A Fully Indigenous Vaccine for India

Published in

Innovate4Health

6 min readMay 12, 2021

By: Jaci McDole

National pride is often overflowing during events such as the Olympic Games and the World Cup, but it is difficult to imagine such pride amid a global pandemic. However, local accomplishments and innovations should be celebrated all-the-more in the most challenging of times.

There are approximately 7.8 billion people worldwide and an estimated 7.9 million vaccinations against COVID-19 occurring each day.[1] It takes 60–110 days and multiple steps at various facilities to produce one batch of COVID-19 vaccine.[2] New technological demands, factory retrofitting, production bottlenecking, and supply chain issues all add to the wait time.[3] In short, during the early days of vaccine roll-out — like most early days for any innovation — the demand for COVID-19 vaccines vastly outweighs the supply.

Strong protection of IP rights is crucial now more than ever. IP enables R&D innovation, including the vaccines currently used to fight the pandemic.[4] IP opens doors for innovative collaboration.[5] And, even as charlatans and scammers attempt to capitalize on pandemic fears by offering fake cures and counterfeit vaccines to a vulnerable, global public, IP offers assurances and bolsters public confidence through quality control and regulation safety approvals.[6]

Like so many pharmaceutical manufacturers around the world, India-based biotechnology company Bharat Biotech started developing a COVID-19 vaccine when the pandemic began in early 2020.[7] In January 2021, Bharat Biotech’s Covaxin became one of two COVID-19 vaccines authorized for emergency use in India, the other being AstraZeneca’s vaccine, known locally as Covishield.[8] Although both vaccines are manufactured in India — the Serum Institute of India is producing Covishield — Covaxin is the only fully indigenous COVID-19 vaccine in use as of March 2021.[9]

Working with the Indian Council of Medical Research and the National Institute of Virology, Bharat Biotech developed its vaccine using Whole-Virion Inactivated Vero Cell derived platform technology, meaning the vaccine contains dead COVID-19 virus incapable of replicating and infecting others “but still able to instruct the immune system to mount a defensive reaction against the infection.”[10] By contrast, Covishield uses the viral vector platform wherein a modified version of a different virus, not the virus that causes COVID-19, delivers instructions to the body’s cells for creating a harmless spike protein, thereby inducing antibody production and activating immune cells.[11]

Like most other COVID-19 vaccines, Covaxin is given in two doses, 28 days apart. Phase three trials demonstrated 81 percent interim efficacy.[12] The vaccine does not require sub-zero storage or reconstitution, and, unlike some other vaccines which must be used within hours, a refrigerated vial of Covaxin can be used for up to 28 days after being opened.[13]

In addition to aiding the supply of vaccines to India’s almost 1.4 billion people, Bharat Biotech is looking to export Covaxin to more than 40 other countries.[14] Brazil has already signed an agreement to acquire 20 million doses of Covaxin, and the company began talks with the Ukrainian government in February 2021.[15] U.S.-based Ocugen Inc. has also teamed up with Bharat Biotech to bring Covaxin to the U.S. market.[16]

Bharat Biotech is a veteran vaccine manufacturer, having previously developed innovative vaccines for Rabies, Japanese Encephalitis, Zika, and even the world’s first Typhoid Conjugate vaccine, among several others.[17] The company’s portfolio boasts more than 16 vaccines and four bio-therapeutics.[18] Bharat Biotech’s website states the company has filed at least 433 patents and owns more than 145 active patents worldwide.[19] Such innovation should be encouraged and supported by policymakers through R&D initiatives and robust IP protection.

The Global Innovation Index 2020 ranks India third in innovation among lower-middle income countries, first in Central and Southern Asia, and 48th overall out of 131 countries.[20] One comment of note from the theme section of the report states:

“India’s investment in R&D has decreased over the last decade from 0.85% of GDP in 2008–2009 to remain stagnant at around 0.7% for the last several years. This is significantly lower than the top five R&D spenders globally in 2017–4.3% for the Republic of Korea, 4.2% for Israel, 3.3% for Japan, and 3.2% for both Switzerland and Finland — and lower than the R&D investments of other BRIC countries, which include Brazil, Russia, India, and China.”[21]

The 2020 U.S. Chamber International IP Index, which evaluates the effectiveness of IP rights systems, ranks India 40th out of 53 economies.[22] Although India made progress by joining Patent Prosecution Highway initiatives, the report cites several hinderances for patent owners, especially where biopharmaceuticals are concerned. Among these are:

· Compulsory licensing for commercial and non-emergency situations;

· Barriers to licensing and technology transfer, including strict registration requirements;

· Limited framework for the protection of biopharmaceutical IP rights;

· Patentability requirements outside international standards;

· No regulatory data protection available or patent term restoration for biopharmaceuticals;

· Lengthy pre-grant opposition proceedings; and

· Limited participation in international treaties.[23]

The Indian government’s frequent use of compulsory licensing is harmful for foreign and domestic innovators alike, especially since the country boasts $20.6 billion in pharmaceutical exports in 2019–2020 and accounts for 50 percent of the global vaccine capacity.[24] Rather, India’s policymakers should focus on reassuring its population, increasing R&D investment, and enabling collaboration agreements.[25] India should take pride in its local innovators, like Bharat Biotech, and further support them through R&D efforts and by strengthening, rather than diminishing, the protection of IP rights. The recent announcement to increase financing for innovation and R&D, especially in the healthcare sector, is an excellent start.[26]

Biopharmaceutical manufacturers are working to rid the world of COVID-19 and other highly infectious diseases, and their innovations are vital for mankind’s continued health and survival. Innovative companies, like Bharat Biotech, are in every country and every region around the world, fighting to improve lives locally and globally. Celebrate and support them.

[1] https://www.census.gov/popclock/world ; https://www.bloomberg.com/graphics/covid-vaccine-tracker-global-distribution/

[2] https://www.cbsnews.com/news/covid-vaccine-johnson-and-johnson-factory/ ; https://blog.jonasneubert.com/2021/01/10/exploring-the-supply-chain-of-the-pfizer-biontech-and-moderna-covid-19-vaccines/ ; https://blogs.sciencemag.org/pipeline/archives/2021/02/02/myths-of-vaccine-manufacturing ; https://www.wsj.com/articles/mrna-covid-19-vaccines-are-fast-to-make-but-hard-to-scale-11614776401?mod=djem10point

[3] https://www.bloomberg.com/news/articles/2020-11-19/moderna-vaccine-production-is-gearing-up-partner-lonza-says ; https://www.msn.com/en-us/money/news/biontech-supercharges-a-factory-to-produce-more-covid-vaccine/ar-BB1dAtvB ; https://www.uschamber.com/press-release/us-chamber-statement-proposed-wto-ip-rights-waiver ; https://fortune.com/2021/03/03/covid-vaccines-pfizer-moderna-big-pharma/

[4] https://catalyst.phrma.org/intellectual-property-is-the-key-to-vaccine-development-manufacturing-and-technology-sharing?utm_term=nap&utm_campaign=COVID-19&utm_medium=email&_hsenc=p2ANqtz-8XwiRJG_xSIdEGLCUykMfJwtAcgMOmMngGqJL3QsHa0kF0jI6UsSoGINTPOiTvPCz0jTwV1Uo1r44tbETvpGLhVp8Ufw&_hsmi=115531700&utm_content=115531700&utm_source=hs_email&hsCtaTracking=74798401-bf92-4c72-9948-25f3c14c0ace%7C35bc3c75-4801-4583-b4ae-4cae0cf3c633

[5] https://www.wsj.com/articles/to-make-more-covid-19-vaccines-rival-drugmakers-team-up-11614081601

[6] https://www.consumer.ftc.gov/blog/2020/07/cracking-down-fake-covid-19-cures ; https://www.dailymail.co.uk/sciencetech/article-9371375/Google-removed-99-million-malicious-Covid-19-ads-2020-figures-show.html ; https://allafrica.com/stories/202103170831.html ; https://www.npr.org/2020/12/25/950224149/interpol-warns-people-about-counterfeit-coronavirus-vaccines

[7] https://www.wsj.com/articles/indias-covid-19-vaccine-is-found-effective-boosting-national-efforts-11614787370

[8] https://www.thehindubusinessline.com/companies/Covaxin-approval-a-giant-leap-for-innovation-bharat-biotech-cmd-krishna-ella/article33485954.ece ; https://news.yahoo.com/Covaxin-covishield-know-indias-covid-074404737.html

[9] https://news.yahoo.com/Covaxin-covishield-know-indias-covid-074404737.html

[10] https://www.bharatbiotech.com/Covaxin.html

[11] https://www.indiatoday.in/coronavirus-outbreak/vaccine-updates/video/bharat-biotech-Covaxin-serum-institute-covishield-difference-1776301-2021-03-06 ; https://www.cdc.gov/coronavirus/2019-ncov/vaccines/different-vaccines/viralvector.html?fbclid=IwAR2sfG_U4uC-l2VMVjGUFWpk3ZkSbLJks-O01QklEzGlL9RcENuclPB5z6M

[12] https://www.bharatbiotech.com/Covaxin.html