Speeding up the cure

Drug regulators must work to compress timeline for trials

There is every reason to believe that the only real solution to the problem of the novel coronavirus is the development of an effective and accessible vaccine. Other forms of intervention are of course important. The ongoing national lockdown, as method of enforcing social distance and thus reducing the rate of transmission of the infection, is one such method. But it can only slow transmission and not stop it. The development and utilisation of therapeutic responses to the infection is also important. But such medicines and therapy can only address the disease and not prevent it. Until a vaccine is found, there will continue to be threats to those immunodeficient because of age or underlying conditions, and consequent effects on social interaction and the broader economy.

It is thus necessary to get a vaccine — as well as more effective medicines — out on an accelerated schedule. There is a general expectation that this will take about 18 months or so. But, in fact, that is itself an accelerated schedule and assumes that everything goes right. It is worth noting that no vaccine for SARS-COV-1, which spread through East Asia in the early 2000s, has yet been introduced. For that matter, there is still no vaccine against HIV in spite of major efforts for decades. Thus, excessive optimism should be discouraged. However, neither of those diseases, virulent as they were, got the focused attention of the medical research industry the way Covid-19 has received. What is important is that these efforts be given whatever support they can from the government and regulators. 

It is in this context that the recent notification from the Indian regulator, the Central Drugs Standards Control Organisation, or CDSCO, to pharmaceutical companies is relevant. The regulator has said that, given the effects of the pandemic, some changes might have to be made to the norms surrounding clinical trials. This follows a similar notification from the United States Food and Drug Administration at the end of last month, which temporarily altered the way in which, for example, the subjects of clinical trials were monitored. It is to be hoped that the European drug regulator — two of the most promising attempts at creating a vaccine are emerging from European companies — will follow suit. 

What is important is that the schedule to get a vaccine out be as compressed as possible. Naturally, it is vital to ensure that the vaccine is tested and does not have any problematic effects on the healthy, and some candidate vaccines have already moved to that stage. But the most difficult, time-consuming, and expensive part of the clinical trial is the last, large-scale test in the patient population. This often takes a year. It is this stage the authorities will have to examine. Is there some way to compress or alter it — as drug companies have suggested — in such a way that it can be embedded into the ongoing efforts by national health services to control the virus’ spread? The Indian regulator must follow up on its important notification by consulting the Indian vaccine developers — Cadila Healthcare and the Serum Institute of India — to see if this is possible.