Tag: ADE

Informed consent disclosure to vaccine trial subjects of risk of COVID-19 vaccines worsening clinical disease

December 7, 2020 / / 0 Comments

COVID-19 vaccines designed to elicit neutralising antibodies may sensitise vaccine recipients to more severe disease than if they were not vaccinated. Vaccines for SARS, MERS and RSV have never been approved, and the data generated in the development and testing of these vaccines suggest a serious mechanistic concern: that vaccines designed empirically using the traditional approach (consisting of the unmodified or minimally modified coronavirus viral spike to elicit neutralising antibodies), be they composed of protein, viral vector, DNA or RNA and irrespective of delivery method, may worsen COVID-19 disease via antibody-dependent enhancement (ADE). This risk is sufficiently obscured in clinical trial protocols and consent forms for ongoing COVID-19 vaccine trials that adequate patient comprehension of this risk is unlikely to occur, obviating truly informed consent by subjects in these trials.

https://pubmed.ncbi.nlm.nih.gov/33113270/

Antibody-dependent enhancement and SARS-CoV-2 vaccines and therapies | Nature Microbiology

December 1, 2020 / / 0 Comments

Antibody-based drugs and vaccines against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) are being expedited through preclinical and clinical development. Data from the study of SARS-CoV and other respiratory viruses suggest that anti-SARS-CoV-2 antibodies could exacerbate COVID-19 through antibody-dependent enhancement (ADE). Previous respiratory syncytial virus and dengue virus vaccine studies revealed human clinical safety risks related to ADE, resulting in failed vaccine trials. Here, we describe key ADE mechanisms and discuss mitigation strategies for SARS-CoV-2 vaccines and therapies in development. We also outline recently published data to evaluate the risks and opportunities for antibody-based protection against SARS-CoV-2. Mechanisms of antibody-dependent enhancement of disease and mitigation strategies for SARS-CoV-2 vaccines and therapies are discussed.
— Read on www.nature.com/articles/s41564-020-00789-5

Antibody-dependent enhancement is a serious concern for #CovidVaccine — in fact, ADE is amongst the reasons why we never got a vaccine for coronavirus diseases in decades of research.