4.6 Article

External validity of phase III trials on vaccines against SARS-CoV-2 to a middle-aged and elderly Western European population

Journal

EUROPEAN JOURNAL OF EPIDEMIOLOGY
Volume 36, Issue 3, Pages 319-324

Publisher

SPRINGER
DOI: 10.1007/s10654-021-00729-5

Keywords

SARS-CoV-2; Vaccines; Phase III trials; Generalizability; External validity; Epidemiology

Funding

  1. Erasmus Medical Center, Rotterdam
  2. Erasmus University, Rotterdam
  3. Netherlands Organization for the Health Research and Development (ZonMw)
  4. Research Institute for Diseases in the Elderly (RIDE)
  5. Ministry of Education, Culture and Science
  6. Ministry for Health, Welfare and Sports
  7. European Commission (DG XII)
  8. Municipality of Rotterdam

Ask authors/readers for more resources

The study aimed to assess the general population's representation in phase-III trials of COVID-19 vaccines and the impact of various exclusion criteria on eligibility. Findings revealed that eligibility for vaccine trials could decrease by half for high-risk individuals, depending on the interpretation and application of exclusion criteria.
Initial results from various phase-III trials on vaccines against SARS-CoV-2 are promising. For proper translation of these results to clinical guidelines, it is essential to determine how well the general population is reflected in the study populations of these trials. This study was conducted among 7162 participants (age-range: 51-106 years; 58% women) from the Rotterdam Study. We quantified the proportion of participants that would be eligible for the nine ongoing phase-III trials. We further quantified the eligibility among participants at high risk to develop severe COVID-19. Since many trials were not explicit in their exclusion criterion with respect to 'acute' or 'unstable preexisting' diseases, we performed two analyses. First, we included all participants irrespective of this criterion. Second, we excluded persons with acute or 'unstable preexisting' diseases. 97% of 7162 participants was eligible for any trial with eligibility for separate trials ranging between 11-97%. For high-risk individuals the corresponding numbers were 96% for any trial with separate trials ranging from 5-96%. Importantly, considering persons ineligible due to 'acute' or 'unstable pre-existing' disease drastically dropped the eligibilities for all trials below 43% for the total population and below 36% for high-risk individuals. The eligibility for ongoing vaccine trials against SARS-CoV-2 can reduce by half depending on interpretation and application of a single unspecified exclusion criterion. This exclusion criterion in our study would especially affect the elderly and those with pre-existing morbidities. These findings thus indicate the difficulty as well as importance of developing clinical recommendations for vaccination and applying these to the appropriate target populations. This becomes especially paramount considering the fact that many countries worldwide have initiated their vaccination programs by first targeting the elderly and most vulnerable persons.

Authors

I am an author on this paper
Click your name to claim this paper and add it to your profile.

Reviews

Primary Rating

4.6
Not enough ratings

Secondary Ratings

Novelty
-
Significance
-
Scientific rigor
-
Rate this paper

Recommended

No Data Available
No Data Available