'Rs 150/dose non-competitive price, not sustainable': Bharat Biotech defends higher pricing of Covaxin

HYDERABAD: Amid heated debates about Covaxin being the most expensive

Covid-19

vaccine in the private market at a price cap of Rs 1,410 per dose despite being indigenously developed, its developer

Bharat Biotech

on Tuesday said the weighted average price for all the supplies realised so far by the company is less than Rs 250 per dose. The company also pointed out that the company has not sought indemnity from the Indian government for any adverse events from Covaxin.

Pointing out that private procurement is discretionary, it said that

vaccines

are provided free of cost by the Indian government to all eligible Indian citizens and the procurement by private hospitals is optional and not mandatory and just gives a choice to citizens who are willing to pay for better convenience. “In our view, the question of product pricing is only of extraneous interest to all concerned, especially when the same vaccine is made available free of cost,” it said

“As directed by the government of India, less than 10% of our total production of Covaxin to date has been supplied to private hospitals, while most of the remaining quantity was supplied to state and central governments. In such a scenario, the weighted average price of Covaxin for all supplies realized by Bharat Biotech is less than ₹ 250 per dose. Going forward, around 75% of the capacity will be supplied to state and central governments with only 25% going to private hospitals,” the company said.



“The supply price of Covaxin to the Indian government at Rs 150 per dose, is a non-competitive price and clearly not sustainable in the long run. Hence a higher price in private markets is required to offset part of the costs. Bharat Biotech has so far invested over Rs 500 crore at risk from its own resources for product development, clinical trials and setting up of manufacturing facilities for Covaxin,” it said.

Pointing to several examples of dual pricing globally, it said Human Papilloma virus vaccine is priced for GAVI supplies at around $4.5 / dose (Rs 320 approx), but is also available in the private market at around Rs 3,500 per dose. Rotavirus vaccines are supplied to the government of India at Rs 60 per dose, but is also available in the private market at around Rs 1,700 a dose. The prices for Covid-19 vaccines internationally have varied between around $10 to $37 a dose (around Rs 730 to Rs 2,700 per dose), it said.

The company said Covaxin is more expensive for the private sector purely due to fundamental business reasons ranging from low procurement volumes, high distribution costs and retail margins among few others as explained above.

Bharat Biotech also pointed out that whole-virion Inactivated Vero Cell vaccines are highly complex to manufacture since the critical ingredient is based on live viruses that require highly sophisticated, multiple level containment and purification methods. “Such high standards of purification automatically lead to significant process losses and low yields save the outcome of a highly purified and safe vaccine,” it said.

Elaborating on the complexity of Covaxin’s manufacturing process, Bharat Biotech said it requires about 10,000 sqm of area to manufacture around 200 million doses annually. In comparison, the same quantity of live virus vaccines can be manufactured from a mere 1,500 sqm. Due to the highly contagious nature of the live SARS-CoV-2 virus, more stringent Biosafety Level-3 (BSL-3) containment facilities are required for the manufacturing of Covaxin, it explained.

“Every batch of manufactured product is subjected to more than 200 quality control tests, prior to its release. It is exactly this complexity that has kept away other companies from developing vaccines, especially whole virion inactivated vaccines. The SARS CoV2 virus provided by ICMR-NIV is also equally available to other manufacturers who wish to develop and manufacture such a vaccine. Companies would need access to cell lines, BSL3 manufacturing & quality control facilities, and several well trained technical teams, to manufacture Covaxin,” it said.

On the support provided by the

Indian Council of Medical Research

and

National Institute of Virology

, it said this was for provision of the SARS-CoV-2 virus, animal studies, virus characterisation, test kits and partial funding for clinical trial sites, in return for which Bharat Biotech would be paying royalties to them based on product sales.

Batting for dual pricing, it said low product price realisation for home-grown innovators dispirits R&D and product development in India. “In the absence of a dual pricing system, Indian vaccine and pharmaceutical companies risk being reduced to mere contract manufacturers with intellectual property licensed from other nations,” it said.