WHO consultation on COVID-19 vaccines research:  Emerging evidence on safety and the need for additional doses of COVID-19 vaccines

Report of consultation is available HERE

In continuation to the scientific discussions on COVID-19 vaccines research, WHO R&D Blueprint team organised a follow-up consultation on emerging evidence on safety and the need for additional doses of COVID-19 vaccines on Monday, 25 October 2021 from 13h00 to 18h00 Geneva time.

The objectives of this consultation was to review the available evidence on vaccines being deployed in terms of:

• Safety in naïve and previously vaccinated populations

• Updated evidence and considerations regarding the administration of additional doses

Agenda is available HERE 

PRESENTERS/PANEL MEMBERS

Invited experts included:

• Leading researchers on COVID-19 vaccine studies
• Global experts on evidence synthesis and critical appraisal of evidence
• Regulatory authorities
• Vaccine developers

Presentations

Introduction

• Global overview of the epidemiologic situation (Maria van Kerkhove)
• Objectives of the meeting
• Current recommendations from SAGE regarding COVID-19 vaccines

Session 1. What do we know and what additional evidence is needed to inform decisions on safety in naïve and previously vaccinated populations?

• COVID-19 Myocarditis  
• Vaccine Safety Updates:​ Myocarditis Following mRNA COVID-19 Vaccination 
• Surveillance Updates of Myocarditis/Pericarditis and mRNA COVID-19 Vaccination in the FDA BEST System 
• Review of Post Authorization Safety Data for Janssen COVID-19 Vaccine 

Evidence of vaccine safety, developer’s perspective 

• Clinical updates of ConvideciaTM:  Efficacy, Booster dose and the Inhalation Route (CanSinoBIO)
• Booster Dose of​ Janssen COVID-19 Vaccine (Ad26.COV2.S) Following Primary Vaccination​ (Janssen)
• MVC-COV1901- Evidence of vaccine safety,developer’s perspective (Medigen)
• Progress on the booster study of inactivated covid-19 vaccine (Sinopharm)
• Updated safety & immunogenicity of 3rd dose CoronaVac® (Sinovac)

Lessons learned from monitoring vaccine safety

• Safety of vaccines: Lessons learned
• Pharmacovigilance – COVID-19 vaccines – Norway

What additional research and strategies are needed?

• Saftey cannot be considered separately from efficacy

Session 2.  Updated evidence and considerations regarding the administration of additional doses

• Emerging data from Israel
• COVID-19 vaccine effectiveness by product and timing in New York state  
• Emerging evidence on safety and the need for additional doses of COVID-19 vaccines in Brazil
• Emerging evidence on additional doses of COVID-19 vaccines and their safety in Brazil 
• Covid-19 Vaccine Effectiveness Assessment in Chile 
• Observational evidence on vaccine effectiveness against the delta variant – latest results and risk of bias considerations  

Emerging data on homologous and heterologous boosting

• Humoral and cellular immune response against SARS-CoV-2 variants following heterologous and homologous Vaccination
• Immunogenicity and reactogenicity of homologous and heterologous boosts after Ad26.COV2.S priming 
• DMID 21-0012 - Heterologous Platform Boost Study​: Mix and Match​  

Conclusion

• Synthesis of the Evidence and Next Steps 

Watch the meeting recording here: