AstraZeneca receives FDA authorisation to resume COVID-19 vaccine trial

AstraZeneca has confirmed that the U.S. FDA has authorised the resumption of Phase III clinical trials of the COVID-19 AZD1222 vaccine in the United States. In recent weeks, the British-Swedish biotech and pharma company also restarted clinical trials in other countries following approvals by national regulatory bodies.

AstraZeneca’s COVID-19 vaccine trials resume globally

Clinical trials for the COVID-19 vaccine, AZD1222, developed by AstraZeneca and Oxford University, have resumed globally, following the regulatory authorities approval in the US, UK, Brazil, South Africa and Japan. The Food and Drug Administration (FDA) has checked globally all safety evidence from the previous trials and determined that the clinical study resumption was safe.

A voluntary vaccine pause for all global studies was initiated on the 6th of September as part of the routine evaluation procedure for the trials safety data analysis and to enable independent monitoring committees to evaluate these safety results. After the safety report findings were supported by the foreign regulators they also announced that the trials were safe to restart.

Pascal Soriot, AstraZeneca’s 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 uncommon for certain participants to feel unwell in large-scale vaccine trials, and each case must be reviewed and evaluated precisely for safety evaluation. In September, AstraZeneca’s voluntary hold on the Phase III global clinical trials was triggered by a woman in the UK experiencing symptoms consistent with a rare but serious spinal inflammatory disorder called transverse myelitis.

The Phase III trial outcomes are anticipated later this year

The late-stage trial outcomes are planned for later this year, depending on the rate of infection among the population where the clinical studies are being performed. Data readouts will be forwarded to regulators and reported in scientific peer-reviewed journals. In countries where this regulatory pathway has been developed, rolling updates of the vaccine programme have been commenced, providing regulators with data access as soon as it becomes available.

Although trials are underway, subject to clinical trial and regulatory guidelines, AstraZeneca and Oxford University will continue to provide reports to the regulatory authorities, research investigators and participants.

In an earlier clinical trial named COV001, the COVID-19 vaccine, AZD1222 showed really promising results, with 100% of the trial participants developing neutralising antibodies after receiving the second dose.

About the AZD1222 COVID-19 vaccine

The University of Oxford and its spin-out company, Vaccitech, co-invented AZD1222. In April this year, AstraZeneca and the University of Oxford entered into a collaboration to enable global development, manufacturing and distribution of the COVID-19 vaccine AZD1222, formerly known as ChAdOx1 nCoV-19.

It uses a replication-deficient chimpanzee viral vector based on a weakened variant of a common cold virus (adenovirus) that causes infections in chimpanzees and contains the genetic material of the SARS-CoV-2 virus spike protein. The surface spike protein produced upon vaccination induces an immune response involving the elimination of the SARS-CoV-2 virus if it later attacks the body.

About AstraZeneca

AstraZeneca is a global, science-led pharma and biotech company dedicated to the research, development and marketing of prescription drugs, mainly for the treatment of diseases in three fields of therapy: oncology, cardiovascular, renal & metabolism, and respiratory & immunology. Headquartered in Cambridge, United Kingdom, AstraZeneca operates in over 100 countries and millions of patients worldwide use its revolutionary medicines.

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