Airways Disorders Network

 

Pediatric Chest Medicine Section

Hope is on the horizon—new RSV protection for all infants

There is a dire unmet need for RSV protection in healthy term infants as available preventive therapies are limited and currently reserved for former preterm infants and those with certain underlying medical conditions (Brady MT, et al. Pediatrics. 2014;134[2]:415). Globally, RSV is a significant cause of lower respiratory tract infection impacting all age groups, yet, in infants and young children, the first infection may cause severe bronchiolitis that can be fatal (Li Y, et al. Lancet. 2022;399:2047).

There are currently three approaches for protection at various stages of clinical development. The first is direct administration of antibodies to the infant. Two potent, longer-lasting, single-dose monoclonal antibody products, including nirsevimab which is a monoclonal antibody to the RSV fusion protein that has an extended half-life, for the general infant population are in phase 3 trials (Hammitt LL, et al. N Engl J Med. 2022;386:837; Griffin PM, et al. N Engl J Med. 2020;383:415).

Passive antibody acquired from maternal vaccination in pregnancy is a second approach. Notably, a recent phase 3 trial that evaluated maternal vaccination did not show significance with respect to the primary end point of medically significant RSV-associated lower respiratory tract infection in infants up to 90 days of life (Madhi SA. N Engl J Med. 2020;383:426).

The third type of protection is active vaccination. Increased understanding of the biology of RSV and related technological advances have resulted in the entry of multiple vaccines into clinical development for pediatrics and adults, some of which may receive regulatory approval in the near future (Munoz FM, et al. Vaccine. 2021;39[22]:3053).

The burden of RSV is tremendous, yet the future of RSV protection looks promising.

Anne C. Coates, MD, FCCP, Member-at-Large
Mary Cataletto, MD, FCCP, Member-at-Large

 

Pediatric Chest Medicine Section

Hope is on the horizon—new RSV protection for all infants

There is a dire unmet need for RSV protection in healthy term infants as available preventive therapies are limited and currently reserved for former preterm infants and those with certain underlying medical conditions (Brady MT, et al. Pediatrics. 2014;134[2]:415). Globally, RSV is a significant cause of lower respiratory tract infection impacting all age groups, yet, in infants and young children, the first infection may cause severe bronchiolitis that can be fatal (Li Y, et al. Lancet. 2022;399:2047).

There are currently three approaches for protection at various stages of clinical development. The first is direct administration of antibodies to the infant. Two potent, longer-lasting, single-dose monoclonal antibody products, including nirsevimab which is a monoclonal antibody to the RSV fusion protein that has an extended half-life, for the general infant population are in phase 3 trials (Hammitt LL, et al. N Engl J Med. 2022;386:837; Griffin PM, et al. N Engl J Med. 2020;383:415).

Passive antibody acquired from maternal vaccination in pregnancy is a second approach. Notably, a recent phase 3 trial that evaluated maternal vaccination did not show significance with respect to the primary end point of medically significant RSV-associated lower respiratory tract infection in infants up to 90 days of life (Madhi SA. N Engl J Med. 2020;383:426).

The third type of protection is active vaccination. Increased understanding of the biology of RSV and related technological advances have resulted in the entry of multiple vaccines into clinical development for pediatrics and adults, some of which may receive regulatory approval in the near future (Munoz FM, et al. Vaccine. 2021;39[22]:3053).

The burden of RSV is tremendous, yet the future of RSV protection looks promising.

Anne C. Coates, MD, FCCP, Member-at-Large
Mary Cataletto, MD, FCCP, Member-at-Large

 

Pediatric Chest Medicine Section

Hope is on the horizon—new RSV protection for all infants

There is a dire unmet need for RSV protection in healthy term infants as available preventive therapies are limited and currently reserved for former preterm infants and those with certain underlying medical conditions (Brady MT, et al. Pediatrics. 2014;134[2]:415). Globally, RSV is a significant cause of lower respiratory tract infection impacting all age groups, yet, in infants and young children, the first infection may cause severe bronchiolitis that can be fatal (Li Y, et al. Lancet. 2022;399:2047).

There are currently three approaches for protection at various stages of clinical development. The first is direct administration of antibodies to the infant. Two potent, longer-lasting, single-dose monoclonal antibody products, including nirsevimab which is a monoclonal antibody to the RSV fusion protein that has an extended half-life, for the general infant population are in phase 3 trials (Hammitt LL, et al. N Engl J Med. 2022;386:837; Griffin PM, et al. N Engl J Med. 2020;383:415).

Passive antibody acquired from maternal vaccination in pregnancy is a second approach. Notably, a recent phase 3 trial that evaluated maternal vaccination did not show significance with respect to the primary end point of medically significant RSV-associated lower respiratory tract infection in infants up to 90 days of life (Madhi SA. N Engl J Med. 2020;383:426).

The third type of protection is active vaccination. Increased understanding of the biology of RSV and related technological advances have resulted in the entry of multiple vaccines into clinical development for pediatrics and adults, some of which may receive regulatory approval in the near future (Munoz FM, et al. Vaccine. 2021;39[22]:3053).

The burden of RSV is tremendous, yet the future of RSV protection looks promising.

Anne C. Coates, MD, FCCP, Member-at-Large
Mary Cataletto, MD, FCCP, Member-at-Large