According to Bharat Biotech, the Firm will deliver more than 50 percent of its production to the center at 150 rupees per dose. The higher rates for state and private hospitals are necessary because they have to fund R&D for other vaccines, the company said.
Last year, Bharat Biotech Chairman Krishna Ella said Indian vaccines, including its Covaxin, developed with help from the government-led Indian Medical Research Council, would cost less than a bottle of water, almost a fifth.
However, the price list announced on Saturday 600 rupees per dose for states and 1,200 rupees for private hospitals. Not only about the prices, but also about Ella’s claim to the role of the ICMR.
On April 21, Ella told NDTV that Bharat Biotech had not yet received government funding to develop a vaccine.
“… We by no means obtained any cash from the Indian government.Even including our clinical trials … for phase 2, phase 3 we spent 350 million rupees.
However, the Clinical Trials Registry of India (CTRI) lists ICMR as a source of “financial and material assistance” in Phase 3 trials of Covaxin in more than 25,000 participants.
That’s not all. Key to the development of Covaxin was the role of the National Institute of Virology of the ICMR in Pune, which performed the critical task of isolating the SARS-CoV-2 strain. clinical trials and human trials with this vaccine.
In fact, government officials have been listed as authors in either Phase 1 or Phase 2 human clinical trials of this vaccine. These include the ICMR CEO Dr. Balram Bhargava, the NIV director, Dr. Priya Abraham and the All India Institute. for Medical Sciences (AIIMS) Dr. Randeep Guleria.
As of September 18, 2020, the ICMR was spending “more than 25 million rupees” from its intramural budget “on work related to vaccine candidate development and preclinical studies.” According to a response from Lok Sabha from Ashwini Kumar Choubey, Minister of State for Health and Family Welfare.
However, it is unclear how much of it was used for Covaxin, as ICMR also worked with other companies to develop their Covid-19 vaccines.
The vaccine was also the subject of controversy earlier this year when it was granted restricted use permission by the top medicines agency, despite not having enough participants enrolled and vaccinated in time to get preliminary information on its effectiveness.
The restricted use permit was granted on January 3 in an emergency “in clinical trial mode” and “in the public interest” situation, citing concerns about mutant strains of the virus and the potential of the vaccine to combat them.
The green light followed the reversal within 24 hours after a committee of experts decided whether approval of the vaccine should be recommended. Covishield, the other Covid-19 vaccine used in India, is the potentially highest cost of producing an inactivated vaccine in a biosecurity level 3 facility, according to experts.
“It’s the need to produce the live virus in a BSL-3 facility, followed by inactivation and testing for total inactivation, which makes the vaccine more expensive,” said Gagandeep Kang, a vaccine expert who first worked with Bharat Biotech in testing the vaccine Collaborated with homemade rotavirus vaccine, Rotavac.
“That means 600 rupees is a ridiculous price,” he added, “for a vaccine that is sold in tens of millions of doses to state governments.” He said. “No vaccine costs that much.”
According to Bharat Biotech, the company will deliver more than 50 percent of its production to the center at 150 rupees per dose. The higher rates for state and private hospitals are necessary because they have to fund R&D for other vaccines, the company said.
As a company, we want to have the maximum possible price. So we want as much as we can, get all the costs for the clinical trials and all other costs back and then give them back for research and development … We need (the) money.
The details of the agreements between ICMR and Bharat Biotech are opaque, particularly with regard to the funding and profit of the vaccine.
Experts expressed doubts about the intellectual property rights of the vaccine: On the one hand, Bharat Biotech signed an agreement with companies such as Ocugen in the United States of Covaxin. On the other hand, the government added the Huffkin Institute for vaccines. , Immunology of India is funded by the NGO Maharashtra and Hyderabad manufacturers to increase its production capacity.
To help Bharat Biotech to help bring its BSL 3 facility in Bengaluru online, the Department of Biotechnology announced a Rs 65 billion grant earlier this year.On April 19, the Treasury Department also relaxed the rules that would allow the Department of Health to prepay Bharat Biotech Rs 1,500 crore to purchase doses of Covaxin.
Detailed inquiries to Bharat Biotech and ICMR went unanswered.
He said the development of Covaxin “was supported by the ICMR”.
DBT supports the development of other vaccine candidates by Bharat Biotech, such as the single dose intranasal vaccine against Covid-19 and the vaccine based on the inactivated rabies vector platform, which are in the early advanced stages of preclinical and clinical development, he said. In this regard, DBT has financially supported Bharat Biotech, he added.