Outcome of a Coalition for Epidemic Preparedness Innovations (CEPI)/Brighton
Collaboration (BC) scientific working meeting, March 12-13, 2020

Background
The SARS-CoV-2 pandemic presents an unprecedented challenge to global health with enormous health
system, social and economic disruption and large numbers of deaths already experienced in many
countries. Epidemiologic features confirm that ongoing spread to less affected areas is now a certainty.
Several academic and commercial vaccine developers are moving quickly, with many different vaccine
strategies including RNA, DNA, protein and viral vectored vaccines, and are planning to enter Phase I trials
and then upscale to measure safety and efficacy with the intention of vaccine deployment. While some
programs will not reach human studies in 2020, others will be in Phase I in days.
The enhanced pathology seen in some SARS or MERS-CoV vaccinated animals when subsequently
challenged with live virus was primarily seen in the lungs. It was described as a lymphocytic and
eosinophilic infiltrate; an observation similar to the enhanced RSV Disease (ERD) described in infants
exposed to natural RSV infection following immunization with a poorly efficient formalin-inactivated RSV
vaccine in 1967. CEPI and the CEPI-funded Brighton Collaboration Safety Platform for Emergency vACcines
(SPEAC) project convened a working meeting consisting of a group of experts (Working Group) in the field
of vaccine immunology and coronaviruses (CoVs) to consider some of the evidence from previous animal
studies of MERS and SARS CoVs and initial data with the novel SARS-CoV-2. Presentations and discussions
were held via a videoconference on March 12 and 13, 2020. This document summarizes the draft
considerations including input from a panel of peer reviewers and additional participants who attended
the conference.
The considerations in this document should be interpreted as general scientific remarks based on current
knowledge to inform a research agenda that could be beneficial for vaccines development. These
considerations are not of a regulatory nature and cannot in any sense replace the need for proper
regulatory consultations on the requirements for vaccines clinical trials. Vaccine developers are therefore
encouraged to seek individual scientific advice from regulatory authorities.

Categories

COVID-19  Coronavirus  Vaccine safety  

Tags

COVID-19  Vaccines  

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