Manufacturers look to boost capacity as govt enhances vaccination scope

Firms work to secure raw material locally as imports remain a challenge

As a huge market opens up before vaccine manufacturers, with the Centre allowing everyone above 18 years of age to take the life-saving jab, firms have geared up for expansion plans to ensure sufficient availability.

From Bharat Biotech and Serum Institute of India (SII)  to Zydus Cadila, all major vaccine makers are en route to expand their production capacity to make Covid-19 vaccines. 

Motilal Oswal says the latest government announcement to allow vaccinations for all can create an additional demand for 1.2 billion doses.

Raw material availability, however, will continue to plague some manufacturers, while others are securing raw material supplies locally.

While Bharat Biotech is eyeing 700 million doses annually, SII may expand to 200 million doses per month. Zydus Cadila is working to expand capacity to 240 million doses annually.

Bharat Biotech on Tuesday said that capacity expansion plan has been implemented across multiple facilities in Hyderabad and Bengaluru to reach 700 million doses per year. This will be one of the largest production capacities globally for inactivated viral vaccines, claimed the biotechnology company.

To further augment capacity, Bharat Biotech has partnered Indian Immunologicals to manufacture the drug substance (bulk drug) for Covaxin. The technology transfer process is underway. Moreover, it has managed to indigenise a component of its proprietary adjuvant in India. It uses Algel-IMDG as adjuvant and now the IMDG component has been synthesised here and it will be manufactured on a commercial scale within the country, said the company.

Sources had indicated earlier that Bharat Biotech was facing challenges to procure the adjuvant (a chemical that improves the immune response of a vaccine) from the US. The Hyderabad-based company had started working with the Council of Scientific and Industrial Research to make indigenous adjuvants.

The world’s largest vaccine maker, SII, is on course to expanding its Covishield capacity to 100 million doses per month by May-June, from the current 60-70 million doses per month. 

Together with this, SII will have 50 million doses per month of the Covovax (the Novavax vaccine) production, taking its total monthly Covid-19 vaccine production to 150 million doses. A source said that after gauging the demand from the open market, the production may be ramped up to 200 million doses per month in the coming months. A decision on the same is still awaited.

Ahmedabad-based pharmaceutical major Zydus Cadila, which is in the final leg of finishing its Phase 3 clinical trials for its novel deoxyribonucleic acid-plasmid Covid-19 vaccine, is working on ramping up the capacity to about 240 million doses a year.

Sharvil Patel, managing director of Zydus Cadila, said the company is working on improving the yield. “We are working to increase the vaccine capacity. As we produce on a large scale, we will be able to scale up further.,” he said.

“Looking at the demand scenario, we can augment more,” added Patel. Zydus has also made arrangements for all requisite raw material needed to make the vaccine for one year.

Raw material availability, however, is a challenge for SII. Its Chief Executive Officer Adar S Poonawalla has already indicated that shortage of raw material from the US is affecting the scale-up of Covovax production. A source close to the development added that if the US sanctions are not eased, Covishield production, too, can hit a stumbling block in a month’s time. 

Poonawalla said SII has started developing local vendors for raw material like cell-culture media, bags, and filters that it imports from the US.

The company did not comment on the matter.

An industry veteran pointed out that a vaccine takes 45 days to reach the market from the factory. 

After a batch is made at the plant, it is tested for 28 days. It then goes to the Central Drugs Laboratory (CDL) in Kasauli. It takes another 20 days before the CDL releases the doses.