Gavi welcomes first-ever prequalification of a maternal RSV vaccine

Gavi, the Vaccine Alliance welcomes the first-ever prequalification of a maternal Respiratory Syncytial Virus (RSV) vaccine to protect infants by the World Health Organisation (WHO). This is an important step towards curbing one of the leading causes of acute lower respiratory infections in children globally. 

Respiratory viruses are responsible for the majority of lower respiratory tract infections and hospitalizations in infants and young children, with RSV being the predominant infectious severe pneumonia agent globally in this population. Annually, RSV is responsible for 33 million cases of lower respiratory tract infections and 3.6 million hospitalisations in children under five years old, primarily during their first year of life. RSV is the second leading cause of infant mortality after malaria, with an estimated 101,400 deaths yearly of children under five years old worldwide, with an estimation of 5 deaths every 2 minutes. More than 99% of these deaths occur in lower- and middle-income countries, and the greatest mortality burden is in Africa. In most of the cases, children die at home before they can even reach a hospital.

RSV infection therefore places a significant economic burden on health systems and households due to high hospitalisation rates. Since there is currently no specific treatment for RSV, the introduction of preventive strategies in countries including maternal vaccination to protect infants will be key to significantly reducing pneumonia cases, preventing infant deaths, decreasing hospitalizations and oxygen use.

Importantly, this prequalification also creates a promising pathway for other RSV products currently in the pipeline, a first critical step towards a sustainable and healthy vaccine market that enables appropriate and affordable products to be made available to those who need them most.

Gavi, the Vaccine Alliance helps vaccinate more than half the world’s children, offering low- and middle-income countries access to vaccines against 20 infectious diseases. 

In 2018, Gavi’s multistakeholder Board identified RSV as a key priority for further expansion of the Gavi portfolio of vaccines, providing in-principle support to products to protect infants; maternal vaccines and long-acting monoclonal antibodies. This decision was contingent on availability of a licensed product, WHO prequalification and WHO Strategic Advisory Group of Experts (SAGE) recommendation, meeting the financial assumptions from the initial investment case presented, and contingent on the availability of funds.  

Now that this first vaccine has been prequalified after the recent WHO/SAGE recommendation of RSV products for infants, and the investment conditions are likely to be fulfilled for maternal vaccines an updated RSV vaccine investment case will be re-presented to the Gavi Board during 2025, along with insights from country demands and on the overall vaccine development pipeline, for assessing a potential future inclusion of the vaccine within Gavi’s portfolio. 
 

A multi-dose vial presentation of the same vaccine is under development by the manufacturer with support from the Gates Foundation to catalyze the delivery of the vaccine in lower-income countries via public-sector purchasers, including potentially Gavi.  

Commenting on the development, Marta Tufet Bayona, Head of Policy  at Gavi, the Vaccine Alliance said. 

“The prequalification of the maternal RSV vaccine to protect infants by the World Health Organisation marks a significant milestone in the fight against one of the leading killers of infants globally, particularly in lower- and middle-income countries where the impact is most profound.

This first ever global approval also opens doors for other innovative RSV products in the pipeline, creating a pathway to a range of affordable tools that will help reduce pneumonia cases, prevent infant deaths, and alleviate the economic burden on health systems.”  

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