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Exclusive | Bharat Biotech working on a war footing to roll out Covaxin from Karnataka site

Malur production site expected to produce 30 million doses in July and 50 million by August. Currently, the entire production of Covaxin is done from its Genome Valley facilities on the outskirts of Hyderabad.

June 10, 2021 / 04:20 PM IST
The NASDAQ-listed Ocugen has rights to commercialise Covaxin in the US.

The NASDAQ-listed Ocugen has rights to commercialise Covaxin in the US.

Bharat Biotech is working on a war footing to roll out its COVID-19 vaccine, Covaxin, from its Malur manufacturing site near Bengaluru, Karnataka, by the end of June, sources told Moneycontrol.

The Malur site has a capacity to manufacture about 10,000 kilolitres (KL) of Covaxin drug substance annually, and will be the biggest production site for the company, Moneycontrol learns from sources.

The site is expected to produce 30 million doses in July and 50 million by August.

Bharat Biotech experts have been frequenting between Hyderabad and Bengaluru in the last few months to help install equipment and to get production batches in place, sources said.

"The (Malur) site is capable of expanding Covaxin production by more than 5 times," a person, who didn't want to be named, said.


COVID-19 Vaccine

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A vaccine works by mimicking a natural infection. A vaccine not only induces immune response to protect people from any future COVID-19 infection, but also helps quickly build herd immunity to put an end to the pandemic. Herd immunity occurs when a sufficient percentage of a population becomes immune to a disease, making the spread of disease from person to person unlikely. The good news is that SARS-CoV-2 virus has been fairly stable, which increases the viability of a vaccine.

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There are broadly four types of vaccine — one, a vaccine based on the whole virus (this could be either inactivated, or an attenuated [weakened] virus vaccine); two, a non-replicating viral vector vaccine that uses a benign virus as vector that carries the antigen of SARS-CoV; three, nucleic-acid vaccines that have genetic material like DNA and RNA of antigens like spike protein given to a person, helping human cells decode genetic material and produce the vaccine; and four, protein subunit vaccine wherein the recombinant proteins of SARS-COV-2 along with an adjuvant (booster) is given as a vaccine.

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Vaccine development is a long, complex process. Unlike drugs that are given to people with a diseased, vaccines are given to healthy people and also vulnerable sections such as children, pregnant women and the elderly. So rigorous tests are compulsory. History says that the fastest time it took to develop a vaccine is five years, but it usually takes double or sometimes triple that time.

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Bharat Biotech is yet to respond to questions from Moneycontrol on the existing capacity, and the timeline of the rollout from the Karnataka site.

Orders and cash

Malur site is critical as the company, flush with orders and cash, is scrambling to expand to manufacturing capacities of Covaxin. With the facility coming on board, Bharat Biotech's internal capacity of Covaxin is expected to hit 500 million doses per annum.

To be sure, the vaccine maker received Rs 65 crore to repurpose its new Karnataka facility to increase Covaxin production capacity.

In addition, the central government has cleared a credit of Rs 1,500 crore in April to ramp up vaccine capacities. The central government has earlier placed orders for 5.5 million doses of Covaxin in January and 20 million doses in March. Later, it followed it up with an order of 50 million doses for May, June and July, by paying an advance of Rs 787.50 crore.


It recently signed another order for 190 million doses till December on payment of 30 percent advance. As per a back-of-the-envelope calculation, at the current price of Rs 150 per dose, this order would fetch Bharat Biotech about Rs 2,838 crore. Bharat Biotech will have to pay a royalty of 5 percent on net sales to ICMR.

Target of 700 million doses per year


Bharat Biotech had, in May, announced that it will add an additional 200 million doses per year of Covaxin from its Chiron Behring Vaccines subsidiary at Ankleshwar, Gujarat. The company's plan is to hit 700 million doses per year by 2021.

Currently, the entire production of Covaxin is done from Bharat Biotech’s Genome Valley facilities on the outskirts of Hyderabad, which has a capacity to produce about 10-12 million doses per month.

The Malur facility, owned by Bharat Biotech's sister concern Biovet, was originally meant to make animal vaccines -- more specifically, Foot & Mouth Disease vaccine. The site was repurposed for manufacturing Covaxin, with multiple production lines. The facility has recently received approval from the Karnataka State Pollution Control Board to begin Covaxin production.

Bharat Biotech had earlier said that it takes around four months for manufacturing, testing and releasing a batch of Covaxin. The company noted that the entire process is complex and multifactorial and requires coordinated efforts from several agencies.
Viswanath Pilla is a business journalist with 14 years of reporting experience. Based in Mumbai, Pilla covers pharma, healthcare and infrastructure sectors for Moneycontrol.
first published: Jun 10, 2021 04:20 pm

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