Abstract
mRNA-based COVID-19 vaccines such as BNT162b2 have recently been a target of anti-vaccination campaigns due to their novelty in the healthcare industry; nevertheless, these vaccines have exhibited excellent results in terms of efficacy and safety. As a consequence, they acquired the first approvals from drug regulators and were deployed at a large scale among priority groups, including healthcare workers. This phase IV study was designed as a nationwide cross-sectional survey to evaluate the post-vaccination side effects among healthcare workers in Slovakia. The study used a validated self-administered questionnaire that inquired about participants’ demographic information, medical anamneses, COVID-19-related anamnesis, and local, systemic, oral, and skin-related side effects following receiving the BNT162b2 vaccine. A total of 522 participants were included in this study, of whom 77% were females, 55.7% were aged between 31 and 54 years, and 41.6% were from Banska Bystrica. Most of the participants (91.6%) reported at least one side effect. Injection site pain (85.2%) was the most common local side effect, while fatigue (54.2%), headache (34.3%), muscle pain (28.4%), and chills (26.4%) were the most common systemic side effects. The reported side effects were of a mild nature (99.6%) that did not require medical attention and a short duration, as most of them (90.4%) were resolved within three days. Females and young adults were more likely to report post-vaccination side effects; such a finding is also consistent with what was previously reported by other phase IV studies worldwide. The role of chronic illnesses and medical treatments in post-vaccination side effect incidence and intensity requires further robust investigation among large population groups.
Highlights
IntroductionOn 21 December 2020, the European Medicines Agency (EMA) recommended the first COVID-19 vaccine, Comirnaty, for conditional marketing authorisation across the Pharmaceuticals 2021, 14, 873
Out of the 536 Slovak healthcare workers who filled in the questionnaire completely, five respondents received viral vector-based vaccines, mainly AstraZeneca-Oxford COVD19 vaccine, and nine respondents received either mRNA-1273 or only the first dose of
The vast majority (91.6%) of the Slovak healthcare workers included in this study reported at least one side effect after receiving an mRNA-based COVID-19 vaccine, BNT162b2; 85.8% experienced local side effects related to the injection site, and 70.5% experienced systemic side effects
Summary
On 21 December 2020, the European Medicines Agency (EMA) recommended the first COVID-19 vaccine, Comirnaty, for conditional marketing authorisation across the Pharmaceuticals 2021, 14, 873. European Union (EU) [1] This approval was depicted as a landmark in our journey towards controlling the coronavirus disease (COVID-19) pandemic caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), first described in Wuhan, China [2]. Comirnaty is a messenger ribonucleic acid (mRNA-based) COVID-19 vaccine developed and manufactured by BioNTech Manufacturing GmbH (Mainz, Germany) and Pfizer Inc (New York, NY, USA); its well-known market name is Pfizer-BioNTech COVID19 vaccine, and it is scientifically referred to as BNT162b2 [3]. The EMA approved another mRNA-based COVID-19 vaccine, Spikevax [4]. (Madrid, Spain); its market name is Moderna COVID-19 vaccine, and the scientific name is mRNA-1273 [5] Spikevax vaccine is developed by Moderna Inc (Cambridge, MA, USA) and manufactured and distributed in the EU by Moderna Biotech Spain S.L. (Madrid, Spain); its market name is Moderna COVID-19 vaccine, and the scientific name is mRNA-1273 [5]
Sign-in/Register to view highlights & summary Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
