Limitations of vaccine effectiveness As with any vaccine, a protective immune response may not be elicited after vaccination. Excipient This medicinal product contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free’. 4.5 Interaction with other medicinal products and other forms of interaction Abrysvo can be administered concomitantly with: seasonal influenza vaccines, either standard dose adjuvanted or high dose unadjuvanted COVID-19 mRNA vaccines, with or without high dose unadjuvanted influenza vaccine administered concomitantly.
A minimum interval of two weeks is recommended between administration of Abrysvo and administration of a tetanus, diphtheria and acellular pertussis vaccine (Tdap). There were no safety concerns when Abrysvo was co-administered with Tdap in healthy non-pregnant women. Immune responses to RSV A, RSV B, diphtheria and tetanus on co-administration were non-inferior to those after separate administration. However, the immune responses to the pertussis components were lower on co-administration compared to separate administration and did not meet the criteria for non- inferiority. The clinical relevance of this finding is unknown.
4.6 Fertility, pregnancy and lactation Pregnancy Data on pregnant women (more than 4 000 exposed outcomes) indicate no malformative nor feto/neonatal toxicity. Results from animal studies with Abrysvo do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3). In a phase 3 study (Study 1), maternal adverse events reported within 1 month after vaccination were similar in the Abrysvo group (14%) and the placebo group (13%). Breast-feeding It is unknown whether Abrysvo is excreted in human milk. No adverse effects of Abrysvo have been shown in breastfed newborns of vaccinated mothers.
Fertility No human data on the effect of Abrysvo on fertility are available. Animal studies do not indicate direct or indirect harmful effects with respect to female fertility (see section 5.3). 4 No safety signals were detected in infants up to 24 months of age. The incidences of adverse events reported within 1 month after birth in infants were similar in the Abrysvo group (38%) and the placebo group (35%). Major birth outcomes assessed in the Abrysvo group compared to placebo included premature birth (207 (6%) and 172 (5%), respectively), low birth weight (186 (5%) and 158 (4%), respectively) and congenital anomalies (205 (6%) and 245 (7%), respectively).