NIAID Concerned AstraZeneca May Have Given Outdated Info From COVID-19 Vaccine US Trial

AstraZeneca Plc AZN may have included outdated data related to the U.S. trials of its COVID-19 vaccine that resulted in an incomplete view of the efficacy data, the U.S. National Institute of Allergy and Infectious Diseases (NIAID) said on Monday.

What Happened: The British drugmaker had said earlier that interim data from U.S. clinical trials in over 32,000 people shows its COVID-19 vaccine developed with Oxford University is 79% effective and safe. That data is now under the spotlight.

The Data and Safety Monitoring Board (DSMB) notified NIAID, and Biomedical Advanced Research and Development Authority (BARDA), and said it was concerned over the initial data provided by AstraZeneca related to the COVID-19 vaccine clinical trial.

A number of countries, mostly in Europe, have over the last few weeks temporarily suspended the use of the AstraZeneca shot after reports linked to blood clots.

See Also: AstraZeneca Review Finds COVID-19 Vaccine Doesn't Increase Risk Of Blood Clots

AstraZeneca had claimed its vaccine was also 100% effective at preventing severe disease, death, and hospitalization.

The Oxford-AstraZeneca vaccines are made in the United Kingdom at Oxford and Keele. A third facility in Wrexham puts the vaccine into vials and packages it up for distribution.

Why It Matters: The fresh spotlight on the vaccine could impact the drugmaker’s plans to secure it for emergency use in the United States, which is already battling shortages, in the near future. 

As of Tuesday morning, nearly 30 million people in the United States have been infected with the coronavirus according to a New York Times database.

Despite more than 100 million vaccine doses having already been administered across the U.S., there is still a need for more vaccines. The U.S. Congress last week passed the $1.19 trillion COVID-19 relief bill that is expected to speed up the production and rollout.

U.S. drugmaker Merck & Co MRK, which has abandoned plans to make its own vaccine, is helping Johnson & Johnson JNJ produce the vaccine. Pfizer Inc PFE and its partner BioNTech SE BNTX have been scaling up vaccine production, as well.

Price Action: AstraZeneca shares traded 2% lower at $50.14 in the pre-market session on Tuesday.