Biological E: The mass producer of Johnson & Johnson vaccine

NEW DELHI: The covid-19 pandemic has come as a boost for domestic vaccine manufacturers, launching Serum Institute of India into global prominence and making another, Bharat Biotech International, a popular name in Indian households.

Biological E Ltd, another Indian vaccine manufacturer, however, had flown under the radar so far. But the US government's announcement on Friday changed that. The Hyderabad-based firm will get an undisclosed amount of investment in lieu of the company manufacturing 1 billion doses of covid-19 vaccines by the end of 2022, including the single-dose vaccine developed by US-based Johnson & Johnson.

Along with Serum Institute and Bharat Biotech, the company has been one of the most active vaccine developers from India during the pandemic, developing a protein subunit vaccine developed by US-based Baylor College of Medicine and mass manufacturing another by Johnson & Johnson.

It is currently conducting phase 1 and 2 clinical trial of the Baylor College-developed vaccine, and plans to soon seek approval from the Drugs Controller General of India for phase 3 trials.

“Biological E was the natural choice to get funding from the US government. The other option would have been Serum (Institute of India) but they already have enough funds from Gavi and Bill Gates. For Biological E, they are manufacturing Johnson & Johnson’s vaccine, they are conducting clinical trials for another vaccine developed by a US institute, and they have an existing relationship with IFC (International Finance Corp),” said a senior official with a vaccine manufacturer, requesting anonymity.

The company, led by Mahima Datla, has borrowed from World Bank arm IFC since 2017, when it first took a loan of $60 million to fund diversification of its product range and increase production capacity. Most recently, the firm borrowed $30 million from IFC in December to expand access to low-cost vaccines for children in developing countries and also help increase production of a covid-19 vaccine when developed.

An August 2020 report from credit ratings agency Icra had pegged the company’s total loans at $120 million, giving it a rating of ‘A’, the third highest rating, but with a negative outlook due to reduced order inflows and continued pricing pressure on some of its vaccines.

It is mostly known for its pentavalent vaccine for children which protects them against five diseases—diptheria, tetanus, whooping cough, hepatitis B, and haemophilus influenzae type B (Hib).

The covid-19 vaccine became a major leap for the company, however, as it announced partnerships with Baylor and J&J on 13 August, and then followed up with another announcement four days later - that it would buy Akorn India Ltd, a subsidiary of US-based Akorn Inc, for an undisclosed amount.

The acquisition also gave the vaccine maker ownership of a plant in Paonta Sahib in Himachal Pradesh, which has a fully staffed sterile injectable manufacturing facility, allowing the company to scale up its vaccine manufacturing to 1 billion doses, only the second firm in India after Serum Institute, and ahead of Bharat Biotech, which plans to have a capacity of around 700 million doses.

“The timing of this acquisition is fortuitous as it will immediately allow us to expand our capacity to manufacture our investigational COVID-19 vaccine. With these capacities, we would be in a position to offer over 1 billion doses per annum,” Biological E managing director Mahima Datla said in a statement on 17 August.