FDA authorises restart of the COVID-19 AZD1222 vaccine US Phase III trial

AstraZenecaClinical trials for the AstraZeneca Oxford coronavirus vaccine, AZD1222, have resumed across the world with regulators in the US, UK, Brazil, South Africa and Japan confirming that it was safe to do so.

The Food and Drug Administration (FDA) authorised the restart in the US, following the resumption of trials in other countries in recent weeks. The FDA reviewed all safety data from trials globally and concluded it was safe to resume the trial.

As part of the standard review process for trial safety events, a voluntary pause to vaccination across all global trials was triggered on 6 September to allow the examination of safety data by independent monitoring committees. The recommendations from these reviews have been supported by international regulators, who also confirmed that the trials were safe to resume.

Pascal Soriot, Chief Executive Officer, 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."

It is not unusual that in large scale vaccine trials, some participants will become unwell, and every case has to be evaluated to ensure the careful assessment of safety.

Results from the late-stage trials are anticipated later this year, depending on the rate of infection within the communities where the clinical trials are being conducted. Data readouts will be submitted to regulators and published in peer-reviewed scientific journals. Rolling reviews of the vaccine programme have already begun in countries where this regulatory pathway has been established, providing regulators access to data as soon as they become available.

While trials are ongoing, AstraZeneca and Oxford University will continue to provide information to regulators, study investigators and participants according to clinical trial and regulatory standards.(1-5)

About AZD1222

AZD1222 was co-invented by the University of Oxford and its spin-out company, Vaccitech. It uses a replication-deficient chimpanzee viral vector based on a weakened version of a common cold virus (adenovirus) that causes infections in chimpanzees and contains the genetic material of the SARS-CoV-2 virus spike protein. After vaccination, the surface spike protein is produced, priming the immune system to attack the SARS-CoV-2 virus if it later infects the body.

About AstraZeneca

AstraZeneca (LSE/STO/Nasdaq: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in three therapy areas - Oncology, Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide.

1. Declaration of Helsinki: Medical Research Involving Human Subjects. Available at https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects/ [Last accessed October 2020].
2. Fleming T, et al, Maintaining confidentiality of interim data to enhance trial integrity and credibility. Available at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2703711/ [Last accessed October 2020].
3. European Medicines Agency: Guideline for good clinical practice E6(R2). Available at https://www.ema.europa.eu/en/ich-e6-r2-good-clinical-practice [Last accessed October 2020].
4. Health Insurance Portability and Accountability Act (HIPAA): Protecting Personal Health Information in Research: Understanding the HIPAA Privacy Rule. Available at https://privacyruleandresearch.nih.gov/pdf/HIPAA_Booklet_4-14-2003.pdf [Last accessed October 2020].
5. General Data Protection Regulation: Article 5, Principles relating to processing of personal data. Available at: https://gdpr-info.eu/art-5-gdpr/ [Last accessed October 2020].

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