Serum Institute of India: Difference between revisions

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{{short description|Indian biotechnology and biopharmaceuticals company}}
{{short description|Indian biotechnology and biopharmaceuticals company}}
{{Use dmy dates|date=October 2018}}
{{Use dmy dates|date=August 2023}}
{{Use Indian English|date=October 2018}}
{{Use Indian English|date=August 2023}}
{{Coord|18.505110|73.945453|display=title}}
{{Infobox company
{{Infobox company
| name = Serum Institute of India Private Limited
| name = Serum Institute of India Private Limited
| logo = Serum-Institute-of-India-logo.png
| logo = Serum-Institute-of-India-logo.png
| logo_size = 250px
| logo_size = 300px
| logo_caption = Serum Institute of India
| type = [[Privately held company|Private]]
| type = [[Privately held company|Private]]
| traded_as =  
| traded_as =  
| genre = <!--Only used with media and publishing companies -->
| fate =  
| fate =  
| predecessor =  
| predecessor =  
| successor =  
| successor =  
| foundation = {{Start date and age|1966|p=y}}
| foundation = {{Start date and age|1966}}
| founder = [[Cyrus S. Poonawalla]]
| founder = [[Cyrus S. Poonawalla]] (Chairman & MD)
| defunct = <!-- {{End date|df=yes|YYYY|MM|DD}} -->
| defunct = <!-- {{End date|df=yes|YYYY|MM|DD}} -->
| hq_location = [[Pune]], India
| hq_location = 212/2, [[Hadapsar]], [[Pune]], India<ref>{{cite web |title=Serum institute HQ Address |url=https://www.seruminstitute.com/contact_us.php#:~:text=Dr.%20Cyrus%20Poonawalla%20(Chairman)%0A212/2%2C%20Hadapsar%2C%20Off%20Soli%20Poonawalla%20Road%2C%0APune%2D411028.%20India}}</ref>
| area_served = Worldwide
| area_served = Worldwide
| key_people = [[Adar Poonawalla]] (Chairman, President & CEO)
| key_people = [[Adar Poonawalla]] (CEO)
| industry = {{ubl|[[Biotechnology]]|[[Biopharmaceuticals]]}}
| industry = {{ubl|[[Biotechnology]]|[[Biopharmaceuticals]]}}
| products = {{hlist|[[Vaccine]]s |[[biopharmaceutical]]s |[[generic drug]]s |[[over-the-counter drug]]s }}
| products = {{hlist|[[Vaccine]]s|[[biopharmaceutical]]s |[[generic drug]]s|[[over-the-counter drug]]s}}
| services =  
| services =  
| revenue = {{increase}} {{INRconvert|5926|c}} (FY 2019–20)<ref name="businesstoday">{{cite news |title=How profitable is Adar Poonawalla's Serum Institute? |url=https://www.businesstoday.in/current/corporate/how-profitable-is-adar-poonawalla-serum-institute/story/439018.html |access-date=25 June 2021 |work=www.businesstoday.in}}</ref>
| revenue = {{increase}} {{INRconvert|25646|mode=historical|year=2021|c}} (FY22)<ref name="Revenue">{{cite news|title=Serum Institute of India Private Limited|url=https://www.careratings.com/upload/CompanyFiles/PR/03012023080634_Serum_Institute_of_India_Private_Limited.pdf|access-date=3 February 2023|work=CARE Ratings}}</ref>
| operating_income =
| operating_income = {{increase}} {{INRconvert|17562|mode=historical|year=2021|c}} (FY22)<ref name="Revenue"/>
| net_income = {{increase}} {{INRconvert|2251|c}} (FY 2019–20)<ref name="businesstoday"/>
| net_income = {{increase}} {{INRconvert|11116|mode=historical|year=2021|c}} (FY22)<ref name="Revenue"/>
| aum = <!-- Only used with financial services companies -->
| assets =  
| equity =  
| owner =  
| owner =  
| num_employees =  
| num_employees =  
| parent =  
| parent = Cyrus Poonawalla Group
| divisions =  
| divisions =  
| subsid = Bilthoven Biologicals BV<ref>{{Cite web|title=Bilthoven Biologicals acquired by Serum Institute of India|url=https://www.thepharmaletter.com/article/bilthoven-biologicals-acquired-by-serum-institute-of-india|access-date=2020-07-10|website=www.thepharmaletter.com}}</ref><br/>
| subsid = Bilthoven Biologicals BV<ref>{{Cite web|title=Bilthoven Biologicals acquired by Serum Institute of India|url=https://www.thepharmaletter.com/article/bilthoven-biologicals-acquired-by-serum-institute-of-india|access-date=2020-07-10|website=www.thepharmaletter.com}}</ref><br/>Vakzine Projekt Management GmbH<ref>{{Cite web|title=Profile|url=https://www.vpm-consult.com/en/company/profile/|access-date=2020-07-10|website=vpm-consult.com|archive-date=6 February 2021|archive-url=https://web.archive.org/web/20210206230016/https://www.vpm-consult.com/en/company/profile/|url-status=dead}}</ref>
            Vakzine Projekt Management GmbH<ref>{{Cite web|title=Profile|url=https://www.vpm-consult.com/en/company/profile/|access-date=2020-07-10|website=www.vpm-consult.com}}</ref>
| homepage = {{official URL}}
| homepage = {{URL|https://www.seruminstitute.com/|seruminstitute.com}}
| footnotes =  
| footnotes =  
}}
}}
{{Coord|18.505110|73.945453|display=title}}
'''Serum Institute of India''' ('''SII''') is an Indian multinational [[biotechnology]] and [[biopharmaceuticals]] company, based in [[Pune]].<ref>{{Cite web|url=https://www.bloomberg.com/research/stocks/private/snapshot.asp?privcapid=12168217|title=Serum Institute of India Pvt. Ltd.: Private Company Information|website=[[bloomberg.com]]|access-date=2018-09-30}}</ref> It is the world's largest manufacturer of [[vaccines]] by volume.<ref name="cnbc"/><ref name="dw"/><ref>{{cite news |last1=Kalra |first1=Aditya |title=Indian vaccine giant Serum plans African plant in global expansion |url=https://www.reuters.com/business/healthcare-pharmaceuticals/indian-vaccine-giant-serum-plans-african-plant-global-expansion-2022-05-23/ |access-date=15 September 2024 |work=Reuters |date=24 May 2022}}</ref> It was founded by [[Cyrus Poonawalla]] in 1966<ref name="cnbc"/> and is a part of Cyrus Poonawalla Group.<ref>{{Cite web|title=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|url=https://economictimes.indiatimes.com/company/|access-date=2020-07-10|website=The Economic Times|archive-date=8 May 2019|archive-url=http://webarchive.loc.gov/all/20190508200151/https://economictimes.indiatimes.com/company/|url-status=dead}}</ref>


'''Serum Institute of India (SII)''' is an Indian [[biotechnology]] and [[biopharmaceuticals]] company. It is the world's largest manufacturer of [[vaccines]]<ref>{{Cite web|url=https://www.bloomberg.com/research/stocks/private/snapshot.asp?privcapid=12168217|title=Serum Institute of India Pvt. Ltd.: Private Company Information|website=[[bloomberg.com]]|access-date=2018-09-30}}</ref><ref>{{Cite web|url=https://www.zaubacorp.com/company/SERUM-INSTITUTE-OF-INDIA-Private-Limited/U80903PN1984PTC032945|title=SERUM INSTITUTE OF INDIA PRIVATE LIMITED - Company, directors and contact details|website=zaubacorp.com|language=en|access-date=2018-09-30}}</ref> located in the city of [[Pune]], [[India]] and was founded by [[Cyrus Poonawalla]] in 1966.<ref name="about">{{cite web |url=https://www.seruminstitute.com/about_us.php |title=About Us |publisher=Serum Institute of India |access-date=8 December 2016}}</ref> The company is a subsidiary of the holding company Poonawalla Investment and Industries.<ref>{{Cite web|title=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|url=https://economictimes.indiatimes.com/company/|access-date=2020-07-10|website=The Economic Times}}</ref>
==History==
 
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 [[vaccine]]s against [[bacterial]] or [[virus]] infections, [[combination vaccine]]s, [[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.<ref>{{cite book|last=Burns|first=Lawton R. |title=India's Healthcare Industry: Innovation in Delivery, Financing, and Manufacturing|publisher=Cambridge University Press|year=2014|isbn=9781316021217|pages=488–489}}</ref>
==Overview==
The Serum Institute of India was founded in 1966 in [[Pune]]. 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 [[vaccine]]s against [[bacterial]] or [[virus]] infections, [[combination vaccine]]s, [[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.<ref>{{cite book|last=Burns|first=Lawton R. |title=India's Healthcare Industry: Innovation in Delivery, Financing, and Manufacturing|publisher=Cambridge University Press|year=2014|isbn=9781316021217|page=488-489}}</ref>


In 2009 the company began developing an intranasal [[swine flu]] vaccine.<ref>{{cite web|url=http://timesofindia.indiatimes.com/life-style/health-fitness/health/India-developing-indigenous-swine-flu-vaccine/articleshow/4873696.cms?referral=PM|title=India developing indigenous swine flu vaccine|work=The Times of India|access-date=1 February 2015}}</ref><ref>{{cite journal |last1=Kulkarni |first1=Prasad S. |last2=Raut |first2=Sidram K. |last3=Dhere |first3=Rajeev M. |title=A post-marketing surveillance study of a human live-virus pandemic influenza A (H1N1) vaccine (Nasovac ®) in India |journal=Human Vaccines & Immunotherapeutics |date=27 October 2014 |volume=9 |issue=1 |pages=122–124 |doi=10.4161/hv.22317 |pmid=23442586|pmc=3667925 |doi-access=free }}</ref> In 2012, the company's first international acquisition was Bilthoven Biologicals, a biopharmaceutical company in Netherlands.<ref>{{Cite web|last=Unnikrishnan|first=C. H.|date=2012-07-04|title=Serum Institute buys Bilthoven Biologicals|url=https://www.livemint.com/Companies/nIr4bpmcCvQMrtuY3pQexI/Serum-Institute-buys-Bilthoven-Biologicals.html|access-date=2020-07-01|website=Livemint|language=en}}</ref> 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.<ref>{{Cite web|url=http://timesofindia.indiatimes.com/city/pune/Fast-acting-anti-rabies-drug-set-for-India-launch/articleshow/51114312.cms|title=Fast-acting anti-rabies drug set for India launch - Times of India|website=The Times of India|access-date=2016-06-12}}</ref><ref>{{cite journal |last1=Kulkarni |first1=Prasad S. |last2=Sahai |first2=Ashish |last3=Gunale |first3=Bhagwat |last4=Dhere |first4=Rajeev M |title=Development of a new purified vero cell rabies vaccine (Rabivax-S) at the serum institute of India Pvt Ltd |journal=Expert Review of Vaccines |date=3 March 2017 |volume=16 |issue=4 |pages=303–311 |doi=10.1080/14760584.2017.1294068 |pmid=28276304|s2cid=3382124 }}</ref>
In 2009, the company began developing an intranasal [[swine flu]] vaccine.<ref>{{cite news|url=http://timesofindia.indiatimes.com/life-style/health-fitness/health/India-developing-indigenous-swine-flu-vaccine/articleshow/4873696.cms?referral=PM|title=India developing indigenous swine flu vaccine|work=The Times of India|access-date=1 February 2015}}</ref><ref>{{cite journal |last1=Kulkarni |first1=Prasad S. |last2=Raut |first2=Sidram K. |last3=Dhere |first3=Rajeev M. |title=A post-marketing surveillance study of a human live-virus pandemic influenza A (H1N1) vaccine (Nasovac ®) in India |journal=Human Vaccines & Immunotherapeutics |date=27 October 2014 |volume=9 |issue=1 |pages=122–124 |doi=10.4161/hv.22317 |pmid=23442586|pmc=3667925 |doi-access=free }}</ref> In 2012, the company's first international acquisition was Bilthoven Biologicals, a biopharmaceutical company in Netherlands.<ref>{{Cite web|last=Unnikrishnan|first=C. H.|date=2012-07-04|title=Serum Institute buys Bilthoven Biologicals|url=https://www.livemint.com/Companies/nIr4bpmcCvQMrtuY3pQexI/Serum-Institute-buys-Bilthoven-Biologicals.html|access-date=2020-07-01|website=Livemint|language=en}}</ref> 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''.<ref>{{Cite news|url=http://timesofindia.indiatimes.com/city/pune/Fast-acting-anti-rabies-drug-set-for-India-launch/articleshow/51114312.cms|title=Fast-acting anti-rabies drug set for India launch - Times of India|website=The Times of India|date=24 February 2016 |access-date=2016-06-12}}</ref><ref>{{cite journal |last1=Kulkarni |first1=Prasad S. |last2=Sahai |first2=Ashish |last3=Gunale |first3=Bhagwat |last4=Dhere |first4=Rajeev M |title=Development of a new purified vero cell rabies vaccine (Rabivax-S) at the serum institute of India Pvt Ltd |journal=Expert Review of Vaccines |date=3 March 2017 |volume=16 |issue=4 |pages=303–311 |doi=10.1080/14760584.2017.1294068 |pmid=28276304|s2cid=3382124 }}</ref>


{{As of|2020|}}, the company is the world's largest vaccine producer by number of doses produced,<ref>{{Cite news|author=Reuters Staff|date=2020-11-23|title=Serum Institute to focus on supplying COVID-19 vaccine to India first|language=en|work=Reuters|url=https://www.reuters.com/article/us-health-coronavirus-india-vaccine-idUSKBN28321S|access-date=2020-11-26}}</ref> manufacturing around 1.5 billion doses of vaccines each year.<ref>{{Cite web|last=Krishnan|first=Murali|date=2020-09-29|title=Coronavirus vaccine: Why does India's Serum Institute have a head start?|url=https://www.dw.com/en/coronavirus-vaccine-why-does-indias-serum-institute-have-a-head-start/a-55089750|access-date=2020-11-26|website=Deutsche Welle|language=en-GB}}</ref> The products developed include tuberculosis vaccine Tubervac ([[BCG vaccine|BCG]]), Poliovac for [[polio]]myelitis, and other vaccinations for the childhood vaccination schedule.<ref>{{Cite web|url=https://www.seruminstitute.com/product_ind_tubervac.php|title=Serum Institute Tubervac (BCG)|website=Serum Institute of India|access-date=2020-06-15}}</ref><ref>{{Cite web|url=https://www.seruminstitute.com/product_ind_poliovac.php|title=Serum Institute Poliovac|website=Serum Institute of India|access-date=2020-06-15}}</ref><ref>{{Cite web|url=https://www.iitk.ac.in/hc/vaccination-schedule|title=Vaccination Schedule|website=Vaccination as per the National Immunization schedule by Government of India|access-date=2020-06-15}}</ref>
{{As of|2023|}}, the company is the world's largest vaccine producer by number of doses produced,<ref>{{Cite news|date=2020-11-23|title=Serum Institute to focus on supplying COVID-19 vaccine to India first|language=en|work=Reuters|url=https://www.reuters.com/article/us-health-coronavirus-india-vaccine-idUSKBN28321S|access-date=2020-11-26}}</ref> manufacturing around 1.9 billion doses of vaccines each year with plans to produce 4 billion doses of vaccines.<ref name="dw">{{Cite web|last=Krishnan|first=Murali|date=2020-09-29|title=Coronavirus vaccine: Why does India's Serum Institute have a head start?|url=https://www.dw.com/en/coronavirus-vaccine-why-does-indias-serum-institute-have-a-head-start/a-55089750|access-date=2020-11-26|website=Deutsche Welle|language=en-GB}}</ref><ref name="cnbc">{{cite news |last1=Choo |first1=Olivia |title=How this millennial CEO steered the world's largest vaccine maker during the pandemic |url=https://www.cnbc.com/2022/12/16/how-this-millennial-ceo-steered-serum-institute-of-india-during-covid.html |access-date=9 October 2023 |work=CNBC |date=16 December 2022 |language=en}}</ref> The products developed include tuberculosis vaccine ''Tubervac'' ([[BCG vaccine|BCG]]), ''Poliovac'' for [[polio]]myelitis, and other vaccinations for the childhood vaccination schedule.<ref>{{Cite web|url=https://www.seruminstitute.com/product_ind_tubervac.php|title=Serum Institute Tubervac (BCG)|website=Serum Institute of India|access-date=2020-06-15}}</ref><ref>{{Cite web|url=https://www.seruminstitute.com/product_ind_poliovac.php|title=Serum Institute Poliovac|website=Serum Institute of India|access-date=2020-06-15}}</ref><ref>{{Cite web|url=https://www.iitk.ac.in/hc/vaccination-schedule|title=Vaccination Schedule|website=Vaccination as per the National Immunization schedule by Government of India|access-date=2020-06-15}}</ref>


==COVID-19 vaccine development==
==Notable vaccine projects==
===COVID-19 vaccine development===
[[File:Oxford AstraZeneca vaccine (Indian version) 2021 B.jpg|180px|thumb|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]]
[[File:Oxford AstraZeneca vaccine (Indian version) 2021 B.jpg|180px|thumb|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]].<ref>{{Cite news|url=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|title=AstraZeneca & Serum Institute of India sign licensing deal for 1 million doses of Oxford vaccine|work=The Economic Times|access-date=2020-06-15}}</ref> 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.<ref>{{cite news |title=Covid-19 vaccine: Serum Institute signs up for 100 million doses of vaccines for India, low and middle-income countries |url=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/ |work=The Financial Express |date=7 August 2020}}</ref><ref>{{cite news |last1=Banerjee |first1=Shoumojit |title=Oxford COVID-19 vaccine at least 6 months away from launch: Serum Institute CEO |url=https://www.thehindu.com/news/national/oxford-covid-19-vaccine-at-least-6-months-away-from-launch-serum-institute-ceo/article32015508.ece |work=The Hindu |date=7 July 2020 |language=en-IN}}</ref><ref>{{cite news |title=Coronavirus (Covid-19) vaccine latest update: Oxford-AstraZeneca corona vaccine production starts; US says 2 billion doses 'ready to go' |url=https://indianexpress.com/article/coronavirus/corona-covid-19-vaccine-update-june-oxford-astrazeneca-moderna-serum-institute-of-india-6447030/ |work=The Indian Express |date=10 June 2020 |language=en}}</ref> This target was later increased to 1 billion doses by the end of 2021.<ref>{{Cite news|title=Indian company aims for a billion Covid vaccines|language=en-GB|work=BBC News|url=https://www.bbc.co.uk/news/av/world-asia-india-55091890|access-date=2021-03-21}}</ref> It is estimated to be priced at ₹225 (around $3) per dose.<ref>{{cite news |title=Serum Institute of India to provide Covid-19 vaccines through COVAX at Rs 225 a dose |url=https://indianexpress.com/article/india/sii-to-provide-covid-19-vaccines-through-covax-at-rs-225-a-dose-india-6544158/ |work=The Indian Express |date=7 August 2020 |language=en}}</ref> In September 2020, trials were halted by [[Drugs Controller General of India|DCGI]] after a volunteer in Oxford developed illness following vaccination, but were soon resumed after consent by the British regulators.<ref>{{Cite web|last=Sharma|first=Milan|title=Serum Institute halts coronavirus vaccine trials in India after notice from DCGI over volunteer's illness in UK|url=https://www.indiatoday.in/india/story/serum-institute-halts-coronavirus-vaccine-trials-in-india-1720423-2020-09-10|access-date=2020-09-10|website=India Today|language=en}}</ref><ref>{{Cite news|date=2020-09-09|title=Oxford vaccine trial paused as participant falls ill|language=en-GB|work=BBC News|url=https://www.bbc.com/news/world-54082192|access-date=2020-09-10}}</ref><ref>{{cite news |last1=Ghosh |first1=Poulomi |title=Serum Institute to resume Covid-19 vaccine trial after DGCI gives nod |url=https://www.hindustantimes.com/india-news/serum-institute-to-resume-covid-19-vaccine-trial-after-dgci-gives-nod/story-1pT8EeMSdwYmUyOJBnz29I.html |work=Hindustan Times |date=12 September 2020 |language=en}}</ref> In December 2020, the Serum Institute of India  sought emergency approval for the vaccine developed with AstraZeneca <ref>{{Cite web|date=2021-12-31|title=India will have Covid-19 vaccine within days: AIIMS director|url=https://www.hindustantimes.com/india-news/india-will-have-covid-19-vaccine-within-days-aiims-director/story-IIoECY3cPkFMh3THZNfz3M.html|access-date=2020-12-31|website=Hindustan Times|language=en}}</ref> which was approved a month later.<ref name="NYT India">{{cite news | first1=Emily | last1=Schmall | first2=Sameer | last2=Yasir | title=India Approves Oxford-AstraZeneca Covid-19 Vaccine and 1 Other | website=The New York Times | date=3 January 2021 | url=https://www.nytimes.com/2021/01/03/world/asia/india-covid-19-vaccine.html | access-date=3 January 2021 | name-list-style=vanc}}</ref> In March 2021, an agreement was reached to supply some doses to the UK.<ref>{{cite web |website =BBC News|title =Covid vaccine: India shortfall behind UK's supply delay|url=
Serum Institute of India partnered with the British-Swedish multinational pharmaceutical company [[AstraZeneca]] for developing [[AZD1222]] (Covishield) in partnership with the [[University of Oxford]].<ref>{{Cite news|url=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|title=AstraZeneca & Serum Institute of India sign licensing deal for 1 million doses of Oxford vaccine|work=The Economic Times|access-date=2020-06-15}}</ref> 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.<ref>{{cite news |title=Covid-19 vaccine: Serum Institute signs up for 100 million doses of vaccines for India, low and middle-income countries |url=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/ |work=The Financial Express |date=7 August 2020}}</ref><ref>{{cite news |last1=Banerjee |first1=Shoumojit |title=Oxford COVID-19 vaccine at least 6 months away from launch: Serum Institute CEO |url=https://www.thehindu.com/news/national/oxford-covid-19-vaccine-at-least-6-months-away-from-launch-serum-institute-ceo/article32015508.ece |work=The Hindu |date=7 July 2020 |language=en-IN}}</ref><ref>{{cite news |title=Coronavirus (Covid-19) vaccine latest update: Oxford-AstraZeneca corona vaccine production starts; US says 2 billion doses 'ready to go' |url=https://indianexpress.com/article/coronavirus/corona-covid-19-vaccine-update-june-oxford-astrazeneca-moderna-serum-institute-of-india-6447030/ |work=The Indian Express |date=10 June 2020 |language=en}}</ref> This target was later increased to 1 billion doses by the end of 2021.<ref>{{Cite news|title=Indian company aims for a billion Covid vaccines|language=en-GB|work=BBC News|url=https://www.bbc.co.uk/news/av/world-asia-india-55091890|access-date=2021-03-21}}</ref> It was estimated to be priced at ₹225 (around $3) per dose.<ref>{{cite news |title=Serum Institute of India to provide Covid-19 vaccines through COVAX at Rs 225 a dose |url=https://indianexpress.com/article/india/sii-to-provide-covid-19-vaccines-through-covax-at-rs-225-a-dose-india-6544158/ |work=The Indian Express |date=7 August 2020 |language=en}}</ref> In September 2020, trials were halted by [[Drugs Controller General of India|DCGI]] after a volunteer in Oxford developed illness following vaccination, but were soon resumed after consent by the British regulators.<ref>{{Cite web|last=Sharma|first=Milan|title=Serum Institute halts coronavirus vaccine trials in India after notice from DCGI over volunteer's illness in UK|url=https://www.indiatoday.in/india/story/serum-institute-halts-coronavirus-vaccine-trials-in-india-1720423-2020-09-10|access-date=2020-09-10|website=India Today|language=en}}</ref><ref>{{Cite news|date=2020-09-09|title=Oxford vaccine trial paused as participant falls ill|language=en-GB|work=BBC News|url=https://www.bbc.com/news/world-54082192|access-date=2020-09-10}}</ref><ref>{{cite news |last1=Ghosh |first1=Poulomi |title=Serum Institute to resume Covid-19 vaccine trial after DGCI gives nod |url=https://www.hindustantimes.com/india-news/serum-institute-to-resume-covid-19-vaccine-trial-after-dgci-gives-nod/story-1pT8EeMSdwYmUyOJBnz29I.html |work=Hindustan Times |date=12 September 2020 |language=en}}</ref> In December 2020, the Serum Institute of India  sought emergency approval for the vaccine developed with AstraZeneca,<ref>{{Cite web|date=2021-12-31|title=India will have Covid-19 vaccine within days: AIIMS director|url=https://www.hindustantimes.com/india-news/india-will-have-covid-19-vaccine-within-days-aiims-director/story-IIoECY3cPkFMh3THZNfz3M.html|access-date=2020-12-31|website=Hindustan Times|language=en}}</ref> which was approved a month later.<ref name="NYT India">{{cite news | first1=Emily | last1=Schmall | first2=Sameer | last2=Yasir | title=India Approves Oxford-AstraZeneca Covid-19 Vaccine and 1 Other | website=The New York Times | date=3 January 2021 | url=https://www.nytimes.com/2021/01/03/world/asia/india-covid-19-vaccine.html | access-date=3 January 2021 | name-list-style=vanc}}</ref> In March 2021, an agreement was reached to supply some doses to the UK.<ref>{{cite web |website =BBC News|title =Covid vaccine: India shortfall behind UK's supply delay|url=
https://www.bbc.co.uk/news/uk-56438629|date =18 March 2021}}</ref>
https://www.bbc.co.uk/news/uk-56438629|date =18 March 2021}}</ref>


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.<ref>{{cite news |title=Serum Institute, Novavax in covid vaccine deal, may produce 100 crore doses |url=https://www.livemint.com/science/health/serum-institute-novavax-in-covid-vaccine-deal-may-produce-100-crore-doses-11596772315738.html |work=Livemint |date=7 August 2020 |language=en}}</ref><ref>{{cite news |title=Novavax signs COVID-19 vaccine supply deal with India's Serum Institute |url=https://in.reuters.com/article/us-health-coronavirus-novavax/novavax-signs-covid-19-vaccine-supply-deal-with-indias-serum-institute-idINKCN25139A |work=Reuters |date=5 August 2020 |language=en}}</ref> The company will also produce Codagenix's [[Nasal administration|nasally administered]] [[COVID-19]] vaccine CDX-005<ref>{{cite news |title=Serum Institute starts manufacturing Codagenix's nasal COVID-19 vaccine |url=https://www.livemint.com/science/health/serum-institute-of-india-starts-manufacturing-codagenix-s-nasal-covid-19-vaccine-11600779086792.html |work=mint |date=22 September 2020 |language=en}}</ref><ref>{{cite news |title=India's Serum Institute starts manufacturing Codagenix's potential Covid-19 vaccine |url=https://www.hindustantimes.com/india-news/india-s-serum-institute-starts-manufacturing-codagenix-s-potential-covid-19-vaccine/story-zGhIAtCJN1tc9etIC34PDN.html |work=Hindustan Times |date=22 September 2020 |language=en}}</ref> (tradename ''[[COVI-VAC]]'').<ref>{{cite web |title=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 |url=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/ |website=Codagenix |access-date=22 April 2021}}</ref>  
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.<ref>{{cite news |title=Serum Institute, Novavax in covid vaccine deal, may produce 100 crore doses |url=https://www.livemint.com/science/health/serum-institute-novavax-in-covid-vaccine-deal-may-produce-100-crore-doses-11596772315738.html |work=Livemint |date=7 August 2020 |language=en}}</ref><ref>{{cite news |title=Novavax signs COVID-19 vaccine supply deal with India's Serum Institute |url=https://in.reuters.com/article/us-health-coronavirus-novavax/novavax-signs-covid-19-vaccine-supply-deal-with-indias-serum-institute-idINKCN25139A |archive-url=https://web.archive.org/web/20200806031243/https://in.reuters.com/article/us-health-coronavirus-novavax/novavax-signs-covid-19-vaccine-supply-deal-with-indias-serum-institute-idINKCN25139A |url-status=dead |archive-date=6 August 2020 |work=Reuters |date=5 August 2020 |language=en}}</ref> The company would also produce Codagenix's [[Nasal administration|nasally administered]] [[COVID-19]] vaccine CDX-005<ref>{{cite news |title=Serum Institute starts manufacturing Codagenix's nasal COVID-19 vaccine |url=https://www.livemint.com/science/health/serum-institute-of-india-starts-manufacturing-codagenix-s-nasal-covid-19-vaccine-11600779086792.html |work=mint |date=22 September 2020 |language=en}}</ref><ref>{{cite news |title=India's Serum Institute starts manufacturing Codagenix's potential Covid-19 vaccine |url=https://www.hindustantimes.com/india-news/india-s-serum-institute-starts-manufacturing-codagenix-s-potential-covid-19-vaccine/story-zGhIAtCJN1tc9etIC34PDN.html |work=Hindustan Times |date=22 September 2020 |language=en}}</ref> (tradename ''[[COVI-VAC (U.S. COVID-19 vaccine)|COVI-VAC]]'').<ref>{{cite web |title=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 |url=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/ |website=Codagenix |access-date=22 April 2021}}</ref>


The company is also manufacturing [[Sputnik V]] vaccine in India in collaboration with [[Gamaleya Research Institute of Epidemiology and Microbiology]] after receiving approval from DGCI.<ref>{{cite news |title=Serum Institute gets DCGI's nod to manufacture Covid vaccine Sputnik V in India |url=https://www.livemint.com/news/india/serum-institute-gets-dcgi-s-nod-to-manufacture-covid-vaccine-sputnik-v-in-india-report-11622818500423.html |work=mint |date=2021-06-04 |language=en}}</ref> 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.<ref>rdif.ru: [https://rdif.ru/Eng_fullNews/6934/ ''press release'']</ref>
The company also manufactured [[Sputnik V]] vaccine in India in collaboration with [[Gamaleya Research Institute of Epidemiology and Microbiology]] after receiving approval from DCGI.<ref>{{cite news |title=Serum Institute gets DCGI's nod to manufacture Covid vaccine Sputnik V in India |url=https://www.livemint.com/news/india/serum-institute-gets-dcgi-s-nod-to-manufacture-covid-vaccine-sputnik-v-in-india-report-11622818500423.html |work=mint |date=2021-06-04 |language=en}}</ref> 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.<ref>rdif.ru: [https://rdif.ru/Eng_fullNews/6934/ ''press release'']</ref>


=== 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 [[Data theft|exfiltration]].<ref>{{Cite news|last=Das|first=Krishna N.|date=2021-03-01|title=Chinese hackers target Indian vaccine makers SII, Bharat Biotech, says security firm|language=en|work=[[Reuters]]|url=https://www.reuters.com/article/health-coronavirus-india-china-idUSKCN2AT21O|access-date=2021-03-01}}</ref>
In March 2021, [[Reuters]] reported that Chinese state-backed cyber-espionage group [[Red Apollo]] targeted the Serum Institute of India's intellectual property for [[Data theft|exfiltration]].<ref>{{Cite news|last=Das|first=Krishna N.|date=2021-03-01|title=Chinese hackers target Indian vaccine makers SII, Bharat Biotech, says security firm|language=en|work=[[Reuters]]|url=https://www.reuters.com/article/health-coronavirus-india-china-idUSKCN2AT21O|url-status=live|access-date=2021-03-01}}</ref>
 
=== R21/Matrix-M malaria vaccine ===
 
On 8 October 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).<ref>{{cite news |title=What is the new anti-malaria vaccine cleared by WHO all about? Will it work for India? |url=https://indianexpress.com/article/health-wellness/who-clears-anti-malaria-vaccine-sii-work-india-know-8967057/ |access-date=9 October 2023 |work=The Indian Express |date=3 October 2023 |language=en}}</ref> The vaccine, jointly developed by The [[University of Oxford]]<ref>{{cite web |title=Oxford R21/Matrix-M™ malaria vaccine receives WHO recommendation for use paving the way for global roll-out {{!}} University of Oxford |url=https://www.ox.ac.uk/news/2023-10-02-oxford-r21matrix-m-malaria-vaccine-receives-who-recommendation-use-paving-way-global |website=www.ox.ac.uk |access-date=9 October 2023 |language=en |date=2 October 2023}}</ref><ref>{{cite web |title=Serum Institute Of India. Press Release - 02 October 2023 |url=https://www.seruminstitute.com/press_release_sii_021023.php |website=www.seruminstitute.com |language=English}}</ref> and the Serum Institute of India in collaboration with [[Novavax]]'s [[Immunologic adjuvant|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==
==See also==
*[[Bharat Biotech]]
* [[Bharat Biotech]]
*[[Cadila Healthcare]]
* [[Biological E. Limited]]
*[[Biotechnology in India]]
* [[Biotechnology in India]]
* [[Pfizer]]


==References==
==References==
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* [http://www.seruminstitute.com Official website]
* [http://www.seruminstitute.com Official website]
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[[Category:Biotechnology companies of India]]
[[Category:Vaccine producers]]
[[Category:Vaccine producers]]
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[[Category:Biotechnology companies established in 1966]]
[[Category:Biotechnology companies established in 1966]]
[[Category:1966 establishments in Maharashtra]]
[[Category:1966 establishments in Maharashtra]]
[[Category:Biopharmaceutical companies]]
[[Category:Immunology organizations]]
[[Category:Immunology organizations]]
[[Category:Pharmaceutical companies of India]]
[[Category:Pharmaceutical companies of India]]
[[Category:COVID-19 vaccine producers]]
[[Category:Poonawalla Group]]
[[Category:Multinational companies headquartered in India]]

Latest revision as of 14:35, 18 February 2026


Serum Institute of India Private Limited
Industry
Founded1966; 60 years ago (1966)
Founder(s)Cyrus S. Poonawalla (Chairman & MD)
Headquarters212/2, Hadapsar, Pune, India[1]
Area served
Worldwide
Key people
Adar Poonawalla (CEO)
Products
RevenueIncrease 25,646 crore (US$Expression error: Unexpected < operator.) (FY22)[2]
Increase 17,562 crore (US$Expression error: Unexpected < operator.) (FY22)[2]
Increase 11,116 crore (US$Expression error: Unexpected < operator.) (FY22)[2]
ParentCyrus Poonawalla Group
SubsidiariesBilthoven Biologicals BV[3]
Vakzine Projekt Management GmbH[4]
Website{{URL|example.com|optional display text}}

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.[5] It is the world's largest manufacturer of vaccines by volume.[6][7][8] It was founded by Cyrus Poonawalla in 1966[6] and is a part of Cyrus Poonawalla Group.[9]

History[edit | edit source]

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.[10]

In 2009, the company began developing an intranasal swine flu vaccine.[11][12] In 2012, the company's first international acquisition was Bilthoven Biologicals, a biopharmaceutical company in Netherlands.[13] 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.[14][15]

As of 2023, the company is the world's largest vaccine producer by number of doses produced,[16] manufacturing around 1.9 billion doses of vaccines each year with plans to produce 4 billion doses of vaccines.[7][6] The products developed include tuberculosis vaccine Tubervac (BCG), Poliovac for poliomyelitis, and other vaccinations for the childhood vaccination schedule.[17][18][19]

Notable vaccine projects[edit | edit source]

COVID-19 vaccine development[edit | edit source]

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.[20] 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.[21][22][23] This target was later increased to 1 billion doses by the end of 2021.[24] It was 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 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 would also produce Codagenix's nasally administered COVID-19 vaccine CDX-005[34][35] (tradename COVI-VAC).[36]

The company also manufactured 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, with the intention to produce over 300 million doses of the vaccine in India per year.[38]

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]

R21/Matrix-M malaria vaccine[edit | edit source]

On 8 October 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).[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[edit | edit source]

References[edit | edit source]

  1. "Serum institute HQ Address".
  2. 2.0 2.1 2.2 "Serum Institute of India Private Limited" (PDF). CARE Ratings. Retrieved 3 February 2023.
  3. "Bilthoven Biologicals acquired by Serum Institute of India". www.thepharmaletter.com. Retrieved 10 July 2020.
  4. "Profile". vpm-consult.com. Archived from the original on 6 February 2021. Retrieved 10 July 2020.
  5. "Serum Institute of India Pvt. Ltd.: Private Company Information". bloomberg.com. Retrieved 30 September 2018.
  6. 6.0 6.1 6.2 Choo, Olivia (16 December 2022). "How this millennial CEO steered the world's largest vaccine maker during the pandemic". CNBC. Retrieved 9 October 2023.
  7. 7.0 7.1 Krishnan, Murali (29 September 2020). "Coronavirus vaccine: Why does India's Serum Institute have a head start?". Deutsche Welle. Retrieved 26 November 2020.
  8. Kalra, Aditya (24 May 2022). "Indian vaccine giant Serum plans African plant in global expansion". Reuters. Retrieved 15 September 2024.
  9. "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.
  10. Burns, Lawton R. (2014). India's Healthcare Industry: Innovation in Delivery, Financing, and Manufacturing. Cambridge University Press. pp. 488–489. ISBN 9781316021217.
  11. "India developing indigenous swine flu vaccine". The Times of India. Retrieved 1 February 2015.
  12. 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.
  13. Unnikrishnan, C. H. (4 July 2012). "Serum Institute buys Bilthoven Biologicals". Livemint. Retrieved 1 July 2020.
  14. "Fast-acting anti-rabies drug set for India launch - Times of India". The Times of India. 24 February 2016. Retrieved 12 June 2016.
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