India Emerges as Hot Spot for Manufacturing COVID-19 Vaccines

By S Harachand, Contributing Editor | 10.20.20

CMOs expand and ‘repurpose’ capacities.

India is fast emerging as the most sought-after destination for manufacturing COVID-19 vaccines even as hundreds of institutions around the world are hotly chasing potential vaccine candidates to stall the pandemic.
 
As the unprecedented scenario hastens the front-runners to breakneck speed, the task of the global distribution of the vaccine doses remains a formidable challenge. This has paved the way for Indian vaccine makers, which manufacture more than 60% of all vaccines sold globally, to take center stage.
 
Multiple companies have already forged deals with Serum Institute of India (SII), the world's largest distributor of vaccines, for manufacturing and distribution alliances for their candidate vaccines.
 
AstraZeneca has signed a licensing deal with SII to manufacture 1 billion doses of the adenovirus vector vaccine developed by Oxford researchers, which is currently undergoing phase 3 trials.
 
Similarly, Novavax reached an agreement with SII for development and commercialization of NVX CoV2373, a recombinant prefusion protein, in low- and middle-income countries (LMIC) and India, in August.
 
In mid-September the Gaithersburg, MD-based vaccine maker expanded the agreement with SII to include the manufacturing of the company’s Matrix M adjuvant component as well.
 
Novavax said the agreement will boost the manufacturing capacity for the vaccine candidate to more than two billion doses annually, when all of the company’s planned capacity has been brought online by mid-2021.
 
The deal is expected to support a minimum of 1 billion doses of NVX-CoV2373 for India and LMIC.
 
Late last month, SII announced the commencement of manufacturing CDX-005, an intranasal, live-attenuated vaccine candidate for SARS-CoV-2 developed by Codagenix Inc. of Farmingdale.
 
In addition, SII pledged to manufacture 100 million more doses of COVID-19 vaccines in 2021 as part of an expanded distribution effort with Gavi, the Vaccines Alliance, and the Bill & Melinda Gates Foundation (BMGF).
 
The collaboration will provide upfront capital to SII to help it increase manufacturing capacity for the candidate vaccines licensed from AstraZeneca and Novavax. The vaccine will have a ceiling price of $3 per dose, a price enabled by investments made by partners such as the Coalition for Epidemic Preparedness Innovations (CEPI), the BMGF and SII, the company said.
 
The vaccines will be distributed by COVAX Facility, a global risk-sharing mechanism for pooled procurement and equitable distribution of COVID-19 vaccines, set up by Gavi with participation from 73 higher-income economies and 92 LIMS, including India.
 
The Pune, Maharashtra-based company has the capacity to make 60 to 70 million doses a month. SII is also working on two in-house initiatives to develop a vaccine to prevent COVID-19.

 
Several Indian vaccine makers already have agreements to manufacture COVID-19 shots that are being developed by global firms.
 
Washington University School of Medicine in St. Louis, Missouri has licensed a single dose intranasal vaccine for coronavirus disease to Bharat Biotech, a leading vaccine and bio-therapeutics manufacturer.  Headquartered in Hyderabad, Bharat Bio is currently developing a vaccine in association with the Indian Council of Medical Research, in addition to vaccine collaborations with the University of Wisconsin and Thomas Jefferson University.
 
Biologicals E has entered into a partnership to manufacture a vaccine candidate developed by Janssen Pharmaceutica, based in Beerse, Belgium.
 
The vaccine is in phase 1/2a clinical trials, said Biological E. The Hyderabad-based vaccine maker might also manufacture a candidate being developed by Baylor College of Medicine in Houston, Texas.
 
Indian Immunologicals, another vaccine maker from Hyderabad, is working with Australia’s Griffith University in Brisbane to test and manufacture the university’s vaccine.

 
One of the leading Indian drug makers Dr Reddy’s Lab has agreed to manufacture Gam-COVID-
Vac (Sputnik V), developed by the Gamaleya Research Institute of Epidemiology and Microbiology of the Russian Health Ministry through striking a deal with the Russian Direct Investment Fund (RDIF).
 
As per the deal, Russia's sovereign wealth fund will supply 100 million doses of the COVID-19 vaccine to Dr Reddy’s.
 
The phase 3 clinical trials of Gam-COVID-Vac enrolling 1,000-2,000 participants are expected to begin soon across the country.
 
Even though an unexpected number of countries have gained the know-how to develop a vaccine, many of them working on potential COVID-19 vaccine candidates are lacking in manufacturing capabilities.
 
In the meantime, plans are afoot with the Indian players to ramp up capacities to cater to the increasing demand. As an interim arrangement, they are "repurposing" their multiproduct capacities or make use of the facilities built to manufacture products that are still in the development stage to produce COVID-19 vaccines.
 
Most firms look avers risking to establish dedicated facilities as the demand for mass-produced vaccines is not assured.
 
At least, seven Indian players are currently in the fray to develop their own vaccines against the pandemic. The new set of guidelines issued the Drugs Controller General of India (DCGI), allowing to approve a vaccine with 50% efficacy, is expected to provide more headwinds to vaccine manufacturing.