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Published on: January 26, 2019
The New Era of Respiratory Syncytial Virus Protection for Infants: A Mini Review of Current Tools for
Santtu Heinonen1,2, Pekka Vartiainen1,2,3,4,5
1FVR-Finnish Vaccine Research, Tampere, Finland.
Insights
New immunizations, including monoclonal antibodies and a maternal vaccine, offer significant protection against respiratory syncytial virus (RSV) in infants. These strategies demonstrate high efficacy and safety, reducing infant RSV burden.
Area of Science:
- Pediatrics
- Immunology
- Infectious Diseases
Background:
- Infant respiratory syncytial virus (RSV) infection poses a significant health burden.
- Historical immunoprophylaxis strategies for RSV have evolved over time.
- Recent advancements have introduced novel prophylactic interventions.
Purpose of the Study:
- To review the history and recent advances in infant RSV immunoprophylaxis.
- To evaluate the efficacy, safety, and impact of new prophylactic strategies.
- To summarize the latest developments in preventing RSV in infants.
Main Methods:
- A narrative review of published literature.
- Emphasis on pivotal clinical trials and regulatory documents.
- Inclusion of recent real-world evidence.
Main Results:
- Three new products approved since 2022: nirsevimab, clesrovimab (monoclonal antibodies), and a maternal RSV vaccine.
- Efficacy against medically attended RSV lower respiratory tract infections ranged from 49% to 76%.
- Efficacy against RSV-associated hospitalization ranged from 55% to 91%, with favorable safety profiles.
Conclusions:
- Newly approved long-acting monoclonal antibodies and maternal RSV vaccine are highly effective.
- These interventions have demonstrated reassuring safety profiles.
- Implementation has substantially reduced the infant RSV burden globally.
Aim:
This mini review describes the history of infant respiratory syncytial virus (RSV) immunoprophylaxis and the latest advances in this area. It also reviews the efficacy, safety and impact of the recently introduced prophylactic strategies.
Method:
This narrative review is based on a targeted review of published literature, with emphasis on pivotal clinical trials, regulatory documents and recent real-world evidence.
Results:
Three immunisation products for preventing RSV in infants have been approved since 2022. These are two long-acting monoclonal antibodies, nirsevimab and clesrovimab, and a maternal RSV vaccine. The efficacy of these interventions has ranged from 49% to 76% against medically attended RSV-associated lower respiratory tract infections and from 55% to 91% against hospitalisation due to RSV-associated lower respiratory tract infection. The efficacy varied between the products and the duration of the follow-up. Similar or higher effectiveness has been reported in post-licensure, real-world evidence studies. Overall, these interventions have been well tolerated, with favourable safety profiles.
Conclusion:
The newly introduced long-acting monoclonal antibodies and the maternal RSV vaccine have proved highly effective and have demonstrated reassuring safety. They have already been implemented in a number of countries and have substantially reduced the RSV burden in infants.
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