Biden To Divert AstraZeneca Materials To India

By Alyssa Aquino
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Law360 (April 26, 2021, 3:35 PM EDT) -- The U.S. government will provide the Indian government with the raw materials to produce the AstraZeneca vaccine, the Biden administration announced Monday.

At the request of the Indian government — which is grappling with a COVID-19 surge that is leading to hundreds of thousands of new infections daily — the U.S. will divert its orders of goods needed to manufacture the AstraZeneca vaccine to the Serum Institute of India, senior administration officials told reporters.

"Because of the scope of the current situation in India and the state of our own production here, this is the most effective and rapid step we can take at this step at scale," an official said.

The U.S. will also ship out 60 million doses of the AstraZeneca vaccine over the coming months, pending a quality control inspection by the U.S. Food and Drug Administration. That review process, which no AstraZeneca vaccine doses have completed, prevents Washington, D.C., from immediately sending finished vaccines to India, according to the government officials.

Though AstraZeneca's vaccine is being rolled out abroad, the company has yet to seek FDA permission to use its vaccine in the U.S. Instead, vaccines from Pfizer Inc., Moderna Inc. and Johnson & Johnson have powered the U.S.' mass vaccination efforts.

"We do not need to use the AstraZeneca vaccine here during the next few months," a senior administration official said.

Ten million AstraZeneca vaccine doses can be sent abroad as soon as the FDA clears them for export and another 50 million will become available throughout May and June. As doses become available, the U.S. will finalize plans on where they will be sent, according to the Biden officials.

The U.S.' immediate aid to India includes on-the-ground assistance from a "strike team" of public health experts and supplies of remdesivir, an antiviral drug that has been used as a virus treatment, rapid-response tests and personal protective equipment. Those health supplies have already been identified and can be immediately transferred, according to an administration official.

An official added that the Biden administration was pursuing options to provide oxygen generators and related equipment, such as cylinders and ventilators, to the Indian government.

Tahir Amin, an intellectual property attorney and the co-founder of the Initiative for Medicines, Access and Knowledge, an organization seeking to increase access to medicine, told Law360 that the U.S.' relief fell short.

"Donations and releasing supplies is useful, but it isn't going to get us where we need to curb the rising cases in India," he said.

Amin said a commitment to temporarily suspending intellectual property rights over COVID-19 vaccines and treatments is vital to combating the virus abroad.

In October, India and South Africa proposed a global IP waiver to the World Trade Organization, saying it would boost global vaccine and treatment production. The proposal has since won the support of over 100 development countries, as well as public health advocates and U.S. Sens. Bernie Sanders, I-Vt., and Elizabeth Warren, D-Mass. However, it has consistently faced opposition from the U.S. and the European Union.

On Monday, Biden administration officials said they had "nothing to say" about an IP waiver.

Amin acknowledged that waiving IP rights wouldn't fix the raw materials supply constraints currently holding up vaccine production. But he argued that manufacturing capabilities could be built up and that the global community has already "wasted" five months by not allowing the waiver.

"If everyone's coming out to end this pandemic, then you have to put everything on the table and so far, we're only putting a fraction on the table instead of trying to get the maximum," Amin said.

--Editing by Marygrace Murphy.

Update: This story has been updated with additional information.

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