Raw material shortage may affect scaling up of Covishield production

Last week, Adar Poonawalla had said on a World Bank panel that a US law blocking the export of key items like bags and filters will likely cause "serious bottlenecks" in vaccine production

The shortage of raw materials may affect the scaling up of the production of the Oxford-Astra­Ze­neca (Covishield) vaccine by the Pune-based Serum Institute of India (SII). 

Last week, Adar Poonawalla, chief executive officer of SII, had said on a World Bank panel that a US law blocking the export of key items like bags and filters will likely cause “serious bottlenecks” in vaccine production.

SII, the world’s largest vaccine maker by volume, is currently producing around 67-70 million doses of Covishield vaccine per month. The biotechnology firm said that while the shortage of raw materials will not affect production at present, it can derail the scale-up, going forward.

“It won’t impact the current production, but the scaling up of Covishield’s future capacity may get impacted,” said a spokesperson for the company.

SII plans to ramp up capacity and make 100 million doses of the Covishield vaccine per month in the next one or two months. The company is also likely to start manufacturing the Novavax vaccine soon. 

The American vaccine development company headquartered in Gaithersburg, Maryland, has got the approval to start clinical trials of the vaccine on Indian citizens. 

According to a person in the know, SII’s target is to make 45-50 million doses of the Novavax vaccine per month. 

This would mean that the company will need to have a combined capacity to make 140-150 million doses of vaccines (Covishield and Novavax) per month by the next quarter.  If the supply of raw materials is disrupted, then this scale-up plan may go haywire.  

The Serum Institute has several supply commitments for these vaccines — the Indian government, the World Health Organization-led COVAX and other bilateral deals.

It has so far supplied around 50-60 million doses of Covishield to the Indian government for the national immunisation programme, and has also supplied 90 million doses to 51 countries. 

India is now vaccinating around 1 million people daily. The Centre has already placed orders for close to 600 million syringes with delivery timelines in September. The target is to immunise 300 million citizens (600 doses) this year.

SII may supply 200-300 million doses to the Indian government alone. However, the company did not confirm this. It has also got supply commitments of 200 million doses to COVAX, the global vaccine alliance initiative. There is an option to supply an additional 900 million doses to COVAX.

Having produced 1.5 billion doses of the vaccine last financial year, SII plans to develop a capacity of 2.3 billion doses in 2021.

But raw material supply issues may pose challenges to this plan. SII’s Poonawalla had said that to make the Novavax vaccine, the company would need critical raw materials from the US. After Pfizer faced difficulties in securing the raw materials for vaccine production, the US administration had announced that it would use the Defense Production Act to boost supplies.

The International Federation of Pharmaceutical Manufacturers & Associations and the Developing Countries Vaccine Manufacturers Network are likely to hold meetings this week to discuss these issues.