Serum Institute of India
An Indian biotechnology and biopharmaceutical company and the world's largest vaccine manufacturer by volume.
Last updated October 28, 2026
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Overview
Serum Institute of India (SII) is an Indian biotechnology and biopharmaceutical company headquartered in Pune, Maharashtra. Founded in 1966 by Cyrus Poonawalla, the company was established to manufacture immunobiological products that India had previously imported at high prices. It developed a business model centered on high-volume production, broad public-health access, and supply to national and international immunization programs. The company’s early products included tetanus antitoxin, snake antivenom, diphtheria-tetanus-pertussis vaccines, and measles-mumps-rubella vaccines. Over time, its portfolio expanded to include vaccines against bacterial and viral diseases, combination vaccines, influenza vaccines, meningococcal vaccines, tuberculosis and polio vaccines, antisera, blood-plasma products, and selected hormone products. Its vaccines have been used in programs supported by organizations including the World Health Organization, UNICEF, and the Pan American Health Organization. SII operates as part of the Cyrus Poonawalla Group and combines research, product development, technology partnerships, and large-scale manufacturing. Its international expansion included the 2012 acquisition of Bilthoven Biologicals in the Netherlands, its first international acquisition. In 2016, with support from MassBiologics at the University of Massachusetts Medical School, the company announced the development of Rabies Human Monoclonal Antibody, marketed as Rabbishield, intended as a fast-acting treatment component for rabies exposure. The company became especially prominent during the COVID-19 pandemic. It partnered with AstraZeneca and the University of Oxford to manufacture AZD1222, marketed in India and many other markets as Covishield. It also entered manufacturing arrangements for Novavax’s NVX-CoV2373, marketed as Covovax, and for Sputnik V in cooperation with Russia’s Gamaleya Institute. These partnerships positioned SII as a major supplier for India and for lower- and middle-income countries, although production, export restrictions, regulatory reviews, and pandemic supply pressures created operational and political challenges. SII is also a manufacturing partner and developer in malaria vaccine production. Its collaboration with Oxford University and Novavax’s Matrix-M adjuvant technology supported the R21/Matrix-M malaria vaccine, which received a World Health Organization recommendation in 2023. The company reported production capacity of approximately 100 million R21 doses annually, with plans to expand it. By 2023, public reference material described SII as producing roughly 1.9 billion vaccine doses annually, with an ambition to reach approximately 4 billion doses. Its core positioning remains global-scale vaccine manufacturing aimed at making immunization products available at comparatively low cost, especially for childhood immunization and public-health programs.
History
Serum Institute of India was founded in Pune in 1966 by Cyrus Poonawalla. Its original purpose was to reduce India’s reliance on imported immunobiological products, which were expensive and difficult to obtain at scale. The company began with products such as tetanus antitoxin and snake antivenom, then moved into major childhood and infectious-disease vaccines including DPT and MMR. As its manufacturing capabilities grew, SII expanded into vaccines for bacterial and viral diseases, combination formulations, influenza, meningococcal disease, tuberculosis, and polio. It also developed antisera, plasma-derived products, and hormone products. This portfolio allowed the company to serve both private healthcare channels and large public-health procurement programs. Its products became part of vaccination initiatives associated with the WHO, UNICEF, and PAHO, helping establish the company as an important supplier to international immunization systems. The company’s growth combined internal research and development with external partnerships and manufacturing scale. In 2009 it began development of an intranasal swine flu vaccine. In 2012 it made its first international acquisition, purchasing Bilthoven Biologicals in the Netherlands. In 2016, working with MassBiologics at the University of Massachusetts Medical School, SII developed Rabies Human Monoclonal Antibody, also known as Rabbishield, adding a specialized biologic to its vaccine-centered business. The COVID-19 pandemic brought unprecedented global attention to SII. The company partnered with AstraZeneca and the University of Oxford to manufacture AZD1222, known in India and many other markets as Covishield. SII was expected to supply very large quantities for India and lower- and middle-income countries. It also contracted to manufacture Novavax’s NVX-CoV2373, marketed as Covovax, and reached arrangements concerning Sputnik V production with the Gamaleya Institute and the Russian Direct Investment Fund. Regulatory pauses, changing export policies, supply constraints, and the enormous demand for COVID-19 vaccines made this period operationally and politically complex. SII continued to develop its role in global vaccine supply after the acute phase of the pandemic. Its collaboration with Oxford University and Novavax technology supported the R21/Matrix-M malaria vaccine. In October 2023, the WHO recommended the vaccine for use, and SII reported annual production capacity of around 100 million doses with plans to expand. Public descriptions in 2023 characterized the company as the world’s largest vaccine producer by volume, with output of approximately 1.9 billion doses annually and an ambition to reach 4 billion doses. Its history reflects the development of an Indian manufacturer into a globally significant biotechnology company focused on affordable, high-volume immunization products.
- 2023
WHO recommendation for R21/Matrix-M
[1]WHO recommends the Oxford-SII malaria vaccine R21/Matrix-M for use.
- 2021
Sputnik V production plan
[1]SII announces plans to produce Sputnik V in India under an arrangement involving the Gamaleya Institute and RDIF.
- 2020
Covishield manufacturing partnership
[1]SII begins large-scale manufacturing arrangements for the Oxford-AstraZeneca COVID-19 vaccine.
- 2016
Rabbishield development
[1]SII and MassBiologics announce development of a human monoclonal antibody for rabies exposure.
- 2012
Bilthoven Biologicals acquisition
[1]The company completes its first international acquisition by acquiring Dutch biopharmaceutical company Bilthoven Biologicals.
- 2009
Intranasal swine flu vaccine development begins
[1]SII begins developing an intranasal vaccine candidate for swine flu.
- 1966
Serum Institute of India is founded
[1]Cyrus Poonawalla establishes SII in Pune to produce immunobiological products previously imported into India.
Products and positioning
A high-volume, cost-conscious vaccine manufacturer serving domestic and international public-health programs through proprietary products and technology partnerships.
Tuberculosis vaccine
Tubervac
Tubervac is SII’s BCG tuberculosis vaccine product. It represents the company’s longstanding participation in routine childhood and infectious-disease immunization programs.
Polio vaccine
Poliovac
Poliovac is a polio vaccination product associated with SII’s supply of vaccines for national and international childhood immunization programs.
Combination vaccine
Measles-mumps-rubella vaccine
SII produces MMR vaccines used to protect against measles, mumps, and rubella. MMR was among the company’s early large-scale vaccine product lines.
COVID-19 vaccine · 2021
Covishield
Covishield is the India-market and widely used international name for SII-manufactured doses of the Oxford-AstraZeneca adenoviral-vector COVID-19 vaccine, AZD1222. It became one of SII’s most prominent products during the pandemic.
COVID-19 vaccine · 2021
Covovax
Covovax is SII’s version of Novavax’s NVX-CoV2373 protein-based COVID-19 vaccine, produced under an arrangement for India and other low- and middle-income countries.
Malaria vaccine · 2023
R21/Matrix-M
R21/Matrix-M is a malaria vaccine jointly developed by Oxford University and SII, using Novavax’s Matrix-M adjuvant technology. WHO recommended it in 2023, and SII established substantial manufacturing capacity for the product.
Rabies monoclonal antibody · 2016
Rabbishield
Rabbishield is the commercial name associated with SII’s Rabies Human Monoclonal Antibody, developed with MassBiologics as a fast-acting anti-rabies biologic.
Controversies
2020
Vaccine trial participant sues Serum Institute of India
A participant in the Covishield vaccine trial sued Serum Institute of India, claiming that he suffered serious neurological impairment after receiving the experimental vaccine. He sought Rs 5 crore in compensation. The reported account does not establish that the claimed causal link was determined.
Brand decisions
2023
Scale production of R21/Matrix-M malaria vaccineProduct launchBackground
The Oxford-SII malaria vaccine received a WHO recommendation following clinical development and regulatory evaluation.
Action taken
SII established capacity to produce approximately 100 million doses annually and announced plans to increase that capacity.
Aftermath
R21/Matrix-M broadened SII’s public-health portfolio beyond routine childhood and COVID-19 vaccines.
2021
Plan Sputnik V production in IndiaProduct launchBackground
India sought additional COVID-19 vaccine manufacturing capacity during the pandemic.
Action taken
SII agreed to produce Sputnik V in cooperation with the Gamaleya Institute and the Russian Direct Investment Fund.
Aftermath
The parties announced an intended production capacity of more than 300 million doses annually.
2020
Manufacture Covishield for India and global marketsProduct launchBackground
The COVID-19 pandemic created urgent demand for a scalable vaccine supply for India and lower- and middle-income countries.
Action taken
SII partnered with AstraZeneca and Oxford University to manufacture AZD1222, marketed as Covishield.
Aftermath
Covishield became a central part of India’s COVID-19 vaccination effort and SII’s international profile.
Reported target price per dose. Approximately ₹225 per dose (2020)
2020
Add Novavax vaccine manufacturingProduct launchBackground
SII expanded its COVID-19 manufacturing portfolio beyond the Oxford-AstraZeneca vaccine.
Action taken
The company agreed to manufacture Novavax’s NVX-CoV2373, marketed as Covovax in India.
Aftermath
The agreement diversified SII’s pandemic vaccine supply and technology partnerships.
2012
Acquire Bilthoven BiologicalsM&ABackground
SII sought international expansion and additional biopharmaceutical manufacturing capabilities.
Action taken
The company acquired Bilthoven Biologicals in the Netherlands, its first international acquisition.
Aftermath
The transaction expanded SII’s international operating footprint and product-manufacturing capabilities.
Recent events
Biocon announces Biocon Biologics–Covidshield Technologies merger[7]
Reported:
Biocon announced that its material subsidiary Biocon Biologics Ltd would merge with Serum Institute of India's wholly owned subsidiary Covidshield Technologies Pvt Ltd, subject to requisite approvals. Biocon Biologics will issue and allot 15% equity shares to Serum on a fully diluted basis.
Serum Institute cuts Covishield price for state governments[8]
Reported:
Serum Institute of India announced a 25% reduction in its Covishield price for state governments, from Rs 400 to Rs 300 per dose, effective immediately. The article reports the reduction amid public criticism of vaccine pricing.
Manjari plant fire to affect vaccine production[9]
Reported:
The Serum Institute of India said a fire at its Manjari plant would affect future production of BCG and Rota vaccines. The fire, which broke out in an under-installation building, killed five people; the article reports that a minister said the initial fire was caused by ongoing welding work.
- Unconfirmed
Serum Institute sues COVID-19 vaccine trial participant[5]
Serum Institute of India sued a COVID-19 vaccine trial participant for defamation after he alleged that the trial caused serious side effects. The company rejected his allegations and said his illness was unrelated to the vaccine trial.
- Unconfirmed
Covishield trial volunteer sues Serum Institute over alleged adverse reaction[6]
A 40-year-old Covishield trial volunteer sued Serum Institute of India for ₹5 crore, alleging that the vaccine caused an adverse reaction including neurological impairment. The hospital's institutional ethics committee reportedly concluded that the adverse reaction was not due to the study vaccine.
Indian authorities investigate reported Covishield trial adverse event[3]
Reported:
The Drugs Controller General of India and the institutional ethics committee at the implementation site were investigating a reported serious adverse event involving a Covishield trial participant. The article does not report a determination about whether the event was caused by the vaccine.
Serum Institute rejects allegation linking trial to volunteer's condition[4]
Reported:
Serum Institute of India rejected a volunteer's allegation that its COVID-19 vaccine trial caused serious side effects, stating that it found no correlation between the trial and his medical condition. The company also said it would seek damages exceeding Rs 100 crore over the allegations.
- Unconfirmed
Vaccine trial participant sues Serum Institute of India[3]
Reported:
A participant in the Covishield vaccine trial sued Serum Institute of India, claiming that he suffered serious neurological impairment after receiving the experimental vaccine. He sought Rs 5 crore in compensation; the reported account does not establish that the claimed causal link was determined.
Novavax expands manufacturing agreement with Serum Institute of India[10]
Reported:
Novavax announced an amendment to its existing agreement with Serum Institute of India under which the institute will also manufacture the antigen component of Novavax’s COVID-19 vaccine candidate NVX-CoV2373. Novavax said planned capacity would bring global manufacturing capacity to more than two billion doses annually by mid-2021.
Sources13 sources
- 1Serum Institute of Indiaen.wikipedia.org
- 2Serum Institute of India official websiteseruminstitute.com
- 3Vaccine trial participant sues Serum Institute of Indiascroll.in
- 4Vaccine trial participant sues Serum Institute of Indiabusinesstoday.in
- 5Vaccine trial participant sues Serum Institute of Indiasott.net
- 6Vaccine trial participant sues Serum Institute of Indiasott.net
- 7Biocon宣布Biocon Biologics与Covidshield Technologies合并businesstoday.in
- 8血清研究所下调Covishield对各邦政府的售价timesofindia.indiatimes.com
- 9马ంజ里工厂火灾将影响疫苗生产aninews.in
- 10Novavax扩大与印度血清研究所的制造协议finanznachrichten.de
- 11Serum cuts vaccine price for states to Rs 300/dose - Daily Excelsiordailyexcelsior.com
- 12Serum Institute reduces price of its COVID-19 vaccine 'Covishield' to Rs 300 per dose to states: CEO Adar Poonawallafreepressjournal.in
- 13SII sues vaccine volunteer for wrong claim - The Tribunetribuneindia.com
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