Bharat Biotech has supplied only 5.45 crore doses of Covaxin since January

After several months of ambiguity and secrecy, Union Ministry of Health & Family Welfare has revealed that Bharat Biotech (BBIL) has supplied only 5.45 crore doses of Covaxin from January 16, 2021 to July 16, 2021 for the National Covid Vaccination Programme. This translates into less than 1 crore doses a month.

Additionally, the intellectual property rights for the indigenous-developed vaccine Covaxin are jointly owned by Indian Council for Medical Research (ICMR) and the private firm Bharat Biotech Ltd (BBIL).

These details were shared by the Ministry in response to Congress MP Mallikarjun Kharge's queries on the exact terms of the MoU signed between ICMR and Bharat Biotech for the development of Covaxin.

The company had stated that its production capability was 2.5 crore doses per month and this would be maintained till August this year. In May, the Ministry had stated that BBIL would be able to produce 6-7 crore doses per month from August. All these claims appear to be misleading.

However, in its response, the Ministry has clarified that production capacity of Covaxin is planned to be increased from 2.5 crore doses per month to 5.8 crore doses per month.

From January 16 to July 16, 2021, 36.01 crore doses of Covishield have been supplied by Serum Institute of India to the Union government. SII also plans to increase its production capacity to more than 12 crore doses per month from 11 crore doses per month.

Though Covaxin was produced in partnership between ICMR and BBIL, the Ministry has stated that ICMR would get only five percent royalty on net sales on a half-yearly basis. ICMR’s logo should feature on the vaccine, but images of from the company show otherwise.

From the response, it is clear that the percentage of royalty was decided on the basis of which other government departments have demanded the licensing of vaccine technologies and standards followed by the World Health Organisation and the United Nations Development Programme.

According to the contract, BBIL had agreed to provide the vaccine at a reasonable and negotiated price to ICMR as well as all Central and state bodies as and when the vaccine became available for use.

After much back and forth over months, the Ministry has clarified that ICMR's total expenditure in the partnership amounted to Rs 35 crore.

The Ministry reiterated that ICMR had not provided any funds to BBIL for Covaxin’s development. However, funds were given for various activities undertaken by ICMR-National Institute of Virology (NIV), Pune, for developing the vaccine.

The Phase-3 clinical trials of Covaxin have been funded by ICMR. The trials were conducted at 25 sites with 25,800 participants.

The Ministry stated that ICMR-NIV in Pune had isolated the live SARS-CoV-2 virus in March 2020, and the research institute was approached by BBIL in April 2020 with a request to hand-over the live SARS-CoV-2 virus isolate. BBIL wanted to develop an inactivated vaccine for SARS-CoV-2 using the well-characterized virus strain available with ICMR.

ICMR decided to hand over the strain to BBIL because the company had a validated BSL-3 facility ready for use. This was essential, the Ministry stated, as during the pre-clinical studies, it is essential to test small animals with SARS-CoV-2 virus.

Other companies with interest in SARS-CoV-2 vaccine development like Serum Institute of India were not interested in developing an indigenous vaccine.

Companies such as Cadila and Biological E did not have a validated BSL-3 facility available. Additionally, ICMR-NIV had previously worked with BBIL for development of an indigenous vaccine for Japanese encephalitis.

The Ministry has also clarified that initially, a non-exclusive license was given with a clear mandate to commercialise the production of the vaccine within a two-year period starting April 2020 to expedite the product development efforts by the company. Even though, it was a non-exclusive license, other companies were not allowed to manufacture the vaccine until early this year.

However, now the Department of Biotechnology has been given the task of upscaling Covaxin production at multiple sites within India.

In this regard, facility augmentation of Bharat Biotech and three Public Sector Enterprises (PSEs) including Haffkine Biopharmaceutical Corporation Ltd, Mumbai; Indian Immunologicals Limited (IIL) and Hyderabad and Bharat Immunologicals Biologicals Limited (BIBCOL), Bulandshahr for augmented production of Covaxin are being supported.

Further, technology transfer of Covaxin production to Gujarat COVID Vaccine Consortium (GCVC), including Hester Biosciences and OmniBRx Biotechnologies, led by Gujarat Biotechnology Research Centre, Department of Science and Technology, Gujarat, is being facilitated by the Department of Biotechnology.

These efforts are expected to enhance the production of Covaxin from the present 1 crore doses per month to 10 crore doses per month in the coming months, stated the Ministry.