AstraZeneca gets FDA approval to restart Phase III Covid-19 vaccine trial

The US Food and Drug Administration (FDA) has authorised the restart of Phase III clinical trial of AstraZeneca and Oxford University’s Covid-19 vaccine candidate, AZD1222, in the country.

Co-invented by the University of Oxford and Vaccitech, its spin-out company, AZD1222 utilises a replication-deficient chimpanzee viral vector based on a weakened form of a common cold virus or adenovirus that causes infections in chimpanzees.

The vaccine also has the genetic material of SARS-CoV-2 virus spike protein.

The surface spike protein is produced following vaccination, priming the immune system to attack the virus if it infects the body at a later point of time.

Trials across the globe restarted after regulatory authorities in the US, UK, Brazil, South Africa and Japan confirmed it was safe to continue.

The latest move comes after the FDA reviewed all safety data from global trials.

On 6 September, AstraZeneca put a voluntary pause to vaccination in all trials as part of the standard review process for trial safety events.

Independent monitoring committees reviewed the trials’ safety data and their recommendations were upheld by international regulators who gave approval for resuming trials after confirming it to be safe.

AstraZeneca CEO Pascal Soriot said: “The restart of clinical trials across the world is great news as it allows us to continue our efforts to develop this vaccine to help defeat this terrible pandemic.

“We should be reassured by the care taken by independent regulators to protect the public and ensure the vaccine is safe before it is approved for use.”

In large scale vaccine trials, it is common for some subjects to become unwell and every case requires analysis to guarantee a thorough assessment of safety.

The company expects results from the late-stage trials later this year.

AstraZeneca initiated rolling reviews of the vaccine programme in some countries in which regulators will get trial data when and where it becomes available.

Last week, the Peruvian government refused to sign a deal with AstraZeneca to purchase vaccines as the latter failed to provide sufficient data from its studies.