Govt Is Trying To Ramp Up Production Of Vaccines, Court Told

Govt Is Trying To Ramp Up Production Of Vaccines, Court Told

Dhananjay.Mahapatra@timesgroup.com

New Delhi:11.05.2021 

Clearing a cloud of claims over monetary aid given to Covid-19 vaccine manufacturers, the Centre informed the Supreme Court that it has provided no financial assistance to either Bharat Biotech or Serum Institute for development of vaccines but financial support of Rs 46 crore was extended for clinical trials.

“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 Centre said in its affidavit filed late on Sunday night in the SC. It clarified that the Indian Council of Medical Research (ICMR) spent Rs 46 crore on clinical trials of the two vaccines.

The Centre also informed the court that it has given 100% advance money to Bharat Biotech International Ltd (BBIL) and Serum Institute of India (SII), totalling Rs 2,520 crore, for procurement of vaccine doses for the months of May, June and July. SII was paid Rs 1,732.5 crore for 11 crore doses of Covishield and BBIL was paid Rs 787.5 crore for 5 crore doses of Covaxin.

It said Covaxin was developed under public private partnership between the ICMR and BBIL. “ICMR has not provided any funds to BBIL for Covaxin development. However, funds have been spent in various activities undertaken by ICMR and National Institute of Virology (NIV), Pune, for Covaxin development. Also, its phase 3 clinical trials have been funded by ICMR. The trials have been conducted at 22 sites in 25,800 participants. Total estimated expenditure of ICMR is 35 crore,” the Centre said.

“The bridging studies of Covishield on 1,600 participants in India were supported by ICMR in partnership with SII. No funds were provided to SII. Funds were transferred to 14 clinical trial sites. Total estimated expenditure of ICMR is Rs 11 crore,” it added.

According to an central government official, the Centre has also helping vaccine development with autonomous institutes of DBT involved in generating animal models for SARS-CoV-2. The immunoassay labs are serving as national service facilities for vaccine development.

In its affidavit, the Centre said the government was trying to ramp up production of vaccines and both BBIL and SII have expanded their facilities to almost double their production and provide 5.5 crore and 6.5 crore doses of vaccines, respectively, by the end of July. It said by then, Sputnik V production by Dr Reddy’s Laboratories would be around 1.2 crore doses.

“As some foreign vaccines have now been administered globally in large numbers, the NEGVAC has decided to allow the conduct of bridging trials of the foreign vaccines simultaneously with its market deployment as opposed to the earlier requirement of conducting bridging trials prior to market deployment, following due safety and quality protocols and in light of the global experience of these vaccines if such vaccines are approved by USA, UK, EU and WHO,” the Centre said.

It added that 11 new vaccines were in various stages of clinical trials. “The department of biotechnology is supporting the research and development of nearly 11 vaccine candidates by industry and public sector laboratories. Three of these vaccine candidates have progressed from proof-of-concept to the clinical development stage and are currently undergoing clinical trials. To further accelerate Covid-19 vaccine development efforts, support for vaccine candidates in clinical development is being provided under ‘Mission Covid Suraksha - the Indian Covid-19 Vaccine Development Mission’,” the government said

As many as 11 new vaccines are in various stages of clinical trials