AstraZeneca Faces Delay in Emergency Use Filing for its COVID-19 Vaccine
AstraZeneca (AZ) reportedly may not file for FDA Emergency Use Authorization (EUA) of its COVID-19 vaccine until mid-May as it needs more time to gather supporting data.
The company previously said it hoped to file for the EUA in April, but it is apparently taking longer than expected to gather real-world data from the UK, including details on effectiveness, transmission rates and safety.
A company spokesperson declined to comment on reports of a delay in the EUA filing, but said the company is “progressing on preparation of the submission.”
The shot is already authorized in Europe, Latin America and parts of Asia. But it has been linked to rare blood clots, and vaccinations were recently paused in the EU, although they are now resuming with a new requirement for a warning on the product information.
AZ has also fallen way behind in promised deliveries to the EU, and the European Commission is now taking legal action over the delayed shipments (DID, April 27).
The U.S. government has a $1.2 billion contract with the company to supply 300 million vaccine doses. But the likely abundance of alternatives with fewer reported risks may impact U.S. demand for the AZ vaccine even if it is authorized (DID, May 22, 2020).
The Biden administration announced earlier this week that it will begin sharing 60 million doses of the unused AZ shot with the rest of the world, including India, which is facing an alarming surge in COVID-19 infections (DID, April 27). — Jason Scott