E-Paper
Covid-19: What you need to know today
It’s still important for the government to work with Serum Institute of India and Bharat Biotech on expanding their capacities and it’s even more important for it to come up with a long-term Covid-19 vaccine strategy.
Tuesday, April 13, may well mark an important milestone in India’s fight against the coronavirus disease.
First, the country’s drugs regulator, Drugs Controller General of India, granted emergency use authorisation (EUA) to Sputnik V, the Covid-19 vaccine developed by Russia’s Gamaleya Institute, and which will be marketed in India by Dr Reddy’s Laboratories. This was expected, after the Subject Expert Committee of India’s Central Drugs Standard Control Organisation recommended the emergency use approval of the vaccine on Monday.
Shortly after, the government announced that it has accepted a recommendation from the National Expert Group on Vaccine Administration for Covid-19 (Negvac), to grant emergency use authorisation to vaccines that already have similar approvals from the US Food & Drug Administration, the UK Medicines and Healthcare products Regulatory Agency, the EU’s European Medicines Agency, Japan’s Pharmaceuticals and Medical Devices Agency, or those listed for emergency use by the World health Organization.
Sputnik V was approved in a hurry, with Russian President Vladimir Putin himself announcing the world’s first “registered” vaccine, and adding that his daughter was among those inoculated. At the time, there wasn’t enough data (there was some) to justify the approval, and the vaccine was eyed with distrust, not just by regulators in western nations, but also anyone who believed in science and data. Subsequent studies showed that the vaccine was hugely (92%) effective – not surprising, because the Russians do have a history of making effective vaccines.
Dr Reddy’s applied for an emergency approval in India on the basis of the final data, but India insisted on a bridging study. The insistence seemed strange (although it is understandable because it is good scientific practice), when seen in the context of the approval of the locally made Covaxin, which was granted an unprecedented and never-heard-of-before emergency use authorisation “in clinical trial mode” by India’s drugs regulator on January 3. There was no way that those approving Covaxin could have known about its efficacy because there was no data at the time – not even interim. Efficacy is the most important criterion for a vaccine’s approval; a safe vaccine, which provokes an immune reaction (the first two are the result of safety and immunogenicity tests), but which isn’t effective, will achieve nothing. That Covaxin eventually proved to be as effective (81%) as the interim data showed was providential – and, also, at a personal level, deeply satisfying because Bharat Biotech, its developer, is a company this writer put on a “companies to watch for” list in a magazine in the early 2000s, and it is always a good feeling to be vindicated. Much like Sputnik V, Covaxin got a bad rap only because its approval was rushed through. As HT has reported, Russia’s sovereign wealth fund, which is managing the commercial aspects of Sputnik V, has already struck deals to make almost 700-800 million doses locally (it has struck deals with five Indian firms), with some of these becoming available in second and third quarters of 2021-22. These companies do not have to separately apply for approval. In addition, there’s the 100 million doses Dr Reddy’s will import and market.
The decision to grant EUA to vaccines approved elsewhere – in the interests of safety, the government has mandated that the first 100 recipients of these in India will be tracked for a week before a wider roll-out – will immediately benefit Johnson & Johnson (its vaccine is approved by FDA, EMA, and WHO), Moderna (FDA, MHRA, EMA, and WHO), and Pfizer-BioNTech (FDA, MHRA, EMA, JPMA and WHO), although the last two will still face significant logistical issues given the very low temperatures at which their vaccines have to be stored and transported. It may also benefit Novavax, which has applied for approval of its vaccine to FDA, MHRA, and EMA. Serum Institute of India has a manufacturing deal with Novavax; the firm will start making its version of it later this year, and hopes to launch it by September. The launch has been delayed by the US government’s decision to restrict the export of raw material.
Last week, Reuters reported that Johnson & Johnson would begin a bridging trial for its single-shot vaccine in India (it has an efficacy of 66.3% overall, but like the Moderna, Pfizer, and AstraZeneca vaccines, it offers 100% protection against severe infection and death). That trial will now not be required; Johnson & Johnson already has a manufacturing partnership with Biological E Ltd, a Hyderabad company that plans to make 1 billion doses of Covid-19 vaccines (not all are J&J ones) by the end of next year.
It’s still important for the government to work with Serum Institute of India and Bharat Biotech (the makers of the first two Covid-19 vaccines approved by India) on expanding their capacities – both sought aid last week – and it’s even more important for it to come up with a long-term vaccine strategy that covers everything from research to manufacturing to the government’s own sourcing requirements (and commitments) to pricing to post-vaccine tracking and monitoring. The first generation of Covid-19 vaccines was initially expected to give people protection from severe disease for a couple of years, but there is no data supporting this. A report last week in the New England Journal of Medicine, and a statement from Pfizer said that the Moderna and the Pfizer-BioNTech vaccines were still effective after six months. But no one is, as yet, clear how long this protection will last. What is clear is the need for a vaccine plan: people may need to take a vaccine every few years, or, at the least, take booster shots that can protect them from variants of the Sars-CoV-2 virus. Much depends on the virus itself.
