AstraZeneca Shoots Down Rumors of EUA Discussions for COVID-19 Vaccine

AstraZeneca has denied claims that it is in talks with the U.S. government about receiving a potential Emergency Use Authorization (EUA) for its COVID-19 vaccine candidate.

The UK-based pharma giant said that it is too soon to consider an EUA for its promising vaccine candidate, AZD1222, which is still in late-stage trials in the UK and Brazil and won’t provide efficacy results until later in the year.

The Trump administration is eager to see the authorization of a vaccine by the FDA ahead of the presidential election in November and AZD1222 is considered a leading candidate.

“AstraZeneca has not discussed Emergency Use Authorization with the U.S. government and it would be premature to speculate on that possibility," the company said.

HHS also denied the claims, telling FDAnews thatpolitics would play no part in any decision to approve a COVID-19 vaccine.

“Data is driving the development of all COVID-19 countermeasures,” said Michael Caputo, HHS assistant secretary for public affairs. “Careless talk about career FDA experts somehow approving an unsafe and ineffective vaccine just for politics only undermines confidence in the public health system.”

AZ has received a $1.2 billion contract from the U.S. government via Operation Warp Speed to accelerate research and production of the hopeful vaccine, an arrangement that also secures 300 million doses of the vaccine for distribution in the U.S. (DID, May 22).

AZ has been busy working out supply deals for the vaccine, most recently reaching a 25 million-dose arrangement with the Australian government. The UK’s government worked out a deal with AZ in May that put the UK first in line to receive the vaccine should it prove effective and safe in late-stage trials (DID, May 19).

The company is also entering into multiple manufacturing agreements. Yesterday, it announced a deal with New Jersey-based Catalent to manufacture the drug substance for AZD1222, at its facility in Harmans, Md.  The deal expands upon a previous agreement between the companies signed in June, under which Catalent will provide large-scale vial filling and packaging of the vaccine from its facility in Anagni, Italy.

AZD1222 is currently in multiple trials around the world and is just entering a phase 3 U.S. study that aims to enroll 30,000 participants. — James Miessler