Doctors in the National Capital are keeping their fingers crossed as a controversy rages over alleged fast-tracking of trials for Covaxin, an indigenous Covid-19 vaccine candidate, to meet an Independence Day deadline.

On July 2, Dr Balram Bhargava, Director-General of the Indian Council of Medical Research (ICMR), wrote to principal investigators of select medical institutions and hospitals to fast-track human clinical trial approvals for the vaccine candidate. Bhargava’s letter said it envisaged to launch the vaccine for public health use — after completion of trials — by August 15.

On Saturday, even as the ICMR, which is developing Covaxin with the Hyderabad-based firm Bharat Biotech, issued a statement defending its decision, a number of experts Mail Today spoke to expressed apprehensions over what they see as an unrealistic deadline.

A tall order?

“As a scientist I do not understand the process behind it. There is no such precedent across the world where you predict a launch of a vaccine six weeks before,” said Dr Arun Gupta, president of the Delhi Medical Council.

“The ICMR should act more responsibly during the pandemic. When the whole world awaits a vaccine, how is the ICMR sure of a launch date without releasing data regarding to validate claims? It raises questions if scientific bodies are used as tools to further political propaganda?” asked Dr Srinivas Rajkumar T, General Secretary Resident Doctors’ Association, AIIMS New Delhi.

“Nevertheless it will be a matter of great joy and pride for the scientific community and people of India if the ICMR does indeed accomplish this impossible feat ahead of the rest of the world,” added Dr Srinivas.

The controversy comes at a time when India remains the fourth worst-affected country in the world after the US, Brazil and Russia with 6,48,315 confirmed Coronavirus cases. Well over18,000 people have died in the country so far even as 3,94,227 patients have recovered from the virus. On Saturday, India recorded 22,771 new coronavirus patients, the highest single-day spike so far.

Clearing the air

On Saturday, the ICMR issued a clarification saying the letter by Dr Bhargava to investigators of clinical trial sites was meant to cut red tape, without bypassing any necessary process, and speed up recruitment of participants. “In the larger public health interest, it is important for ICMR to expedite clinical trials with a promising indigenous vaccine. Faced with the unprecedented nature of the Covid-19 pandemic, all other vaccine candidates across the globe have been similarly fasttracked,” ICMR said in a statement, rejecting allegations of rushing through the process.

All pre-clinical studies for the vaccine have been completed successfully, and Phase 1 and 2 human trials are to be initiated, added the ICMR statement.

A question of safety

But many experts are of the opinion that vaccines ought to go through detailed research before they are launched. “Unlike a drug which is given to only people who are indicative, a vaccine is given to everyone.

So one has to be careful about what happens to children, adults and those with co-morbidities. These are very detailed examinations of risks and benefits and ethical committees will have an upper hand in taking the decisions. We as investigators have to be careful because there are multiple sites while the trial is done and taken forward,” said Dr Giridhar R Babu, professor and head of life course epidemiology at the Public Health Foundation of India (PHFI).

Certain other medical experts are not so suspicious of the initiative. Dr NN Mathur, Director of Delhi-based Lady Hardinge Medical College, said there didn’t appear to be anything unethical about it, provided all the mandatory trial phases were complete. “It will only be unethical if the phases are not completed, which doesn’t seem to be the case here,” said Dr Mathur, who calls the initiative a bit of a “gamble” for vaccine manufacturing companies.

“As long as they are ready to take the risk, it isn’t unethical. They are doing production as well as testing simultaneously, so that if the initial phases of the vaccine are passed, there is no delay on account of production,” adds Dr Mathur.

Dr Bhawna Sirohi, Director, Medical Oncology, Max Healthcare, NCR, isn’t too dismissive of the initiative, either. “A vaccine can be perceived as successful or viable in case it meets two basic criteria: One, whether it is safe for the patient and second is the question of efficacy.

Theoretically, the safety of the vaccine can be ensured within such as time period. The ICMR is a research driven body and they have advisers such as Dr Randeep Guleria of the AIIMS who enjoy high levels of credibility.

Considering that China released the structure of the virus last year and that cutting-edge Indian research institutions such as the National Institute of Virology have been working on it, till the time I know the sample size and the numbers of the trial, I wouldn’t want to shoot the messenger down before having seen the message,” says Dr Sirohi.

The vaccine candidate in question is derived from a strain of SARS-CoV-2 isolated by ICMR-National Institute of Virology, Pune.

Bharat Biotech International Ltd and Zydus Cadila are two Indian companies that have received approval from the Drugs Controller General of India (DCGI) to conduct human clinical trials of their vaccine candidates developed indigenously to combat the Coronavirus pandemic. Bharat Biotech is among seven Indian firms working on Covid-19 vaccines. More than a dozen vaccines from over 100 candidates globally are currently being tested in humans, and some have shown potential in early-stage trials. However, no vaccine has yet been approved for commercial use.

Political blame game

Even as the country battles the pandemic, it hasn’t stopped the Opposition from looking for political motives into the government’s vaccination initiative. Congress leader Prithviraj Chavan alleged the ICMR’s plans to launch a coronavirus vaccine by August 15 were aimed only at enabling Prime Minister Narendra Modi to make a grand announcement from Red Fort. CPI (M) General Secretary Sitaram Yechury, too, accused the ICMR of trying to fast-track the production of a coronavirus vaccine so that PM could make an announcement on Independence Day.

Delhi Congress’ vice president, Abhishek Dutt said he hoped all safety measures and risk factors had been kept in mind. “The whole world is scrambling to get a vaccine. I hope our government will keep all safety measures in mind,” he said.

(With inputs from Aasheesh Sharma and Milan Sharma in New Delhi)