People drive past a mural honouring the warriors of COVID-19, during unlock-2, in New Delhi, on Thursday, July 2, 2020. (Express Photo By Amit Mehra)
Coronavirus (Covid-19) Vaccine: The Indian Council of Medical Research has promised to “launch” a Coronavirus vaccine, which is still to undergo clinical trials, “for public health use latest by August 15”, a deadline that some medical experts called “totally unrealistic if not entirely impossible”.
In a letter to hospitals that have been selected for carrying out the clinical trials for a candidate vaccine developed by Bharat Biotech, the ICMR director general Balram Bhargava has said that “in view of public health emergency” and the “urgency to launch the vaccine”, all the stakeholders are being “strictly advised to fast track all approvals related to the initiation of the clinical trial, and ensure that the subject enrolment is initiated no later than July 7, 2020”.
“It is envisaged to launch the vaccine for public health use latest by August 15, 2020 after completion of all clinical trials,” the letter states.
Vineeta Bal, an immunologist and a visiting professor at the Indian Institute of Science Education and Research (IISER) in Pune, said she was unable to comprehend how the vaccine which was still under trial could be ready so soon.
“August 15 is a completely unrealistic target. There is no vaccine that has become ready so fast. There are several processes involved, and even in the best case scenario, considering that we are in an emergency situation, the August 15 timeline seems totally unrealistic, if not entirely impossible,” Bal said.
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Anant Bhan, who works on bioethics, also questioned the timeline, and wondered whether the ICMR had pre-decided the success of clinical trials.
“For a vaccine for which pre-clinical development is still ongoing, as per (ICMR’s) letter itself, how can clinical trial recruitment be starting on July 7? And that the vaccine would be launched on August 15? A vaccine trial completed in little over a month, efficacy pre-decided?,” Bhan said in a series of tweets.
The candidate vaccine, named Co-vaxine, developed by Bharat Biotech in association with Pune-based National Institute of Virology, has just been cleared for Phase-I and Phase-II trials by the Drug Controller General of India.
Usually, these trials take months, and have to be followed by phase-III trials which is when volunteers are actually given the vaccine shots and their immune response to the disease is tracked. The clinical trials have to be followed by data analysis and verification, which usually needs to be published in a peer-reviewed journal before the vaccine is cleared for public use.
Some of the steps in this process can be expedited, or even bypassed, but not all.
When asked about the August 15 reference, Lokesh Sharma, Scientist, ICMR, said: “It is not to be interpreted as a deadline. This is our aim, which depends on cooperation of institutes. If we are going to start work, we should do so with an aim and it should be of success. Our expectation and aim is that the trial will be complete. Anyway, the product is ready. Hence, we are going into trial. This is the DG’s personal concern. Hence, the letter.”
However, an examination of the Clinical Trials Registry shows a conflicting timeline for the vaccine. Although the ICMR letter has a timeline of only five and a half weeks, a clinical trial registration for the vaccine states that the duration of the trial will be one year and three months. The registration was last edited on Thursday.
When asked about the discrepancy, one of the participating institutions said, “Emergency operation has to be done, so we are trying.”
The clinical trial registration states there will be two phases of the trial. In the first phase, there are three groups and will take at least 28 days. The second phase will take at least two weeks. The timepoints for evaluation include Day 14, Day 28, Day 104, and Day 194 for both phases.
The culmination of the Phase 2 also does not call for public health use, but further enrollment of participants.
In addition,the registration shows that seven out of 12 ethics committees have not yet approved the trial. The trial will have a sample size of 1,125 people.
One group of 125 subjects will receive two doses of the vaccine two weeks apart or the control vaccine. After one more week after vaccination, a Data Safety Monitoring Board (DSMB) will review the data and recommend a higher dose for Group 2 and 3.
Group 2 and 3 will also receive two doses of vaccinee and controls two weeks apart. The DSMB will then recommend progression.
“An interim report based on the safety and immunogenicity of the three formulations from Group 1, Group 2 and Group 3 will be notified to the Central Drugs Standard Control Organisation (CDSCO), India, for further progressing the clinical development of the vaccine. This interim report will contain a detailed analysis of the data based on the primary and secondary objectives of all visits through Day 28 (Immunogenicity & Safety). The ultimate goal is the selection of a safe, well-tolerated, and immunogenic intramuscular vaccine, which will be further, evaluated in the phase 2 study,” the registration states.
Phase 2 will involve 750 healthy volunteers of a different age bracket to be vaccinated two weeks apart, another DSMB review, and further enrollment of participants.
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