Serum Institute of India

Short description: Indian biotechnology and biopharmaceuticals company

Serum Institute of India Private Limited

Serum Institute of India

Type| Private
Industry|

* Biotechnology
* Biopharmaceuticals

Founded| 1966 (60 years ago) (1966)
Founder| Cyrus S. Poonawalla (Chairman & MD)
Headquarters| Pune, Maharashtra, India

Area served

| Worldwide

Key people

| Adar Poonawalla (CEO)
Products|

* Vaccines
* biopharmaceuticals
* generic drugs
* over-the-counter drugs

Revenue|  ₹25,646 crore (US$3.6 billion) (FY22)[1]

Operating income

|  ₹17,562 crore (US$2.5 billion) (FY22)[1]

Net income

|  ₹11,116 crore (US$1.6 billion) (FY22)[1]
Parent| Cyrus Poonawalla Group
Subsidiaries| Bilthoven Biologicals BV[2]
Vakzine Projekt Management GmbH[3]
Website| {{{1}}}

[ ⚑ ]  18°30′18″N 73°56′44″E﻿ / ﻿18.505110°N 73.945453°E﻿ / 18.505110; 73.945453 Serum Institute of India (SII) is an Indian biotechnology and biopharmaceuticals company, based in Pune. It is the world's largest manufacturer of vaccines.[4][5] It was founded by Cyrus Poonawalla in 1966[6] and is a part of Cyrus Poonawalla Group.[7]

## Contents

* 1 Overview
* 2 COVID-19 vaccine development
* 2.1 Attempted data theft
* 3 Other vaccine development
* 3.1 R21/Matrix-M malaria vaccine
* 4 See also
* 5 References
* 6 External links

## Overview

The Serum Institute of India was founded in 1966 in the city of Pune, India. The company set out to produce immunobiologicals, which were imported into India at high prices. Among the first products the Serum Institute of India manufactured in large quantities were the tetanus antitoxin, snake antivenom, DPT vaccine, and MMR vaccine. The company's product lines was expanded to include different types of vaccines against bacterial or virus infections, combination vaccines, influenza vaccine, and meningococcal vaccine. Besides vaccine the company also manufactures antisera, blood plasma, and hormone products. As of 2014 the vaccines manufactured by the Serum Institute of India have been used in international vaccination programmes run by the World Health Organization (WHO), UNICEF, and the Pan American Health Organization (PAHO). Today the Serum Institute of India is run by the Poonawalla Group and engages in research, development, and manufacturing.[8]

In 2009, the company began developing an intranasal swine flu vaccine.[9][10] In 2012, the company's first international acquisition was Bilthoven Biologicals, a biopharmaceutical company in Netherlands.[11] In 2016, with support from US-based Mass Biologics of University of Massachusetts Medical School, the Serum Institute of India invented a fast-acting anti-rabies agent, Rabies Human Monoclonal Antibody (RMAb), also known as Rabishield.[12][13]

As of 2023[update], the company is the world's largest vaccine producer by number of doses produced,[14] manufacturing around 1.9 billion doses of vaccines each year with plans to produce 4 billion doses of vaccines.[15][16] The products developed include tuberculosis vaccine Tubervac (BCG), Poliovac for poliomyelitis, and other vaccinations for the childhood vaccination schedule.[17][18][19]

## COVID-19 vaccine development

A vial of the Oxford-AstraZeneca COVID-19 vaccine that is locally produced in the Serum Institute of India (SII) as "Covishield" COVID-19 vaccine

The company has partnered with the British-Swedish multinational pharmaceutical company AstraZeneca, which is developing AZD1222 (Covishield) in partnership with the University of Oxford.[20] It is reported that Serum Institute of India would provide 100 million (10 crore) doses of the vaccine for India and other low and middle-income countries.[21][22][23] This target was later increased to 1 billion doses by the end of 2021.[24] It is estimated to be priced at ₹225 (around $3) per dose.[25] In September 2020, trials were halted by DCGI after a volunteer in Oxford developed illness following vaccination, but were soon resumed after consent by the British regulators.[26][27][28] In December 2020, the Serum Institute of India sought emergency approval for the vaccine developed with AstraZeneca [29] which was approved a month later.[30] In March 2021, an agreement was reached to supply some doses to the UK.[31]

Serum Institute of India has also reached an agreement with Novavax for the production of Novavax's NVX-CoV2373 (Covovax) vaccine for India and other low and middle-income countries.[32][33] The company will also produce Codagenix's nasally administered COVID-19 vaccine CDX-005[34][35] (tradename COVI-VAC).[36]

The company is also manufacturing Sputnik V vaccine in India in collaboration with Gamaleya Research Institute of Epidemiology and Microbiology after receiving approval from DCGI.[37] On 13 July 2021, RDIF published a press release saying SII is starting the production of Sputnik V doses in September 2021. They intend to produce over 300 million doses of the vaccine in India per year.[38]

### Attempted data theft

In March 2021, Reuters reported that Chinese state-backed cyber-espionage group Red Apollo targeted the Serum Institute of India's intellectual property for exfiltration.[39]

## Other vaccine development

### R21/Matrix-M malaria vaccine

On October 8, 2023, the R21/Matrix-M malaria vaccine received a recommendation for use by the World Health Organization’s Strategic Advisory Group of Experts (SAGE) and the Malaria Policy Advisory Group (MPAG).[40] The vaccine, jointly developed by The University of Oxford[41][42] and the Serum Institute of India in collaboration with Novavax's adjuvant technology, demonstrated notable efficacy along with a positive safety profile. Furthermore, the Serum Institute of India had successfully established production capacity for 100 million doses annually, with plans to double this capacity over the next two years.

The R21/Matrix-MTM malaria vaccine was jointly developed by the Jenner Institute at Oxford University and Serum Institute of India, with support from various organizations including the European and Developing Countries Clinical Trials Partnership (EDCTP), the Wellcome Trust, and the European Investment Bank (EIB). As of now, the vaccine has obtained licenses for use in Ghana, Nigeria, and Burkina Faso.

## See also

* Bharat Biotech
* Zydus Lifesciences
* Cadila Pharmaceuticals
* Biotechnology in India

## References

1. ↑ 1.0 1.1 1.2 "Serum Institute of India Private Limited". CARE Ratings. https://www.careratings.com/upload/CompanyFiles/PR/03012023080634_Serum_Institute_of_India_Private_Limited.pdf.
2. ↑ "Bilthoven Biologicals acquired by Serum Institute of India". https://www.thepharmaletter.com/article/bilthoven-biologicals-acquired-by-serum-institute-of-india.
3. ↑ "Profile". https://www.vpm-consult.com/en/company/profile/.
4. ↑ "Serum Institute of India Pvt. Ltd.: Private Company Information". https://www.bloomberg.com/research/stocks/private/snapshot.asp?privcapid=12168217.
5. ↑ "SERUM INSTITUTE OF INDIA PRIVATE LIMITED - Company, directors and contact details" (in en). https://www.zaubacorp.com/company/SERUM-INSTITUTE-OF-INDIA-Private-Limited/U80903PN1984PTC032945.
6. ↑ "About Us". Serum Institute of India. https://www.seruminstitute.com/about_us.php.
7. ↑ "Poonawalla Investments AND Industries Private Limited Information - Poonawalla Investments AND Industries Private Limited Company Profile, Poonawalla Investments AND Industries Private Limited News on The Economic Times". https://economictimes.indiatimes.com/company/.
8. ↑ Burns, Lawton R. (2014). India's Healthcare Industry: Innovation in Delivery, Financing, and Manufacturing. Cambridge University Press. pp. 488–489. ISBN 9781316021217.
9. ↑ "India developing indigenous swine flu vaccine". The Times of India. http://timesofindia.indiatimes.com/life-style/health-fitness/health/India-developing-indigenous-swine-flu-vaccine/articleshow/4873696.cms?referral=PM.
10. ↑ Kulkarni, Prasad S.; Raut, Sidram K.; Dhere, Rajeev M. (27 October 2014). "A post-marketing surveillance study of a human live-virus pandemic influenza A (H1N1) vaccine (Nasovac ®) in India". Human Vaccines & Immunotherapeutics 9 (1): 122–124. doi:10.4161/hv.22317. PMID 23442586.
11. ↑ Unnikrishnan, C. H. (2012-07-04). "Serum Institute buys Bilthoven Biologicals" (in en). https://www.livemint.com/Companies/nIr4bpmcCvQMrtuY3pQexI/Serum-Institute-buys-Bilthoven-Biologicals.html.
12. ↑ "Fast-acting anti-rabies drug set for India launch - Times of India". 24 February 2016. http://timesofindia.indiatimes.com/city/pune/Fast-acting-anti-rabies-drug-set-for-India-launch/articleshow/51114312.cms.
13. ↑ Kulkarni, Prasad S.; Sahai, Ashish; Gunale, Bhagwat; Dhere, Rajeev M (3 March 2017). "Development of a new purified vero cell rabies vaccine (Rabivax-S) at the serum institute of India Pvt Ltd". Expert Review of Vaccines 16 (4): 303–311. doi:10.1080/14760584.2017.1294068. PMID 28276304.
14. ↑ "Serum Institute to focus on supplying COVID-19 vaccine to India first" (in en). Reuters. 2020-11-23. https://www.reuters.com/article/us-health-coronavirus-india-vaccine-idUSKBN28321S.
15. ↑ Krishnan, Murali (2020-09-29). "Coronavirus vaccine: Why does India's Serum Institute have a head start?" (in en-GB). https://www.dw.com/en/coronavirus-vaccine-why-does-indias-serum-institute-have-a-head-start/a-55089750.
16. ↑ Choo, Olivia (16 December 2022). "How this millennial CEO steered the world's largest vaccine maker during the pandemic" (in en). CNBC. https://www.cnbc.com/2022/12/16/how-this-millennial-ceo-steered-serum-institute-of-india-during-covid.html.
17. ↑ "Serum Institute Tubervac (BCG)". https://www.seruminstitute.com/product_ind_tubervac.php.
18. ↑ "Serum Institute Poliovac". https://www.seruminstitute.com/product_ind_poliovac.php.
19. ↑ "Vaccination Schedule". https://www.iitk.ac.in/hc/vaccination-schedule.
20. ↑ "AstraZeneca & Serum Institute of India sign licensing deal for 1 million doses of Oxford vaccine". The Economic Times. https://economictimes.indiatimes.com/industry/healthcare/biotech/pharmaceuticals/astrazeneca-serum-institute-of-india-sign-licensing-deal-for-1-billion-doses-of-oxford-vaccine/articleshow/76202016.cms.
21. ↑ "Covid-19 vaccine: Serum Institute signs up for 100 million doses of vaccines for India, low and middle-income countries". The Financial Express. 7 August 2020. https://www.financialexpress.com/lifestyle/health/covid-19-vaccine-serum-institute-signs-up-for-100-million-doses-of-vaccines-for-india-low-and-middle-income-countries/2047884/.
22. ↑ Banerjee, Shoumojit (7 July 2020). "Oxford COVID-19 vaccine at least 6 months away from launch: Serum Institute CEO" (in en-IN). The Hindu. https://www.thehindu.com/news/national/oxford-covid-19-vaccine-at-least-6-months-away-from-launch-serum-institute-ceo/article32015508.ece.
23. ↑ "Coronavirus (Covid-19) vaccine latest update: Oxford-AstraZeneca corona vaccine production starts; US says 2 billion doses 'ready to go'" (in en). The Indian Express. 10 June 2020. https://indianexpress.com/article/coronavirus/corona-covid-19-vaccine-update-june-oxford-astrazeneca-moderna-serum-institute-of-india-6447030/.
24. ↑ "Indian company aims for a billion Covid vaccines" (in en-GB). BBC News. https://www.bbc.co.uk/news/av/world-asia-india-55091890.
25. ↑ "Serum Institute of India to provide Covid-19 vaccines through COVAX at Rs 225 a dose" (in en). The Indian Express. 7 August 2020. https://indianexpress.com/article/india/sii-to-provide-covid-19-vaccines-through-covax-at-rs-225-a-dose-india-6544158/.
26. ↑ Sharma, Milan. "Serum Institute halts coronavirus vaccine trials in India after notice from DCGI over volunteer's illness in UK" (in en). https://www.indiatoday.in/india/story/serum-institute-halts-coronavirus-vaccine-trials-in-india-1720423-2020-09-10.
27. ↑ "Oxford vaccine trial paused as participant falls ill" (in en-GB). BBC News. 2020-09-09. https://www.bbc.com/news/world-54082192.
28. ↑ Ghosh, Poulomi (12 September 2020). "Serum Institute to resume Covid-19 vaccine trial after DGCI gives nod" (in en). Hindustan Times. https://www.hindustantimes.com/india-news/serum-institute-to-resume-covid-19-vaccine-trial-after-dgci-gives-nod/story-1pT8EeMSdwYmUyOJBnz29I.html.
29. ↑ "India will have Covid-19 vaccine within days: AIIMS director" (in en). 2021-12-31. https://www.hindustantimes.com/india-news/india-will-have-covid-19-vaccine-within-days-aiims-director/story-IIoECY3cPkFMh3THZNfz3M.html.
30. ↑ Schmall, Emily; Yasir, Sameer (3 January 2021). "India Approves Oxford-AstraZeneca Covid-19 Vaccine and 1 Other". https://www.nytimes.com/2021/01/03/world/asia/india-covid-19-vaccine.html.
31. ↑ "Covid vaccine: India shortfall behind UK's supply delay". 18 March 2021. https://www.bbc.co.uk/news/uk-56438629.
32. ↑ "Serum Institute, Novavax in covid vaccine deal, may produce 100 crore doses" (in en). Livemint. 7 August 2020. https://www.livemint.com/science/health/serum-institute-novavax-in-covid-vaccine-deal-may-produce-100-crore-doses-11596772315738.html.
33. ↑ "Novavax signs COVID-19 vaccine supply deal with India's Serum Institute" (in en). Reuters. 5 August 2020. https://in.reuters.com/article/us-health-coronavirus-novavax/novavax-signs-covid-19-vaccine-supply-deal-with-indias-serum-institute-idINKCN25139A.
34. ↑ "Serum Institute starts manufacturing Codagenix's nasal COVID-19 vaccine" (in en). mint. 22 September 2020. https://www.livemint.com/science/health/serum-institute-of-india-starts-manufacturing-codagenix-s-nasal-covid-19-vaccine-11600779086792.html.
35. ↑ "India's Serum Institute starts manufacturing Codagenix's potential Covid-19 vaccine" (in en). Hindustan Times. 22 September 2020. https://www.hindustantimes.com/india-news/india-s-serum-institute-starts-manufacturing-codagenix-s-potential-covid-19-vaccine/story-zGhIAtCJN1tc9etIC34PDN.html.
36. ↑ "Codagenix and Serum Institute of India Announce Commencement of First-in-Human Trial of COVI-VAC, A Single Dose, Intranasal Live Attenuated Vaccine for COVID-19". https://codagenix.com/news/codagenix-and-serum-institute-of-india-announce-commencement-of-first-in-human-trial-of-covi-vac-a-single-dose-intranasal-live-attenuated-vaccine-for-covid-19/.
37. ↑ "Serum Institute gets DCGI's nod to manufacture Covid vaccine Sputnik V in India" (in en). mint. 2021-06-04. https://www.livemint.com/news/india/serum-institute-gets-dcgi-s-nod-to-manufacture-covid-vaccine-sputnik-v-in-india-report-11622818500423.html.
38. ↑ rdif.ru: press release
39. ↑ Das, Krishna N. (2021-03-01). "Chinese hackers target Indian vaccine makers SII, Bharat Biotech, says security firm" (in en). Reuters. https://www.reuters.com/article/health-coronavirus-india-china-idUSKCN2AT21O.
40. ↑ "What is the new anti-malaria vaccine cleared by WHO all about? Will it work for India?" (in en). The Indian Express. 3 October 2023. https://indianexpress.com/article/health-wellness/who-clears-anti-malaria-vaccine-sii-work-india-know-8967057/.
41. ↑ "Oxford R21/Matrix-M™ malaria vaccine receives WHO recommendation for use paving the way for global roll-out | University of Oxford" (in en). 2 October 2023. https://www.ox.ac.uk/news/2023-10-02-oxford-r21matrix-m-malaria-vaccine-receives-who-recommendation-use-paving-way-global.
42. ↑ "Serum Institute Of India. Press Release - 02 October 2023" (in English). https://www.seruminstitute.com/press_release_sii_021023.php.

## External links

* Official website

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