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Pre-produced Covishield, Covaxin in 6-month race against expiry

Pre-produced Covishield, Covaxin in 6-month race against expiry

Both COVID-19 vaccines being administered in India's extensive vaccination programme - Serum-Oxford-AstraZeneca's Covishield and Bharat Biotech's Covaxin - have a very short shelf life of just six months

India's coronavirus vaccination drive is faced with a new challenge - to administer the vaccines in stock before they cross their six-month expiry date.

Both Made-in-India COVID-19 vaccines being administered in the country's extensive vaccination programme - Serum-Oxford-AstraZeneca's Covishield and Bharat Biotech's Covaxin - have a very short approved shelf life of just six months. A part of this has already been spent post-production in cold storages. Serum Institute of India, for instance, was permitted by the government to pre-produce and stockpile Covishield doses starting October-November, 2020.

Dr Suresh Jadhav, Executive Director, Serum Institute of India, told BusinessToday.In that the company has already supplied 20 million doses to the Government of India and they need to be used "within weeks and months" before they expire. Of the 20 million doses supplied by Serum till date, Centre has administered just a little over two million shots so far. Serum has a stock of another 50-60 million doses. It is also producing at a monthly average of 50-60 million which will go up to 100 million a month by April. Dr Jadhav was speaking at Business Today webinar on 'Supply Chain Dynamics in India's Mega Vaccination'.

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This is the first mass scale 'adult vaccination' drive in India and the main challenges include increasing hesitancy, doubts and fears of side effects, negative news on deaths after vaccination, wait-and-watch attitude, etc say experts. World over, many celebrities and national leaders are coming forward to take the vaccine to boost confidence of the masses. At present, the Indian government is of the view that the Prime Minister and other political leaders will be considered for vaccination only in the next round. Similar to Covaxin and Covishield, vaccines of Moderna and Pfizer-Biontech also have six-month expiry period, but supplies and consumption are fast in most of the developed nations, say sources.

Reportedly, Bharat Biotech, which produces indigenous COVID-19 vaccine Covaxin, also has a stockpile of about 20 million doses of the jab and is planning to increase production to 700 million doses per annum by the end of the year. The company has not responded to queries from Business Today till the time of publishing.

India started the coronavirus vaccination drive among priority groups like healthcare and frontline workers from January 16. As of Tuesday only 2,023,809 people have taken the vaccine, significantly less the expected turnout.

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Dr Jadhav says Serum, which was allowed to stockpile the vaccines since October-November even before getting the 'emergency use authorisation' from the Drug Controller General of India (DCGI), has so far made about 100 million doses. Of this, 20 million has been given to India and 8 million were exported to other countries (like Bhutan, Maldives, Bangladesh, Nepal, Seychelles and Brazil). Serum is currently proucing 50-60 million doses a month and is planning to increase production to 100 million doses from April.

"These are costly vaccines and the government needs to quickly utilise the supplied stocks of about 18 million. We have sufficient stocks for India and if required can give additional quantities," says Dr Jadhav.

Serum is planning to give half its production to India and the rest to developing nations through the COVAX alliance.

Meanwhile, stability studies are going on with positive results to increase the shelf life of the vaccine to nine months, says Dr Jadhav. "This can be acheived soon and with better stability data, eventually it can be increased to one or one and a half years going forward," he adds. India's plans are to innoculate 30 crore people with coronavirus vaccines by July.

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Rajiv Nath, Chairman and Managing Director of Hindustan Syringes & Medical Devices Ltd, said that unlike vaccines, needles have a longer shelf life of about 5 years, but it is a challenge to make huge quantities of the needles. Different new forms of vaccines are being developed like single dose and nasal sprays and droplets. Such vaccines require special syringes and delivery platforms which will require time to design and make them.

"Consumption needs to be ramped up to match at least production of vaccines, syringes and then start depletion of stockpiles of inventories by starting vaccination of 60+ & essential services and products providers, including journalists in field and airline staff," added Nath.

Jack Muhs, President - Indian sub-continent, Middle East and Africa of Fedex Express, notes that the scale of vaccine supply has created many challenges like cold chain management, packaging, tracking the supplies and last mile delivery. "It has been a continuing exercise working with regulatory agencies, manufacturers and other stakeholders," he says.

According to Dr Rana Mehta, Leader, PwC India, the coronavirus pandemic saw the emergence of a new business model involving regulatory flexibility, collaborations among competitors and governments pre-purchasing vaccines etc and the learnings will be useful in future to handle such pandemics and even drug development.

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