Gave some aid for clinical trials of covid vaccines, not R&D: Centre to SC

The Centre has informed the Supreme Court that no governmental aid, assistance or grant was made either for research or development of COVID-19 vaccines - Covaxin and Covishield - but some financial assistance was given for conducting clinical trials.

In an affidavit filed in the apex court on Sunday night, the Centre has said that Covaxin has been developed under public private partnership between the Indian Council of Medical Research (ICMR) and Bharat Biotech International Ltd (BBIL).

ICMR has not provided any funds to BBIL for Covaxin development. However, funds have been spent in various activities undertaken by ICMR-NIV, Pune for Covaxin development. Also phase 3 clinical trials of Covaxin have been funded by ICMR. The trials have been conducted at 22 sites in 25,800 participants, the affidavit said, adding that total estimated expenditure of ICMR in this was 35 crore.

It said the bridging studies of Covishield in 1,600 participants in India were supported by ICMR in partnership with the Serum Institute of India (SII).

No funds were provided to SII. Funds were transferred to 14 clinical trial sites, it said, adding, ICMR also supported laboratory studies on characterization of immune response related to Covishield at ICMR-National AIDS Research Institute (NARI), Pune.

It said that total estimated expenditure of ICMR on this was 11 crore.

It is submitted that no governmental aid, assistance or grant is made either for research or development of either Covaxin or Covishield. However, they were given some financial assistance for conducting clinical trials, the affidavit said.

A bench headed by Justice D Y Chandrachud is hearing a suo motu case for ensuring distribution of essential supplies and services during the COVID-19 pandemic.

In its affidavit filed in compliance with the April 30 order passed by the top court, the Centre has given details of support to BBIL and SII for the production of the vaccines in the form of advance payment released to them for the vaccine doses for months of May, June and July.

It is submitted that, financial support to Bharat Biotech International Ltd (BBIL) and Serum Institute of India Pvt Ltd (SIIPL), for the production of Covaxin and Covishield, in the form or advance payment (not support or investment) of Rs 1,732.50 crore was released to Serum Institute of India (SII) for 11 crore doses of Covishield vaccine for the months of May, June and July and similarly, an advance payment of Rs 787.50 crores was released to Bharat Biotech India Ltd (BBIL) for 05 crore Covaxin doses for the months of May, June and July, it said.

The affidavit said the current procurement price of Government of India is based on the price negotiated by the National Expert Group on Vaccine Administration for COVID-19 (NEGVAC).