India’s Oldest Private Vaccine Maker Gears Up to Produce 30 Cr Doses

To fight against novel coronavirus pandemic, India plans to vaccinate all its citizens by December, according to the top official of the central government. Around 216 crore vaccine doses would become available between August and December, Dr Vinod Kumar Paul, member of Niti Ayog said on Thursday.

Biological E, India’s oldest private vaccine maker would supply 30 crore doses of its COVID-19 vaccine candidate between August to December this year, according to ministry of health and family welfare. In April, the Hyderabad-based pharma giant received an approval to start the phase III clinical trial of its recombinant protein vaccine candidate in India. It has already completed the phase I and phase II clinical trials of its COVID-19 vaccine in the country.

Biological E’s sub unit vaccine, modelled after the hepatitis B vaccine, uses traditional protein-based vaccine platforms. The vaccine candidate “includes an antigen developed by Texas Children’s Hospital Center for Vaccine Development and in-licensed from BCM Ventures, Baylor College of Medicine’s integrated commercialization team and Dynavax Technologies Corporation’s advanced adjuvant CpG 1018TM.”

“We are delighted with the success of the phase I/II clinical trials of our COVID-19 vaccine candidate. The results of these clinical trials are very positive and promising. We believe that our vaccine candidate will become another effective global COVID-19 vaccine as we move forward into Phase III clinical trials,” said Mahima Datla, managing director, Biological E. Limited.

“This vaccine could one day soon fill urgently needed gaps and vaccine supply shortages in Africa, Latin America, and in low-income Asian countries. It’s so exciting to partner with BE helping India to provide a vaccine to halt the COVID-19 pandemic globally,” said Dr Peter Hotez, professor and dean of the National School of Tropical Medicine at Baylor and co-director of Texas Children’s Hospital Center for Vaccine Development.

Last year, Biological E has signed an agreement with Janssen Pharmaceutica NV, one of the Janssen Pharmaceutical companies of Johnson & Johnson for “enhancing the manufacturing capacities for drug substance and drug product for Johnson & Johnson’s COVID-19 vaccine Ad26.COV2.S.”

Coalition for Epidemic Preparedness Innovations earlier announced that it will contribute up to $5 million toward the cost of scaling up the process for manufacturing Biological E’s COVID-19 vaccine. It would explore providing additional funding to Bio E with the goal of potentially enabling the production of 100 million doses in 2021, a released mentioned.

Founded in 1953 by KVK Raju, Biological E is the first private sector biological products company in India. It supplies its vaccines to over 100 countries and its therapeutic products are sold in India and the United States.

The vaccine manufacturer started its vaccine manufacturing journey in 1962 with tetanus.”In recent years, Biological E has embarked on new initiatives for organisational expansion such as developing generic injectable products for the regulated markets, exploring synthetic biology and metabolic engineering as a means to manufacture APIs sustainably and developing novel vaccines for the global market,” the vaccine manufacturer said.

“Bio E’s vaccine candidate has the potential to be produced at scale, and characteristics which could make it suitable for broad distribution in developing countries,” Datla added. The first pharmaceutical company in southern India is all set to roll out billion of doses of its COVID-91 vaccine in the coming months.

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