Mazur NI
Terstappen J
Baral R
Bardaji A
Beutels P
Buchholz UJ
Cohen C
Crowe JE, Jr
Cutland CL
Eckert L
Feikin D
Fitzpatrick T
Fong Y
Graham BS
Heikkinen T
Higgins D
Hirve S
Klugman KP
Kragten-Tabatabaie L
Lemey P
Libster R
Lowensteyn Y
Mejias A
Munoz FM
Munywoki PK
Mwananyanda L
Nair H
Nunes MC
Ramilo O
Richmond P
Ruckwardt TJ
Sande C
Srikantiah P
Thacker N
Waldstein KA
Weinberger D
Wildenbeest J
Wiseman D
Zar HJ
Zambon M
Bont L
Lancet Infect Dis. 2023;23e2-e21
Respiratory syncytial virus is the second most common cause of infant mortality and a major cause of morbidity and mortality in older adults (aged >60 years). Efforts to develop a respiratory syncytial virus vaccine or immunoprophylaxis remain highly active. 33 respiratory syncytial virus prevention candidates are in clinical development using six different approaches: recombinant vector, subunit, particle-based, live attenuated, chimeric, and nucleic acid vaccines; and monoclonal antibodies. Nine candidates are in phase 3 clinical trials. Understanding the epitopes targeted by highly neutralising antibodies has resulted in a shift from empirical to rational and structure-based vaccine and monoclonal antibody design. An extended half-life monoclonal antibody for all infants is likely to be within 1 year of regulatory approval (from August, 2022) for high-income countries. Live-attenuated vaccines are in development for older infants (aged >6 months). Subunit vaccines are in late-stage trials for pregnant women to protect infants, whereas vector, subunit, and nucleic acid approaches are being developed for older adults. Urgent next steps include ensuring access and affordability of a respiratory syncytial virus vaccine globally. This review gives an overview of respiratory syncytial virus vaccines and monoclonal antibodies in clinical development highlighting different target populations, antigens, and trial results.