Although the AZD1222 COVID-19 vaccine trial was put on pause while its sponsor, AstraZeneca, investigated a reported side effect associated with the vaccine candidate, BBC reports today that Oxford University, the vaccine maker, has declared the vaccine safe and hence moves forward with its research. The prestigious British university declared that it was “expected” that at least “some participants will become unwell” in such a large clinical trial. Originally developed at Oxford and known as ChAdOx1 nCoV-19, AstraZeneca partnered with the university to co-develop and hopefully commercialize the investigational product.
In the British press, it was reported that Sir Patrick Vallance, chief scientific advisor for the UK government, informed Downing Street via a press conference that what happens actually happens a lot in research. It’s part of the process.
Proceed with the Study
Oxford now will proceed with the study based on the recommendations of the independent safety review committee and the UK MHRA (food and drug regulator for the UK). BBC reported that on Twitter, Matt Hancock, Health Secretary, welcomed the news of the trial restart, noting, “This pause shows we will always put safety first. We will back our scientists to deliver an effective vaccine as soon as possible.”
Confidentiality Precludes Disclosure, but A Leak
Unfortunately, or fortunately, depending on one’s point of view, Oxford will not disclose why the study participant experienced the bout of illness, potentially associated with the trial. Why? Confidentiality. However, the New York Times did report that a UK volunteer was diagnosed with transverse myelitis, a spinal cord-based inflammatory syndrome, often caused by viral infections.
Now it would appear the trial may be starting again. This trial has attracted much interest. In the US, it’s been associated with speculation that perhaps, if the data looks overwhelmingly good, the AZD1222 product could be subject to an emergency use authorization (EUA) action in America. TrialSite wrote about some attributes of the protocol that were different than other Phase 3 COVID-19 vaccine trials.
With a potential resurgence of SARS-CoV-2 infections and fall and winter around the corner, the world needs a safe and effective vaccine sooner rather than later.