AstraZeneca Resumes Phase 3 US Trial for its COVID-19 Vaccine

AstraZeneca recently announced that the Phase 3 clinical trial for its COVID-19 vaccine, AZD122, has resumed in the US after FDA deemed it safe to do so. 

All clinical trials for AZD122 have now resumed globally after regulators in the UK, Brazil, South Africa, and Japan also reviewed all safety data from trials globally and confirmed it a safe move. 

“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,” Pascal Soriot, chief executive officer of AstraZeneca, said in the announcement. 

On September 3, AstraZeneca announced that AZD1222 expanded into a Phase 3 clinical trial in the US to assess its safety, efficacy, and immunogenicity. 

The trial was funded by National Institute of Allergy and Infectious Disease (NIAID). The US Biomedical Advanced Research and Development Authority (BARDA) also granted AstraZeneca $1 billion for the development, production, and delivery of the vaccine. 

But on September 8, AstraZeneca paused the clinical trial of AZD122 due to an unexplained illness that occurred in the UK Phase 3 trial. 

AstraZeneca and the University of Oxford, the trial’s sponsor, were not able to disclose further medical information.

But just a few weeks after, the company resumed the trial strictly in the UK following confirmation by the Medicines Health Regulatory Authority that it was safe to do so.

In general, all studies conducted by pharmaceutical companies have prespecified guidelines, which ensure that a study may be paused or stopped if any unexpected serious adverse events related to the study product occur. 

When this happens, researchers will carefully review information and then decide when the study can resume. 

A study pause is done by the study sponsor and is a common component of clinical trial protocol, while a regulatory hold of a clinical trial is a requirement by regulatory health authorities, including FDA. 

AstraZeneca stated that it is committed to the safety of trial participants and the highest standards of conduct in clinical trials.

“AstraZeneca and Oxford University will continue to provide information to regulators, study investigators and participants according to clinical trial and regulatory standards,” the company stated. 

Results from the late-stage trials are expected later this year, contingent on rate of infection within the communities where the trials are taking place. 

Additionally, rolling reviews of the company’s vaccine program have already begun in countries where this regulatory pathway has been established. Regulators will be given access to data as soon as it becomes available.

AstraZeneca is one of the top pharmaceutical companies with promising COVID-19 treatments currently in clinical trials. 

In mid-October, the company announced that its COVID-19 antibody, AZD7442, will advance into two Phase 3 clinical trials at sites in and outside the US. 

AZD7442 is a combination of two LAABs created from convalescent patients after SARS-CoV-2 infection.

The LAABs were created with AstraZeneca’s proprietary half-life extension technology to boost the durability of the therapy for six to 12 months following a single administration, AstraZeneca said. 

The first trial will evaluate the safety and efficacy of AZD7442 to prevent infection for up to 12 months in nearly 5,000 participants, while the second trial will evaluate post-exposure prophylaxis and pre-emptive treatment in approximately 1,100 participants. 

Additionally, AstraZeneca will supply up to 100,000 doses of its vaccine starting at the end of 2020 and the US government can acquire up to an additional one million doses in 2021 under a separate agreement.