Table 1. Characteristics of 21 Vaccines Approved by the FDA From 2010 to 2020.

Characteristic	Median (IQR)
Indication, No. (%)
Influenza	5 (23.8)
Meningococcus	5 (23.8)
DTaPa	2 (9.5)
Otherb	9 (42.9)
Vaccines granted accelerated approval, No. (%)	4 (19.0)
Clinical development period, yc	8.1 (6.1-10.5)
FDA review period, mod	12.0 (10.8-21.0)
No. of clinical trials supporting vaccine approvale	7 (5-13)
No. of pivotal efficacy trials	2 (1-3)
No. of trials considered essential to establish lot-to-lot consistencyf	1 (1-1)
No. of patients in the safety database	6710 (4576-15 997)
Duration of follow-up for serious adverse events, mo	6 (6-12)

Abbreviations: BLA, biologics licensing applications; DTaP, diphtheria, tetanus, and acellular pertussis; FDA, US Food and Drug Administration; IND, investigational new drug; IQR, interquartile range.

^aCategory includes all combination vaccines in which DTaP was a component.

^bIncludes 1 vaccine each for pneumococcus, adenovirus, human papillomavirus, cholera, shingles, hepatitis B, dengue virus, smallpox and monkeypox, and ebolavirus.

^cDefined as IND (when clinical testing can begin) to FDA approval.

^dDefined as BLA submission (when vaccine sponsors submit data for FDA approval) to FDA approval.

^eTotal clinical trials include pivotal and supportive studies supporting vaccine approval.

^fIf a pivotal efficacy study was also considered essential to establish lot-to-lot consistency, it was included in both categories.