The Vaccine Conundrum

Just as a new COVID strain ravages Europe, the Indian drug regulator has approved two vaccine candidates for use in differing capacities. One is based on the Oxford-AstraZeneca vaccine, produced by the Serum Institute of India, called Covishield. The second vaccine, Covaxin has been developed by homegrown company Bharat Biotech in association with ICMR (Indian Council of Medical Research).

Off the bat, it is mighty impressive that companies have developed a vaccine at such an accelerated pace, while typical vaccine development cycles take anywhere between 5 to 10 years. That being said, not all vaccines are equal. Russian and Chinese variants haven't gathered much steam outside their native countries. Even the leading candidates from Moderna and Pfizer vary in efficacy.

 

Another very important aspect to bear in mind is that the efficacy figures presented are based out of a small proportion of volunteers who were part of double blind fold vaccine trials across the globe. In essence, it is a statistical extrapolation when companies claim their vaccine is 92% effective or 95% effective. Also, these figures are the outcome of clinical trials, of which the Phase 3 trials are cornerstone in determining vaccine efficacy and safety on humans.

 

With this backdrop, let us look at the peculiarity playing out in the scenario detailed in the first paragraph.

Covishield is running from the strengths of the trials conducted in Brazil and UK and the fact that it has been approved in the UK. Even so, a notable observation here is the efficacy of Covishield varied greatly based on the volume of vaccine administered- from about 60% to 90%.

Covaxin, on the other hand, does not have its Phase 3 trial results published in the public domain. In essence, the efficacy data is unknown.

 

The argument of the regulator might be that with various strains of the virus appearing, it would be prudent to approve vaccines for the near term. But if the shots being given to health care staff and frontline workers are not effective, the whole exercise is moot.

 

While the regulatory standpoint is not entirely conjecture, the line of reasoning behind the decision appears flimsy given that India has seen a decreasing trend in the number of active cases and that COVID-19’s fatality rate is far lower at around 2% on average as compared to other deadly diseases like the Spanish Flu or Ebola.

 

To clear the air, the intention behind raising these questions is not to cast aspersions on Bharat Biotech, the regulator or the government, but to seek full disclosure. All of us want to leave behind the nightmare of 2020, but we would want to leave it behind for good.