For all those anxiously waiting for the arrival of a good vaccine so we can get readily inoculated and start the process of methodically cutting the transmission of the SARS-CoV-2 virus (most likely almost all the billions of humans on Planet earth) the news that two of the six major clinical trials have ben paused was bad news indeed. However, we must analyze these facts with the proper scientific light to understand.
In an article dated September 8, 2020, Katherine J. Wu and Katie Thomas informed the NY Times readers (like yours truly) that: “pharmaceutical company AstraZeneca halted large, late-stage global trials of its coronavirus on Tuesday because of a serious suspected adverse reaction in a participant, the company said.” As we discussed in our previous article, that clinical event was a case of transverse myelitis in a British participant that the researchers eventually determined was a coincidence and not an adverse effect of the studied vaccine. The clinical trial was resumed. However, the scientists in charge of the review board in the USA have not yet authorized the re-start of the same.
On October 12, 2020, Virginia Hughes, Katie Thomas, Carl Zimmer and Katherine J. Wu (her, again?) wrote an article in the NY Times saying: “Johnson and Johnson has paused the large late-stage clinical trial of its coronavirus vaccine because of an ‘unexplained illness’ in one of the volunteers, the company said on Monday.” We still do not have any information about that incident as it is under review at present. In their website, the company said that: “following our guidelines, the participant’s illness is being reviewed and evaluated by the ENSEMBLE independent Data Safety Monitoring Board (DSMB) as well as our internal clinical and safety physicians.”
We understand the natural reaction of so many people, including us for a brief moment, of despairing about this temporary setback, as we are all scared of the tragic consequences of the pandemic in our societies and tired of the Social Isolation. After that initial deception, we must understand that those trials were stopped precisely because the system of safety safeguards of the clinical trials does work. Whenever there is a major adverse clinical event, the administrators say, “hands off” and everybody along the long process of scientific evaluation must stop it quickly. Patients are still monitored but there is no drug administration until further notice. The institutional review board (composed of entirely independent scientists and clinicians) will take all the needed time to check each nook and cranny of the trial.
On October 16, 2020, Albert Bourla, Chairman and CEO of Pfizer, said in an open letter that: “we are operating at the speed of science. This means that we may know whether our vaccine is effective by the end of October. to do so, we must a certain number of COVID-19 cases in our trial to compare the effectiveness of the vaccine in vaccinated individuals to those who received a placebo. since we must wait for a certain number of cases to occur, this data may come earlier or later based on changes in the infection rates.”
Last Monday we were watching CNN at early dawn when Rosemary Church, its lovely presenter with a plum accent, announced that British scientists of the Imperial College were about to start a clinical trial that might provide the definitive answer as to whether a vaccine candidate has immunogenicity or not: a Human Challenge COVID study. They chose19 previously immunized young participants that would be expressly exposed to the SARS-CoV-2 virus to determine whether their acquired immunity is sustainable for a certain period of time or not. Bravo for these heroes!
There is widespread skepticism about the safety of a future vaccine(s) in the USA, especially among various Minority communities that discreetly feel they are being used as “guinea pigs” to advance research. This cautious attitude might start to allay their reasonable fears, one step at a time. Congratulations for these corporate “johnny-come-lately” but nonetheless “never-too-late” opportune exercises in a long-in-coming Cultural Sensitivity prurience.
Like the lovely lady of this tableau, we are all anxiously peeking through the window for the arrival of Ms. Right. We intentionally used the Ms. article as “la vacuna” (vaccine) has a feminine gender in the Castilian language.
Note – The feature image, Déjà from Alfred Stevens 1862-1864, was taken from Wikimedia Commons..
Stay distant. Stay safe. Stay beautiful.
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