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India emerging as major COVID-19 vaccine manufacturer

Serum Institute of India plans to make low-cost COVID-19 vaccines available to the developing world

At least six Indian companies are developing or co-developing COVID-19 vaccines, but India’s biggest contribution to fighting the pandemic is likely to come from its manufacturing might.

The Serum Institute of India, the world’s largest vaccine manufacturer by volume, is partnering to manufacture the ChAdOx1 nCoV-19 adenovirus vaccine candidate that is being developed by the University of Oxford’s Jenner Institute, as well as a live-attenuated vaccine that Codagenix Inc. is developing.

The Serum Institute of India Pvt. Ltd. (SII) has announced plans to produce 60 million doses of ChAdOx1 this year. It is making the investment at-risk, before safety and efficacy are known. The company plans to run clinical trials of the vaccine candidate in India with enrollment starting in May or June.

The company could manufacture hundreds of millions of doses annually of COVID-19 vaccines at its plant in Pune, the company’s chairman Cyrus Poonawalla told BioCentury.

“I am completely against any IP in public health.”

Cyrus Poonawalla, Serum Institute of India

 

The Oxford group is backed by the Coalition for Epidemic Preparedness Innovations (CEPI). In addition to SII, Oxford has signed up Merck KGaA (Xetra:MRK), Halix B.V., Advent s.r.l. and Cobra Biologics AB to manufacture its vaccine (see “Oxford Adds to Surge of Pandemic Deals”).

Oxford has launched a 1,112-person Phase I trial of its ChAdOx1 nCoV-19 vaccine and has stated that it could have doses ready for emergency use this year. The university has stated that it will not seek patents or other intellectual property protection for the vaccine.

Serum Institute opposes IP on vaccines

The Oxford group’s decision to eschew IP is in tune with SII’s approach to vaccines.

“I am completely against any IP in public health and I oppose companies depriving the world of a technology that could help save children’s and adults’ lives,” Poonawalla told BioCentury. “You can have IP on a computer or a cosmetic or even a vitamin or something like Viagra. When it comes to a COVID-19 vaccine or any vaccine against a communicable disease, I am dead against IP.”

Poonawalla believes that patents on vaccines increase prices and that companies like SII can make sufficient profits with small margins on immense volumes. “IP causes the price to go up so children in Africa and southeast Asia and elsewhere would be deprived of a wonderful drug that otherwise would make the world a happier place to live in.”

SII sells 400 million doses of measles vaccine annually and makes “ten or fifteen cents on each,” Poonawalla reported. “If there is a successful COVID-19 vaccine, we intend to use the same template.”

While it plans to sell the vaccine for 1,000 rupees ($13.25) and make pennies per dose, SII is pressing governments to make the vaccines available at no charge.

SII would distribute and sell the Codagenix vaccine at a similar margin, Poonawalla said.

SII has agreed to provide milestone-based funding of preclinical and clinical development, Codagenix CEO J. Robert Coleman told BioCentury. He added that the company plans to start a Phase I trial by August or September.

Codagenix declined to provide information about its commercial agreement with SII.

SII’s manufacturing facilities are certified by the WHO but have not been licensed by FDA or EMA. The company does not plan to seek FDA or EMA licensure for its COVID-19 vaccines and will market products only in developing countries, Poonawalla said.

Indian vaccine development programs

While a vaccine manufactured by SII would be sold in India, it is less than certain that India would have unrestricted access at an affordable price to COVID-19 vaccines manufactured in the U.S. or Europe.

At least six Indian companies are developing COVID-19 vaccines (see “Indian SARS-CoV-2 Vaccines”).

Table: Indian SARS-CoV-2 vaccines

The Serum Institute of India, which makes more vaccine doses than any other company worldwide, is laying plans to make hundreds of millions of doses of COVID-19 vaccines. At least five other Indian companies are developing or co-developing vaccines in response to the pandemic.

Bharat Biotech International Ltd. is partnered with the University of Wisconsin-Madison and FluGen Inc. to develop CoroFlu. CoroFlu is a version of FluGen’s M2SR influenza vaccine that has had SAR-CoV-2 sequences added to it. M2SR has been tested in Phase I and II trials.

Bharat is responsible for manufacturing CoroFlu. Clinical trials could start this fall, according to the University of Wisconsin.

Zydus Cadila Group (NSE:CADILAHC; BSE:532321) is working on two COVID-19 vaccine candidates, a DNA vaccine and a live-attenuated recombinant measles virus vector vaccine.

The latter is being developed by Zydus unit Etna Biotech, an Italian company that Zydus acquired from Crucell N.V. in 2008.

Further analysis of the coronavirus crisis can be found at https://www.biocentury.com/coronavirus.

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