U.S. ships over 110 million COVID-19 vaccine doses abroad; India does not take any due to liability issues

An Indian official involved in the vaccine negotiations told The Hindu that several ‘challenges remain’ in terms of resolving the larger issue of commercial orders for the three U.S. vaccine manufacturers.

Airport personnel handle unloaded consignment as 5,00,000 doses of Moderna COVID-19 vaccine gifted from the United States arrived at Paro International Airport in Bhutan on July 12, 2021.

The U.S. has shipped more than 110 million doses of COVID-19 vaccines to middle and low income countries, U.S. President Joe Biden announced on Tuesday. This exceeds a commitment to donate at least 80 million doses of mostly AstraZeneca vaccine globally. India did not appear on an official list of countries that had received U.S. vaccines, a consequence of unresolved liability issues between the government of India and vaccine manufacturers.

An Indian official involved in the vaccine negotiations told The Hindu that while U.S. donated vaccines could be accepted with an implicit indemnity cover from the government, several “challenges remain” in terms of resolving the larger issue of commercial orders for the three U.S. vaccine manufacturers (Pfizer, Moderna and Johnson & Johnson), and those are now holding up all COVID-19 vaccine imports from the U.S.

In an interview to

NDTV , the government’s vaccine panel chief, N.K. Arora, suggested that India could reconsider its position on

sovereign indemnity for U.S. vaccines if a larger number of doses, between “100 to 200 million doses” were offered, but that India is going ahead with its vaccine plans to inoculate all eligible adults with COVID-19 vaccines without factoring in vaccines imported from the U.S.

Thus far, India has only

given approval to pharma company Cipla on Tuesday to import the Moderna mRNA vaccine. In early July, a shipment of 7.5 million doses of Moderna vaccines was bound for India. This shipment, a part of the donations from international vaccine distribution facility COVAX, were held back at the last minute, as neither the government, nor Cipla were willing to sign the liability waiver, according to the official who spoke to The Hindu .

Pfizer is yet to apply for approval in India. During his remarks on Tuesday, Mr. Biden said that the U.S. would begin shipping by the end of this month some of the 500 million doses of Pfizer-BioNTech vaccines that it had committed to foreign countries. The U.S. is also expanding manufacturing at home and abroad, including in India, according to Mr. Biden.

The U.S. has donated and shipped more than 110 million doses of COVID-19 vaccines to more than 60 countries, ranging from Afghanistan to Zambia, the White House announced on Tuesday.

 

“We have committed to over a half a billion doses. And we’re trying to provide for more and provide for the capacity of countries like India to be able to produce the vaccine themselves. And we’re helping them do that. That’s what we’re doing now,” he said.

India and the U.S., along with their Quad partners Japan and Australia, plan to supply at least one billion doses of the Johnson and Johnson (J&J) vaccine across Asia by the end of 2022. These will be produced in India by Hyderabad-based Biological E.

But the road ahead is far from clear. After the press reported earlier this week that J&J had withdrawn an application for accelerated approval of its Janssen COVID-19 vaccine in India, the company said that it remained in talks with the Indian government on “how best to accelerate our ability to deliver our COVID-19 vaccine to India.” In Parliament last week, Minister of State for Health Bharti Pravin Pawar said the government-instituted vaccine panel was in “continuous dialogue with Pfizer, Moderna and Johnson & Johnson to discuss and address various issues including the issue of indemnity”.

Most of the 111,701,000 doses donated by the U.S. so far have been distributed via COVAX. Indonesia has received the largest share (8 million doses) according to a ‘factsheet’ released by the White House on Tuesday. Several South Asian countries were on the list: Afghanistan (3.3 million doses), Bhutan (500,000 doses), Nepal (c.1.5 million doses), Sri Lanka (1.5 million doses), Pakistan and Bangladesh (5.5 million doses each). Mr. Biden said that countries which had vaccinated their populations should provide vaccines or financial support to the 100 or so nations in need of vaccines.

“I think those countries that have been able to cover their population and have the ability to provide either dollars and/or vaccine for the 100 or so... poor nations that need help should do so.”

“We had that discussion at the G7 [Group of Seven]. A number of those countries said they were going to do that. Some have followed through,” he said.

At the G7 meeting in Cornwall in June, rich countries pledged a billion doses of COVID-19 vaccines to developing countries over the next year, most of which will be delivered via COVAX. The World Health Organisation has estimated that 11 billion doses are required globally to significantly address the pandemic.