Vaccine shipments, legal hurdles on Jaishankar’s agenda

Vaccine shipments, legal hurdles on Jaishankar’s agenda

Minister is due to meet U.S. officials on sharing stockpile, early EUA.

Ironing out issues over procuring more vaccines for Indians, including the U.S. demand for indemnity and early Emergency Use Authorisation, is expected to dominate the agenda as External Affairs Minister S. Jaishankar began a series of meetings in Washington over Thursday and Friday, with the U.S. government and industry groups on COVID-19 related issues.

Officials, however, stressed that vaccine procurement is not the “only agenda” for the EAM’s visit as discussions on the Indo-Pacific, Quad cooperation and strategic issues will also take place. However, a substantial part of Mr. Jaishankar’s discussions with the U.S. State Department will focus on requests for Washington to share its stockpile of AstraZeneca vaccines, as well as to release more vaccine ingredients and components required for manufacturing in India.

Sources also confirmed that India’s joint proposal at the WTO for a TRIPs or patent waiver on vaccines will come up during his talks with U.S. Trade Representative Katherine Tai. And his discussions with the U.S. Chamber of Commerce’s “Global Task Force” for industry heads will include many pharmaceutical companies, where stepping up India’s vaccine imports will be on the agenda.

Suppliers’ constraints

According to officials, India has already been in touch with all three U.S. vaccine manufacturers — Pfizer, Moderna and Johnson & Johnson — to try and smooth the way for vaccines to be made available in India. In the past few weeks, senior government officials in Delhi and Indian Ambassador to the U.S. Taranjit Singh Sandhu have held virtual meetings with Moderna CEO Stephane Bancel, J&J Chairman & CEO Alex Gorsky and Pfizer CEO Albert Bourla.

Sources aware of the meetings said the four issues raised by the U.S. CEOs were over legal indemnity, or a demand for immunity over adverse reactions; a need for a centralised mechanism to negotiate purchases, rather than the Modi’s government’s plan to route these through individual States; upfront orders with substantial advance payments; and an early Emergency Use Authorisation (EUA) by India for all the vaccines.

Government officials would not confirm the exact number of vaccine doses that might be made available, and said the decisions on each of these concerns would be taken in conjunction with the Ministries of Finance, Commerce and Health. India has not agreed to indemnity for any of the three vaccines approved already (Covishield, Covaxin and Sputnik), but it has agreed to fast-track procedures for U.S. vaccines, amongst other global vaccines, including waiving bridge trials for all of them.

However, agreeing to centralised bookings and advance payments will require a U-turn by the government that has left it to the States to negotiate.

Sources said India’s own request for a share of the 80-million dose AZ stockpile the that the U.S. hopes to distribute now hinges on the U.S. Food and Drug Administration (FDA) clearing the vaccine for domestic use first, and they hope for a decision on this by July 4.

Crucial ingredients

Meanwhile, nearly a month after the U.S. announced it would ease export restrictions on vaccine ingredients and components, there has been only one diverted shipment of ingredients, sufficient for only 20 million doses, and officials said it will be impossible to scale up India’s vaccine production without this.

The government has also updated its requests for Indian missions to follow up with foreign governments, and the list now includes drugs to fight mucormycosis or “black fungus”, as well as special ECMO machines that oxygenate the blood supply.

When asked about the fate of drugs previously requested from the U.S., like Remdesivir, which has now been dropped from medical protocols, the sources said these would be processed by the Health Ministry.

The sources said they do not expect a definitive answer on the vaccine supply during Mr. Jaishankar’s visit, but hope that the issues will be smoothed out, as the government wants to proceed with its vaccination plans from July. With only 4.2 crore Indians vaccinated — about 3.1% of the population thus far —India lags behind other major countries, including the U.S., that has fully vaccinated about 40% of its population.

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