Deadline for Desi Vaccine: Should politics dictate science?

Science should not be subordinated to political deadlines and exigencies.

This sums up the response from the scientific community in the wake of a storm over the August 15 deadline set by the Indian Council of Medical Research (ICMR) for the launch of the indigenous COVID-19 vaccine, Covaxine, for public use.

There is no alternative to following best international practices and rigour involved in vaccine development and there should be no room for short cuts when it comes to public health and safety, the scientists say.

While there is no doubt that the ongoing pandemic infuses a sense of urgency in efforts to find a solution, it is science, and not politics, that should guide the parameters and pace of research.

“A vaccine for COVID-19 cannot be expected before early next year as the process involves a lot of clinical trials and data testing,” the director of Hyderabad-based Centre for Cellular and Molecular Biology (CCMB) Dr Rakesh K Mishra said.

If everything goes absolutely like a textbook plan, then we will have the vaccine ready in six to eight months, he says.

“The ICMR’s letter in this regard (to the 12 hospitals and research institutions selected for conducting human clinical trials) may be for internal consumption and aimed at putting pressure on hospitals to get ready for clinical human trials,” the scientist said.

Even the most optimistic estimates say the new vaccine candidates could be ready for public use towards the end of the year or early 2021. “Releasing a vaccine into the general population without rigorously ensuring safety and efficacy will be dangerous and counterproductive,” says senior science writer M Somasekhar.

“Someone should brief the ICMR director general about the processes involved in (launching) a vaccine (for public use). Bharat Biotech has just got the permission for Phase 1 and 2. It will take them a good 4 months at the fastest and based on outcome of Phase 3. Which magic wand does ICMR have to produce it in six weeks?” wondered K Sujatha Rao, former union health secretary.

While vaccine trials can be fast-tracked, it still takes over a year to launch the product, the experts say. In a pandemic, emergency-use approval can be given if the data from the first two trial phases is compelling enough. This would allow the launch without the third phase being conducted, but such approvals will have to carry a set of riders pertaining to submission of additional data and adverse event reports.

Unfeasible timeline

The Indian Academy of Sciences has warned against “any hasty solution that may compromise rigorous scientific processes and standards”. “Administrative approvals can be expedited, but the ‘scientific processes of experimentation and data collection’ have a natural time span that cannot be hastened without compromising standards of scientific rigour,” the IASc said.

While welcoming the development of the indigenous vaccine by Hyderabad-based Bharat Biotech India Limited, in coordination with ICMR and National Institute of Virology (NIV), the scientists’ body said, “We strongly believe that the announced timeline is unfeasible. This timeline has raised unrealistic hopes and expectations in the minds of our people.”

The president of the Academy Prof Partha P Majumder said the deadline sought by the ICMR was “unheard of” and such an approach could give a bad name to the industry of biomedical research and pharmaceuticals.

Ministry modifies statement

The Ministry of Science and Technology, which said last week that it was “unlikely” that vaccines that have started human trials will be ready for public use before 2021, has revised the statement.

The revised statement has dropped the claim pertaining to the timeline.

The original statement read: “Along with the two Indian vaccines, Covaxin and ZyCov-D, the world over, 11 out of 140 vaccine candidates have entered the human trials. None of these vaccines is unlikely to be ready for mass use by 2021.”

The ministry later revised it to omit the last sentence. The reason given was that the sentence was removed because of “bad grammar”.

Vaccines normally take years, if not decades, to develop, with each phase taking months of study. The first phase establishes safety, while the second and third phases establish both safety and efficacy over larger sample sizes. Only after a vaccine successfully passes all three phases can it be released to the public.

The BBIL, in its application with the Clinical Trials Registry of India (CTRI), estimated that Phase I and II trials will take a year and three months, including at least a month for Phase I alone.

The ICMR’s clarification that its circular was only meant to cut the red tape and not the rigour of the scientific processes has not served to clear the air. The scientific community argues that cutting red tape should not mean creating a situation where hospital ethics committees are put under duress, researchers made to go easy on informed consent for participants, outcomes are fudged and dissent faces disciplinary actions.

The envisaged timeline for the indigenous vaccine is markedly shorter than other front-runner vaccine efforts from American and Chinese drug makers, most of which started human clinical trials months ago and are now entering the last of the three-stage human trials.

The opposition parties have interpreted the deadline as giving Prime Minister Narendra Modi an opportunity to win political points during his Independence Day speech.

“Even the most ambitious companies in the world that are in more advanced stages of development for their COVID-19 vaccines have a longer time-frame. Even having all the trial results, with safety and efficacy data, by August 15 is difficult. This raises several questions,” said Dr Anant Bhan, Researcher at Global Health, Bioethics and Health Policy.

“This should not be done at the cost of efficacy and safety,” said Dr Shashank Joshi, Dean of the Indian College of Physicians.

Front-runners in race

In the global race to develop a vaccine against coronavirus, following are the front-runners:

The University of Oxford, in collaboration with AstraZeneca, is testing a vaccine using a weakened version of a common cold virus. This vaccine has progressed to Phase-III trials stage and is expected to be available towards the end of the year.

CanSino Biological, in collaboration with the Beijing Institute of Biotechnology, has developed a vaccine. Special permission has been given for its use among military personnel.

Moderna, in collaboration with the US National Institute of Allergy and Infectious Diseases, is expected to start Phase-III trials this month.

Pfizer (in collaboration with Germany’s BioNTech) has been giving patients its experimental RNA vaccine at low- and mid-level doses. A launch is expected by the end of the year.

Inovio Pharmaceuticals, in collaboration with the International Vaccine Institute, has a DNA vaccine in Phase I trials. The Phase II and Phase III trials are set to commence later this month.