Many EU Countries Halt Inoculations With AstraZeneca Vaccine

France, Italy and Germany have become the latest European countries to halt inoculations with AstraZeneca’s COVID-19 vaccine after 37 cases of blood clots were reported, joining an increasing number of other member states in temporarily putting them on pause as a safety review is conducted.

Although the company has offered reassurances, concluding from a review of safety data from more than 17 million vaccinated people in the EU and UK that its vaccine “showed no evidence of an increased risk” of blood clots, a cascading number of European countries have suspended its use so far, including Denmark, Estonia, Ireland, Latvia, Lithuania, Luxembourg, the Netherlands, and Spain.

The World Health Organization and the European Medicines Agency (EMA) have said that the evidence does not point to the vaccine as the cause of the blood clots, but the EMA will hold an emergency meeting on Thursday to conclude its review and detail any further actions if needed.

AZ’s new problems come at a very bad time for Europe, which is experiencing another wave of infections that is causing member states to issue lockdowns despite ongoing vaccinations.

The company has warned that its supply woes will probably extend into the second quarter, further impeding its efforts to meet COVID-19 vaccine supply commitments to the European Union.

After running into production snags in Europe, AZ had planned to tap its international supply chain to deliver half of the EU’s second quarter shipments and ten million first quarter doses. But the company said it is now experiencing export restrictions that will limit its first quarter vaccine deliveries to 30 million doses and likely reduce second quarter deliveries as well.

Under its contract, AZ is supposed to supply 300 million doses by the end of June, but it’s been dropping its targets after experiencing delays. It had originally pledged to deliver 90 million doses in the first quarter, but that number has dropped over time from 40 million to just 30 million. It is now aiming to deliver a total of 100 million doses to the EU in the first half of the year (DID, March 2). According to reports, the company’s contract with the bloc also includes an option for 100 million more doses, and it protects AZ from lawsuits over late deliveries.

Europe has called on the U.S. to release some of its domestically manufactured stock of AZ vaccine doses, which aren’t yet in use as the vaccine has not received FDA emergency clearance. 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 in the U.S. upon authorization (DID, March 15).

In the U.S., meanwhile, results of the company’s phase 3 U.S. trial are reportedly under review by the study’s data safety monitoring board and AZ is expected to file for Emergency Use Authorization from the FDA within weeks. — James Miessler