Version 1
: Received: 30 October 2024 / Approved: 31 October 2024 / Online: 31 October 2024 (08:42:24 CET)
How to cite:
Platschek, B.; Boege, F. The Post-Acute Covid-Vaccination Syndrome in the light of Pharmacovigilance. Preprints2024, 2024102497. https://doi.org/10.20944/preprints202410.2497.v1
Platschek, B.; Boege, F. The Post-Acute Covid-Vaccination Syndrome in the light of Pharmacovigilance. Preprints 2024, 2024102497. https://doi.org/10.20944/preprints202410.2497.v1
Platschek, B.; Boege, F. The Post-Acute Covid-Vaccination Syndrome in the light of Pharmacovigilance. Preprints2024, 2024102497. https://doi.org/10.20944/preprints202410.2497.v1
APA Style
Platschek, B., & Boege, F. (2024). The Post-Acute Covid-Vaccination Syndrome in the light of Pharmacovigilance. Preprints. https://doi.org/10.20944/preprints202410.2497.v1
Chicago/Turabian Style
Platschek, B. and Fritz Boege. 2024 "The Post-Acute Covid-Vaccination Syndrome in the light of Pharmacovigilance" Preprints. https://doi.org/10.20944/preprints202410.2497.v1
Abstract
Background/Objectives: Clinical studies show that SARS-Cov-2 vaccination sometimes entails a severe and disabling chronic syndrome termed post-acute-Covid-vaccination syndrome (PACVS). PACVS shares similarities with long COVID. After more than three years, PACVS is still not officially recognised, while long Covid has been registered by health authorities within little over a year. Here we address possible reasons for that discrepancy. Methods: We analyse to which extent common symptoms of PACVS have been registered by European pharmacovigilance as adverse vaccination reactions and which consequences have been drawn thereof. Results: (i) PACVS is distinguished from normal vaccination reactions solely by prolonged duration. (ii) Symptom duration is poorly monitored by post-authorization pharmacovigilance. (iii) PACVS-specific signals were faithfully recorded by health authorities but haven’t prompted appropriate reactions. (iv) The most widely applied SARS-Cov-2 vaccine has been modified after roll-out without renewed phase III evaluation; the modification has increased DNA-contamination, which is thought to aggravate the spectrum of adverse events. (v) Crossing of Pharmacovigilance data with corresponding estimates of applied vaccine doses suggest a PACVS-prevalence of 0.003 % in the general population. In contrast, occupational surveillance studies suggest a PACVS-prevalence of 0.9 % in young and middle-aged persons. Conclusions: (a) Denial of official recognition of PACVS is unjustified. (b) PACVS seems to target preferentially young and middle-aged persons. (c) Without official disease recognition, access to public health care and welfare services is made difficult for PACVS-affected persons, which creates considerable socio-economic problems. (d) Without official disease recognition, development and evaluation of therapies for PACVS is impaired.
Keywords
Pharmacovigilance; Post-Acute Covid-Vaccination Syndrome (PACVS); Post-Acute COVID-19 Syndrome PACS, chronic disease symptoms; product information sheets of SARS-Cov-2 vaccines; European Medical Agency EMA; EudraVigilance
Subject
Public Health and Healthcare, Health Policy and Services
Copyright:
This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
