Probability of Success and Timelines for the Development of Vaccines for Emerging and Reemerged Viral Infectious Diseases

Analysis noted success probabilities and timelines varied widely across different vaccine types and diseases, but if a SARS-CoV-2 vaccine is licensed within 18 months of start of pandemic, it will mark an unprecedented achievement for non-influenza viral vaccine development.

SPS commentary:

Analysis covered 606 trials of 220 distinct development trajectories among 267,343 enrolled participants. It reported the following:

  • Probability of vaccines progressing from phase 2 to licensure within 10 years was 10.0% (95% CI, 2.6% to 16.9%), with most approvals representing H1N1 or H5N1 vaccines.
  • Average timeline from phase 2 to approval was 4.4 years (range, 6.4 weeks to 13.9 years).
  • Probabilities of advancing from phase 1 to 2, phase 2 to 3, and phase 3 to licensure within the total available follow-up time were 38.2% (CI, 30.7% to 45.0%), 38.3% (CI, 23.1% to 50.5%), and 61.1% (CI, 3.7% to 84.3%), respectively.

Annals of Internal Medicine