on the government’s clinical trial registry, only five of the 12 institutes that are supposed to conduct clinical trials have so far received approval from their ethics committees, a mandatory requirement before starting a trial. “Even India’s premier institute, All India Institute of Medical Sciences (AIIMS) in Delhi, is yet to get an approval,” a source said.Principal investigators for these trials told ET that by August 15, 2020, they will only get an idea on the immunogenicity and efficiency of the vaccine. “I am fine if they replace the deadline from August 2020 to 2021. It’s impossible to produce a vaccine in a month even with accelerated approvals,” said one of the principal investigators on condition of anonymity. Chandramani Singh, additional professor at AIIMS Patna, who is also the principal investigator of the Patna site of this trial, said his institute was planning to start the trial in the next 7-15 days because the enrolment of healthy volunteers needed to be done carefully. “It won’t be ethical to share when the vaccine will be launched before the trial is over,” Singh told ET.Chandrashekhar Gillurkar, senior diabetologist at Gillurkar Multispeciality Hospital in Nagpur, said they expect to publish the phase 1trial in the first week of August. “The trial will be looking at antibodies developed after the administration of vaccine and the IgG titer count,” he said. IgG titer count is a measurement of the amount of antibodies developed in a blood sample.R Vasudev, assistant professor at King George Hospital, Visakhapatnam, who is the principal investigator of the Visakhapatnam site for the trial said they have not received any letter from ICMR and have asked Bharat Biotech to get a clarification on the diktat. King George has the mandate to conduct phase 2 study and is in the process of recruiting 100-150 participants. “It is not possible to launch the vaccine for commercial use by August 2020,” said Vasudev. The Drug Controller General of India (DCGI) had last week granted Bharat Biotech permission to initiate Phase I & II human clinical trials of its vaccine candidate ‘Covaxin’, which it developed in collaboration with ICMR’s National Institute of Virology (NIV).

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