U.S. vaccine ‘gift’ to India may not be substantial

U.S. vaccine ‘gift’ to India may not be substantial

Vaccine gifts of 2-3 million doses may have little impact on India: officials

The government on Friday welcomed the U.S. decision to lift restrictions under its Defence Production Act on the export of vaccine ingredients to AstraZeneca vaccine manufacturers worldwide, which would help the Serum Institute of India produce more doses.

However, Washington’s announcement of gifting India and dozens of other countries with a first tranche of 25 million doses of assorted American vaccines could run into regulatory delays, as issues of indemnity and authorisation have not been resolved at present.

“Indian diplomacy is focussed on securing the vaccine supply chain,” said External Affairs Minister S. Jaishankar, who had raised the issue of easing U.S. exports of vaccine ingredients and components to India during his visit to Washington last week. On Thursday, the U.S. White House announced that it was relaxing export restrictions for U.S. companies to supply manufacturers of AstraZeneca, Novavax, and Sanofi vaccines.

“This policy change will hopefully increase the supply of raw materials globally and to India; boosting our vaccine production capacity and strengthening our united fight against this pandemic,” tweeted SII CEO Adar Poonawalla, thanking Mr. Jaishankar and U.S. President Joseph Biden for the move.

While the government said the U.S.’s decision on vaccine ingredients was a big relief, officials questioned whether the U.S. government’s other big announcement of plans to gift 25 million doses of Pfizer, Moderna and Johnson & Johnson vaccines would have a major impact, as it is not expected to be a substantial number.

In a briefing for journalists on Friday, U.S. State Department Coordinator for Global COVID Response and Health Security Gayle Smith said the U.S. is still trying to “match” the vaccine donations with “where they can be most effectively supported”.

“In terms of the actual number of doses, we’ve done some notional planning, but the refinement of the actual dose numbers will be determined in consultation with the governments and their health experts, the state of their vaccine plans and delivery, and with COVAX,” said Ms. Smith, referring to the global vaccine alliance.

According to the White House “Factsheet” on regional distribution, India is one of 16 Asian countries that will receive a total of seven million (70 lakh) vaccines, and also part of a grouping of another 13 high priority countries that would receive a total of six million vaccines.

“As a result, India’s dose will not be more than about two to three million doses in total,” estimated one government official, pointing out that India is vaccinating about 2.8 million people a day at present.

It is also unclear how quickly these vaccines could be distributed in India, given procedures and approvals required. In a notification on June 1, the government amended its previous order of April 15, further easing the Emergency Use Authorisation (EUA) trial and testing requirements for all vaccines that have received clearances from the U.S. FDA, WHO, United Kingdom, Japan and Europe.

However, the three American companies will still need to apply for and be granted the Authorisation. At present, India has granted EUA only for Covishield, Covaxin and Russian-developed Sputnik, and according to a press note by National Expert Group on Vaccine Administration for COVID-19 (NEGVAC) Chairman Dr Vinod Paul last week, “No application of any foreign manufacturer for approval is pending with the drugs controller.”

Meanwhile, the issues over granting indemnities or a waiver of liabilities in case of adverse effects of the vaccines have not yet been resolved between the government and U.S. manufacturers. According to MEA sources, the government expects that Washington will help in ensuring that the vaccines being gifted will adhere to local regulations on indemnity.

The government also hopes that the U.S. will redouble efforts to disburse the bigger tranche of 60 million AstraZeneca vaccines at the earliest, as these have the approvals needed, and are the most widely used vaccines in India.

Bhutan, which needs its second dose of about 5,50,000 AstraZeneca vaccines by the end of June has also requested the U.S. to provide these. However, Ms. Smith made it clear that the AZ vaccines could only be distributed once the U.S. FDA clears them, a process that has already been held up for more than a month. If they are held up further, the concern is that the vaccines may even expire.

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