Environmental Risk Assessment of Recombinant Viral Vector Vaccines against SARS-Cov-2.

Aline Baldo,Katia Pauwels,Nicolas Willemarck,Amaya Leunda

doi:10.3390/vaccines9050453

Aline Baldo, Katia Pauwels + Show 2 more

Open Access

https://doi.org/10.3390/vaccines9050453

Copy DOI

Journal: Vaccines	Publication Date: May 3, 2021
Citations: 14	License type: CC BY 4.0

Affiliation: Sciensano (Belgium)

Abstract

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is the causative agent of the coronavirus disease 2019 (COVID-19) pandemic. Over the past months, considerable efforts have been put into developing effective and safe drugs and vaccines against SARS-CoV-2. Various platforms are being used for the development of COVID-19 vaccine candidates: recombinant viral vectors, protein-based vaccines, nucleic acid-based vaccines, and inactivated/attenuated virus. Recombinant viral vector vaccine candidates represent a significant part of those vaccine candidates in clinical development, with two already authorised for use in the European Union and one currently under rolling review by the European Medicines Agency (EMA). Since recombinant viral vector vaccine candidates are considered as genetically modified organisms (GMOs), their regulatory oversight includes besides an assessment of their quality, safety and efficacy, also an environmental risk assessment (ERA). The present article highlights the main characteristics of recombinant viral vector vaccine (candidates) against SARS-CoV-2 in the pipeline and discusses their features from an environmental risk point of view.

Highlights

The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the causative agent of the coronavirus disease 2019 (COVID-19) pandemic has caused millions of deaths worldwide and economic and social chaos internationally [1,2]
In this article we present the general principles of the environmental risk assessment (ERA) and we elaborate on key features in relation to several recombinant viral vector COVID-19 vaccine candidates at various stages of clinical development or already approved for marketing in the European Union (EU) (Table 1)
The immune response was inferior to those seen following natural infection and those reported for other SARS-CoV-2 vaccine candidates [93]

Summary

Introduction

The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the causative agent of the coronavirus disease 2019 (COVID-19) pandemic has caused millions of deaths worldwide and economic and social chaos internationally [1,2]. Many efforts have been directed towards the rapid development of effective and safe COVID-19 vaccine candidates by use of a range of vaccine platforms. Four vaccines are already authorised for use in the European Union (EU): two nucleic acid-based vaccines, BNT162b2 (Cominarty, Pfizer/BioNTech) and mRNA-1273 (COVID-19 Vaccine Moderna), and two recombinant adenoviral vector vaccines, ChAdOx1-S (COVID-19 Vaccine AstraZeneca) and Ad26.CoV2.S (COVID-19 Vaccine Janssen). Vaccines based on recombinant viral vectors are subject to additional regulatory requirements, as they are considered genetically modified organisms (GMOs). Some of these requirements, which have their legal basis in Directive 2001/18/EC [5], aim to assess aspects related to potential risks for human health and the environment, including animals, plants and micro-organisms, what is called the “environmental risk assessment (ERA)”

Results

Discussion

Conclusion