Need for caution: On Russia’s Sputnik V vaccine

Russia’s candidate vaccine for COVID-19 appears to have found a midwife in India. The Russian Direct Investment Fund (RDIF), which is piloting the Sputnik V vaccine, has announced a partnership with the Hyderabad-based Dr. Reddy’s Laboratories to conduct a Phase-3 trial, or large multi-location human trials here. Were the candidate vaccine, developed by Russia’s Gamaleya, to prove safe and efficacious, the RDIF would supply 100 million doses through its partnership with Dr. Reddy’s Laboratories. However, there is no agreement to manufacture the vaccine here unlike the deal between the Pune-based Serum Institute of India and the United Kingdom-based AstraZeneca, for the Oxford University-developed ChAdOx1 vaccine. Sputnik V is being developed as a two-dose vaccine on a human adenovirus vaccine platform. Several vaccines that are in development are also being deployed on similar platforms, and the evidence so far is that none of these has been commercially approved for use in humans though there is an experimental vaccine for Ebola. Results of the Phase-1 and Phase-2 trials of the vaccine, published in The Lancet, suggest that the evidence so far is that it has proven safe and efficacious enough to progress to the next stage of trials. Controversially, Sputnik V has been granted a pre-approval by Russia’s regulators even before Phase-3 trials have been completed.

There is immense political pressure globally on regulatory agencies to get a vaccine out at the earliest. Thus, it is incumbent on a company conducting such trials to be particularly vigilant that all good practices and necessary protocols are scrupulously followed. It is well acknowledged that two-thirds of the most common vaccines produced globally are made in India. The Serum Institute has committed to producing 100 million doses of its vaccine for India and other ‘Low and Middle Income Countries’ at less than $3 per dose. Reportedly, half of these are for India. All in all, there seems to be a guarantee for only about 150 million doses for India, which given the country’s population is minuscule. All of this of course does not account for the vaccines that are being indigenously developed in India: Covaxin, by Bharat Biotech, based on a strain sourced from the Indian Council of Medical Research, and ZyCov-D, the plasmid DNA-vaccine being developed by Zydus Cadilla. In Phase-2 trials now, both are being tested for their ability to produce a satisfactory immune response. India has the capabilities for vaccine manufacture, cold chain storage and distribution to ensure access to citizens — and the world — in reasonable time, but it must not forget that vaccines must go through their inevitably long gestation to ensure that only those that are safe and efficacious make their way to the market.

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Printable version | Oct 27, 2020 8:39:17 AM | https://www.thehindu.com/opinion/editorial/need-for-caution-the-hindu-editorial-on-russias-sputnik-v-vaccine/article32633644.ece

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