The European CAPVAXIVE (VPC21) marketing authorization opens the way to large protection against invasive pneumococcal infections and pneumonia caused by Streptococcus pneumoniae among populations aged 18 and over.
Ten capvaxive serotypes are common with the VPC20 (Prevenar 20, Pfizer) and 11 are specific to it. Thus, thanks to its composition, the VPC21 covers the serotypes responsible for approximately 88 % of invasive pneumococcal infections (IIP) in adults over 65 years (according to 2022 data from the National Reference Center for Pneumococci), while those included in the VPC20 vaccine, currently recommended in France, are responsible for 64 % of IIPs in the same population, points.
The Phase 3 Phase 3 Pivot trial confirms the efficiency and good tolerance of the Capvaxive vaccine in adults aged 18 and more naive of antipneumococcal vaccination. It is administered by intramuscular injection into a single dose. Co-administration is possible with the quadrivalent vaccine against flu (inactivated with fragmented virion). It should be made available in the fall of 2025 in France.
Age greater than or equal to 65, risk factor alone
Each year, pneumococci are responsible for around 130,000 pneumonies and 6,000 cases of invasive pneumococcal infections (meningitis and bacteremia). Pneumococci leads between 4,000 and 12,000 deaths, 90 % of whom occur in people over 65.
« In adults, hospitalizations for invasive pneumococcal infections are often long (11 days on average) and complex, with mortality (10 to 30 %) or a significant cognitive and functional decline “Said Professor Paul Loubet, infectiologist at the Nîmes University Hospital.
-Age over 65 is an important risk factor. About 60 % of IIPs occur in adults aged 65 and over. The risk of IIP in a person ≥ 65 years compared to another <65 years is multiplied by 4.5 and the severity of the infection is multiplied by 3. In addition, a quarter of patients ≥ 65 years hospitalized for IIP are without comorbidity.
Regarding acute community pneumonia, 75 % of hospitalization cases also occur in adults over the age of 65 and half of them do not present comorbidity. It is therefore essential to be able to protect these elderly people against the serotypes responsible for the most invasive forms.
The vaccine currently recommended for the prevention of pneumococcal infections in adults, prevenar20 (VPC20) in injection at one dose, is reimbursed in people 18 and over at risk of severe forms. The High Authority for Health (HAS) spoke at the end of January in favor of expanding the care for all people aged 65 and over, and no longer only those with risk factors. Refund in this indication is expected in the summer.
For Capvaxive, the HAS indicated in an April framing note studying the demand for integrating the vaccine into the vaccination strategy against pneumococcal infections of adults, that is to say adults at risk and all adults aged 65 and over. The publication of recommendations is expected in March 2026.
According to a virtual press conference of the MSD laboratory
