A proposal for accelerated approval for Russia’s Spunik V COVID-19 vaccine dominated the deliberations of the subject expert committee (SEC) of India’s apex drug regulator, the Central Drugs Standard Control Organisation (CDSCO), during its 150th meeting on April 1.
The SEC examined the interim safety and immunogenicity data of Sputnik V vaccine generated in India along with the interim data from the ongoing Russian study and sought additional clarification and data for further evaluation. Half a dozen sets of information, including details of package insert, factsheet, dosage, schedule, contraindications, warning, precautions, storage conditions and lot-to-lot consistency data with regards to clinical trial outcomes will have to be produced by Russia’s Indian clinical trial collaborator, Dr Reddy’s Laboratories, when SEC meets next.
Approval for the Russian COVID-19 vaccine in India is critical for at least four reasons.
First and foremost, India’s two approved COVID-19 vaccine makers – Serum Institute of India and Bharat Biotech – are struggling to keep pace with the increasing demand for COVID-19 vaccines within India. Their production capacities are limited, and they have both national as well as international commitments to fulfill. Shortage of vaccines are being reported from several parts of the country and the central government – the single entity that drives COVID-19 vaccine supplies throughout India – is under immense pressure to get enough vaccines for multi-phase inoculation that will take months and years to cover Indian population in a meaningful way. To make matters worse, second wave of COVID-19 infections is sweeping through the country. The third vaccine, which is the closest to being made available to augment the existing supplies, is Sputnik V. The advantage it has over other vaccines that are in the same phase of clinical trial is that it is already been administered on a mass scale in Russia and several other countries. By clearing its apprehensions, Sputnik V can be the next COVID-19 vaccine for India in the coming months.
The second reason why Sputnik V is important is the model Russian Direct Investment Fund (RDIF), the agency that is engaged in getting commercial tie-ups with other pharmaceutical companies and vaccine makers for production and supply of Sputnik V, has adopted to scale up its production. It has technology transfer partnerships with at least seven Indian pharmaceutical companies to manufacture and sell Sputnik V in India. An approval for the vaccine would mean not just one Dr Reddy’s manufacturing the vaccine, but half a dozen other facilities producing it simultaneously and adding millions of doses of COVID-19 vaccines into the distribution system within no time. With Serum and Bharat both talking about the need for additional funds to augment production capacity quickly, government may find Sputnik V to be a more convenient way of increasing vaccine availability without making any financial commitments.
The third reason why Sputnik V is important is linked again to the model RDIF has adopted. It can be a template which the central government can look at if it wants not just the Russian vaccine, but other COVID-19 vaccines too manufactured through third party arrangements. India’s public sector vaccine producing entities, for instance, can be asked to produce say a Bharat Biotech vaccine, if technology transfer can be facilitated.
Finally, the scrutiny of Sputnik V vaccine also tells us about the need for better coordination among regulators – some sort of harmonisation in regulatory approvals – during pandemic times. The often heard concern about regulatory harmonisation is that the mighty and the powerful in that particular sector – pharmaceutical or vaccine manufacturing in this case – get undue advantage to set the standards or rules unrealistically and unnecessarily high to make it difficult for competition in the developing countries to match. The pandemic times should set a different standard where World Health Organisation (WHO) and not regulators of US or Europe lead this harmonisation effort. Imagine if there was a system where COVID-19 vaccines are approved for emergency use through a single common protocol followed by all regulators. India, and other countries as well, would have by now allowed more companies to produce and supply their vaccines. While it is not easy to have such a consensus in matters of science, it could well be a template for future pandemics.
For now, regulatory approval for Sputnik V is the most keenly awaited decision from India’s SEC.