Will a new tuberculosis vaccine be approved by the FDA, EMA, or PMDA before 2028?

On July 18, 2021, the current vaccine for tuberculosis, the Bacillus Calmette–Guérin (BCG) vaccine, turned 100 years old. While it is considered critical for preventing disseminated TB forms and TB meningitis in children in endemic countries, some correlates of protection as a result of receiving the BCG are unclear from studies and it may have limited efficacy in certain contexts.

TB vaccine candidates hold potential for future immunisation programmes. Recent years have shown our ability to more rapidly develop drugs than in the past, and this has understandably led to a renewed interest in mRNA-based solutions for TB.

The Tuberculosis Vaccine Initiative published in their 2021 report that VPM1002, GamTBvac, M72/AS01E, MIP, and MTBVAC are in phase III trials (typically the last phase of testing before data for a medical intervention is sent away for approval to a regulatory body). The completion times reach until 2027, but this is no guarantee of their efficacy or safety.