U.S. to Begin Sharing AZ Shots With Other Countries as It Moves to Support India

The Biden administration has decided to begin sharing its AstraZeneca (AZ) vaccine supply with the rest of the world while the shots go unused in the U.S., as the government also begins delivering supplies of raw materials needed to make the vaccine in COVID-ridden India.

President Biden, who has said that the U.S. will have enough authorized vaccine supply to inoculate all adults by the end of June, has faced increasing calls to help other countries combat the pandemic by sharing the government’s supplies of AZ vaccine doses, which will go unused until the vaccine receives Emergency Use Authorization.

The administration is currently “looking at options to share American-made AZ vaccine doses during the next few months,” White House Press Secretary Jen Psaki said Monday.

“Given the strong portfolio of vaccines that the U.S. has already authorized and that is available in large quantities … and given AZ is not authorized for use in the U.S., we do not need to use AZ in our fight against COVID over the next few months,” she said.

She noted that the U.S. will not export any AZ doses until their quality has been confirmed by the FDA in light of the Emergent BioSolutions Bayview, Md., facility material mix-up (DID, April 5). She said that details should emerge “in the near future” about recipients and planning.

The U.S. previously took smaller-scale action to share supplies of its AZ shots, sending 1.5 million doses to Canada and 2.5 million to Mexico in March, marking a reversal of the prior administration’s policy (DID, March 19). The U.S. is expected to share up to 60 million doses of the AZ vaccine now that it has expressed its willingness to export the vaccine to other nations.

The government is also providing support to India, which has been reeling from an unprecedented surge in coronavirus cases, by providing raw materials needed to manufacture the AZ vaccine. The aid is reciprocal, Biden said, citing the help the Indian government gave to the U.S. early on in the health crisis when American hospitals were overburdened with COVID-19 patients.

“Just as India sent assistance to the U.S. as our hospitals were strained early in the pandemic, we are determined to help India in its time of need,” the president said.

The White House said that the U.S. is “working around the clock” to send available resources to India as it faces staggering numbers of new infections. And the federal government is also funding a significant expansion of manufacturing capacity for Biological E, an Indian vaccine manufacturer, that will enable it to produce at least 1 billion doses of COVID-19 vaccines by the end of 2022. The company is also developing its own coronavirus vaccine. Its candidate recently showed promise in a phase 1/2 trial, clearing the way for a late-stage trial.

The U.S. is also pitching in with supplies of therapeutics, rapid diagnostics, ventilators and personal protective equipment, as well as oxygen generators and related supplies that are urgently needed, the White House said.

The U.S. and India have seen the highest number of coronavirus cases in the world, according to WHO data.

In other news, the European Commission, backed by all 27 of its member states, has moved to bring legal proceedings against AZ over its failure to meet its supply commitments to the bloc, which set a 300 million-dose target by the end of the second quarter. The first hearing will take place in the Brussels Court on Wednesday, a commission spokesperson told FDAnews.

“This action is due to the continuous breach of the terms of the contract and to the lack of a reliable strategy by the company to timely ensure the supply of vaccines in the current circumstances. Our main objective is to ensure the speedy delivery of vaccines in line with the advance purchase agreement,” the spokesperson said. “The action will seek to have the speedy delivery of vaccines in line with the [agreement].”

The litigation against the drugmaker, while intended to accelerate supplies of vaccines to the EU, could have a damaging effect on public confidence in the two-dose shot.

Only 31.3 million doses of AZ’s vaccine have been distributed in the EU as of Monday, according to Europe’s vaccine tracker data.

AZ did not return a request for comment by deadline. — James Miessler