Table 1.
Clinical Trials for COVID-19 Vaccine Options: Pregnancy, Lactation, and Contraception Requirement Criteria by Initiating Party, Location, and Phase (n = 90)
| Pregnancy Exclusion |
Lactation Exclusion |
Contraception Requirement |
||||
|---|---|---|---|---|---|---|
| n (%) | p Value | n (%) | p Value | n (%) | p Value | |
| Sponsor | ||||||
| Nonpharmaceutical | 42 (100.0) | .50 | 32 (76.2) | .29 | 21 (50.0) | .03 |
| Pharmaceutical | 46 (95.8) | 41 (85.4) | 35 (72.9) | |||
| Location∗ | ||||||
| U.S. | 11 (100.0) | .99 | 9 (81.8) | .99 | 8 (72.7) | .53 |
| International | 70 (98.6) | 60 (84.5) | 44 (62.0) | |||
| Phase† | ||||||
| 1 | 27 (100.0) | .79 | 24 (88.9) | .36 | 21 (77.8) | .16 |
| 1/2 | 22 (95.7) | 18 (78.3) | 15 (65.2) | |||
| 2 | 5 (100.0) | 5 (100.0) | 3 (60.0) | |||
| 2/3 | 2 (100.0) | 2 (100.0) | 1 (50.0) | |||
| 3 | 30 (96.8) | 23 (74.2) | 16 (51.6) | |||
| 4 | 2 (100.0) | 1 (50.0) | 0 (0.0) | |||
∗
Trials that included both U.S. and international locations were excluded for this analysis (n = 8).
†
The p value represents overall χ2 test.