The world has placed high hopes on the COVID-19 vaccine candidate originally developed in Oxford (ChAdOx1 nCoV-19) and now licensed by AstraZeneca, known as AZD1222. However, since the AstraZeneca-sponsored Phase 3 clinical trial commenced confidence in this particular candidate could be eroding. First the study was adversely impacted by a material safety incident in the UK that caused a several week delay in the clinical trial in America. Recent news based on interim study data of a 70% effectivity rate was treated with excitement in British tabloids but since the data disclosure, the UK-based company has subsequently shared that significant errors occurred in the process of administering the vaccine to some of the study participants. Could this error as well as a number of other irregularities and omissions associated with how AstraZeneca (at least at first) shared data erode confidence in the reliability of the results? Will the vaccine’s considerable efficacy hold up under more scrutiny?
Recently, The New York Times’ Rebecca Robbins and Benjamin Mueller take a critical look at the recent positive reports balanced by some of the more questionable data points surfacing during this pivotal Phase 3 clinical trial.
A Promising Candidate’s Chances Fade
Originally considered one of the top vaccine candidates, the continuous erosion in confidence leads many to speculate that the probability of AZD1222 becoming approved for emergency use authorization, at least by the U.S. Food and Drug Administration (FDA), declines by the week. Geoffrey Porges, an often quoted investment bank analyst with SVB Leerink commented in the NY Times piece, “I think they (AstraZeneca) have really damaged confidence in their whole development program.”
Back in late August, TrialSite published a piece raising questions about a purported “October Surprise.” That is, there were rumors that the present administration was in discussions with a pharmaceutical company to accelerate a COVID-19 vaccine via Emergency Use Authorization (EUA) timed to occur before or near the presidential election. These rumors were shared in credible publications such as the Financial Times. Was AstraZeneca’s AZD1222 the “chosen one”? It was rumored to be so.
TrialSite was the only media platform to identify an important anomaly associated with this Phase 3 AstraZeneca AZD1222 protocol: that was that the duration from the study’s estimated start date to the estimated primary completion date equaled only 3.5 months. Unprecedented for a Phase 3 vaccine trial and nowhere near as lengthy as the other Phase 3 COVID-19 vaccine trials, including the ones sponsored by Chinese companies. There was one other exception: the Sputnik V vaccine out of Russia. Put another way, the trial protocol was designed so that the estimated primary completion date would have occurred around the time of the election. How times have changed in just a few months.
The Hope: AZD1222 Comes Through
Regardless, the hope is that despite some challenges along the way, AZD1222 turns out to be a compelling vaccine candidate: the world needs multiple high quality vaccines to combat COVID-19.
Call to Action: Follow the link to visit Rebecca Robbins and Benjamin Mueller’s recent article in the NY Times.