RSV vaccines

Adverse events after nirsevimab administration may include a rash, rash maculo-papular and rash papular. There may also be an injection site reaction including injection site pain, induration, edema and site swelling. Very rare cases of serious hypersensitivity reactions have been reported following nirsevimab administration, these reactions included urticaria, dyspnea, cyanosis, and/or hypotonia. ^{Go to footnote 11}

Recipients of the maternal RSVPreF vaccine may experience injection site pain, which is mild to moderate. Systemic symptoms, including muscle pain and headaches may also occur. ^{Go to footnote 22}

In clinical trials, serious adverse events included a numerical increase in preterm births in maternal vaccine recipients(this was not statistically significant overall, and available data are insufficient to establish or exclude a causal relationship between preterm birth and the vaccine). A numerical increase in hypertensive disorders of pregnancy were also observed among vaccine recipients (not statistically significant). In infants of vaccine recipients, low birth weight cases were higher compared to the placebo group (not statistically significant). Post-authorization safety evaluations from the first season of use in the US concluded that the RSVPreF vaccine is not associated with increased risk for preterm birth or SGA at birth. ^{Go to footnote 33, Go to footnote 44}