Naslov
Reporting of adverse events of COVID-19 vaccines and drugs from the FDA adverse event reporting system and eudravigilance during the COVID -19 pandemic

Autori
Krautwurst, Yannick

Vrsta, podvrsta i kategorija rada
Ocjenski radovi, diplomski rad, diplomski

Fakultet
Medicinski fakultet

Mjesto
Split

Datum
14.09

Godina
2022

Stranica
79

Mentor
Pranić, Shelly

Ključne riječi
adverse events ; COVID-19 ; vaccines ; drugs ; reporting

Sažetak
Objectives: The aims of this study were to determine whether there are differences in the frequency of adverse events (AEs) from COVID-19 vaccines compared to widely issued vaccines and from COVID-19 drugs in contrast to a widely prescribed drug reported to the FDA Adverse Event Reporting System (FAERS) or EudraVigilance (EV) during the COVID-19 pandemic. Materials and methods: The FAERS and EV adverse event databases were searched for adverse event reports filed in the U.S. and EU from November 2019 to March 2022. We included all COVID-19 vaccines and drugs which have been approved or emergency use authorized by both the FDA and EMA as of March 31, 2022. The numbers of AEs (serious or non-serious) and the numbers of reaction groups of AEs from Comirnaty (Pfizer-BioNTech), Spikevax (Moderna), or Jcovden (Janssen) COVID-19 vaccines were compared to tetanus and human papillomavirus (HPV) vaccines from January 2021 to March 2022 separately in FAERS and EV. The numbers of AEs (serious or non-serious) and the numbers of reaction groups of AEs from remdesivir, nirmatrelvir/ritonavir, tocilizumab, tixagevimab/cilgavimab, sotrovimab, or casirivimab/imdevimab were compared to methotrexate during three time periods: pre- pandemic (November 7, 2019, to January 29, 2020), first wave (January 30, 2020, to July 15, 2020), and subsequent waves (July 16, 2020, to March 31, 2022). Results: In both the FAERS and EV databases, there was no statistical difference in the number of serious or non-serious AEs from the COVID-19 vaccines compared to the tetanus and HPV vaccines (P=0.406 for both comparisons), although numbers of reported AEs from COVID-19 vaccines are higher in both databases. The median number of serious AEs from COVID-19 vaccines was greater in the FAERS database than in the EV database (94 ([IQR 17-1575]) vs. 11131 ([IQR 120-161077]) although this comparison did not reach statistical significance (P=0.077). For non-serious AEs from COVID-19 vaccines, the EV database reported a greater median number (17376 [IQR 209-251219]) compared to the FAERS database (59 [IQR 21-429]). There were more serious AEs recorded for methotrexate (median 14601 [IQR 8899-26493]) compared to the COVID-19 drugs (P=0.047) in the FAERS database, while in the EV database there were more both serious and non-serious AEs for methotrexate (median 5370 [IQR 3868-12883]) ; P=0.026 and median 754 [IQR 672-1649] ; P=0.043, respectively). There was a median of 1755 (IQR 297-7980) serious and 1191 (IQR 370-1821) non- serious AEs from COVID-19 drugs in the FAERS database (P=0.018 and P=0.002, respectively) in the subsequent waves of COVID-19 than in the pre- pandemic and first wave. Similarly, there was a median of 234 (IQR 145-3576) serious and 97 (IQR 45-476) non-serious AEs for COVID-19 drugs in the EV database (both P=0.002) respectively) in the subsequent waves of COVID-19 than in the pre- pandemic and first wave. Conclusions: Adverse event reporting systems are important and beneficial tools for pharmacovigilance. Reporting of AEs from COVID-19 vaccines has been significantly high, which may indicate a rise in safety issues and concomitant AEs or a change in reporting behavior or both, while reporting of AEs from COVID-19 drugs has been low, which may indicate that the safety profile of the COVID-19 drugs is sufficient, that the overall use of these drugs is rather low or at least lower than methotrexate, or that reporting behavior is insufficient. Among the two databases, reporting of AEs from COVID-19 vaccines has been higher in the EV database than in the FAERS database, and, in contrast, reporting of AEs of COVID-19 drugs has been higher in the FAERS database than in the EV database for the investigated period. Generally, reporting of AEs has not relevantly changed during the COVID-19 pandemic, although the introduction of COVID-19 vaccines and mass-vaccinations worldwide likely led to stimulated reporting of vaccine AEs, while general under-reporting likely still prevails. Our results may indicate a deficit in the U.S. reporting behavior of AEs following vaccine administration, but this requires further investigation.

Izvorni jezik
Engleski

Znanstvena područja
Kliničke medicinske znanosti, Javno zdravstvo i zdravstvena zaštita, Farmacija

POVEZANOST RADA