AstraZeneca Covid-19 Vaccine Trials Resume in U.K.--Update

By Peter Loftus 

AstraZeneca PLC said Saturday clinical trials for its experimental coronavirus vaccine have resumed in the U.K. after regulators concluded it was safe to do so, following a pause in studies globally after a person who received the vaccine had an unexplained illness.

Trials in other countries, including the U.S., remain paused while AstraZeneca works with national health authorities, the company said.

AstraZeneca said Tuesday it paused trials globally of a vaccine it licensed from the University of Oxford after a vaccinated woman in the U.K. experienced the unexplained illness, which a U.S. official described as a spinal cord problem.

The pause gave independent committees and country regulators time to evaluate the case and determine whether it would be safe for testing to begin again.

A U.K. committee has concluded its investigation and recommended to the U.K. Medicines & Healthcare products Regulatory Agency it would be safe to resume the trials. The regulatory agency confirmed that it was safe to resume, the company said.

The MHRA couldn't immediately be reached for comment.

AstraZeneca said it couldn't disclose further medical information.

Also Saturday, Pfizer Inc. and partner BioNTech SE said they asked U.S. regulators to permit expanding the late-stage trial testing for their experimental Covid-19 vaccine to about 44,000 people, up from 30,000.

Pfizer expected to reach its initial target of enrolling 30,000 subjects next week. A larger trial will increase diversity and include people as young as 16 years old, as well as people diagnosed with viral diseases such as HIV, hepatitis C and hepatitis B, the company said.

Pfizer still expected to have results by the end of October, and aimed to file for regulatory authorization or approval, if the results are positive, by the end of October, a company spokeswoman said.

Jared S. Hopkins contributed to this article

Write to Peter Loftus at [e-mail]

(END) Dow Jones Newswires

September 12, 2020 11:38 ET (15:38 GMT)

Copyright (c) 2020 Dow Jones & Company, Inc.