Premarket Development Times for Innovative Vaccines–To What Extent Are the Coronavirus Disease 2019 (COVID-19) Vaccines Outliers?

Beall RF, Kesselheim AS, Hollis A - Clinical Infectious Diseases

  • Innovation Incentives and Competition
  • Regulation and Clinical Evidence

Summary:

Using patent filing dates as a marker of commercial development initiation, the authors found that the BioNTech/Pfizer COVID-19 vaccine had a 10-year development timeline from key patent filings to regulatory authorization, which aligns with the established pattern of shortening vaccine development timelines since the 1980s and does not represent an outlier compared to other recently approved vaccines. The findings suggest that COVID-19 vaccine development timelines are comparable to other modern vaccines and drugs, indicating that vaccine hesitancy concerns about rapid development may not be supported by objective measures of drug development time.

VIEW SOURCE

Recent Work from PORTAL

Talk bubble graphics representing commentary and opinion.

How Congress Can Fix Expert Advisory Committees

Daval CJR, Kesselheim AS - STAT

  • Regulation and Clinical Evidence
Simple graphic of magnifying glass examining papers to signify reviewing research publications.

International Regulatory Status and Reimbursement Recommendations of Haematological Malignancy Drugs Withdrawn from the FDA Accelerated Approval Pathway

Mulsant SS, Kesselheim AS, Naci H - Journal of Cancer Policy

  • Price, Value, and Access
  • Regulation and Clinical Evidence
Talk bubble graphics representing commentary and opinion.

Politics and the Patient Encounter, in Dire Times

Avorn J - MedPage Today

  • Regulation and Clinical Evidence