In August 2023, the pharmaceutical company Pfizer announced that its Abrysvo vaccine against respiratory syncytial virus (RSV) was indicated to immunize pregnant women – and protect their babies from birth to six months of age – and people over 60 years of age – in which helps prevent lower respiratory tract disease – had been approved by the European Commission.
The Spanish Agency for Medicines and Health Products (AEMPS), belonging to the Ministry of Health, has now approved its marketing in Spain, making it the first vaccine authorized for the immunization of RSV in pregnant women and older adults in our country. . Its price is 234.95 euros in pharmacies, and for now the National Health System will only finance it for pregnant women.
Abrysvo is a bivalent prefusion F protein vaccine that is administered by intramuscular injection in a single dose to pregnant women between 24 and 36 weeks of gestation, and to the population over 60 years of age, and that would provide protection from 89% in the first year and 79% in the second year against lower respiratory tract diseases (ERVBI), caused by RSV.
Pfizer’s medical director, José Chaves, explained during the press conference held on Tuesday that for the moment the Ministry of Health and the General Directorate of Pharmacy have authorized the financing of Abrysvo for pregnant women, but “it is not yet funded.” for those over 60 years of age”, although it has marketing authorization for both indications with a medical prescription. “We are still in talks with Health, but the Ministry’s greatest urgency was to finance it for the indication of pregnant women,” he added.
Reduce the number of hospitalizations in babies and older adults
According to the Spanish Association of Pediatrics (AEP), RSV affects 60% of all children under 1 year of age and, in addition to being one of the main causes of consultation in primary care and pediatric emergencies, it is also the main cause of hospitalization. in periods of maximum incidence, especially in children under six months, since it is responsible for 80% of bronchiolitis and pneumonia in babies.
This season, the Beyfortus vaccine – which was approved in 2022 by the European Commission – began to be administered in Spain to babies under six months of age and children up to 24 months of age at risk of serious illness. However, immunizing the mother is a great advance because the pregnant woman develops her own antibodies and transmits them to the fetus through the placenta.
Health has authorized the financing of Abrysvo for pregnant women, but “it is not yet funded for those over 60 years of age,” although it has marketing authorization for both indications with a medical prescription.
Regarding the vaccination of those over 60-65 years of age, the professor of Preventive Medicine and Public Health at the Rey Juan Carlos University, Ángel Gil, has pointed out that “RSV also has a very important impact on the adult population, particularly in those over 60 years of age, in adults with chronic heart disease, COPD, asthma or immunocompromised, but also in healthy older adults.”
The expert has explained that administering this vaccine to adults will not prevent infection, but it will prevent them from developing a serious illness that requires hospitalization or even causes death. RSV affects in a similar way to the flu virus, but its lethality is greater, probably because it is not diagnosed in time, Gil explained, which is why he indicates the need to “incorporate rapid diagnostic tests to know if we are facing a case of COVID-19, flu or RSV.”
Pfizer has also launched two additional clinical trials to evaluate the effectiveness of Abrysvo in children at increased risk for RSV disease, ages two to 18, and in adults ages 18 to 60 with underlying medical conditions, such as asthma, diabetes or COPD.
