The COVID-19 vaccine trial involving AstraZeneca (Oxford) vaccine candidate AZD1222 in Palm Beach County has been paused for “political pressure,” reports the study principal investigator. This dovetails with reports from the Financial Times and observations made by TrialSite of at least one important anomaly associated with this pivotal Phase 3 clinical trial. Although by August 17, the researchers reported at a news conference that they were ready to commence the study and administer the vaccine to the first ten subjects. Now the study is on hold purportedly because the U.S. Food and Drug Administration (FDA) questions whether a European trial is sufficient for the initiation of manufacturing and distribution of the vaccine. According to the principal investigator Dr. Larry Bush, the FDA is evaluating whether the trial can be bypassed completely for the use of an emergency utilization access (EUA) as the vaccine results were positive in Europe. The FDA typically approves drugs and vaccines based on trials in the United States and not those undertaken in other national jurisdictions. Self-described as “apolitical,” the principal investigator suggests powerful political interests, possibly part of the current administration’s camp seeking to “short-circuit” U.S. vaccine trials on COVID-19 so that the administration can announce an EUA for a vaccine before the end of the year. Could all of this be true, or is this information itself the result of a misinformation campaign?
Post Tipped-off to Trial Delay
The Palm Beach Post uncovered the delay for this clinical trial to be held in Palm Beach County from a reader after reaching out to the trial site organization, JEM Research Institute (conducting the study at JFK Medical Center), and was told there were no vaccine appointments despite the fact that she was a registered study participant.
When asked about a delay, JEM Research Institute founder Dr. James Goldenberg referred all questions to study sponsor AstraZeneca. At least for the Palm Beach Post, the UK-based pharmaceutical company didn’t return the call for comment, reports journalist John Pacenti.
JEM Research Institute had already kicked off the trial with a splash including a media event with Mayor Dave Kerner reports Mr. Pacenti. Principal investigator Dr. Bush, reports the Palm Beach Post, commented that the county was selected as it was a COVID-19 hot spot.
‘Having a Pandemic in Election Year…A Problem’
Dr. Bush summed it up when he stated, “What is holding all this up is the political pressure.” Commenting on the unfortunate confluence of forces, “I think having a pandemic in an election year is a problem. Either way, people use that as a point that they are right and the other side is wrong,” commented Dr. Bush. This physician is opposed to the EUA for an experimental vaccine as the Palm Beach Post reported his position: “If President Donald Trump’s FDA does approve emergency access utilization for the vaccine the true effectiveness of it may never be known and a bad precedent will be set for vaccine trials going forward.” Of course, it will be quite difficult to find trial subjects for a vaccine with EUA status.
On the other hand, EUA can be a very good thing, such as the use of blood plasma reports Bush. He commented that in the case of one study evidencing that plasma was ineffective, that was due to the fact that bureaucratic red tape was slowing down the process, and patients were not receiving the regimen early enough.
As TrialSite reported rumblings from the Financial Times suggested pressure from the top of the U.S. executive branch to streamline the EUA approval for AZD1222. TrialSite, after reviewing all Phase 3 vaccine candidates, found an anomaly with this study: this study timeline is unbelievably compressed with the estimated start date of August 17, followed by the estimated primary completion date on December 2, 2020. Does this unprecedented timeline compression have a purpose above and beyond good science and public health?
AZ Ramps up Production Capacity
CBS recently reported that AstraZeneca has the capacity to produce up to 3 billion doses upon approval, and the Anglo-Swedish multinational drugmaker is moving full throttle with manufacturing planning regardless of the outcome—so-called “at-risk” production. Have they been given certain communications from the top?
Monitoring this Situation Closely
TrialSite is monitoring this situation closely. That politics over good science will drive an EUA is unacceptable, and an independent media will certainly call this out should such a situation unfold, regardless of political participants. Of course, right now, all of the information is based on snippets and data points, and hence the actual situation in its entirety.
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