Hyderabad’s Biological E set to give fourth vaccine for India

M Somasekhar

Hyderabad: Biological E, the country’s first manufacturer of vaccines in the private sector is all set to launch India’s fourth vaccine against COVID 19 by August 2021.

According to the Indian Council of Medical Research( ICMR) , Biological E is testing a two-dose vaccine similar to ‘Covaxin’, made by Bharat Biotech, another Hyderabad -based, vaccine maker.

The Niti Aayog member (health) Dr V K Paul recently said, “Biological E has finished phase-1/2 trials. They are submitting the data in the next few days after which they will initiate phase-3 trials of the vaccine.”

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Paul said that the vaccine would be approved and available for use by August. “This is a very positive, a very significant development as Biological E has the capacity of manufacturing 7 crore vaccines per month,” he has been quoted in the media.

As on date India has given approval for the use of three vaccines—Covaxin of Bharat Biotech-ICMR; Covishield of Astra Zeneca-Oxford-Serum Institute of India and Sputnik V of Gamelaya Research Institute of Epidemiology and Microbiology, Moscow, Russia.

The record surge in daily cases that has crossed 3 lakhs and deaths of over 2000 in the past few days pushing the country towards a ‘health emergency’ has necessitated the urgent demand to mass produce vaccines or import to protect the lives of crores of people.

Coincidentally, Sputnik V will be imported by Hyderabad-based, Dr Reddy’s first and also manufactured by Hetero Biopharma, Gland Pharma and Virchow Biotech in millions of doses in Hyderabad itself.

As per data available the total manufacturing capacity of the country’s 7 vaccine makers—SII, Bharat Biotech, Sanofi Shantha, Panacea Biotech, Zydus Cadila, Biological E, Hester Biosciences is estimated to be 8.2 billion doses per annum. The country’s demand is huge and many new players have entered the market.

Biological E can be a big player

Biological E had announced two major partnerships in COVID-19 vaccine development. It signed up with Johnson and Johnson for a single shot vaccine and another with Dynavax Technologies & Baylor College, US.

Its journey in vaccine manufacturing began in 1962 with tetanus and is now gearing up to produce at least a billion plus doses of the COVID-19 vaccine.

However, the company itself was started in 1953 by Dr Datla K V K Raju as a biological products maker producing liver extracts and anti-coagulants. It was in the Azamabad industrial cluster in the heart of Hyderabad where the famous tobacco makers, VST and Golconda Cigarette companies too flourished.

 In recent years as it grew, BE has established modern manufacturing facilities at the Genome Valley, Shameerpet on the outskirts of Hyderabad. The facilities have been inspected by multiple regulatory agencies. They were also visited by Ambassadors of over 60 nations in late 2020. It has seven WHO pre-qualified vaccines and is working to expand its pipeline of generic vaccines.

BE partners with global healthcare agencies, including the WHO, UNICEF, GAVI etc. So far it has supplied over 2 billion doses of vaccines to more than 100 countries.

The big boost

On March 12, the company got a huge boost when the US International Development Finance Corporation announced financial support to produce at least a billion doses of COVID 19 vaccines by the end of 2022.

The vaccines will be manufactured with “Stringent Regulatory Authorization and/or World Health Organization Emergency Use Listing, including Johnson & Johnson vaccines,” the U.S. agency said in a release

The announcement is part of the agency’s Global Health and Prosperity Initiative, under which it is working to increase manufacturing, production and distribution of vaccines, including COVID-19 vaccines. The cooperation on boosting vaccine manufacturing capability was discussed by the leaders of the U.S., India, Japan and Australia in their first virtual summit recently.

The Quad group agreed to expand efforts to ramp up vaccine manufacturing in the region, including boosting India’s vaccine output.

“Japan, through JICA (Japan international Cooperation Agency), is in discussions to provide concessional yen loans for the Government of India to expand manufacturing for COVID-19 vaccines for export, with a priority on producing vaccines that have received authorization from WHO Emergency Use Listing (EUL) or Stringent Regulatory Authorities,” a statement said.

The company has tied up with Johnson and Johnson to manufacture its single dose vaccine to fulfill the global supply orders and commitment. The vaccine is undergoing trials in India too.

The COVID-19 journey

Meanwhile, in December 2020, the company under the able stewardship of Mahima Datla, Managing Director had announced that it secured $5 million funding from the Coalition for Epidemic Preparedness Innovations (CEPI) for scaling up manufacturing of its protein subunit COVID-19 vaccine.

“CEPI and BE are committed to global equitable access of COVID-19 vaccines and have agreed that vaccine output funded by CEPI’s investment will be made available for procurement and allocation, if proven to be safe and effective, through the COVID-19 Vaccine Global Access (COVAX) Facility,” BE and CEPI said in a joint statement.

The BE COVID-19 vaccine is being developed in collaboration with the Baylor College of Medicine, Houston in the US. It launched a Phase 1/2 clinical trial to evaluate the safety and immunogenicity of the vaccine candidate in November 2020 and is gearing up to do the Phase 3 trials now.

It is based on SARS-CoV-2 Spike protein subunit, which is combined with two adjuvants –Alhydrogel (Alum) and CpG 1018 –to boost efficacy.

In 2019-20, Biological E had acquired a sterile injectable manufacturing facility in Himachal a Pradesh from Akron Inc. US, with a capacity to produce 135 million units annually. With these developments BE will have a capacity to produce over a billion doses of vaccines annually, Mahima Datla stated.

The company has a strong relationship with the World Bank’s funding arm, IFC, which has provided nearly $100 million in the last 5 years for the expansion and diversification of the company.

Somasekhar Mulugu, former Associate Editor & Chief of Bureau of The Hindu BusinessLine, is a well-known political, business and science writer and analyst based in Hyderabad

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