AstraZeneca Still Anticipates Conclusive Vaccine Data by End of Year if Trials Resume

As long as a safety review of an AstraZeneca COVID-19 trial that’s been paused due to an illness allows the trial to resume, the drugmaker expects to stay on track and submit its vaccine candidate for regulatory approval by the end of the year.

AstraZeneca CEO Pascal Soriot offered assurances Thursday that the vaccine’s timeline will likely remain the same if trials are allowed to come back online after safety evaluations.

“Of course, it depends on the time of this review, but if the review by the safety committee allows us to restart the trial, I still think we are on track for having a set of data that we would submit before the end of the year,” he said at an online summit. “After this, it depends on how fast the regulator will review and give approval. So, we could still have a vaccine by the end of this year.”

Though the UK-based company has initiated a freeze of the late-stage trial, it has not been determined that the vaccine had anything to do with a single patient’s serious adverse event in the UK.

An AstraZeneca spokesperson Wednesday shot down reports that Soriot had said the safety issue was confirmed to be symptoms from transverse myelitis, adding that the CEO said there will be no conclusions until more tests are conducted. The spokesperson told FDAnews that the tests will be given to an independent safety monitoring committee for review and establishment of a final diagnosis (DID, Sept. 10).

In Thursday’s virtual summit, Soriot cited two other high-profile vaccine candidates — Pfizer’s and Moderna’s — that are “advancing quite quickly” in late-stage trials and said he believes they will also deliver conclusive phase 3 data before the end of the year. — James Miessler