Nationalist Congress Party leader and Member of Parliament Supriya Sule, on February 3, 2022 claimed that the government has only distributed COVID-19 vaccines and has had no role in the development of any vaccine.

While delivering her speech on the fourth day of the Parliament's Budget session, Sule said, "The government has distributed the vaccine and has not made it. Serum Institute of India (SII) has made the vaccine, which it has been doing for years." She also said that the Defence Research and Development Organisation (DRDO), which is a leading scientific institution, is now making masks and sanitisers and that this is not what 'Make in India' should represent.

Her speech was tweeted by Rajya Sabha MP and Shiv Sena leader Priyanka Chaturvedi.

Since Sule didn't specify which vaccine she was referring to, there appear to be two misconceptions. Firstly, if she meant Covaxin, she didn't acknowledge the contribution of Indian Council of Medical Research (ICMR) and National Institute of Virology (NIV) in the development of the vaccine. Secondly, if the NCP leader was speaking of Covishield, then it was incorrect to say that the vaccine was developed by SII.

Covaxin: ICMR-NIV Helped Make It

ICMR, which is funded by the Union Ministry of Health & Family Welfare, its institute NIV and Bharat Biotech International Limited, a biotechnology company, partnered to develop and manufacture Covaxin. The inactivated vaccine was developed from an Indian strain of the novel coronavirus, which was isolated by NIV.

Dr Rajni Kant, Director, ICMR-Regional Medical Research Centre (RMRC), Gorakhpur, said ICMR was also involved in trial phases. "Vaccine development is a multiple-stage process, it involves the exploratory stage, isolation of the virus, checking the safety and efficacy of the virus and so on. All three trials were done by ICMR whereas the development or industrial part was done by Bharat Biotech," said Dr Kant.

Dr Samiran Panda, additional director general and head of Epidemiology and Communicable Diseases (ECD), Division at ICMR, also told FactChecker that ICMR's involvement goes much beyond providing the strain. "Apart from providing the live virus, we conducted its sequencing and concentration as well. Even culturing of the virus is a humongous task which is followed by inactivating it," said Dr Panda. After the vaccine was developed, its concentration was checked in NIV's laboratory, he added.

FactChecker also accessed ICMR Director General Dr Balram Bhargava's book Going Viral, which delves deeper into the making of the vaccine and ICMR's involvement in the preclinical stages of making the vaccine. In a chapter titled 'An Indian Vaccine: From Dream to Roll-Out', Dr Bharagava wrote that anti-SARS-CoV-2 ELISA test kits developed by ICMR-NIV were used for preclinical studies that required detecting antibodies which would be generated following vaccination. "We monitored the work and sprang into action to expedite the necessary approvals and ensure supplies of critical equipment and materials, including reagents," wrote Dr Bhargava, which was published in November 2021.

Once the vaccine could generate antibodies in small animals, it was tested on larger animals such as monkeys, comparable to humans in terms of their body structure and immune systems. "The ICMR-NIV's BSL-4 lab, the only state-of-the-art facility in India for primate studies, once again took up the challenge to carry out this critical research," read an excerpt from the book.

Further, Dr Bhargava wrote that a special team from ICMR and NIV travelled to several areas of Maharashtra to identify sites for animal capture and performed large animal experiments in NIV's high-security containment facility.

FactChecker also reached out to Dr Priya Abraham, director of NIV, Pune to get an insight into NIV's contribution in making the vaccine. However, she said ICMR had instructed her not to interact with the media.

Covishield: Not Developed by SII

Sule claimed that Serum Institute of India made the vaccine. If she was referring to Covishield, the fact is that SII didn't develop the vaccine, it just manufactured it. Covishield was developed in the United Kingdom by Oxford University, in partnership with British-Swedish multinational pharmaceutical company AstraZeneca, which also manufactures and distributes it across the world. In India, the vaccine is manufactured by SII and called Covishield.

"The authorisation of COVID-19 Vaccine AstraZeneca manufactured by AstraZeneca, and Covishield manufactured by Serum Institute of India, enables global access to the vaccine during the pandemic," according to AstraZeneca's website.

The AstraZeneca vaccine was co-invented by the University of Oxford' Jenner institute and its spin-out company, Vaccitech. It uses a replication-deficient chimpanzee viral vector based on a weakened version of a common cold virus (adenovirus) that causes infections in chimpanzees and contains the genetic material of the SARS-CoV-2 virus spike protein. After vaccination, the surface spike protein is produced, priming the immune system to attack the SARS-CoV-2 virus if it later infects the body.

FactChecker had tried contacting Sule for a comment via call and email, but had not received a response by the time of publishing this article.

(With inputs from Isha Bajpai)