VACCELERATE Report on unanswered COVID-19 vaccines and vaccination priority questions for future trials

Identifying and filling public health knowledge gaps in COVID-19 vaccine development has been deemed one of the key network objectives and included as one of the work streams within VACCELERATE.
 

This work is based on close collaboration with other work streams within VACCELERATE, general public outreach and is anchored in a broad European and international dialogue about new COVID-19 vaccine clinical trials aiming to inform both ongoing and future studies through a living document of priority questions that reflects knowledge gaps and emerging priorities from the public health perspective.
 

In spring 2021, a stakeholder survey helped us identify a list of emerging and unanswered public health and clinical research questions in relation to vaccine safety, efficacy, vaccination schemes.
 

Please follow this link to read the full report here.
 

A total of 89 responses to the stakeholder survey have been received, resulting in 148 submitted priority topics. Responses have been received from 23 countries across the EU but also associated countries via clinical sites registered in the EUVAP platform.
 

The analysis of the responses has been done internally by RegionH/CHIP as task leader. All the responses have been analyzed thematically and grouped into broader thematic categories resulting in eight thematics and ‘Other’ categories found in the Figure below:
 

Survey responses spring 2021

After further categorization, the survey replies have been grouped and compiled into a final list of 17 priority questions that are listed below.
 

VACCELERATE survey priority questions

Vaccine administration  

  • 1. How can immunisation schedule (booster timing and number) and technologies (vaccine dose and type) be optimised to ensure maximum protection? *
  • 2. What is the comparative advantage of heterologous vs. homogenic vaccination in terms of efficacy, safety and duration of protection? *
  • 3. Can novel vaccines achieve non-inferiority efficacy and safety by non-parenteral route and possibly with only one dose?
  • 4. What should the vaccination strategy be for recovered patients?

Vaccination in immunocompromised  

  • 5. What is the vaccine efficacy and are there other immunological correlates of protection than antibodies in various immunocompromised groups?
  • 6. How can immunisation schedule (booster timing and number) and technologies (vaccine dose and type) be optimised for the immunocompromised group to ensure maximum protection?

Pediatric vaccination  

  • 7. What is the efficacy and the specific immune response to the vaccine in children, including immunocompromised pediatric population? *
  • 8. What are the long-term safety considerations of vaccination in children?
  • 9. What is the relationship in terms of protection between vaccination and immuno-mediated diseases such as MIS-C?

Long-term protection and immunity  

  • 10. How long does immunity (humoral-cellular) last after vaccination with current vaccines?
  • 11. Are currently available vaccines effective against SARS-CoV-2 variants in the short- and long-term and is there a need to develop new vaccine to protect against the VOCs?
  • 12. What is the best measure of protective immunity after vaccination at the individual level and when after vaccination should it be taken?

Protection against new variants  

  • 13. Are currently available vaccines effective against SARS-CoV-2 variants in the short- and long-term and is there a need to develop new vaccine to protect against the VOCs? *

Long-term vaccine safety/side effects  

  • 14. What are the long-term adverse side effects of vaccination in terms of vaccine-related or vaccine-induced diseases (autoimmune, oncologic, fertility etc.)?

Infection transmission prevention  

  • 15. Are current vaccines and vaccine strategies effective in preventing SARS-CoV-2 transmission?

Public health/policy  

  • 16. How can awareness of and confidence in vaccine programmes be improved to address vaccine hesitancy and misinformation with focus on specific population groups?
  • 17. How can wide-scale global vaccination coverage be ensured within reasonable timelines, especially in resource-limited settings?

*Topic addressed in the VACCELERATE clinical trials (see Appendix 4)
 

This project has received funding from the European Union’s Horizon 2020 Research and Innovation programme under Grant Agreement No 101037867.