Context
As the Covid-19 pandemic is ravaging humankind worldwide, there has been an unprecedented response from the global scientific community to find a vaccine candidate to combat the virus — the solidarity trial of the World Health Organisation, the UK’s recovery trial and’ ‘Operation Warp Speed’ by the US are three of the leading efforts in vaccine development to combat the pandemic.
According to the WHO, as of July 15, 2020, there are 163 vaccine candidates that are at various stages of research and development worldwide. The proposed landscape of vaccine development makes it the biggest scientific endeavour while a pandemic is still on.
What Does It Take To Make A Vaccine?
Apart from scientific knowledge and expertise, vaccine development has a long and uncertain trajectory, sometimes sans any results. We cannot pre-determine how long it can will for an effective vaccine to be developed and made available for the masses as preventive medicine. Any new vaccine candidate is subjected to an elaborate regulatory process, which requires research companies/agencies to conduct animal studies (pre-clinical evaluation) and Phase I to Phase III human trials.
This multi-step process is essential to ascertain the safety and efficacy of a vaccine before it is approved for marketing or used as a public health intervention. As per the WHO guidelines, based on the results of Phase I and II, Phase III trials are recommended to be ‘conducted on 20,000 to 30,000 people’. Before, inoculating such a large population with a novel vaccine, the regulatory agencies have to ensure that the initial two stages fulfil all prescribed gold standards of safety and efficacy.
The WHO has listed 23 vaccines as of yet that have been approved for clinical evaluation i.e. for human trials. Two of the 23 vaccines have reached the Phase-III human trials, out of which the one being developed by the British-Swedish drug company AstraZeneca and the University of Oxford seems most promising, according to experts.
As the world is racing against time, with tens of thousands succumbing to the deadly virus daily, these vaccine candidates, however, remain just ‘candidates’. According to an analysis of vaccine development projects from 1998 to 2009, it was found that an average vaccine takes 10.71 years to be developed from the preclinical phase, and has a market entry probability of 6%.
If we go back into the past, the fastest-ever developed and the approved vaccine was that for mumps, which took four years to be ready, from collecting samples to its licensing in 1967. Most recently, the Ebola vaccine, whose Phase I trials began in 2014, got approval for use only in 2019, a full five years later.
In addition, there are high rates of failure, which makes vaccine research and development an expensive affair. An estimated 3.7 billion USD has already been pumped in for a prospective Covid-19 vaccine, as reported in the data compiled by Policy Cures Research, a global health think-tank.
How Far Is India From Developing A Vaccine?
Meanwhile, in India, Hyderabad-based Bharat Biotech International Ltd. (BBIL) has developed an indigenous and inactivated vaccine candidate ‘Covaxine’, which has been approved for human clinical trials by the Drug Controller General of India (DGCI). The Indian Council of Medical Research (ICMR), New Delhi, and the National Institute of Virology (NIV), Pune, have played an instrumental role in the development of Covaxine, as acknowledged by BBIL.
Following the announcement of the indigenous vaccine, on July 2, 2020, ICMR Director-General Dr Balram Bhargava sent what seemed to be a ‘threatening’ letter to the supposed 12 principal investigator sites to complete the further phases of the human trials by August 15, 2020. Dr Bhargava wrote,
“It (ICMR) has envisaged launching the vaccine for public health use latest by 15 August 2020 after completion of all clinical trials. BBIL is working expeditiously to meet the target. However, the final outcome will depend on the cooperation of all clinical trial sites involved in this project.” The DG-ICMR in his letter directed the principal investigators to fast track all approvals and ensure that subject enrolment is initiated “no later than 7th July.”
Further, the letter clearly states, that “the non-compliance will be viewed very seriously.”
Firstly, the most challenging and daunting task will be finding volunteers who can give ‘informed consent’ (at least theoretically) to get a shot of an untested vaccine — in this case, introducing an inactivated Covid pathogen into their bodies. This very procedure requires the approval of the ethics committee of each of the institutions chosen to conduct the trials.
At least six of the 12 designated hospitals, including AIIMS, Delhi, have expressed concern over the direction that five days is too short a period to complete the approval process. Interestingly, in its submission to the Clinical Trial Registry of India (CTRI), BBIL has stated that the duration of the trial will span over a year and three months. With the requisite protocols followed, the trial will need follow-ups on Day-14, Day 28, Day 104 and Day 194, which sums up to a time-span of six months. Evidently, the ICMR doesn’t seem to be on the same page with its collaborator.
The letter by the DG-ICMR faced criticism by health experts, and also from the Council and Fellowship of the Indian Academy of Sciences (IASc), which comprises the country’s 1,110 foremost scientists. The target set by the ICMR is ‘infeasible’ and has raised ‘unrealistic’ hopes and expectations in the minds of our citizens, the IASc said in its public statement dated July 5, 2020.
On July 4, 2020, after being called out by experts over their unreasonable claims, the ICMR issued a clarification, justifying that the letter by the DG was “meant to cut unnecessary red tape” and the “trials will be done following the best practices and rigour and will be reviewed, as required, by a Data Safety Monitoring Board (DSMB).” However, the Council’s clarification remained silent on the ‘unrealistic and near-impossible timeline’ it had set in its July 2, 2020, letter to the principal investigators.
Who Will Get The Vaccine First?
Considering all optimism in the claims of a successful vaccine in the near future, the most important question, which has ethical implications, is: “who should get it first?” The question pertaining to the best way of developing a vaccine might seem academic, but the result can determine how much it will cost to make the drug and, most importantly, who can afford it?
Provided that the vaccine actually is made available for use in such a short period of time, say by the beginning of 2021, there is a possibility of the big pharma companies and research agencies monopolising the technology and cost of the preventive drug. Our biggest concern now is to ensure that the world’s poorest don’t get ignored in the process.
To avoid such a predicament, world leaders need to come together and sign a global access agreement. Such an agreement could guarantee that vulnerable sections of the population — healthcare workers, the elderly and people in resource-poor settings. Further, it would also allow whichever company, university or country that wins the race of the Covid-19 vaccine to promptly transfer its biotechnology across borders.
What Can We Do Until We Are Vaccinated?
Given the present state of affairs, the most valuable thing we can do is help and cooperate with healthcare workers. We as citizens have to follow public health recommendations of the government or WHO. These include practising social distancing, staying home, washing hands with soap, and avoid touching the face.
The urgency of finding an effective vaccine against the contagion is unquestionable. However, the ICMR, or for that matter any research agency around the world, cannot afford to be lackadaisical and hasty when it comes to developing the vaccine. In India, the ICMR has so far been lauded for its interventions in dealing with the pandemic, and any undue haste may do harm to its credibility and have serious and long-standing implications on the country’s citizens.