No Moderna doses for India till 2022: Report
The Indian government’s discussions with US pharmaceutical major Moderna for making its mRNA technology-based coronavirus disease (Covid-19) vaccine part of the country’s vaccine programme may take till 2022 because the US company’s supplies are “fully booked till 2021” according to an internal government report.
The report, a copy of which has been reviewed by HT, added that the government has gone through indemnity agreements of pharmaceutical companies such as Pfizer with other countries and noted that indemnity clauses are part of purchase agreements.
The government set up a five-member team of senior officials headed by Niti Aayog Member (Health) to deal with issues related to procurement of Covid-19 vaccines from foreign manufacturers The team also includes officials from the external affairs ministry, health ministry and the department of legal affairs.
“Discussions with Moderna yielded their interest in supplies of their vaccine only in 2022 as their orders were fully booked for the year 2021. Moderna’s leadership also showed interest in a discussion for production of Moderna vaccines in India in next few years,” the report added.
HT tried contacting Moderna but could not get a response immediately.
Currently India has made available three COVID vaccines, Covaxin, Covishield and Sputnik. Till Thursday evening, it had completely vaccinated 88 million people, and partially (one dose) vaccinated 242.5 million. It needs another 1.5 billion doses by the end of the year to completely vaccinate the entire adult population -- its stated target.
It is widely known that efforts to source vaccines made by Moderna and Pfizer, both with an efficacy of around 95% against the original Wuhan strain of the SARS-CoV-2 virus that causes Covid-19 have been stuck on account of supply constraints -- most of the output of the companies is spoken for -- and the indemnity issue.
The Centre constituted a team of officials on June 11 to deal with various issues related to procurement of Covid-19 vaccine from foreign manufacturers. This team is in continuous dialogue with Pfizer, Moderna and Johnson & Johnson to discuss and address various issues including the issue of indemnity, the health ministry informed Parliament on Friday.
None of the companies that make vaccines currently approved in India have been given such protection by the government.
“Pfizer agreed to supply several million doses of Pfizer vaccines but insisted on an indemnity agreement to waive off liability of the company, as well as on sovereign jurisdiction and arbitration,” the report said, adding that Indian missions overseas had established that such agreements were indeed in place and briefed “relevant authorities in India for further discussion and action as deemed appropriate.”
On June 29 the Drugs Controller General of India (DCGI), on Tuesday, granted permission to Mumbai-based pharmaceutical firm Cipla to import Moderna’s COVID-19 vaccine, making it the fourth vaccine in the country to be given the Emergency Use Authorisation (EUA). On behalf of Moderna, Indian pharmaceutical company Cipla Ltd applied to the country’s drugs regulator, the Drugs Controller General of India, for grant of approval to import the vaccine to India. However, this pertains to doses made available by the company under the World Health Organization (WHO) and Gavi’s COVAX mechanism. Cipla is facilitating this, and the approvals are part of the process. In a statement last month, Cipla said it is “supporting Moderna with the regulatory approval and importation of vaccines to be donated to India. At this stage, there is no definitive agreement on commercial supplies.” It wasn’t clear how many doses will be imported, and when.
The proposal of Indian companies to manufacture US vaccines in India was also taken up and discussed in the meetings held with the leadership of US based vaccine manufacturers. Biological E already has a contract manufacturing arrangement with Johnson & Johnson.
In a written response to a question in the Lok Sabha, minister of state for health Dr Bharati Pravin Pawar said on Friday that as on date, no foreign COVID-19 vaccine has been purchased or received as donation by the Government of India.
“No domestic manufacturer of Covid vaccine has demanded indemnity against adverse effects of vaccination,” the health ministry informed Parliament on Friday.