AstraZeneca’s press release reminded that, “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.”
From the CEO of AstraZeneca
Pascal Soriot, Chief Executive Officer of AstraZeneca, 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 that some participants will become unwell; 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 program 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.
AZD1222 is 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.
This news is encouraging and leads us to beleive that COVID-19 vaccines could soon be used. Vaccines are the only way to defeat SARS-CoV-2 (the virus that causes COVID-19).
In Other News
Qatar signed a deal with Moderna (MRNA) to buy its COVID-19 vaccine as soon as it’s granted approval.
Click to read more about COVID-19 and AstraZeneca.
Tracking the News from AstraZeneca About Experimental Vaccine, AZD1222, for COVID-19
News from AstraZeneca About COVID-19 Vaccine, AZD1222
From AstraZeneca (AZN) we learned that its COVID-19 vaccine, AZD1222, which is being developed in collaboration with Oxford University, has produced a similar immune response in older and younger adults. A spokesman from the firm stated that the results have further built the body of evidence for the safety and immunogenicity of AZD1222.
On October 23, 2020 AstraZeneca’s vaccine, AZD1222, resumed trials across the world with regulators in the US, the UK, Brazil, South Africa and Japan confirming that it was safe to do so. The FDA has authorized 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.