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Serum Institute of India (SII) is an Indian multinational
biotechnology Biotechnology is a multidisciplinary field that involves the integration of natural sciences and Engineering Science, engineering sciences in order to achieve the application of organisms and parts thereof for products and services. Specialists ...
and
biopharmaceuticals A biopharmaceutical, also known as a biological medical product, or biologic, is any pharmaceutical drug product manufactured in, extracted from, or semisynthesized from biological sources. Different from totally synthesized pharmaceuticals, t ...
company, based in
Pune Pune ( ; , ISO 15919, ISO: ), previously spelled in English as Poona (List of renamed Indian cities and states#Maharashtra, the official name until 1978), is a city in the state of Maharashtra in the Deccan Plateau, Deccan plateau in Western ...
. It is the world's largest manufacturer of
vaccines A vaccine is a biological preparation that provides active acquired immunity to a particular infectious or malignant disease. The safety and effectiveness of vaccines has been widely studied and verified. A vaccine typically contains an ag ...
by volume. It was founded by Cyrus Poonawalla in 1966 and is a part of Cyrus Poonawalla Group.


History

The Serum Institute of India was founded in 1966 in the city of
Pune Pune ( ; , ISO 15919, ISO: ), previously spelled in English as Poona (List of renamed Indian cities and states#Maharashtra, the official name until 1978), is a city in the state of Maharashtra in the Deccan Plateau, Deccan plateau in Western ...
, 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 Antivenom, also known as antivenin, venom antiserum, and antivenom immunoglobulin, is a specific treatment for envenomation. It is composed of antibodies and used to treat certain venomous bites and stings. Antivenoms are recommended only if ...
,
DPT vaccine The DPT vaccine or DTP vaccine is a class of combination vaccines to protect against three infectious diseases in humans: diphtheria, pertussis (whooping cough), and tetanus (lockjaw). The vaccine components include diphtheria and tetanus t ...
, and
MMR vaccine The MMR vaccine is a vaccine against measles, mumps, and rubella (German measles), abbreviated as ''MMR''. The first dose is generally given to children around 9 months to 15 months of age, with a second dose at 15 months to 6 years of age, w ...
. The company's product lines was expanded to include different types of
vaccine A vaccine is a biological Dosage form, preparation that provides active acquired immunity to a particular infectious disease, infectious or cancer, malignant disease. The safety and effectiveness of vaccines has been widely studied and verifi ...
s against
bacterial Bacteria (; : bacterium) are ubiquitous, mostly free-living organisms often consisting of one biological cell. They constitute a large domain of prokaryotic microorganisms. Typically a few micrometres in length, bacteria were among the ...
or
virus A virus is a submicroscopic infectious agent that replicates only inside the living Cell (biology), cells of an organism. Viruses infect all life forms, from animals and plants to microorganisms, including bacteria and archaea. Viruses are ...
infections, combination vaccines,
influenza vaccine Influenza vaccines, colloquially known as flu shots or the flu jab, are vaccines that protect against infection by influenza viruses. New versions of the vaccines are developed twice a year, as the influenza virus rapidly changes. While their ...
, and
meningococcal vaccine Meningococcal vaccine refers to any vaccine used to prevent infection by '' Neisseria meningitidis''. Different versions are effective against some or all of the following types of meningococcus: A, B, C, W-135, and Y. The vaccines are between ...
. Besides vaccine, the company also manufactures antisera,
blood plasma Blood plasma is a light Amber (color), amber-colored liquid component of blood in which blood cells are absent, but which contains Blood protein, proteins and other constituents of whole blood in Suspension (chemistry), suspension. It makes up ...
, and
hormone A hormone (from the Ancient Greek, Greek participle , "setting in motion") is a class of cell signaling, signaling molecules in multicellular organisms that are sent to distant organs or tissues by complex biological processes to regulate physio ...
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 The World Health Organization (WHO) is a list of specialized agencies of the United Nations, specialized agency of the United Nations which coordinates responses to international public health issues and emergencies. It is headquartered in Gen ...
(WHO),
UNICEF UNICEF ( ), originally the United Nations International Children's Emergency Fund, officially United Nations Children's Fund since 1953, is an agency of the United Nations responsible for providing Humanitarianism, humanitarian and Development a ...
, and the
Pan American Health Organization The Pan American Health Organization (PAHO) is a specialized agency of the United Nations (UN) in charge of international health cooperation in the Americas. It fosters technical cooperation among member countries to fight communicable and non ...
(PAHO). The Serum Institute of India is run by the Poonawalla Group and engages in research, development, and manufacturing. In 2009, the company began developing an intranasal
swine flu Swine influenza is an infection caused by any of several types of swine influenza viruses. Swine influenza virus (SIV) or swine-origin influenza virus (S-OIV) refers to any strain of the influenza family of viruses that is endemic in pigs. As ...
vaccine. In 2012, the company's first international acquisition was Bilthoven Biologicals, a biopharmaceutical company in Netherlands. In 2016, with support from US-based Mass Biologics of
University of Massachusetts Medical School The UMass Chan Medical School is a public medical school in Worcester, Massachusetts. It is part of the University of Massachusetts system. It consists of three schools: the T.H. Chan School of Medicine, the Morningside Graduate School of Biom ...
, the Serum Institute of India invented a fast-acting anti-
rabies Rabies is a viral disease that causes encephalitis in humans and other mammals. It was historically referred to as hydrophobia ("fear of water") because its victims panic when offered liquids to drink. Early symptoms can include fever and abn ...
agent, Rabies Human Monoclonal Antibody (RMAb), also known as ''Rabbishield''. , the company is the world's largest vaccine producer by number of doses produced, manufacturing around 1.9 billion doses of vaccines each year with plans to produce 4 billion doses of vaccines. The products developed include tuberculosis vaccine ''Tubervac'' ( BCG), ''Poliovac'' for
polio Poliomyelitis ( ), commonly shortened to polio, is an infectious disease caused by the poliovirus. Approximately 75% of cases are asymptomatic; mild symptoms which can occur include sore throat and fever; in a proportion of cases more severe ...
myelitis, and other vaccinations for the childhood vaccination schedule.


Notable vaccine projects


COVID-19 vaccine development

Serum Institute of India partnered with the British-Swedish multinational pharmaceutical company
AstraZeneca AstraZeneca plc () (AZ) is a British-Swedish multinational pharmaceutical and biotechnology company with its headquarters at the Cambridge Biomedical Campus in Cambridge, UK. It has a portfolio of products for major diseases in areas includi ...
for developing AZD1222 (Covishield) in partnership with the
University of Oxford The University of Oxford is a collegiate university, collegiate research university in Oxford, England. There is evidence of teaching as early as 1096, making it the oldest university in the English-speaking world and the List of oldest un ...
. It was reported that Serum Institute of India would provide 100 million (10
crore Crore (; abbreviated cr) denotes the quantity ten million (107) and is equal to 100 lakh in the Indian numbering system. In many international contexts, the decimal quantity is formatted as 10,000,000, but when used in the context of the India ...
) doses of the vaccine for India and other low and middle-income countries. This target was later increased to 1 billion doses by the end of 2021. It was estimated to be priced at ₹225 (around $3) per dose. 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. In December 2020, the Serum Institute of India sought emergency approval for the vaccine developed with AstraZeneca, which was approved a month later. In March 2021, an agreement was reached to supply some doses to the UK. Serum Institute of India also reached an agreement with
Novavax Novavax, Inc. is an American biotechnology company based in Gaithersburg, Maryland, that develops vaccines to counter serious infectious diseases. Prior to 2020, company scientists developed experimental vaccines for influenza and respiratory sy ...
for the production of Novavax's
NVX-CoV2373 The Novavax COVID-19 vaccine, sold under the brand names Nuvaxovid and Covovax, among others, is a subunit vaccine, subunit COVID-19 vaccine developed by Novavax and the Coalition for Epidemic Preparedness Innovations. Updated versions of ...
(Covovax) vaccine for India and other low and middle-income countries. The company would also produce Codagenix's nasally administered
COVID-19 Coronavirus disease 2019 (COVID-19) is a contagious disease caused by the coronavirus SARS-CoV-2. In January 2020, the disease spread worldwide, resulting in the COVID-19 pandemic. The symptoms of COVID‑19 can vary but often include fever ...
vaccine CDX-005 (tradename '' COVI-VAC''). The company also manufactured Sputnik V vaccine in India in collaboration with Gamaleya Research Institute of Epidemiology and Microbiology after receiving approval from DCGI. 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. In March 2021,
Reuters Reuters ( ) is a news agency owned by Thomson Reuters. It employs around 2,500 journalists and 600 photojournalists in about 200 locations worldwide writing in 16 languages. Reuters is one of the largest news agencies in the world. The agency ...
reported that Chinese state-backed cyber-espionage group Red Apollo targeted the Serum Institute of India's intellectual property for exfiltration.


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 The World Health Organization (WHO) is a list of specialized agencies of the United Nations, specialized agency of the United Nations which coordinates responses to international public health issues and emergencies. It is headquartered in Gen ...
and the Malaria Policy Advisory Group (MPAG). The vaccine, jointly developed by The
University of Oxford The University of Oxford is a collegiate university, collegiate research university in Oxford, England. There is evidence of teaching as early as 1096, making it the oldest university in the English-speaking world and the List of oldest un ...
and the Serum Institute of India in collaboration with
Novavax Novavax, Inc. is an American biotechnology company based in Gaithersburg, Maryland, that develops vaccines to counter serious infectious diseases. Prior to 2020, company scientists developed experimental vaccines for influenza and respiratory sy ...
's
adjuvant In pharmacology, an adjuvant is a drug or other substance, or a combination of substances, that is used to increase the efficacy or potency of certain drugs. Specifically, the term can refer to: * Adjuvant therapy in cancer management * Anal ...
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 The Wellcome Trust is a charitable foundation focused on health research based in London, United Kingdom. It was established in 1936 with legacies from the pharmaceutical magnate Henry Wellcome (founder of Burroughs Wellcome, one of the predec ...
, and the
European Investment Bank The European Investment Bank (EIB) is the European Union's investment bank and is owned by the 27 member states. It is the largest multilateral financial institution in the world. The EIB finances and invests both through equity and debt sol ...
(EIB). As of now, the vaccine has obtained licenses for use in Ghana, Nigeria, and Burkina Faso.


See also

* Bharat Biotech * Biological E. Limited * Biotechnology in India


References


External links


Official website
{{Authority control Biotechnology companies of India Vaccine producers Manufacturing companies based in Pune Indian companies established in 1966 Biotechnology companies established in 1966 1966 establishments in Maharashtra Pharmaceutical companies Immunology organizations Pharmaceutical companies of India COVID-19 vaccine producers