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Saturday, July 31, 2021

An Expert Explains: Challenge ahead in vaccinating India

Covid-19 vaccines are being developed at a pace faster than for any other disease, yet there are shortages. India will look forward to procuring more vaccines and a proposed IP waiver from global manufacturers.

Written by Virander S Chauhan | New Delhi |
Updated: May 11, 2021 6:53:26 pm
Covid-19 vaccine, Coronavirus vaccine, Indoia vaccination programme, India covid vaccination, covid vaccination online booking, vaccination shortage, Covid in India, India Covid vaccine, India Covid variant, Indian ExpressQueue at a Covid-19 vaccination centre in New Delhi. (Express photo by Praveen Khanna)

Covid-19 vaccines were developed at an astonishing pace. No other disease has seen so many vaccines developed so fast. Out of 250 candidate vaccines that were being developed, at least 10 have already been approved for emergency use in different parts of the world. Most of the first flush of approved vaccines were based on two technologies never used in humans earlier. These include mRNA-based vaccines of Pfizer-BioNTech, Moderna, and the viral vector-based vaccines of Astra Zeneca/Oxford University, Sputnik V, Janssen of Johnson and Johnson, and Coronavac of CanSino Biologics from China.

Vaccines based on the time-tested technology of using an inactivated virus include Covaxin of Bharat Biotech-ICMR and vaccines from Sinovac and Sinopharm from China. All these are safe and efficacious in protecting from severe disease and death but not necessarily from infection. These are given as two jabs, with the exception of Janssen, a single-shot vaccine, possibly a trendsetter for future vaccines.

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At least 50 more vaccines are in the pipeline with three or four close to approvals in different parts of the world. Several, including a DNA-based vaccine from Zydus Cadila in India, are in the final stages of development.

So many and yet shortage

With so many vaccines being developed, it may create the impression that it is not very difficult to make efficacious vaccines against a virus like SARS-CoV-2. Far from it! Vaccine development is a highly complex and a specialised enterprise. Under normal circumstances, it takes 10-15 years to develop any vaccine after the scientific rationale has been worked out. The world over, and now very much in India, the question being raised is that even after so many vaccines having been approved, why is there a huge shortage of supply, and unjustifiable and inequitable access to these vaccines?

First, with about seven billion people to be vaccinated worldwide, with mostly two jabs each, the demand is obviously very high. Second, the rich nations have behaved as they always do. More than 80% of available vaccines have been ordered and/or already stocked by a few countries representing only about 20% of the world population. Even with a WHO-led effort like COVAX, only about 1% of the African population has received vaccines so far.

There are other complexities as well. For example, as of now, only three vaccines — Pfizer, Moderna, and recently Janssen — have been approved by the US FDA. The most affordable AstraZeneca vaccine still awaits approval. With recent reports of Pfizer getting approval for immunising the age group 12-16, and Moderna and Janssen close to completing safety and efficacy trials in this age group, it is clear that western countries, which have already immunised a significant portion of their adult populations, will proceed to vaccinate young children and, perhaps, even babies. It will therefore become even more difficult to access these vaccines in the free market.

On the other hand, approval for Sputnik V was recently denied in Brazil. Vaccines of China’s Sinovac and Sinopharm are not yet approved in western countries. Efficacious and safe vaccines, regardless of their origin, need to be critically but quickly examined and added to the pool.

The Expert

Dr Virander Singh Chauhan is a former UGC Chairman and a former director of the International Centre for Genetic Engineering and Biotechnology, where he currently holds the Arturo Falaschi Chair.

Shortage in India

India is in the grip of the most ferocious second wave of the pandemic seen anywhere in the world. With more than 4 lakh cases reported per day, there is a serious concern that the virus could mutate into more dangerous variants and if the chain of viral multiplication is not controlled soon, it will become a global problem. New waves the world over are driven by mutants and although current vaccines seem effective against these, the chances of emergence of immune-escape mutants will only increase if the pandemic is not brought under control.

India, with its inherently fragile healthcare system, has come under immense pressure as never before. There is an acute shortage of medical oxygen, and there is a big gap in the supply chain of the ambitious programme to vaccinate all its adult population. Although India ranks number three after the US and China in the absolute number of vaccines administered, only about 13% of its population has received a single jab and about 2% fully vaccinated. Many countries have already vaccinated more than half their adult population.

With India being known as the hub of vaccine manufacturing, everybody is asking why it is so, and why is it difficult to ramp up production of the two available vaccines. Vaccines are complex formulations of many components and depend on a seamless supply of raw materials that are mostly imported. From production of the bulk material to filling of the formulation in vials is a highly complex and time-consuming process that cannot be hastened. Ramping up of existing production, even after adequate funds are available, will inevitably take a minimum 2-3 months.

Even if the licence is granted to vaccine manufacturers, actual production will take several months of preparation to kick off. The vaccination drive to cover India’s adult population will therefore face a supply chain crunch at least for the next few months, unless a large number of vaccines are imported. This option should be carefully but quickly considered.

With at least three or four more vaccines, including Sputnik V, Janssen, and Novavax, already slated to be produced in India and several more being indigenously developed, India would certainly be producing vaccines to vaccinate major parts of the world, hopefully by the end of 2021. There is a joint proposal of India and South Africa that will be taken up once again at the World Trade Organization, and as per the latest update, the US has already responded positively in support of the proposal when it comes up for consideration sometime soon. Under this proposal, companies already producing Covid vaccines will be expected to share their IPR for at least a given period with enough safeguards of their own interests. That will greatly help in producing high quality and affordable vaccines for the whole world and, hopefully, all this will happen before the virus is able to develop immune escape mutants. The race is on and humanity has no option but to defeat the virus and stay ahead in this race.

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