Immunisation: Time to consider new preventative solutions beyond vaccines
 
More details
Hide details
1
Paris VII University, France
 
2
Programme for Global Health, Royal Institute International Affairs, Chatham House, United Kingdom
 
3
Ministry of Health, Spain
 
4
Paediatrics and Nursery Department, Voghera Civil Hospital, Italy
 
5
National Institute for Viral Disease Control and Prevention, Chinese Centers for Diseases Control and Prevention, China
 
6
Clinic for Child and Adolescent Medicine, Sana Hospital Lichtenberg, Germany
 
7
Department of Medicine and Surgery, Pediatric Clinic, Pietro Barilla Children's Hospital, Italy
 
8
Department of Pediatrics and Pediatric Neuropsychiatry, Sapienza University of Rome, Italy
 
 
Publication date: 2023-04-27
 
 
Popul. Med. 2023;5(Supplement):A1587
 
ABSTRACT
Background and Objective: The pace of innovation is accelerating and new preventative technologies for infectious diseases are emerging to address unmet medical needs. Most imminent is the use of long-acting monoclonal antibodies (mAb) to prevent Respiratory Syncytial Virus (RSV) lower respiratory tract infection in infants during their first RSV season. Innovative products, such as prophylactic mAbs may challenge existing legislative and regulatory immunisation categorization schemes. Indeed, due to the lack of precedent mAbs for prevention of broad populations, uncertainty remains in the assessment of upcoming prophylactic RSV mAbs, which, in some countries, are categorized neither as a treatment nor as a vaccine, with associated consequences in terms of registration, recommendation, funding, and implementation. Methods: These findings are based on views and insights gathered from 9 global experts (EU, Japan, China, UK) during an advisory board held in July 2022 to discuss RSV prevention strategies, completed by a desk research. Results: Beneath the umbrella of immunization, active and passive immunization exist, which differ in mechanism of action but serve the same public health purpose. As such, the legislative and regulatory categorization of preventative solutions should not be dictated by what the product is, in terms of technology or mechanism of action, but rather by what the product does, in terms of impact on healthcare systems and population. By terminology, prophylactic mAbs work as passive immunisation and should fall under the remit of National Immunisation Technical Advisory Groups or other relevant recommendation bodies for inclusion into National Immunisation Programs, to facilitate equitable access and maximize the public health impact through high uptake. Conclusions: Current regulations, policy and legislative frameworks need to evolve to embrace innovative preventative technologies to allow their inclusion into routine immunization programs and recognize them as immunisation tools in our regulatory and access pathways.
ISSN:2654-1459
Journals System - logo
Scroll to top