Coronavirus (39) India is the world’s biggest vaccine supplier
For the last couple of weeks, reports of the second wave of COVID-19 in India have caught the attention of the whole world. The daily figures rose to 379,459 new confirmed cases and 3,647 deaths due to COVID-19 yesterday in India1 and are expected to continue to rise for another two weeks, with a peak of nearly five hundred thousand new cases a day and more than 5000 deaths per day due to COVID-19 by mid-May.2
The world is now more connected than before, so this wave of COVID-19 in India will definitely affect the world’s economy, as India is the sixth largest economy in the world.3 Moreover, mutations of the virus may evolve every time the virus is passed on, so the higher the number of cases of infection, the higher the chance of a new variant emerging with higher transmissibility and/or higher resistance to the currently-available vaccines and therapies against COVID-19.
However, as the crisis is hitting India, the news reports also showed us something we might not have known before: India is the world’s biggest supplier of vaccines.4 You might be interested to know more about the vaccine industry in India and how that industry is involved in manufacturing vaccines against COVID-19. Let us have a look at this issue in this blog post.
India is the world’s biggest supplier of vaccines
The seven largest vaccine manufacturers in India have an installed capacity to manufacture a total of 8.2 billion doses of different vaccines per year.5 The first two largest vaccine manufacturers in India can already produce about 2.5 million doses a day.6 These vaccine manufacturers play a very important role in providing vaccines against COVID-19 worldwide.
Serum Institute of India (SII): the largest vaccine manufacturer in India
The Serum Institute of India (SII) is based in Pune and was founded in 1966 by Dr. Cyrus Poonawalla. According to the company’s website, it is the world's largest vaccine manufacturer by number of doses produced and sold globally. The company mainly produces traditional vaccines: its products include Polio vaccine, Diphtheria, Tetanus, Pertussis, Hib, BCG, r-Hepatitis B, Measles, Mumps and Rubella vaccines. The vaccines produced are being used in about 170 countries in the world in their national immunization programmes. Around 65% of the children in the world receive at least one vaccine manufactured by SII.7
Last June, SII obtained permission from AstraZeneca to manufacture Covishield, the COVID-19 vaccine which was co-developed by the University of Oxford and AstraZeneca. Under the agreement, the company will supply a total of one billion doses of Covishield for low- and middle-income countries. The company was expected to produce 100 million doses of Covishield per month.8
However, there was a fire at one of its facilities in January. Moreover, due to the surge in number of domestic COVID-19 cases, the Indian government started halting the exports of Covishield in March. Only 64 million dose of Covishield were exported before the halt in exports, 28 million of which went to COVAX, an organization co-led by GAVI (a global vaccine alliance), the Coalition for Epidemic Preparedness Innovations and WHO, one of the aims of which is to guarantee fair and equitable delivery of COVID-19 vaccines to poorer countries.8 This delayed planned deliveries of Covishield to 64 lower-income countries through COVAX.
In addition to Covishield, SII is also set to launch the production of millions of a protein vaccine, Covovax, developed by Novavax.9 The company’s CEO, Adar Poonawalla, said on Twitter that the vaccine is expected to be produced by September 2021. The company has initiated the Phase II and Phase III bridging trials for this vaccine.9
Bharat Biotech: the second largest vaccine manufacturer in India
The second largest vaccine manufacturer in India is Bharat Biotech. It was found in 1996 and is currently based in Hyderabad. The company owns over 160 patents and its products are used in over 123 countries. Since its establishment, the company has delivered over 4 billion vaccine doses worldwide. Its key focus is to develop and provide vaccines and therapeutics to the developing world.10
Since the beginning of the pandemic last year, Bharat Biotech collaborated with the Indian Council of Medical Research to develop an inactivated vaccine, Covaxin, against COVID-19. The company was given permission in January 2021 by the Indian government for emergency use of Covaxin. It is expected the company can make 12.5 million doses each month.8
Bharat Biotech is also conducting clinical trials for a intranasal viral vectored vaccine against COVID-19. The chairman of the company, Krishna Ella, expected that the vaccine could be available to the market by June this year if a protocol for all phases of clinical trials is clearly defined by the Indian government. If the company obtains emergency use approval from the government, he expected that the company can produce more than 1 billion doses.5
Other vaccine manufacturers in India
Besides the two biggest vaccine manufacturers, the other large vaccine manufacturers in India also fully participate in the campaign to manufacture vaccines against COVID-19. Biological E., another vaccine manufacturer based in Hyderabad, has signed a contract with Johnson & Johnson to produce 600 million doses of Ad26.COV2.S, a one-shot, adenovirus-vectored vaccine which has been approved to be used in the US.5
Moreover, Biological E. also cooperates with US organizations to develop an additional vaccine against COVID-19, a recombinant protein-subunit vaccine including antigen developed by Texas Children’s Hospital Center for Vaccine Development and advanced adjuvant CpG 1018TM from Dynavax. Biological E. announced on 24th April that it has successfully completed the Phase I/II clinical trial of this COVID-19 vaccine candidate in India and received approval to start the Phase III clinical trial from the Central Drugs Standard Control Organization- Subject Expert Committee.11
Biological E. was founded in 1953 as the first private-sector biological products company in India and the first pharmaceutical company in Southern India. It develops, manufactures and supplies vaccines and therapeutics. Its vaccine products are sold to over 100 countries.11
In addition, Dr. Reddy’s Laboratories, together with Panacea Biotech, Stelis Biopharm, Gland Pharma and Virchow Biotech, are about to produce an adenovirus vaccine, Sputnik V from Russia, for domestic use since the approval of its restricted use by the Indian government on the 12th of this month. It is expected that 850 million doses of Sputnik V per year could be produced from these vaccine manufacturers.5
Other than manufacturing COVID-19 vaccines that were developed elsewhere, there are several vaccine companies in India that developed COVID-19 vaccines by themselves, although most of them are currently far away from being launched. Among the COVID-19 vaccines undergoing clinical trials, a DNA plasmid-based vaccine, ZyCov-D, developed by Ahmedabad-based company Zydus Cadila, is in Phase 3 trials, and the initial data from the study is expected to be ready by May 2021.12,13 The production of the ZyCoV-D vaccine has started with a yearly capacity of 240 million doses. It is expected to get emergency use authorization in May or June.14
Hopefully with the production of different COVID-19 vaccines by the vaccine manufacturers in India, and the ease of the export ban of raw material for vaccines from the US, the production of COVID-19 vaccines in India could be ramped up to its full capacity to provide as much vaccine as possible in time to alleviate the dire situation in India.
References
1. https://www.worldometers.info/coronavirus/country/india/
2. IIT scientists revise prediction on when COVID cases could peak in India. Mint, 6 Apr 2021. https://www.livemint.com/news/india/iit-scientists-revise-prediction-on-when-covid-cases-could-peak-in-india-11619437014161.html
3. "World Economic Outlook Database, April 2021". IMF.org. International Monetary Fund. April 2021. Retrieved 6 April 2021.
4. Why India's Covid crisis matters to the whole world. By Rebecca Morelle. BBC news, 28th April, 2021. https://www.bbc.co.uk/news/world-asia-india-56907007
5. How much vaccine can India make? And the catch...By Rai Vinaykumar. Business Today, April 14, 2021. https://www.businesstoday.in/coronavirus/after-launching-how-much-vaccine-can-india-make-and-the-catch/story/436474.html
6. India’s vaccine crisis is a warning to the world. By Grace Browne. WIRED, 29 April, 2021. https://www.wired.co.uk/article/india-vaccine-production
7. Serum Institute of India website. https://www.seruminstitute.com/about_us.php
8. India’s COVID-vaccine woes — by the numbers. How an explosion of coronavirus cases in India is putting global vaccine supplies at risk. T.V. Padma, Nature news, 15 April, 2021. https://www.nature.com/articles/d41586-021-00996-y
9. Serum Institute to delay launch of Novavax vaccine in India. Pharmaceutical Technology, 29 Mar 2021. https://www.pharmaceutical-technology.com/news/serum-institute-novavax-vaccine/
10. Bharat Biotech website. https://www.bharatbiotech.com
11. Biological E. Limited gets CDSCO nod to start Phase III clinical trial of its COVID-19 vaccine candidate. Biological E. press release, April 24, 2021. https://www.biologicale.com/news.html
12. DBT-BIRAC supported indigenously developed DNA vaccine candidate by Zydus Cadila, approved for Phase III clinical trials. pib.gov.in. Press Information Bureau, 3 January 2021.
13. Cadila Healthcare testing two-shot regimen for ZyCoV-D, data likely by May. By Das, Sohini. Business Standard, 22 April 2021. https://www.business-standard.com/article/current-affairs/cadila-healthcare-testing-two-shot-regimen-for-zycov-d-data-likely-by-may-121042200011_1.html
14. Cadila Healthcare starts production of Covid vaccine candidate. Mint news, 27 April 2021. https://www.livemint.com/companies/news/cadila-healthcare-starts-production-of-covid-vaccine-candidate-11619244017749.html
For the last couple of weeks, reports of the second wave of COVID-19 in India have caught the attention of the whole world. The daily figures rose to 379,459 new confirmed cases and 3,647 deaths due to COVID-19 yesterday in India1 and are expected to continue to rise for another two weeks, with a peak of nearly five hundred thousand new cases a day and more than 5000 deaths per day due to COVID-19 by mid-May.2
The world is now more connected than before, so this wave of COVID-19 in India will definitely affect the world’s economy, as India is the sixth largest economy in the world.3 Moreover, mutations of the virus may evolve every time the virus is passed on, so the higher the number of cases of infection, the higher the chance of a new variant emerging with higher transmissibility and/or higher resistance to the currently-available vaccines and therapies against COVID-19.
However, as the crisis is hitting India, the news reports also showed us something we might not have known before: India is the world’s biggest supplier of vaccines.4 You might be interested to know more about the vaccine industry in India and how that industry is involved in manufacturing vaccines against COVID-19. Let us have a look at this issue in this blog post.
India is the world’s biggest supplier of vaccines
The seven largest vaccine manufacturers in India have an installed capacity to manufacture a total of 8.2 billion doses of different vaccines per year.5 The first two largest vaccine manufacturers in India can already produce about 2.5 million doses a day.6 These vaccine manufacturers play a very important role in providing vaccines against COVID-19 worldwide.
Serum Institute of India (SII): the largest vaccine manufacturer in India
The Serum Institute of India (SII) is based in Pune and was founded in 1966 by Dr. Cyrus Poonawalla. According to the company’s website, it is the world's largest vaccine manufacturer by number of doses produced and sold globally. The company mainly produces traditional vaccines: its products include Polio vaccine, Diphtheria, Tetanus, Pertussis, Hib, BCG, r-Hepatitis B, Measles, Mumps and Rubella vaccines. The vaccines produced are being used in about 170 countries in the world in their national immunization programmes. Around 65% of the children in the world receive at least one vaccine manufactured by SII.7
Last June, SII obtained permission from AstraZeneca to manufacture Covishield, the COVID-19 vaccine which was co-developed by the University of Oxford and AstraZeneca. Under the agreement, the company will supply a total of one billion doses of Covishield for low- and middle-income countries. The company was expected to produce 100 million doses of Covishield per month.8
However, there was a fire at one of its facilities in January. Moreover, due to the surge in number of domestic COVID-19 cases, the Indian government started halting the exports of Covishield in March. Only 64 million dose of Covishield were exported before the halt in exports, 28 million of which went to COVAX, an organization co-led by GAVI (a global vaccine alliance), the Coalition for Epidemic Preparedness Innovations and WHO, one of the aims of which is to guarantee fair and equitable delivery of COVID-19 vaccines to poorer countries.8 This delayed planned deliveries of Covishield to 64 lower-income countries through COVAX.
In addition to Covishield, SII is also set to launch the production of millions of a protein vaccine, Covovax, developed by Novavax.9 The company’s CEO, Adar Poonawalla, said on Twitter that the vaccine is expected to be produced by September 2021. The company has initiated the Phase II and Phase III bridging trials for this vaccine.9
Bharat Biotech: the second largest vaccine manufacturer in India
The second largest vaccine manufacturer in India is Bharat Biotech. It was found in 1996 and is currently based in Hyderabad. The company owns over 160 patents and its products are used in over 123 countries. Since its establishment, the company has delivered over 4 billion vaccine doses worldwide. Its key focus is to develop and provide vaccines and therapeutics to the developing world.10
Since the beginning of the pandemic last year, Bharat Biotech collaborated with the Indian Council of Medical Research to develop an inactivated vaccine, Covaxin, against COVID-19. The company was given permission in January 2021 by the Indian government for emergency use of Covaxin. It is expected the company can make 12.5 million doses each month.8
Bharat Biotech is also conducting clinical trials for a intranasal viral vectored vaccine against COVID-19. The chairman of the company, Krishna Ella, expected that the vaccine could be available to the market by June this year if a protocol for all phases of clinical trials is clearly defined by the Indian government. If the company obtains emergency use approval from the government, he expected that the company can produce more than 1 billion doses.5
Other vaccine manufacturers in India
Besides the two biggest vaccine manufacturers, the other large vaccine manufacturers in India also fully participate in the campaign to manufacture vaccines against COVID-19. Biological E., another vaccine manufacturer based in Hyderabad, has signed a contract with Johnson & Johnson to produce 600 million doses of Ad26.COV2.S, a one-shot, adenovirus-vectored vaccine which has been approved to be used in the US.5
Moreover, Biological E. also cooperates with US organizations to develop an additional vaccine against COVID-19, a recombinant protein-subunit vaccine including antigen developed by Texas Children’s Hospital Center for Vaccine Development and advanced adjuvant CpG 1018TM from Dynavax. Biological E. announced on 24th April that it has successfully completed the Phase I/II clinical trial of this COVID-19 vaccine candidate in India and received approval to start the Phase III clinical trial from the Central Drugs Standard Control Organization- Subject Expert Committee.11
Biological E. was founded in 1953 as the first private-sector biological products company in India and the first pharmaceutical company in Southern India. It develops, manufactures and supplies vaccines and therapeutics. Its vaccine products are sold to over 100 countries.11
In addition, Dr. Reddy’s Laboratories, together with Panacea Biotech, Stelis Biopharm, Gland Pharma and Virchow Biotech, are about to produce an adenovirus vaccine, Sputnik V from Russia, for domestic use since the approval of its restricted use by the Indian government on the 12th of this month. It is expected that 850 million doses of Sputnik V per year could be produced from these vaccine manufacturers.5
Other than manufacturing COVID-19 vaccines that were developed elsewhere, there are several vaccine companies in India that developed COVID-19 vaccines by themselves, although most of them are currently far away from being launched. Among the COVID-19 vaccines undergoing clinical trials, a DNA plasmid-based vaccine, ZyCov-D, developed by Ahmedabad-based company Zydus Cadila, is in Phase 3 trials, and the initial data from the study is expected to be ready by May 2021.12,13 The production of the ZyCoV-D vaccine has started with a yearly capacity of 240 million doses. It is expected to get emergency use authorization in May or June.14
Hopefully with the production of different COVID-19 vaccines by the vaccine manufacturers in India, and the ease of the export ban of raw material for vaccines from the US, the production of COVID-19 vaccines in India could be ramped up to its full capacity to provide as much vaccine as possible in time to alleviate the dire situation in India.
References
1. https://www.worldometers.info/coronavirus/country/india/
2. IIT scientists revise prediction on when COVID cases could peak in India. Mint, 6 Apr 2021. https://www.livemint.com/news/india/iit-scientists-revise-prediction-on-when-covid-cases-could-peak-in-india-11619437014161.html
3. "World Economic Outlook Database, April 2021". IMF.org. International Monetary Fund. April 2021. Retrieved 6 April 2021.
4. Why India's Covid crisis matters to the whole world. By Rebecca Morelle. BBC news, 28th April, 2021. https://www.bbc.co.uk/news/world-asia-india-56907007
5. How much vaccine can India make? And the catch...By Rai Vinaykumar. Business Today, April 14, 2021. https://www.businesstoday.in/coronavirus/after-launching-how-much-vaccine-can-india-make-and-the-catch/story/436474.html
6. India’s vaccine crisis is a warning to the world. By Grace Browne. WIRED, 29 April, 2021. https://www.wired.co.uk/article/india-vaccine-production
7. Serum Institute of India website. https://www.seruminstitute.com/about_us.php
8. India’s COVID-vaccine woes — by the numbers. How an explosion of coronavirus cases in India is putting global vaccine supplies at risk. T.V. Padma, Nature news, 15 April, 2021. https://www.nature.com/articles/d41586-021-00996-y
9. Serum Institute to delay launch of Novavax vaccine in India. Pharmaceutical Technology, 29 Mar 2021. https://www.pharmaceutical-technology.com/news/serum-institute-novavax-vaccine/
10. Bharat Biotech website. https://www.bharatbiotech.com
11. Biological E. Limited gets CDSCO nod to start Phase III clinical trial of its COVID-19 vaccine candidate. Biological E. press release, April 24, 2021. https://www.biologicale.com/news.html
12. DBT-BIRAC supported indigenously developed DNA vaccine candidate by Zydus Cadila, approved for Phase III clinical trials. pib.gov.in. Press Information Bureau, 3 January 2021.
13. Cadila Healthcare testing two-shot regimen for ZyCoV-D, data likely by May. By Das, Sohini. Business Standard, 22 April 2021. https://www.business-standard.com/article/current-affairs/cadila-healthcare-testing-two-shot-regimen-for-zycov-d-data-likely-by-may-121042200011_1.html
14. Cadila Healthcare starts production of Covid vaccine candidate. Mint news, 27 April 2021. https://www.livemint.com/companies/news/cadila-healthcare-starts-production-of-covid-vaccine-candidate-11619244017749.html
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