Indian Pharma industry's COVID-19 vaccine plans

(Reuters) - Several Indian pharmaceutical companies are working to develop or manufacture at least eight anti-COVID-19 formulations as the world’s largest producer of vaccines prepares for a massive response to the coronavirus pandemic.

India, which has itself been badly hit by the pandemic with nearly 10 million infections, the second-highest in the world, is focusing on affordable vaccines instead of the expensive messenger RNA shots of Pfizer Inc and Moderna Inc.

Here is a look at the companies that are developing or manufacturing vaccines in India:

Serum Institute of India (SII) - The world’s largest vaccine producer will manufacture AstraZeneca Plc’s Covishield and another formulation developed by U.S. rival Novavax Inc. Organizations such the GAVI vaccine group and the Bill & Melinda Gates Foundation are backing both candidates for large-scale distribution around the globe.

SII has secured funding from GAVI and the Gates Foundation to deliver up to 200 million doses of both vaccines for India and other low-and middle-income countries.

AstraZeneca said in June it had licensed SII to supply 1 billion doses of its vaccine to more than 60 low and middle-income countries. SII is also working on developing in-house vaccines and has partnered with U.S. biotech firm Codagenix and Austria’s Themis to potentially manufacture their COVID-19 vaccine candidates.

SII has already made and stockpiled more than 50 million doses of COVISHIELD and aims to ramp up production to 400 million doses by mid-2021. It has already applied for emergency use authorization of the vaccine in India.

The company could sell the vaccine at 250 rupees ($3.39) per dose to the Indian government and 1,000 rupees on the country’s private market. By comparison, the Pfizer’s supply deal with the U.S. government amounts to $39 for a two-dose course, while Moderna plans to charge between $25 and $37 per dose.

Bharat Biotech - Based in the southern Indian city of Hyderabad, the company is developing a whole-virion inactivated vaccine called COVAXIN in partnership with state-run Indian Council of Medical Research.

It recently applied for emergency use authorisation in the country and is in talks with more than 10 countries in South America, Asia and Eastern Europe to sell it there.

It has not issued any production or price forecasts.

The company is also conducting pre-clinical studies of another vaccine with the Thomas Jefferson University of the United States.

Biological E. Ltd - The firm started phase I and phase II trials of its vaccine candidate in November. It is being developed in partnership with the Baylor College of Medicine in Houston and Dynavax Technologies.

The Hyderabad-based company’s trial will test two doses of the vaccine in about 360 healthy subjects and it expects results by February.

Cadila Healthcare Ltd - Zydus Cadila is developing an indigenous DNA-based vaccine, ZyCoV-D. Zydus plans to complete late-stage trials for ZyCoV-D by February or March, and could produce up to 100 million doses a year initially.

Hetero Biopharma - Another Hyderabad-based private pharmaceutical company, Hetero will manufacture more than 100 million doses of the Russian Sputnik V COVID-19 vaccine a year, under a deal inked with the Russian Direct Investment Fund. (RDIF)

Dr. Reddy’s Laboratories Ltd - The drugmaker is conducting clinical trials of Sputnik V in India and expects late-stage trials to be completed by March 2021. It will also distribute the finished vaccine in India once approved but there is no current plan for it to produce it.