AstraZeneca halted COVID-19 vaccination trials this past week when a patient in the trial suffered a serious adverse reaction according to StatNews. (https://www.statnews.com/2020/09/11/ethics-halting-vaccine-trial-pandemic-conversation-ruth-faden/) We have not been told what that reaction was, but it was significant enough to halt the entire trial. A safety review is underway.
In the vaccine race to contain the SARS-CoV-2 virus, AstraZeneca appeared to be the front-runner and close to ending its clinical trials. It was hoped that the results of the trials would be evaluated, and the ‘go-ahead’ issued to start manufacturing vaccines by the end of this year.
Clinical trials have requirements for continuing and halting. It is reported that the halt in this case was voluntary. That does not compute. Each decision step of the clinical trial should have a stop or continue option explicitly stated. Is the stoppage due to something outside the clinical test? Anything is possible when large-scale testing is involved.
The Condition of Anonymity
It seems that leaks are not limited to governments. This trial is being conducted in the United Kingdom. It is reported that one of the participants developed transverse myelitis which is an inflammation of both sides of the spinal cord. Transverse myelitis disrupts the communications along the spinal cord that acts as a conduit throughout the body.
It can be caused by a viral agent. People can recover, but it takes time – weeks to even years. Is transverse myelitis a potential side effect of the AstraZeneca vaccine for COVID-19? It is not known at this time. Halting the trial will prevent inadvertent viral infections in other test patients.
Nine drug companies are developing vaccines for COVID-19. All are committed to safety and security for a world-wide vaccine that can be used by billions. Each of these nine companies made a joint pledge to reaffirm their company’s safety and security efforts to minimize the risk of endangering the test patients or potentially millions of people down the road.
Operation Warp Speed
The United States was hoping for the first viable vaccine to be available to the public in October. Plans (https://www.hhs.gov/coronavirus/explaining-operation-warp-speed/index.html) must be in place to facilitate the final analyses, verification, and formal release to the public. As of now, it is unlikely that a vaccine will be released before Thanksgiving.
Pfizer and Moderna
are two of the nine companies with ongoing clinical trials. Assuming success by the end of this year, vaccinations would be released to the highest risk people (around 25 million). With vaccine mass production starting in early 2021, it will still take at least six months to make the required number of vaccines to immunize all Americans.
Record numbers of new COVID-19 cases will not be a thing of the past. Expect to see headlines from this state or another, or from this country or another as we head into the influenza season. More people are interacting socially, and infections are spreading. What is not spreading, and not being reported very loudly, is that hospitalizations and daily deaths are not increasing to a noticeable degree.
France has seen huge increases, probably due to the Tour de France. United States college campuses are reporting near exponential increases in COVID-19 positive cases. Yet, France has an increase of 20-some daily deaths to 30-some – hardly enough to represent the huge increases in new cases.
Likewise, American colleges have reported no (zero) hospitalizations and no (zero) deaths from the dramatic increases in new COVID-19 cases on campuses. Is the virus getting weaker? Are we getting stronger? No one seems to know exactly.
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