AstraZeneca Could File for Emergency Use Authorization as Soon as This Month

AstraZeneca (AZ) could be ready to request Emergency Use Authorization (EUA) from the FDA for its COVID-19 vaccine before the end of the month as its U.S. phase 3 trial nears having enough data to adequately assess its efficacy.

An AZ spokesperson told FDAnews that the late-stage trial data is expected to become available “in the coming weeks,” after which the company will waste no time in filing for emergency authorization. The FDA, which is expected to move quickly in its review of the EUA filing, took about three weeks each to evaluate and authorize Pfizer/BioNTech, Moderna and Johnson & Johnson vaccines.

AZ expects to make approximately 30 million doses available to the U.S. government by the end of this month, with another 20 million anticipated to be delivered by the end of April.

The two-dose AZ shot, which could become the fourth COVID-19 vaccine authorized in the U.S. if it makes it over the FDA’s hurdles, has become a point of contention between the U.S. and EU. The trade bloc, which has already reviewed and authorized the vaccine, has clamored for the U.S. to share domestically made shots that have so far gone unused.

AZ has seen continuous delays in meeting its supply commitments with the EU to the frustration of officials and member states, with some countries seeking stocks of nonEU-authorized vaccines as an alternative (DID, March 11).

EU officials claimed last week that the U.S. has refused to export any AZ vaccines to Europe despite the vaccine’s current lack of FDA authorization. White House Coronavirus Response Coordinator Jeff Zients said during a briefing Friday that the U.S. has a “small inventory” of AZ doses that it intends to hold and distribute upon authorization.

A Biden administration official previously told FDAnews that the government is still allowing vaccine manufacturers to export domestically made doses so long as they manage to meet their U.S. supply commitments (DID, March 12).

The exact figures of the U.S.’ current stock of the AZ vaccine are not known, but the government has a $1.2 billion contract with the company for 300 million doses (DID, May 22, 2020).

According to the primary analysis of AZ’s phase 3 trials in the UK, Brazil and South Africa, the vaccine provided full protection against severe infection, hospitalization and death. The analysis found that the vaccine held 76 percent efficacy after the initial dose and an efficacy of 82 percent when a second shot was given at least 12 weeks later. — James Miessler