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The US has eased export of raw materials for Covishield production in India, paving the way for Serum Institute of India to scale up capacity. Mint looks at what raw materials have been in shortage, and how significantly the move can help improve vaccine supplies.

How are vaccines manufactured?

Vaccine production is a complicated process which involves multiple raw materials like cell culture medium, single-use bioreactor bags, filters and resins, each of which are critical to production.

Most vaccine platforms, be it adenovirus vector-based vaccines like Covishield and Sputnik V or wholly inactivated virus like Covaxin, first start with the growth of specific cells in a medium and kept in single-use bioreactor bags. The cells are specific to each vaccine—vero cells for Covaxin or a type of human embryonic kidney cell, HEK293, for Covishield and Sputnik.

Once the cell growth has reached sufficient quantity, they are infected with the modified virus that makes up Covishield or Sputnik or the SARS-COV2 in case of Covaxin.

When the viruses have multiplied into large quantities after a period of time, these are harvested and the bioreactor bags are disposed of. Then starts the process of filtration and purification, which involves the use of specific filters, resins, cassettes and other apparatus, many of which are imported from the US. For Covaxin, there is also an additional process of inactivation—killing the virus with a chemical agent—that takes place during this stage. After purification, the viruses are converted into formulations, packaged in vials and shipped. The entire process could take up to a few months, depending on the vaccine.

What are the issues hindering covid-19 vaccine manufacturing?

Indian vaccine manufacturers have had problems obtaining the raw materials involved in all these processes, which in turn is also putting hurdles in scaling up production capacity, an issue that has been raised repeatedly by Serum Institute of India and Bharat Biotech International. The issue stems primarily from the US invoking the Defense Production Act to restrict exports of bioreactor bags, filters and other key raw materials used to make vaccines. Serum Institute CEO Adar Poonawalla said the US restrictions are also affecting production of Covovax, its next covid-19 vaccine, originally developed by US-based Novovax.

What has the US done to help the situation?

The US government on Sunday said it has identified sources of specific raw material in the country that are urgently required for manufacturing Covishield in India, and will immediately make these available for India. The move is part of an exception to the DPA and also involves providing medical equipment and protective gear to help India respond to a massive surge in covid-19 cases.

Will this help vaccine supplies?

It is not yet clear how quickly Serum Institute can ramp up production. For now, Poonawalla has said that the company will be scaling up its Covishield manufacturing capacity from 60-70 million per month now to around 100 million in July. There is no clarity on production capacity and expansion for Covovax.

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