The vaccine gap

Timelines suggest govt must focus on health infra too

The member of the government think tank NITI Aayog who is responsible for health, V K Paul, recently said that it was expected that 2.16 billion doses of various vaccines for the novel coronavirus would be manufactured in India between August and December of 2021. The hope essentially is that, by the end of this calendar year, more than enough doses would have been manufactured in India to have vaccinated the entire population. This statement comes in the context of a stalling vaccination programme, which has not been able to keep up the original pace of around 3 million shots a day. Given the scarcity of vaccines, questions of distribution — between states, between free public shots and paid-for shots through private hospitals, between the first and second dose, and between those over 45 and those in the age group 18-44 — have become major issues. These dilemmas can only be addressed properly when the supply increases.

Yet Dr Paul’s hope about manufacturing depends upon several variables that may not work out as expected. For one, he was hoping for 200 million doses of the vaccine developed by the US-based company Novavax, which is being made in India by the Serum Institute of India (SII) under licence. But this vaccine has not yet been approved anywhere in the world. Even if approvals come through on the preferred timeline, SII has had problems with its supply chain for the Novavax vaccine, partly due to export restrictions in the US. Several other smaller-run vaccines that are supposed to make up the numbers — such as a nasal vaccine from Bharat Biotech and an mRNA vaccine from US-based HDT Bio Corporation, in partnership with Gennova Biopharmaceuticals — have barely begun early trials. Several other candidate vaccines will also have to face raw material shortages of the sort that might bedevil the Novavax vaccine. These include a vaccine developed by scientists at the Texas Medical Centre in the US and California-based Dynavax Technologies, which is being licensed by the Indian company Biological E. It is hoped that 300 million doses of this vaccine will be produced before December. But, again, this vaccine has only just begun its Phase 3 trials in 15 locations across India.

The question that needs to be asked, clearly, is why existing vaccines are not being licensed or manufactured at scale in India yet. Biological E itself had spoken of negotiations with Johnson & Johnson for their one-shot vaccine. In the past, its managing director had said the company hoped to produce 600 million shots of the vaccine in a year. It is hard to see why turning this into a reality is not being prioritised. Questions are being asked also as to why J&J, in spite of recent liberalisation, has nevertheless sought permission for a clinical trial in India. Similar questions can and must be asked about the hurdles in the way of Pfizer’s effective mRNA vaccine, including liability waivers. The European Union, the UK, the US, and Canada have all managed the liability issue; why is India delaying? It is clear that, given these constraints, the government’s timeline may well be optimistic. Thus, till supply improves, India must also focus on flexible and supportive medical infrastructure. The lessons of the second wave, especially from those places that were hit early, must be learned and redeployed elsewhere in the country — and to prepare for the third wave that some public health experts have said is certain to hit.