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. 2020 Oct 13;38(47):7485–7489. doi: 10.1016/j.vaccine.2020.09.067

Table 2.

Number of products (out of 12) with harmonized language between FDA and EMA for each prescribing information element.

Prescribing information element Number of vaccines harmonized (out of 12)
Indication 6
Recommended Age Range 5
Dosing 4
Contraindications 5
Warnings & Precautions 0
Adverse Events 0
Concomitant Administration 2
Pregnancy Assessment 7
Pediatric Assessment 7
Patient Counseling Information 0