Respiratory syncytial virus vaccine

A minimum interval of two weeks is recommended between administration of bivalent, recombinant vaccine and administration of a tetanus, diphtheria and acellular pertussis vaccine (Tdap). There were no safety concerns when bivalent, recombinant vaccine 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.

RSVPreF3 vaccine may be administered concomitantly with inactivated seasonal influenza vaccines (standard dose unadjuvanted, high dose unadjuvanted, or standard dose adjuvanted).

Upon concomitant administration of RSVPreF3 vaccine with seasonal influenza vaccines, numerically lower RSV A and B neutralising titres and numerically lower influenza A and B haemagglutination inhibition titres were observed as compared to the separate administration. This was not observed consistently across studies. The clinical relevance of these findings is unknown.

If RSVPreF3 vaccine is to be given at the same time as another injectable vaccine, the vaccines should always be administered at different injection sites.

Concomitant administration of RSVPreF3 vaccine with other vaccines than those listed above has not been studied.

Safety and immunogenicity data on RSV vaccines are not available for immunocompromised individuals. Patients receiving immunosuppressive treatment or patients with immunodeficiency may have a reduced immune response to RSV vaccines.

As with other intramuscular injections, the vaccine should be given with caution in individuals receiving anticoagulant therapy or those with thrombocytopenia or any coagulation disorder (such as haemophilia) because bleeding or bruising may occur following an intramuscular administration in these individuals.

There are no data from the use of adjuvanted RSVPreF3 vaccine in pregnant women. After administration of an investigational unadjuvanted RSVPreF3 vaccine to 3 557 pregnant women in a single clinical study, an increase in preterm births was observed compared to placebo. Currently no conclusion on a causal relationship between administration of unadjuvanted RSVPreF3 and preterm birth can be drawn. Results from animal studies with an investigational unadjuvanted RSVPreF3 vaccine and results with adjuvanted RSVPreF3 vaccine do not indicate direct or indirect harmful effects with respect to reproductive toxicity. Adjuvanted RSVPreF3 vaccine is not recommended during pregnancy.

There are no data on the excretion of adjuvanted RSVPreF3 vaccine in human or animal milk. The vaccine is not recommended in breast-feeding/lactating women.

Fertility

There are no data on the effects of adjuvanted RSVPreF3 vaccine on human fertility. Animal studies with an investigational unadjuvanted RSVPreF3 vaccine or adjuvanted RSVPreF3 vaccine do not indicate direct or indirect harmful effects with respect to reproductive toxicity.

No studies on the effects of adjuvanted RSVPreF3 vaccine on the ability to drive and use machines have been performed.

The vaccine has a minor influence on the ability to drive and use machines. Some of the undesirable effects (e.g. fatigue) may temporarily affect the ability to drive or use machines.

Summary of the safety profile

The safety profile presented below is based on a placebo-controlled Phase III clinical study (conducted in Europe, North America, Asia and Southern hemisphere) in adults ≥60 years of age in which more than 12 000 adults received one dose of adjuvanted RSVPreF3 vaccine and more than 12 000 received placebo.

In study participants 60 years of age and older, the most commonly reported adverse reactions were injection site pain (61%), fatigue (34%), myalgia (29%), headache (28%), and arthralgia (18%). These adverse reactions were usually mild or moderate in intensity and resolved within a few days after vaccination. Most other adverse reactions were uncommon and similarly reported between the study groups.

Tabulated list of adverse reactions

Adverse reactions are listed below by MedDRA system organ class and frequency.

Very common (≥1/10), Common (≥1/100 to <1/10), Uncommon (≥1/1 000 to <1/100), Rare (≥1/10 000 to <1/1 000), Very rare (<1/10 000)

Adverse reactions: