A year on, Quad initiative for 1 billion India-made vaccines runs into rough weather

Production of Johnson & Johnson jab at Hyderabad-based firm’s facility stalled over indemnity and safety issues

Updated - May 15, 2022 01:56 pm IST

Published - May 14, 2022 08:09 pm IST - NEW DELHI

Photo used for representation purpose only.

Photo used for representation purpose only. | Photo Credit: K. Murali Kumar

More than a year after the first Quad summit where the leaders of the U.S., India, Japan and Australia launched an ambitious initiative to produce one billion doses of COVID-19 vaccines for distribution in the Indo-Pacific region, the project is floundering, and officials concede that it is unlikely to meet its target by 2022-end for a number of reasons.

While the original plan to produce the single-shot Johnson & Johnson vaccine at the Hyderabad-based Biological E facility for the Quad Vaccine Initiative (QVI) ran into trouble over legal indemnity issues, and then over safety concerns, the other vaccine being produced at the facility, Corbevax, has yet to receive WHO Emergency Use Listing (EUL) needed for distribution.

In addition, experts say there is now an “oversupply” of vaccines in South East Asian countries and other regions of the world, bringing down the demand for vaccines. Ahead of the third Quad summit in Tokyo on May 24, officials are reviewing how best to take the initiative forward, sources said.

After the Quad virtual summit in March 2021, a White House “Fact Sheet” on the vaccine announcement had said that the “United States, through the Development Finance Corporation (US-DFC), will work with Biological E Ltd., to finance increased capacity to support Biological E’s effort to produce at least 1 billion doses of COVID-19 vaccines by the end of 2022 with Stringent Regulatory Authorization (SRA) and/or World Health Organization (WHO) Emergency Use Listing (EUL), including the Johnson & Johnson vaccine”.

The fact that the Johnson & Johnson vaccine was named specifically was significant at the time as Biological E had already signed a separate agreement in August 2020 for the manufacture of the vaccine, and sources said it had produced about 10 million doses by the time.

However, subsequently matters came to a head over J&J’s plans to export additional doses to India, as the Indian government refused to sign a liability waiver which would indemnify J&J from the side-effects of the vaccine. More recently, J&J faced another blow from the U.S. Food and Drug Administration, which limited the use of the vaccine in the U.S. due to the risk of blood clots.

Sources said Biological E has not, as a result, produced any more doses of the J&J vaccine, and at present, its entire production line is dedicated to producing the U.S.-developed Corbevax vaccine.

This poses another problem as Corbevax has not so far received WHO-EUL clearance, and Biological E’s application for the EUL is “under review”, and therefore it is ineligible to be included in the Quad Vaccine Initiative.

Yet another problem now is the excess production of vaccines that has led to a sharp drop in demand for vaccines. According to Gagandeep Kang, renowned virologist and Professor at the Christian Medical College, Vellore, who has been involved in the initiative as a board member of the Coalition for Epidemic Prevention and Innovation (CEPI), vaccine shortages ended after a bumper production of nearly 11 billion doses in 2021.

“If anything, the vaccine industry is a victim of its spectacular success in producing a COVID vaccine very quickly. As a result, those vaccines that came a bit later to the table, even if they are cheaper and safer, are struggling, while donors are trying to find willing recipients,” Dr. Kang told The Hindu.

Sources said that the vaccine initiative had not reached a dead-end despite the non-production of the J&J vaccine. The statement issued after the Quad summit in March 2021 said the DFC would “finance increased capacity to support Biological E’s effort to produce at least 1 billion doses of COVID-19 vaccines by the end of 2022,” and according to the sources, the DFC’s financing arrangement finalised in October 2021 for $50 million had achieved its objective of expanding the Hyderabad based company’s capacity, adding two lines of production.

The event in October was attended by the U.S. Chargé d’affaires Patricia Lacina, Ministry of External Affairs Joint Secretary Vani Rao, Japanese Consul General Taga Ma-sayuki, and Australian Consul General Sarah Kirlew as a mark of the Quad’s commitment. Even so, it is unclear how the funding will now be used to complete the production of one billion vaccines with WHO-EUL authorisation in just over seven months.

Quad countries have delivered vaccines to countries such as Thailand and Cambodia under a separate commitment made in September 2021, but the original initiative for a billion India-made vaccine doses, developed and funded by the U.S. and distributed by Japan and Australia, appears to have hit a roadblock.

The Hindu reached out to Biological E, the Ministry of External Affairs and the U.S Embassy, but all of them declined to comment. Biological E spokespersons directed all queries on the Quad initiative to Johnson and Johnson, where a spokesperson said the company “believes Biological E will be an important part of our network, where multiple manufacturing sites are involved in the production of our vaccine across different facilities, sometimes in different countries and continents”.

However, despite repeated requests, the spokesperson refused to divulge the status of the Johnson and Johnson production line at Biological E or comment on how many doses had been produced under the Quad initiative, if any.

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