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COVID-19 vaccines: concerns beyond protective efficacy and safety.
Expert Rev Vaccines. 2021 08; 20(8):1013-1025.ER

Abstract

INTRODUCTION

Several vaccine candidates have been developed using different platforms, including nucleic acids (DNA and RNA), viral vectors (replicating and non-replicating), virus-like particles, peptide-based, recombinant proteins, live attenuated, and inactivated virus modalities. Although many of these vaccines are undergoing pre-clinical trials, several large clinical trials investigating the clinical efficacy and safety of coronavirus disease 2019 (COVID-19) vaccines have produced promising findings.

AREAS COVERED

In this review, we provide a status update on COVID-19 vaccines currently undergoing clinical trials and discuss issues of concern beyond vaccine efficacy and safety, including dosing regimens, the mixed vaccine strategy, prior severe acute respiratory syndrome coronavirus-2 infection, antibody levels, cellular immunity and protection, variants of concern, COVID-19 vaccine distribution, vaccination willingness, herd immunity, immunity passports, and vaccine indications.

EXPERT OPINION

Four vaccines have obtained emergency use authorization, 87 are at the clinical development stage, and 186 are in pre-clinical development. While the knowledge and development of COVID-19 vaccines is rapidly expanding, the benefits of COVID-19 vaccines must outweigh the potential risks of adverse events. To combat the COVID-19 pandemic, clinicians should consistently update COVID-19-associated information, and healthcare authorities and manufacturers should work together to provide adequate and appropriate vaccinations for the prevention of COVID-19.

PLAIN LANGUAGE SUMMARY

What is the context?Severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) caused a global pandemic: the coronavirus disease 2019 (COVID-19) outbreak. The development and implementation of the COVID-19 vaccine could be an important measure to control the COVID-19 pandemic.What is new?Several phase 3 clinical trials have demonstrated the effectiveness and safety of COVID-19 vaccines for the prevention of SARS-CoV-2 infections. Several COVID-19 vaccines have obtained emergency use authorization and been implemented in many countries. Although concerns regarding unusual blood clots and low platelet counts have been raised, the benefits of COVID-19 vaccines outweigh the potential risks of adverse events.What is the impact?Except for children, the COVID-19 vaccine is recommended for all people, including those pregnant or immunocompromised. Healthcare authorities should advise people receiving the vaccine that they must seek medical attention if they have associated thromboembolism and thrombocytopenia symptoms. More studies are necessary to determine the appropriate vaccine dose and regimen strategy, as well as the effectiveness of COVID-19 vaccines against variants of concerns. A global effort must be made to achieve widespread vaccination and herd immunity.

Authors+Show Affiliations

Department of Internal Medicine, Kaohsiung Veterans General Hospital, Tainan Branch, Tainan, Taiwan.Department of Pharmacy, National Taiwan University Cancer Center, Taipei, Taiwan.Department of Intensive Care Medicine, Chi Mei Medical Center, Liouying, Tainan, Taiwan.Department of Pediatrics, National Taiwan University Children's Hospital and National Taiwan University College of Medicine, Taipei, Taiwan.Department of Medicine, College of Medicine, National Cheng Kung University, Tainan, Taiwan.Department of Laboratory Medicine, National Taiwan University Hospital, National Taiwan University College of Medicine, Taipei, Taiwan. Department of Internal Medicine, National Taiwan University Hospital, National Taiwan University College of Medicine, Taipei, Taiwan.

Pub Type(s)

Journal Article
Review

Language

eng

PubMed ID

34180347

Citation

Lai, Chih-Cheng, et al. "COVID-19 Vaccines: Concerns Beyond Protective Efficacy and Safety." Expert Review of Vaccines, vol. 20, no. 8, 2021, pp. 1013-1025.
Lai CC, Chen IT, Chao CM, et al. COVID-19 vaccines: concerns beyond protective efficacy and safety. Expert Rev Vaccines. 2021;20(8):1013-1025.
Lai, C. C., Chen, I. T., Chao, C. M., Lee, P. I., Ko, W. C., & Hsueh, P. R. (2021). COVID-19 vaccines: concerns beyond protective efficacy and safety. Expert Review of Vaccines, 20(8), 1013-1025. https://doi.org/10.1080/14760584.2021.1949293
Lai CC, et al. COVID-19 Vaccines: Concerns Beyond Protective Efficacy and Safety. Expert Rev Vaccines. 2021;20(8):1013-1025. PubMed PMID: 34180347.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - COVID-19 vaccines: concerns beyond protective efficacy and safety. AU - Lai,Chih-Cheng, AU - Chen,I-Tzu, AU - Chao,Chien-Ming, AU - Lee,Ping-Ing, AU - Ko,Wen-Chien, AU - Hsueh,Po-Ren, Y1 - 2021/07/05/ PY - 2021/6/29/pubmed PY - 2021/9/15/medline PY - 2021/6/28/entrez KW - COVID-19 KW - cellular immunity KW - protective efficacy KW - safety KW - sars-cov-2 KW - vaccination willingness KW - vaccine KW - variants of concern SP - 1013 EP - 1025 JF - Expert review of vaccines JO - Expert Rev Vaccines VL - 20 IS - 8 N2 - INTRODUCTION: Several vaccine candidates have been developed using different platforms, including nucleic acids (DNA and RNA), viral vectors (replicating and non-replicating), virus-like particles, peptide-based, recombinant proteins, live attenuated, and inactivated virus modalities. Although many of these vaccines are undergoing pre-clinical trials, several large clinical trials investigating the clinical efficacy and safety of coronavirus disease 2019 (COVID-19) vaccines have produced promising findings. AREAS COVERED: In this review, we provide a status update on COVID-19 vaccines currently undergoing clinical trials and discuss issues of concern beyond vaccine efficacy and safety, including dosing regimens, the mixed vaccine strategy, prior severe acute respiratory syndrome coronavirus-2 infection, antibody levels, cellular immunity and protection, variants of concern, COVID-19 vaccine distribution, vaccination willingness, herd immunity, immunity passports, and vaccine indications. EXPERT OPINION: Four vaccines have obtained emergency use authorization, 87 are at the clinical development stage, and 186 are in pre-clinical development. While the knowledge and development of COVID-19 vaccines is rapidly expanding, the benefits of COVID-19 vaccines must outweigh the potential risks of adverse events. To combat the COVID-19 pandemic, clinicians should consistently update COVID-19-associated information, and healthcare authorities and manufacturers should work together to provide adequate and appropriate vaccinations for the prevention of COVID-19. PLAIN LANGUAGE SUMMARY: What is the context?Severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) caused a global pandemic: the coronavirus disease 2019 (COVID-19) outbreak. The development and implementation of the COVID-19 vaccine could be an important measure to control the COVID-19 pandemic.What is new?Several phase 3 clinical trials have demonstrated the effectiveness and safety of COVID-19 vaccines for the prevention of SARS-CoV-2 infections. Several COVID-19 vaccines have obtained emergency use authorization and been implemented in many countries. Although concerns regarding unusual blood clots and low platelet counts have been raised, the benefits of COVID-19 vaccines outweigh the potential risks of adverse events.What is the impact?Except for children, the COVID-19 vaccine is recommended for all people, including those pregnant or immunocompromised. Healthcare authorities should advise people receiving the vaccine that they must seek medical attention if they have associated thromboembolism and thrombocytopenia symptoms. More studies are necessary to determine the appropriate vaccine dose and regimen strategy, as well as the effectiveness of COVID-19 vaccines against variants of concerns. A global effort must be made to achieve widespread vaccination and herd immunity. SN - 1744-8395 UR - https://www.unboundmedicine.com/medline/citation/34180347/COVID_19_vaccines:_concerns_beyond_protective_efficacy_and_safety_ L2 - https://www.tandfonline.com/doi/full/10.1080/14760584.2021.1949293 DB - PRIME DP - Unbound Medicine ER -