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The world is facing an exceptional situation due to COVID-19: it has lost lakhs of lives even as the global economy has shrunk by an unexpected amount. A simple virus – and our governments’ response to it – has us locked up while it disrupts all of our efforts in a variety of fields accumulated over many years. A vaccine is expected to be a powerful tool in our armamentarium to beat back this virus and regain our lost freedoms. We need such a tool fast, but when we do get it, we must also know that it is safe to use and efficacious.
At the global level, more than 180 vaccines are in various stages of development. Of them, a little over a dozen are in one of the three stages of human trials. We can expect a few of these vaccines early next year if clinical trials provide fruitful results. The Indian pharmaceutical industry has an excellent track record in vaccine development. Three Indian companies are at the forefront of COVID-19 vaccine development. The Serum Institute of India, a Pune-based company, is collaborating with Oxford University in the UK to manufacture a vaccine developed by the university.
Bharat Biotech India Limited (BBIL), a Hyderabad-based company, is with the support of the Indian Council of Medical Research (ICMR) developing a vaccine called COVAXIN. BBIL has already completed the animal-trials stage and has received the Drug Controller General’s permission to conduct human trials. On July 2, ICMR director general Balram Bhargava sent out a letter to the trial’s 12 participating centres to fast-track procedures so that the vaccine can be made available by August 15. His letter also states that “this is one of the top priority projects that is being monitored at the topmost level of the government” and that “non-compliance will be viewed very seriously”.
This letter has attracted serious criticism from the Indian scientific community. The deadline of August 15 is an unreasonable one. There are three phases in drug or vaccine clinical trials. It is impossible to complete all of them within this very short time. Such haste will seriously affect the trial process and the vaccine’s safety. As per the details in the trial registry submitted by BBIL, it will take at least a year to complete the phase 1 trials, and then phase 2 and phase 3 will need to be carried out. Phase 1 trials are meant to test the vaccine’s safety and are carried out in a small number of healthy volunteers. This phase of the COVAXIN trial will take a minimum of 28 days to complete.
Once the safety is ensured, we start phase 2 to assess the immunogenicity of the vaccine – or its efficacy – in healthy volunteers. In the usual circumstances, this phase can take several months; even if we super-fast-track it, it will take four weeks. So if we are super-efficient and the trial takes place like a well-oiled machine, we can have the phase 2 trial’s data in 2 months’ time.
After this, we need the large phase 3 trial with several thousand individuals, analysing efficacy and safety together. This phase will require several months to complete however efficient and fast we are. Marketing a vaccine without phase 3 trials will be a very risky affair. Even if we combine phases 2 and 3, we will still need several months.
So the vaccine will not be available before the end of this year or early next year, provided the clinical trials are successful. Why then did ICMR set the impossible target of August 15? Is it due to the pressure by the “topmost level”? It is perfectly acceptable and justifiable for the political leadership of any country to request their scientific organisations to fast-track the development of an indigenous vaccine. But it is the responsibility of senior scientific advisors, especially the director-general of ICMR, to convince the “topmost level” the dangers of setting such an impossible target.
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I don’t believe our government will ask our research organisations to super-fast-track the trial, to develop a vaccine without ensuring its safety and efficacy, endangering the lives of the citizens. Politicians are often the first individuals to grasp the potential for adverse consequences – especially such as one a bad vaccine can unleash. But even if we believe there was a request from the political leadership to accelerate the trial, I don’t think ICMR made a serious attempt to convince the political leadership on the dangers of maintaining such a tight schedule.
Next, if ICMR has independently decided to fast-track the trial, to render the vaccine ready for clinical use in six weeks’ time, this is a very unfortunate situation. ICMR has since issued a press release clarifying the matter and stressing that they would never compromise on the trial protocols. The Indian Academy of Sciences, a highly reputed organisation of Indian scientists, has released a statement cautioning against reputational damage that could be incurred by rushing the vaccine. It is good to know that the scientific community of the country has stood up for the right cause.
Governments at the Centre and in the states should always seek and respect the opinion of their scientific advisors. At the same time, responsible scientific advisors should stand up for what is right and try their best to convince the political leadership of the long-term consequences of decisions that can appear to have short-term benefits. The right balance is the key to the success of the scientific initiatives of any government. Our country has a strong political leadership and a vibrant and efficient scientific community. Together we can face any challenges.
Dr Abdul Ghafur is a consultant in infectious diseases, Apollo Hospital, Chennai.