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The Safety of mRNA-1273, BNT162b2 and JNJ-78436735 COVID-19 Vaccines: Safety Monitoring for Adverse Events Using Real-World Data

Two mRNA COVID-19 vaccines (mRNA-1273, Moderna; and BNT162b2, Pfizer-BioNTech) and one viral vector vaccine (JNJ-78436735, Janssen/Johnson and Johnson) are authorized in the US to hinder COVID-19 infections. We analyzed severe and common adverse events in response to COVID-19 vaccines using real-wor...

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Autores principales: Sa, Soonok, Lee, Chae Won, Shim, Sung Ryul, Yoo, Hyounggyoon, Choi, Jinwha, Kim, Ju Hee, Lee, Kiwon, Hong, Myunghee, Han, Hyun Wook
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8879025/
https://www.ncbi.nlm.nih.gov/pubmed/35214779
http://dx.doi.org/10.3390/vaccines10020320
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author Sa, Soonok
Lee, Chae Won
Shim, Sung Ryul
Yoo, Hyounggyoon
Choi, Jinwha
Kim, Ju Hee
Lee, Kiwon
Hong, Myunghee
Han, Hyun Wook
author_facet Sa, Soonok
Lee, Chae Won
Shim, Sung Ryul
Yoo, Hyounggyoon
Choi, Jinwha
Kim, Ju Hee
Lee, Kiwon
Hong, Myunghee
Han, Hyun Wook
author_sort Sa, Soonok
collection PubMed
description Two mRNA COVID-19 vaccines (mRNA-1273, Moderna; and BNT162b2, Pfizer-BioNTech) and one viral vector vaccine (JNJ-78436735, Janssen/Johnson and Johnson) are authorized in the US to hinder COVID-19 infections. We analyzed severe and common adverse events in response to COVID-19 vaccines using real-world, Vaccine Adverse Effect Reporting System (VAERS) data. From 14 December 2020 to 30 September 2021, 481,172 (50.7 ± 17.5 years, males 27.89%, 12.35 per 100,000 people) individuals reported adverse events (AEs). The median time to severe AEs was 2 days after injection. The risk of severe AEs following the one viral vector vaccine (OR = 1.044, 95% CI = 1.005–1.086) was significantly higher than that after the two mRNA vaccines, and the risk among males (OR = 1.374, 95% CI = 1.342–1.406) was higher than among females, except for anaphylaxis. For common AEs, however, the risk to males (OR = 0.621, 95% CI = 0.612–0.63) was lower than to females. In conclusion, we provided medical insight and clinical guidance about vaccine types by characterizing AEs using real-world data. In particular, COVID-19 mRNA vaccines are safer than viral vector vaccines with regard to coagulation disorders, whereas inflammation-related AEs are lower in the viral vaccine. The risk–benefit ratio of vaccines should be carefully considered, and close monitoring and management of severe AEs is needed.
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spelling pubmed-88790252022-02-26 The Safety of mRNA-1273, BNT162b2 and JNJ-78436735 COVID-19 Vaccines: Safety Monitoring for Adverse Events Using Real-World Data Sa, Soonok Lee, Chae Won Shim, Sung Ryul Yoo, Hyounggyoon Choi, Jinwha Kim, Ju Hee Lee, Kiwon Hong, Myunghee Han, Hyun Wook Vaccines (Basel) Article Two mRNA COVID-19 vaccines (mRNA-1273, Moderna; and BNT162b2, Pfizer-BioNTech) and one viral vector vaccine (JNJ-78436735, Janssen/Johnson and Johnson) are authorized in the US to hinder COVID-19 infections. We analyzed severe and common adverse events in response to COVID-19 vaccines using real-world, Vaccine Adverse Effect Reporting System (VAERS) data. From 14 December 2020 to 30 September 2021, 481,172 (50.7 ± 17.5 years, males 27.89%, 12.35 per 100,000 people) individuals reported adverse events (AEs). The median time to severe AEs was 2 days after injection. The risk of severe AEs following the one viral vector vaccine (OR = 1.044, 95% CI = 1.005–1.086) was significantly higher than that after the two mRNA vaccines, and the risk among males (OR = 1.374, 95% CI = 1.342–1.406) was higher than among females, except for anaphylaxis. For common AEs, however, the risk to males (OR = 0.621, 95% CI = 0.612–0.63) was lower than to females. In conclusion, we provided medical insight and clinical guidance about vaccine types by characterizing AEs using real-world data. In particular, COVID-19 mRNA vaccines are safer than viral vector vaccines with regard to coagulation disorders, whereas inflammation-related AEs are lower in the viral vaccine. The risk–benefit ratio of vaccines should be carefully considered, and close monitoring and management of severe AEs is needed. MDPI 2022-02-17 /pmc/articles/PMC8879025/ /pubmed/35214779 http://dx.doi.org/10.3390/vaccines10020320 Text en © 2022 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/).
spellingShingle Article
Sa, Soonok
Lee, Chae Won
Shim, Sung Ryul
Yoo, Hyounggyoon
Choi, Jinwha
Kim, Ju Hee
Lee, Kiwon
Hong, Myunghee
Han, Hyun Wook
The Safety of mRNA-1273, BNT162b2 and JNJ-78436735 COVID-19 Vaccines: Safety Monitoring for Adverse Events Using Real-World Data
title The Safety of mRNA-1273, BNT162b2 and JNJ-78436735 COVID-19 Vaccines: Safety Monitoring for Adverse Events Using Real-World Data
title_full The Safety of mRNA-1273, BNT162b2 and JNJ-78436735 COVID-19 Vaccines: Safety Monitoring for Adverse Events Using Real-World Data
title_fullStr The Safety of mRNA-1273, BNT162b2 and JNJ-78436735 COVID-19 Vaccines: Safety Monitoring for Adverse Events Using Real-World Data
title_full_unstemmed The Safety of mRNA-1273, BNT162b2 and JNJ-78436735 COVID-19 Vaccines: Safety Monitoring for Adverse Events Using Real-World Data
title_short The Safety of mRNA-1273, BNT162b2 and JNJ-78436735 COVID-19 Vaccines: Safety Monitoring for Adverse Events Using Real-World Data
title_sort safety of mrna-1273, bnt162b2 and jnj-78436735 covid-19 vaccines: safety monitoring for adverse events using real-world data
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8879025/
https://www.ncbi.nlm.nih.gov/pubmed/35214779
http://dx.doi.org/10.3390/vaccines10020320
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