June 8, 2022

FDA expands U.S. safety investigation of AstraZeneca COVID-19 vaccine, report says, raising prospect of further delays

AstraZeneca’s large late-stage US trial has been on hold since September, after a volunteer in the UK fell ill with an “unexplained illness”.

vincenzo pinto/Agence France-Presse/Getty Images

The U.S. Food and Drug Administration has expanded its investigation into AstraZeneca’s COVID-19 vaccine study, a report says, raising the prospect of further delays.

AstraZeneca AZN,
-1.16%
and its partner, the University of Oxford, voluntarily suspended its phase 3 study of the vaccine worldwide on September 9, after a volunteer in the United Kingdom developed a “unexplained illness”.

Regulators in the UK, Brazil, India and South Africa have since cleared AstraZeneca AZN,
-1.67%
to resume its clinical trials, but the UK drugmaker’s late-stage US trials remained on hold.

The FDA has requested additional data, the Reuters report said, citing two sources. The data was due to arrive this week, after which the agency would need time to analyze it.

When the British drugmaker suspended its trials, it said unexplained illnesses can arise ‘by chance’ in large trials and should be looked at independently.

A Information sheet for trial participants from Oxford University says ‘unexplained neurological symptoms’, which included change in sensation or limb weakness, were either considered unlikely to be associated with the vaccine or it There was “insufficient evidence” to say with certainty whether the illnesses “were or were not related to the vaccine”.

Read: There are four coronavirus vaccines in late-stage studies – here’s how they differ

Sources told Reuters the FDA was interested in other vaccines developed by the Oxford researchers, which used an adenovirus found in chimpanzees. The news agency said the regulator wanted to see if similar side effects showed up in trials of other vaccines designed by the same researchers.

However, the expanded investigation does not show that the FDA believes there were any safety issues associated with any of these vaccines, the report added, with one source saying the regulator “was thorough.”

An AstraZeneca spokesperson said, “We continue to work with the FDA to facilitate the review of the information needed to make a decision regarding resuming the US trial.”

The FDA declined to comment.

Read: AstraZeneca vaccine will ‘most likely’ be rolled out in the UK early next year

Dr Anthony Fauci, director of the US National Institute of Allergy and Infectious Diseases, said on September 9 that AstraZeneca’s decision to suspend global trials of its experimental coronavirus vaccine was “unfortunate” – but not a rare safety precaution in a vaccine development process.

In June, World Health Organization chief scientist Dr. Soumya Swaminathan described AstraZeneca’s experimental vaccine as likely the world’s leading candidate and the most advanced in development.

Swaminathan also stated that Moderna’s ARNM,
-1.52%
The COVID-19 vaccine candidate was not “far behind” that of AstraZeneca.

Read: Moderna climbs after saying COVID-19 vaccine generates antibodies in older people

However, on Thursday, Moderna’s chief executive said the company would not be able to seek emergency use authorization from the FDA. before November 25 at the earliest, dealing a blow to US President Donald Trump’s hopes of having the vaccine ready before Election Day on Nov. 3.

Shares of AstraZeneca were trading up 2.20% at the start of European trading on Thursday.

Berenberg analysts launched coverage on Wednesday with buy recommendations on AstraZeneca, GlaxoSmithKline GSK,
-0.32%,
Bristol-Myers Squibb BMY,
-0.20%
and Novartis NVS,
-0.24%.