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Serum Institute of India

Coordinates: 18°30′18″N 73°56′44″E / 18.505110°N 73.945453°E / 18.505110; 73.945453
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Serum Institute of India Private Limited
Company typePrivate
Industry
Founded1966; 58 years ago (1966)
FounderCyrus S. Poonawalla (Chairman & MD)
HeadquartersPune, Maharashtra, India
Area served
Worldwide
Key people
Adar Poonawalla (CEO)
Products
RevenueIncrease ₹25,646 crore (US$3.1 billion) (FY22)[1]
Increase ₹17,562 crore (US$2.1 billion) (FY22)[1]
Increase ₹11,116 crore (US$1.3 billion) (FY22)[1]
ParentCyrus Poonawalla Group
SubsidiariesBilthoven Biologicals BV[2]
Vakzine Projekt Management GmbH[3]
Websitewww.seruminstitute.com Edit this at Wikidata

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 multinational biotechnology and biopharmaceuticals company, based in Pune.[4] It is the world's largest manufacturer of vaccines by volume.[5][6][7] It was founded by Cyrus Poonawalla in 1966[5] and is a part of Cyrus Poonawalla Group.[8]

History

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The Serum Institute of India was founded in 1966 in the city of Pune, India. The company set out to produce immunobiologicals, which were then being 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). The Serum Institute of India is run by the Poonawalla Group and engages in research, development, and manufacturing.[9]

In 2009, the company began developing an intranasal swine flu vaccine.[10][11] In 2012, the company's first international acquisition was Bilthoven Biologicals, a biopharmaceutical company in Netherlands.[12] 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 Rabbishield.[13][14]

As of 2023, the company is the world's largest vaccine producer by number of doses produced,[15] manufacturing around 1.9 billion doses of vaccines each year with plans to produce 4 billion doses of vaccines.[6][5] The products developed include tuberculosis vaccine Tubervac (BCG), Poliovac for poliomyelitis, and other vaccinations for the childhood vaccination schedule.[16][17][18]

Notable vaccine projects

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COVID-19 vaccine development

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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

Serum Institute of India partnered with the British-Swedish multinational pharmaceutical company AstraZeneca for developing AZD1222 (Covishield) in partnership with the University of Oxford.[19] It was 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.[20][21][22] This target was later increased to 1 billion doses by the end of 2021.[23] It was estimated to be priced at ₹225 (around $3) per dose.[24] 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.[25][26][27] In December 2020, the Serum Institute of India sought emergency approval for the vaccine developed with AstraZeneca,[28] which was approved a month later.[29] In March 2021, an agreement was reached to supply some doses to the UK.[30]

Serum Institute of India 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.[31][32] The company would also produce Codagenix's nasally administered COVID-19 vaccine CDX-005[33][34] (tradename COVI-VAC).[35]

The company also manufactured Sputnik V vaccine in India in collaboration with Gamaleya Research Institute of Epidemiology and Microbiology after receiving approval from DCGI.[36] On 13 July 2021, RDIF published a press release saying SII is starting the production of Sputnik V doses in September 2021, with the intention to produce over 300 million doses of the vaccine in India per year.[37]

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.[38]

R21/Matrix-M malaria vaccine

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On October 8, 2023, the R21/Matrix-M malaria vaccine received a recommendation for use by the Strategic Advisory Group of Experts (SAGE) of the World Health Organization and the Malaria Policy Advisory Group (MPAG).[39] The vaccine, jointly developed by The University of Oxford[40][41] 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

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References

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  1. ^ a b c "Serum Institute of India Private Limited" (PDF). CARE Ratings. Retrieved 3 February 2023.
  2. ^ "Bilthoven Biologicals acquired by Serum Institute of India". www.thepharmaletter.com. Retrieved 10 July 2020.
  3. ^ "Profile". vpm-consult.com. Retrieved 10 July 2020.
  4. ^ "Serum Institute of India Pvt. Ltd.: Private Company Information". bloomberg.com. Retrieved 30 September 2018.
  5. ^ a b c Choo, Olivia (16 December 2022). "How this millennial CEO steered the world's largest vaccine maker during the pandemic". CNBC. Retrieved 9 October 2023.
  6. ^ a b Krishnan, Murali (29 September 2020). "Coronavirus vaccine: Why does India's Serum Institute have a head start?". Deutsche Welle. Retrieved 26 November 2020.
  7. ^ Kalra, Aditya (24 May 2022). "Indian vaccine giant Serum plans African plant in global expansion". Reuters. Retrieved 15 September 2024.
  8. ^ "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". The Economic Times. Archived from the original on 8 May 2019. Retrieved 10 July 2020.
  9. ^ Burns, Lawton R. (2014). India's Healthcare Industry: Innovation in Delivery, Financing, and Manufacturing. Cambridge University Press. pp. 488–489. ISBN 9781316021217.
  10. ^ "India developing indigenous swine flu vaccine". The Times of India. Retrieved 1 February 2015.
  11. ^ 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. PMC 3667925. PMID 23442586.
  12. ^ Unnikrishnan, C. H. (4 July 2012). "Serum Institute buys Bilthoven Biologicals". Livemint. Retrieved 1 July 2020.
  13. ^ "Fast-acting anti-rabies drug set for India launch - Times of India". The Times of India. 24 February 2016. Retrieved 12 June 2016.
  14. ^ 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. S2CID 3382124.
  15. ^ "Serum Institute to focus on supplying COVID-19 vaccine to India first". Reuters. 23 November 2020. Retrieved 26 November 2020.
  16. ^ "Serum Institute Tubervac (BCG)". Serum Institute of India. Retrieved 15 June 2020.
  17. ^ "Serum Institute Poliovac". Serum Institute of India. Retrieved 15 June 2020.
  18. ^ "Vaccination Schedule". Vaccination as per the National Immunization schedule by Government of India. Retrieved 15 June 2020.
  19. ^ "AstraZeneca & Serum Institute of India sign licensing deal for 1 million doses of Oxford vaccine". The Economic Times. Retrieved 15 June 2020.
  20. ^ "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.
  21. ^ Banerjee, Shoumojit (7 July 2020). "Oxford COVID-19 vaccine at least 6 months away from launch: Serum Institute CEO". The Hindu.
  22. ^ "Coronavirus (Covid-19) vaccine latest update: Oxford-AstraZeneca corona vaccine production starts; US says 2 billion doses 'ready to go'". The Indian Express. 10 June 2020.
  23. ^ "Indian company aims for a billion Covid vaccines". BBC News. Retrieved 21 March 2021.
  24. ^ "Serum Institute of India to provide Covid-19 vaccines through COVAX at Rs 225 a dose". The Indian Express. 7 August 2020.
  25. ^ Sharma, Milan. "Serum Institute halts coronavirus vaccine trials in India after notice from DCGI over volunteer's illness in UK". India Today. Retrieved 10 September 2020.
  26. ^ "Oxford vaccine trial paused as participant falls ill". BBC News. 9 September 2020. Retrieved 10 September 2020.
  27. ^ Ghosh, Poulomi (12 September 2020). "Serum Institute to resume Covid-19 vaccine trial after DGCI gives nod". Hindustan Times.
  28. ^ "India will have Covid-19 vaccine within days: AIIMS director". Hindustan Times. 31 December 2021. Retrieved 31 December 2020.
  29. ^ Schmall E, Yasir S (3 January 2021). "India Approves Oxford-AstraZeneca Covid-19 Vaccine and 1 Other". The New York Times. Retrieved 3 January 2021.
  30. ^ "Covid vaccine: India shortfall behind UK's supply delay". BBC News. 18 March 2021.
  31. ^ "Serum Institute, Novavax in covid vaccine deal, may produce 100 crore doses". Livemint. 7 August 2020.
  32. ^ "Novavax signs COVID-19 vaccine supply deal with India's Serum Institute". Reuters. 5 August 2020. Archived from the original on 6 August 2020.
  33. ^ "Serum Institute starts manufacturing Codagenix's nasal COVID-19 vaccine". mint. 22 September 2020.
  34. ^ "India's Serum Institute starts manufacturing Codagenix's potential Covid-19 vaccine". Hindustan Times. 22 September 2020.
  35. ^ "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". Codagenix. Retrieved 22 April 2021.
  36. ^ "Serum Institute gets DCGI's nod to manufacture Covid vaccine Sputnik V in India". mint. 4 June 2021.
  37. ^ rdif.ru: press release
  38. ^ Das, Krishna N. (1 March 2021). "Chinese hackers target Indian vaccine makers SII, Bharat Biotech, says security firm". Reuters. Retrieved 1 March 2021.
  39. ^ "What is the new anti-malaria vaccine cleared by WHO all about? Will it work for India?". The Indian Express. 3 October 2023. Retrieved 9 October 2023.
  40. ^ "Oxford R21/Matrix-M™ malaria vaccine receives WHO recommendation for use paving the way for global roll-out | University of Oxford". www.ox.ac.uk. 2 October 2023. Retrieved 9 October 2023.
  41. ^ "Serum Institute Of India. Press Release - 02 October 2023". www.seruminstitute.com.
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