NEW DELHI – India is taking a multipronged approach to developing and distributing vaccines against COVID-19, with at least 10 different products under development, domestically or through collaborations with foreign developers.

Vaccinations are likely to begin early next year but, with a population of around 1.2 billion, it is unlikely India will be able to vaccinate everybody it needs to before the end of 2022. In fact, the first target is to vaccinate 300 million high-risk people, about a quarter of the population, by the end of August 2021.

India has the second highest number of reported cases of COVID-19 in the world after the U.S., a little over 10 million. It also has the third highest number of deaths at more than 146,000, according to Johns Hopkins University of Medicine data.  

Most promising candidates

The Drugs Controller General of India (DCGI) is currently evaluating three vaccines candidates for emergency approval. These are:

  • Pfizer Inc./Biontech SE’s BNT-162b2, now branded Comirnaty, that has already been approved for emergency use in the U.S., Canada, the U.K. and the EU;
  • Covishield, developed by Oxford University and Astrazeneca plc, that will be manufactured by the Serum Institute of India Pvt. Ltd. (SII), the largest vaccine manufacturer in the world by volume and is currently in phase III trials; and
  • Covaxin, an inactivated vaccine developed by Bharat Biotech International Ltd. and the Indian Council of Medical Research (ICMR) that started phase III trials in November and is targeting enrollment of 26,000 participants.

“This gives us hope for manufacturing the vaccines, not just for India but also for the world,” said Vinod Paul, a member of the National Institution for Transforming India (NITI Ayog), a government-supported policy think tank. He said the participation of several indigenous players “has created an Apollo 11 moment for India.”

More COVID-19 vaccines for India

There are at least six other COVID-19 vaccines being developed or tested in India.

Cadila Healthcare Ltd. (Zydus Cadila) is working with India’s Department of Biotechnology (DBT) to develop ZyCov-D at the Vaccine Technology Center in Ahmedabad. India’s first DNA plasmid vaccine, it is currently in phase II trials, with an application to start phase III trials due soon, Zydus Cadila’s chairman, Pankaj Patel, said earlier this month. Patel said the vaccine can remain stable at high temperatures of 30 degrees Celsius for about three months.

SII is working with Novavax Inc., of the U.S., on NVX-CoV2373, based on a virus protein subunit engineered from the genetic sequence of SARS-CoV-2. In December, India’s Central Drugs Standard Control Organization (CDSCO) asked SII to submit a revised protocol for phase III trials of NVX-CoV2373.

SII has also announced a deal with New York’s Codagenix Inc. to develop Covi-vac, a single-dose intranasal, live attenuated vaccine. A randomized, double-blind, placebo-controlled, dose-escalation phase I trial started in the U.K. in mid-December.

Hyderabad-based Biological E. Ltd. is working with the U.S.-based biopharmaceutical firm Dynavax Technologies Corp. and Baylor College of Medicine, in Houston, on a vaccine candidate that includes an antigen in-licensed from BCM Ventures, Baylor’s integrated commercialization team, and Dynavax’s advanced adjuvant, CpG 1018. Phase I/II trials started in November and results are expected in February. The vaccine comprises the receptor binding domain of the spike protein of SARS-CoV-2 along with the adjuvant CpG 1018 plus alum.

Gennova Biopharmaceuticals Ltd., out of Pune, and HDT Bio Corp., from Seattle, are developing an mRNA-based vaccine called HGCO 19 that received permission in December to initiate phase I/II trials.

Bharat Biotech Ltd. has also signed an exclusive deal with Thomas Jefferson University, from Philadelphia, to develop a vaccine based on an inactivated rabies vaccine platform used as a vehicle for coronavirus proteins.

Russia’s Sputnik V

Russia has also announced that some 300 million doses of its human adenovirus vaccine, Sputnik V, will be produced in India through tie-ups with local partners, including Dr. Reddy’s Laboratories Ltd. and Hetero Biopharma Ltd.

Dr. Reddy’s has completed phase II trials for Sputnik V and planned to start phase III trials on Dec. 22. Dr. Reddy’s and the Russian Direct Investment Fund (RIDF) entered a partnership in September to conduct clinical trials and distribute the first 100 million doses.

“We are working towards making the vaccine available with a combination of import and indigenous production model,” said Dr. Reddy’s managing director, G.V. Prasad.

For its part, Hetero also signed a deal with RIDF to produce another 100 million doses of Sputnik V.

Details of two other Indian companies that are expected to produce the Russian vaccine have not been released yet.

Vaccine distribution

Regardless of how many of those COVID-19 vaccines eventually make it to the Indian market, distributing them will be a massive undertaking.

The Indian government has identified about 300 million people as high priority for vaccination by August 2021, beginning with health care workers, followed by front-line staff such as army and police, and then adults over the age of 50 and people with co-morbidities. Vaccinating the rest of the population, another 800 million people, is likely to take until the end of 2022.

In a December report, Ernst & Young and the Federation of Indian Chambers of Commerce & Industry (FICCI) estimated that the country may need between 130,000 to 140,000 vaccination centers, about 100,000 health care professionals as inoculators and an additional 200,000 support staff for mass-inoculation just to cover the first 300 million targets.

India will work with the United Nations Development Program (UNDP) to use the Electronic Vaccine Intelligence Network (EVIN) to identify primary beneficiaries and distribution networks. EVIN was launched in India in 2015 to coordinate vaccine logistics and cold chains for the country’s universal immunization program.

Despite the challenges it faces, India is one of the largest manufacturers of vaccines in the world. As such, it is part of the COVAX initiative both as a recipient and supplier. GAVI, the vaccines alliance, is heading up COVAX and announced on Dec. 18 that it has deals in place for almost 2 billion doses of different vaccines.

Under existing agreements, India could receive as many as 250 million vaccine doses from COVAX.

The global initiative has an agreement in place with SII for 200 million doses of either the Astrazeneca/Oxford or the Novavax vaccines as well as options for another 900 million.

“The advance purchase commitments under the COVAX initiative is encouraging as it will further bolster our fight and ensure equitable access at the most affordable price from Serum Institute of India,” said SII CEO Adar Poonawalla during a Dec. 18 meeting when COVAX announced new vaccine access deals.