Kritička procjena farmakovigilancije VAERS-a: Je li američki sustav prijavljivanja nuspojava cjepiva (VAERS) funkcionalan sustav farmakovigilancije? / Critical Appraisal of VAERS Pharmacovigilance: Is the U.S. Vaccine Adverse Events Reporting System (VAERS) a Functioning Pharmacovigilance System?

Published on 3 November 2022 at 07:07

 

Kritička procjena farmakovigilancije VAERS-a: Je li američki sustav prijavljivanja nuspojava cjepiva (VAERS) funkcionalan sustav farmakovigilancije?

Omjer potpuno cijepljenih pojedinaca koji su podlegli štetnom događaju je visok. Budući da otprilike 1 od svakih 400 pojedinaca doživi neželjeni događaj (~1 od svakih 25 000 za smrt) u kontekstu potpuno cijepljene populacije protiv COVID-19 u Sjedinjenim Državama, stoga nije jasno zašto se te injekcije i dalje koriste u ljudskoj populaciji, pogotovo zato što do danas nisu poznati dugoročni učinci i ne postoje dugoročni podaci. Bilo je važno kontekstualizirati broj smrtnih slučajeva budući da je neproporcionalan broj svih nedostajućih podataka AE smrtni slučajevi. Možda se čini da broj nestalih VAERS ID-ova nije razlog za brigu s analitičke točke gledišta, ali podsjećam čitatelja da to nisu samo podaci: to su ljudi. Ovo izvješće bavilo se trima problemima koji odgovaraju na pitanje VAERS farmakovigilancije analizom VAERS podataka u odnosu na: 1. izbrisana izvješća, 2. odgođeno unošenje izvješća i 3. ponovno kodiranje MedDRA (Medical Dictionary for Regulatory Activities) pojmova iz teških u blage.

 

Critical Appraisal of VAERS Pharmacovigilance: Is the U.S. Vaccine Adverse Events Reporting System (VAERS) a Functioning Pharmacovigilance System?

The ratio of fully vaccinated individuals succumbing to an adverse event is high. With approximately 1 in every 400 individuals experiencing an adverse event (~1 in every 25,000 for death) in the context of the COVID-19 fully vaccinated population in the United States, it is therefore unclear why these injections are continuing to be used in the human population, especially since no long-term effects are known and no long-term data exists, to date. It was important to contextualize death counts since a disproportionate number of all the missing data AEs are deaths. It may appear that the number of missing VAERS IDs is nothing to be concerned about from an analytical point of view, but I remind the reader that these are not just data: they are people. This report addressed three issues that respond to the question of VAERS pharmacovigilance by analyzing VAERS data in relation to: 1. deleted reports, 2. delayed entry of reports, and 3. recoding of MedDRA terms from severe to mild.

 

Science, Public Health Policy, and the Law Volume 3:100–129 October, 2021 Clinical and Translational Research;

https://61ee839e4c3e409708bac62c--i-do-not-consent.netlify.app/media/Pharmacovigilance%20VAERS%20paper%20FINAL_OCT_1_2021.pdf