India fast-tracks quest for anti-COVID vaccine, but challenges remain

Many jaws would have dropped and eyes rolled in disbelief among the scientific community around the world when the Indian Council for Medical Research (ICMR) declared on July 3 that India’s vaccine against Coronavirus is being planned for ‘launch by August 15.’

Researchers worldwide are developing more than 145 vaccines against Coronavirus and several of them are going through various stages of trials but no one has fixed any deadline. In normal circumstances, a vaccine would have taken five to six years. Even if it is ‘fast-tracked,’ scientists say, it would take at least 12 to 24 months for it to be safely administered.

In scientific parlance, ‘fast-tracking’ a vaccine trial does not mean cutting corners or shortening the testing process. Since the trials are done in phases, it only means that experiments in a particular phase would be started even before the results of its previous phase are revealed or made publicly available.

For India, the good news is that Bharat Biotech International Ltd (BBIL), a Hyderabad-based private company, has developed Covaxin, a vaccine against Coronavirus, in collaboration with the ICMR and the National Institute of Virology (NIV). But it is yet to be fully tested for efficacy and safety.

The SARS-CoV-2 or Coronavirus strain was isolated in NIV, Pune, and transferred to Bharat Biotech. BBIL has been given permission to go for clinical trials based on promising results obtained from animal studies.

BBIL has planned clinical trials or trials on human beings by injecting Covaxin in 1,200 volunteers. Since the process has been fast-tracked in view of the urgency caused by the pandemic, BBIL has coalesced phase-I and II trials.

ICMR believes that in the next 42 to 45 days, scientists, physicians, and academicians working in 12 prominent universities and medical colleges around the country would have gathered enough evidence to give a verdict on the efficacy of the vaccine. Therefore, these six or seven weeks are going to be crucial in India’s efforts to finding a shield in its fight against Coronavirus.

The phase-1 trials are expected to begin in these select 12 hospitals in a day or two where the volunteers, both male and female, in the 18-55 age group, would be enrolled after a thorough medical checkup. Pregnant women would be excluded. Only those volunteers who are medically fit would be admitted for the trials. Their blood samples would be taken for determining the levels of antibodies produced in response to the vaccine.

Throughout the trials, they would be under observation. Dr. Ravikumar, Pro Vice-Chancellor, SRM University, said, “should any emergency arise, the hospital is equipped to deal with the situation.” The university is one of the 12 institutions selected for conducting the trials.

The volunteers under observation would be tested periodically and their blood samples taken. Dr. Satyajit Mohapatra, Professor of Pharmacology at SRM University, said data and samples would be collected strictly as per protocol, kept confidential and sent to BBIL. Even the profiles of volunteers such as their name, address etc. would be kept confidential.

Dr. Melvin George, Associate Professor of Clinical Pharmacology, SRM University, said the volunteers participating in the trials could continue their daily routine but would need to follow the same preventive precautions as any other person such as social distancing, handwashing, wearing masks, etc as they were yet to understand how effective the vaccine was.

This is a randomized controlled trial, meaning that the choice of who receives the vaccine or the control injection would be on the basis of a randomization sequence created by a computer program. There would also be double-blinding, which means that neither the investigators nor the participant would be aware if they were receiving COVID vaccine or control injection.

In normal circumstances, after pre-clinical studies, the first phase would take around 6 to 18 months. During this period, the tests would be repeated periodically. This would be followed by second and third phase of trials where the vaccine would be administered on a larger number of people and across various categories. Once the efficacy and safety is proven, the regulatory authorities provide licences to manufacturers for commercial production and market release.

Due to the pandemic scenario, world over, there has been a fast-tracking in the duration of the trials. In the case of ICMR, it has decided to club Phases I and II into one seamless phase. After the two ‘observations,” if majority of candidates do not report any problems and the results turn out to be good, the government may allow the vaccine to be manufactured. Meanwhile, the testing process would continue through its normal course of 194 days for the first phase and similarly other tests would be done for the next 2 years on a minimum. According to one view, the vaccine, if found safe, may be prescribed for frontline medical professionals and workers.

Though accelerated approval process is a well-known practice, ICMR’s diktat to hospitals has baffled the doctors and scientists. Dr. S. Krishnaswamy, (retired) Professor Bioinformatics Madurai Kamaraj University told The Federal that fast- tracking per se is fine as in this case the Drug Controller of India has allowed BBIL to conduct Phases-I and II trials together but what is disturbing is the ‘letter by ICMR Director-General which ‘smacks of politicisation of a scientific discovery process.’ He says it appears ‘this is for purposes without considering the safety of people in mind.’

He says the statement that the project is being ‘monitored by topmost level’ is uncalled for. Similarly, the last sentence in the letter that ‘non-compliance would be viewed seriously,’ is a complete threat. He accuses ICMR of clubbing Phase I, II, and III together and says this is not going to work. He says, if ethical practices are not followed, a faulty trial may derail the achievements of NIV and BBIL.

According to Navaneeth Rao, cell biologist and senior drug development scientist with international experience, “drug development is one aspect of human endeavour that is marked more by failures than anything else.” He says in this context he is amazed that ‘we would have a vaccine by August 15.’ He says, “this is not in the realm of realistic possibility.” This is because “a vaccine has to be extremely safe, modestly effective and it has to be widely available.” Only then, he says, there is a chance of it being effective. “We need to know the reality and landscape of the vaccine and not set hopes too much. Because failure in this front is going to be catastrophic,” he warns.