Science community calls for transparency on AstraZeneca’s halted US COVID-19 vaccine trial

pharmafile | September 23, 2020 | News story | Research and Development AstraZeneca, COVID-19, Vaccine 

The halting of AstraZeneca’s COVID-19 vaccine trial around the world was cause for much initial concern over the eventual safety and efficacy of the therapy. Trials have resumed in the UK, Brazil and South Africa, but US trials remain on hold. Now, voices in the scientific community are calling for transparency from the trial organisers as to why.

The initial reason for pausing the study on 6 September was due to a UK participant developing a serious inflammatory condition. The University of Oxford, AZ’s partner in developing the therapy, argued that:  “After independent review, these illnesses were either considered unlikely to be associated with the vaccine or there was insufficient evidence to say for certain that the illnesses were or were not related to the vaccine.”

When an effective vaccination programme relies on the trust of the public, scientists have now been voicing concern that a lack of transparency from the therapy’s developers could impact the successful roll out if it eventually passes regulatory hurdles.

Dean of Brown University’s School of Public Health, Ashish Jha, remarked that: “Normally, companies wouldn’t give out information in the middle of a trial, but this is an exceptional case and we need to have radical transparency,” while Gigi Gronvall, Immunologist and Senior Scholar at Johns Hopkins Center for Health Security, echoed the sentiments, saying:  “It is important for everyone to be transparent and honest. Eventually, it’s the public who will either take this vaccine or not, so it is to their advantage to be transparent as possible.”

Virologist and vaccine specialist Peter Hotez, of the Baylor College of Medicine, also commented: “History tells us that we have several good vaccines that went unused because of communication failures and public misperceptions. It’s important to remember that we have a very active anti-vaccine, anti-science movement that began in the UK and has been amplified in America.”

So far, there has been no word from either AZ or the FDA on why the study had not resumed in the US.

“Regulators in each individual country determine when trials can start and they do this in their own timeframe,” AZ said in a statement. “Companies provide the information to the regulators to enable them to make this determination. On the current US status specifically, we are continuing to work with the FDA to facilitate review of the information and the agency will decide when the US trial can resume.”

The impact of a fall in trust in vaccine programmes is particularly perilous in the US, where the virus has claimed more than 200,000 lives; a recent poll conducted by Pew Research indicated that only half of US citizens “definitely” or “probably” intend to receive vaccination – a drop of 21 points since May.  

Matt Fellows

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