Experts point out flaws in study finding high efficacy of biologic and insist its utility as a reinforcer is unproven
Despite the fact that since last Wednesday, December 21st, started the application of the Abdalá vaccine as reinforcement in Mexico City, Doubts persist among various experts about its effectiveness in its application as a reinforcer. In response, the CDMX government has uploaded the scientific information published so far, which has only confirmed and increased the doubts.
What is clear is that to date no studies have been published on the effectiveness of the Abdalá vaccine, produced in Cuba, as reinforcement for a population already vaccinated with a complete schedule of this or other vaccines.
On the other hand, although there seems to be no doubt about the effectiveness of Abdalá, yes, there are many on the studio, published on September 23 of this year in the magazine The Lancet Regional Health Americaswhich has been used to claim that this is over 92% and that it is 98.2% to prevent serious illness and 98.7% to prevent deaths from covid-19.
the immunologist Irma Aguilar Delfin makes known various flaws in the study design and reportsstarting with what appears to be a typographical error, since the study begins by reporting that it “included 1,355,638 people”, of whom 1,324 were partially or fully vaccinated and 31,433 were not vaccinated.
Aguilar Delfín points out that the sum of vaccinated plus unvaccinated does not provide the total population studied; however, in the rest of the study, a total of one million 324 thousand 205 vaccinated are managed. The error, although apparently minor, raises questions about the peer review the report would have had.
However, the main problem with this study is that it is not a phase 3 clinical trial itselfin which patients and control group were followed up promptly, as well as reporting details such as, for example, those who have comorbidities, but from a general retrospective observational study of health services in Havana, Cuba, which remains credible.
Up until now, critics have overlooked it yes there is one study phase 3 of the vaccine that meets the conditions to be randomized, double-blind, and with a control group that received a placebo; However, the report of this study, which the CDMX government has uploaded to the vacunacion.cdmx.gob.mx page, it was only published (on September 10 2022) in an early version on the medRxiv website and not in a peer-reviewed journal.
This clinical trial demonstrated the efficacy of the Abdala vaccine against symptomatic disease was 92.3%; 92.0% for mild or moderate disease and 94.5% for severe forms of covid-19; in addition to the fact that only the deaths occurred in the control group.
Press reports indicate this The CDMX population that will travel to vaccination sites is small for applying reinforcement; There is currently no way to know whether this is due to distrust of the Abdalá vaccine, doubts about its effectiveness as a booster, or whether a booster is not deemed necessary.
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