The trial was originally halted because a British participant developed severe inflammatory disease. In the United States, it has been suspended for almost two weeks, while trials in other countries, including the United Kingdom, have resumed.
Ashish Jha, Dean of the School of Public Health at Brown University, said: “Normally companies wouldn’t release information in the middle of a trial, but this is an exceptional case and we need ‘radical transparency. Otherwise, the public risks losing confidence in the whole process. ”
AstraZeneca advises participants at the resumption of trials that the “unexplained neurological symptoms” were unlikely to be associated with the vaccine or that there was “not enough evidence” to say whether or not they were associated, and independent evaluators therefore recommended continuing vaccinations. . Clinical trials typically do not release data until they reach predetermined milestones.
The vaccine approval process in the United States has become highly political, with critics accusing the Trump administration of trying to rush a vaccine ahead of the November presidential election.
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As the political argument has intensified, polls show the public is rapidly losing confidence in the safety of a possible vaccine. The latest Pew Research poll shows that only half of Americans now say they would definitely or likely be vaccinated by then. This is down 21 points from May.
Gigi Gronvall, immunologist and senior researcher at the Johns Hopkins Center for Health Security, said that when developing a vaccine in these “extraordinary times,” companies and regulators should be more open about why the US trial has not been restarted.
“It is important that everyone is transparent and honest,” she said. “Ultimately, it’s the public who will take this vaccine or not, so it is to their advantage to be as transparent as possible.”
Neither AstraZeneca nor the United States Food and Drug Administration would explain why the trial did not restart.
Vaccine makers, including AstraZeneca, Pfizer and Moderna, have tried to be more transparent by publishing their testing protocols.
Peter Hotez, virologist and vaccine specialist at Baylor College of Medicine, said the disease developed by the trial participant was likely unrelated to the vaccine, but warned that communication issues could make the public more susceptible to refuse a vaccine, even if it was safe and effective.
He said it was “disastrous” that details of the disease were released on a private call with AstraZeneca and investors, and called for Operation Warp Speed, the US government’s plan to invest in Covid-19 vaccines, to resume communications from pharmaceutical companies. .
“History tells us that we have several good vaccines that have not been used because of communication failures and public misconceptions,” he said. “It’s important to remember that we have a very active anti-vaccine and anti-science movement that started in the UK and has grown in America.”
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