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New Delhi: In an attempt to bring more Covid-19 vaccines to India to combat the new, more aggressive wave of infection, the Narendra Modi government has invited a number of foreign drugmakers to bring their vaccines to India. But their entry could take time, Pfizer being likely to ask for the signing of an obligation to indemnify and Moderna says it has “its hands full”.
The government on Tuesday authorized the granting of an emergency license for vaccines that have received authorization in the United States, United Kingdom, Europe, Japan or the World Health Organization (WHO) .
Pfizer will reassess the Modi government’s position on compensating vaccine manufacturers, industry sources told ThePrint.
The U.S. pharmaceutical giant, which was the first to apply for an Emergency Use Authorization (EUA) for its vaccine in India, withdrew its application earlier this year, sources attributing the move to Indian government resistance to sign indemnification obligations. These are the legal obligations that protect the company from lawsuits in case the vaccine ends up causing side effects.
Meanwhile, Johnson & Johnson were eager to come to India and had recently informed the Central Drugs Standard Control Organization (CDSCO) of their intention to begin “transition clinical trials” soon. However, the single-dose vaccine has run into problems, with the United States calling for an immediate halt in its use after six women developed a rare and severe form of blood clotting after receiving the vaccine.
Speaking of which, a senior CDSCO official told ThePrint, “We will be approving vaccines given all the global movement around the product.”
Also read: The science behind the Sputnik V vaccine and decoding India’s disastrous second wave
‘India must compensate the manufacturers’
Pfizer is reportedly firm on signing a compensation bond before agreeing to an agreement to send its vaccine to India.
“Pfizer has signed the indemnity bond with all the countries where it has supplied its Covid-19 vaccine. The price discussion would not begin until India agreed to sign the bond, ”said an industry source familiar with the matter.
In January, the Center said in response to a request from RTI that it currently had no proposal to indemnify or exempt vaccine manufacturers from liability for serious side effects or adverse reactions after the ‘inoculation.
Health Secretary Rajesh Bhushan did not respond to ThePrint’s text messages for comment on the matter.
According to Christian Medical College vaccine expert and microbiologist, Vellore, Dr Gagandeep Kang, however, India should move forward with manufacturers’ compensation.
“Globally, most countries and Covax compensate manufacturers. India does not, at least so far. We should go ahead, but then for all manufacturers, not for anyone in particular, ”Kang said.
In its official response, Pfizer said, “We have taken note of the recent announcement regarding the regulatory pathway for global vaccines.”
The company spokesperson added, “We remain committed to continuing our engagement with the (Indian) government to make the Pfizer and BioNTech vaccine available for use in the government immunization program in the country.”
Moderna does not want to enter India
Vaccine manufacturers are likely to tailor their strategies to the capacity available and what they can save for the Indian market, which is of considerable size.
Ray Jordan, spokesperson for Moderna, told ThePrint in an email that he would not be able to comment on “any discussions or negotiations over the supply.”
However, the Center for Cellular and Molecular Biology (CCMB), under the aegis of the Council for Scientific and Industrial Research (CSIR), had been in talks with the US biotech company for about six months to bring its vaccine to India.
“Despite discussions with them for several months, the company was not really keen to bring its Covid-19 vaccine to India, probably because it has its hands full, at the moment. But with this new announcement coming, the Indian government through CSIR could start pushing them again, ”said a senior CSIR official.
In its email to ThePrint, Moderna listed the committed order supply agreements that the company has already signed. Orders, in total, exceed 1000 million (100 crore) in doses to countries such as the United States, European Union, Canada, Korea, Japan, Switzerland, Colombia, Israel, Taiwan, Singapore and Qatar, among others.
In the United States, the Moderna vaccine is available for $ 30 (over Rs 2,250) for two doses.
“The price of the mRNA vaccine will become quite reasonable (in India) if Moderna accompanies us and allows our pharmaceutical companies to produce the vaccine here. The technology is very simple and it will take us 8-9 months to start manufacturing, ”CSIR told ThePrint.
(Edited by Sanghamitra Mazumdar)
Also read: US halts Johnson & Johnson single-dose Covid vaccine after 6 cases of blood clotting
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