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AstraZeneca to share more data on Covid vaccine after US calls trial results outdated
The company will “immediately engage” with the independent panel monitoring the trial to share its analysis with the latest efficacy data.
AstraZeneca Plc said it will release up-to-date results from the final stage trial of its Covid vaccine within 48 hours, responding to criticism from a US science agency that had said that its analysis of the shot’s effectiveness included old information.
Results published Monday were based on an interim analysis of data through Feb. 17, AstraZeneca said in a statement. The company will “immediately engage” with the independent panel monitoring the trial to share its analysis with the latest efficacy data.
In a brief statement last night, the National Institute for Allergy and Infectious Diseases said the monitoring board charged with ensuring the safety and accuracy of the vaccine trial had expressed concern that results included outdated information.
The institute, headed by Anthony Fauci, urged AstraZeneca to work with the data and safety monitoring board to “ensure the most accurate, up-to-date efficacy data be made public as quickly as possible.”
The disclosure marks the latest hitch for AstraZeneca, which said on Monday that the vaccine was found to be 79% effective in preventing Covid-19 in a U.S. clinical trial of more than 30,000 volunteers. The shot, developed with the University of Oxford and viewed as a frontrunner to help curb the pandemic, has been beset by complications.
It’s now at the center of a supply showdown with the European Union, just days after concerns about blood clots prompted a dozen countries to suspend immunizations.
More Concerns
“The last thing this vaccine needs is more concern when we kind of thought we were at that point now where we’d put to bed all the other concerns,” said Paul Griffin, an associate professor of medicine at the University of Queensland in Brisbane, who is conducting clinical studies in Australia on four Covid-19 vaccine candidates.
After the vaccine was cleared for use in the UK and many other nations, AstraZeneca is preparing to seek approval from the US Food and Drug Administration. That greenlight may now be delayed.
The shares traded 1.1% lower Tuesday in London.
The efficacy rate in the US trial was stronger than the 70% figure AstraZeneca reported from an earlier study. But those data were an average of different readings -- 62% and 90% -- from two arms of the trial. Because of a manufacturing error, one group of participants had received a lower first dose, which produced the higher reading, compared with those getting two standard doses. Further analysis suggested it was the greater dosing gap rather than amount that had created the difference.
Something ‘Significant’
The Data and Safety Monitoring Board, an independent panel, also brought its concerns about the US trial results to the British drugmaker and to the Biomedical Advanced Research and Development Authority, a U.S. agency that partially funded the shot’s development.
“It was referring to outdated information, and it’s kind of hard to imagine how outdated information could be included when these vaccines are all fairly new,” said Griffin, an infectious-disease physician and microbiologist. “The impression I got was that it seemed to be something very significant they were alluding to.”
