Many who would once have judged delusional to be a laboratory guinea pig, in the pandemic assumed that joining a essay of vaccines against him coronavirus it was an opportunity. But 58% of the 24.141 local volunteers from these studies could face several dilemmas, given the date overlap Between those trials and the official vaccination campaign.
Before going to the circumstances that concern the essays started by five labs or, as doctors like to say, five “sponsors” or “sponsors”, Sonia Tarragona, Chief of Cabinet of the Ministry of Health of the Nation, clarified to this medium that it is not planned to issue any official recommendation dedicated to these people, in relation to their participation (or not) in the vaccination campaign.
A clarification: there is a sixth “sponsor”, Medicago, which is starting a trial in Argentina, but at the end of this note no details could be found.
The doubts are many because the circumstances are diverse. First of all, the obvious: many of the volunteers does not know if he received “vaccine” or “placebo”, and not everyone remembers his right to demand the opening of the double blind, that is, to have their condition revealed within the trial.
Vaccination center against Covid-19 at the San Martín Theater. Photo Maxi Failla
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This right runs in two ways: if the laboratory that recruited them considers their drug to be effective (approved), and if – Tarragona emphasized – “the country in which these people reside enables them to be vaccinated.”
In the latter case, to “open” the study, the laboratories require the patient to present a test, basically the slip of the “turnero” of the corresponding jurisdiction. Without a specific shift, they do not provide information.
A parenthesis: what has been said so far excludes the 6,000 participants of the trial of Pfizer, whose “placebo” participants have already been timely vaccinated by the company.
In addition, it should exclude the 3,198 from the trial that Janssen began in November 2020. At the request of this medium, Johnson & Johnson explained: “All the individuals participating in the Ensemble clinical study included in the placebo branch are cited to receive our vaccine against COVID-19. We are dedicating our best efforts to reach all participants as soon as possible”.
The doubts then lie with the 3,007 participants in the trial of Sinopharm, the 7,500 of Curevac and the almost 4,500 of Cansino, which is carrying out two different studies in Argentina: a phase 3, with 3,570 volunteers, and a phase 2, for people with HIV, which is starting now and expects to recruit 876 volunteers.
Tradeoffs
The doubts of these people involve several fronts.
On one side are the summoned to be vaccinated who ask for the opening of the double blind and until the last minute they feel “cutting nails”, without knowing whether to go to the appointment of their local health authority or not. The problem in this case concerns the very short times of the evolution of events.
It happened to a 55-year-old woman who asked not to be named that she was given her turn to get vaccinated in CABA on Sunday at 8 p.m. The shift was Monday at 2:00 p.m. at the Usina del Arte. Since he lives in Saavedra, he had to cross the entire City of Buenos Aires.
Immediately (Sunday at the last minute) he sent the double-blind opening request to the laboratory’s WhatsApp reference, but he waited until 1:00 the next day for a response. Obviously he had to run away.
Vacc campaigns
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Two experts linked to the “sponsors” explained that they are required between 12 and 48 hours (according to the laboratory) to open a double blind, information that in all cases comes from the headquarters abroad.
In the shoes of the volunteer, the ghosts in that wait are not few: “lose turn forever“, In a context of global dose shortages, when, in addition, no cautious doctor would lightly recommend”give it the same”.
On this, Tarragona pointed out that “no one has considered giving two different vaccines so far”. In other words, he emphasized: “Whoever received the vaccine in a trial is vaccinated. The one who received a placebo, has to ask for the double blind and wait to be summoned ”.
While a leading immunologist cautiously suggested that “there really should be no problem with giving a second vaccine at least three months after the last dose received,” the recommendation is await official information of the competent health authorities.
Percentages
Clarion could find out that between the 20% and 22% of the participants (of the standing studies) they came down from the trial that had recruited them.
One of the sources that confirmed this data assured that, “when they had the turn to be vaccinated in the campaign, they requested the opening of the double blind, which automatically pulled them out of the essay”.
This “automatically” is being especially heavy for the participants of the trial of Cansino, a vaccine initially raised as a single dose (like Janssen), but which a few days ago reported a kind of “swerve” to its volunteers: decided to give them a second dose as a booster.
We are talking about 3,570 participants in a phase 3 trial who, as long as they do not “get off”, will be able to receive a second injection, yes or yes with doses of Cansino. For those in the “placebo” branch, it will be the first dose. For those in the “vaccine” branch, the reinforcement.
But many of these participants (in their fifties or forties) are killed by doubt: considering the times of the official campaign, ¿it makes sense to continue in the rehearsal when, above all, the efficacy of this drug with both one and two doses is unknown?
In some remote part of the head, outside the individualism that usually guides everything, they weigh the quota of philanthropy that in part had led them to jump into the pool of such an essay, in a context of global emergency
More doubts
The eager forever they also have their doubts at this time. We talk about the people who deduce to be in the placebo branch of a certain trial, either because they had no symptoms when they received the doses, or because they paid for test antibodies in a private lab and they don’t have them. In both cases, the conclusion is risky.
But the doubt that afflicts them has to do with waiting or not. In the informed consent they signed, the laboratory in question promised to “vaccinate everyone” at the end of the study. That is, when the drug is approved and its effectiveness is disseminated.
The volunteers of Sinopharm they know that that matter is not so simple. Not only have efficacy data been disseminated, but the vaccine arrives in official consignments in Argentina. Wouldn’t it be reasonable for the placebo arm of the local trial to get the vaccine now?
Although the request to open the double blind has already been made to the laboratory, the order from China does not arrive, as he could find out Clarion from industry sources not happy with this delay.
Given the long-awaited news of the official shift, the uncertainty of these people is whether to get vaccinated or, instead, to endure the laboratory in which they were recruited to open the double blind at once. This way they would receive the doses they deserve.
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