New Delhi: In an attempt to bring more Covid-19 vaccines to India to tackle the new and more aggressive wave of the infection, the Narendra Modi government has invited a number of foreign drug makers to bring their vaccines to India. But their entry could take time, with Pfizer likely to ask for signing of an indemnity bond and Moderna said to have its “hands full”.
The government Tuesday allowed the grant of emergency licence for vaccines that have received authorisation in the US, the UK, Europe, Japan, or from the World Health Organization (WHO).
Pfizer will reassess the Modi government’s stance on indemnifying the vaccine makers, industry sources told ThePrint.
The American pharma giant, which was the first to apply for emergency use authorisation (EUA) to its vaccine in India, withdrew its application earlier this year, with sources attributing the decision to resistance of the Indian government to sign indemnity bonds. These are the legal bonds that protect the company from being sued in case the vaccine ends up causing any side-effects.
Meanwhile, Johnson & Johnson has been keen on coming to India, and had recently informed the Central Drugs Standard Control Organisation (CDSCO) about its plan to start ‘bridging clinical trials’ soon. The single-dose vaccine, however, has run into trouble with the US calling for an immediate pause in its use after six women developed a rare and severe form of blood clotting after receiving the shot.
Speaking about it, a senior CDSCO official told ThePrint: “We will approve vaccines considering all the global movements around the product.”
‘India must indemnify manufacturers’
Pfizer is said to be firm on signing an indemnity bond before agreeing to a deal to send its vaccine to India.
“Pfizer has signed the indemnity bond with every country it has been supplying its Covid-19 vaccine. The discussion of pricing would only start when India would agree to sign the bond,” said an industry source privy to the matter.
In January, the Centre had in response to an RTI application said it currently has no proposal to indemnify or exempt vaccine manufacturers from any liability in case of serious side-effects or adverse reactions after inoculation.
Health Secretary Rajesh Bhushan did not respond to ThePrint’s text messages for a comment on this.
According to vaccine expert and microbiologist at Christian Medical College, Vellore, Dr Gagandeep Kang, however, India should go ahead with indemnifying manufacturers.
“Globally, most countries and Covax are indemnifying manufacturers. India is not doing it, at least till now. We should go ahead, but then for all the manufacturers, not for anyone specific,” Kang said.
In its official response, Pfizer said: “We have noted the recent announcement with regard to the regulatory pathway for global vaccines.”
The company spokesperson added: “We remain committed to continuing our engagement with the (Indian) Government towards making the Pfizer and BioNTech vaccine available for use in the Government’s immunization program in the country.”
Moderna not keen to enter India
The vaccine makers are likely to design their strategies based on available capacities and how much they can spare for the Indian market, which is of a considerable size.
Ray Jordan, the spokesperson at Moderna, told ThePrint in an email that he would not be able to offer comment on “any possible discussions or negotiations about supply”.
However, the Centre for Cellular and Molecular Biology (CCMB), under the Council of Scientific & Industrial Research (CSIR), had been in talks with the American biotechnology firm for the last around six months to bring its vaccine to India.
“Despite talking with them for several months, the company was not really keen to bring its Covid-19 vaccine in India, probably because they have their hands full, right now. But with this new announcement coming in, the Indian government via CSIR may start pushing them again,” said a senior official at CSIR.
In its email to ThePrint, Moderna listed supply agreements of committed orders that the company has already signed. The orders, in total, exceed 1,000 million (100 crore) doses to countries including the US, the European Union, Canada, Korea, Japan, Switzerland, Colombia, Israel, Taiwan, Singapore and Qatar, among others.
In the US, the Moderna vaccine is available for $30 (over Rs 2,250) for two doses.
“Price of the mRNA vaccine will become quite reasonable (in India) if Moderna comes on board with us and allows our pharma companies to produce the vaccine here. The technology is very simple and we will take 8-9 months to start manufacturing,” the CSIR told ThePrint.
(Edited by Sanghamitra Mazumdar)