15-valent pneumonia vaccine! EU approval of Vaxneuvance: for people aged 6 weeks - under 18 years old!

October 25, 2022 /BioValleyBIOON/ --Merck & Co has announced that the European Commission (EC) has approved Vaxneuvance (15-valent pneumococcal conjugate vaccine [PCV], V114) to expand its indication for active immunization of infants, children and adolescents aged 6 weeks to under 18 years of age to prevent invasive diseases, pneumonia and acute otitis media caused by 15 serotypes of Streptococcus pneumoniae
。 In the EU, Vaxneuvance has previously been approved for use in adults aged 18 and over
.

Vaxneuvance is a 15-valent vaccine consisting of pneumococcal polysaccharides from 15 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, 33F) pneumococcal polysaccharides combined with CRM197 carrier protein, including serotypes 22F and 33F, which are commonly associated
with invasive pneumococcal disease (IPD) worldwide.

In terms of U.
S.
regulation, Vaxneuvance received FDA approval in July 2021 for active immunization against invasive pneumococcal disease (IPD)
caused by the 15 Streptococcus pneumoniae serotypes mentioned above.
In June 2022, Vaxneuvance received FDA approval to expand its indications for children aged 6 weeks to 17 years
.
With this expanded indication, Vaxneuvance is the first approved pneumococcal conjugate vaccine for children in the United States in nearly a decade that will help protect the pediatric population from IPD
.
Previously, the US FDA has granted Vaxneuvance breakthrough drug designation (BTD) for the prevention of IPD
caused by vaccine serotypes in pediatric populations aged 6 weeks to under 18 years of age and adults aged 18 years and older.

Dr.
Eliav Barr, Head of Global Clinical Development and Chief Medical Officer at Merck Research Laboratories, said: "Vaxneuvance was developed to maintain a robust immune response to the serotypes contained in currently available pneumococcal conjugate vaccines (PCVs), while expanding coverage to disease-causing serotypes
that may pose significant risks to infants and children.
With this approval, we are pleased to bring an important new option
for PCV to vulnerable populations in Europe, including infants under one year of age, who typically have the highest prevalence rates.
" ”

Pneumococcal disease is an infection
caused by Streptococcus pneumoniae.
The different strains of this bacterium are called serotypes
.
Invasive pneumococcal disease (IPD)
occurs when Streptococcus pneumoniae invades parts of the body where bacteria are not normally present.
Although there are about 100 different serotypes, there are fewer
causative serotypes of IPD in children.
Serotypes 3, 22F, and 33F are 3 of the top 5 serotypes responsible for IPD cases in children
.
IPD can lead to hospitalization or death
.
Some examples of IPD include bacteremia (bloodstream infection) and meningitis (meningeal infection), which can lead to long-term neurological complications
.
Children under 2 years of age are particularly vulnerable to IPD
.

The approval of the EU paediatric population indication is based on data
from 8 randomized, double-blind clinical studies.
The studies enrolled about 8400 people, 5400 of whom were vaccinated with Vaxneuvance
.
The studies evaluated the use of Vaxneuvance in a variety of paediatric populations at risk of pneumococcal disease, including healthy infants, children, adolescents, premature infants, HIV-infected children, or children
with sickle cell disease (SCD).

The use of Vaxneuvance in a variety of clinical settings has also been evaluated
.
For example, Vaxneuvance was used as an interchangeable vaccine after initiating the infant 13-valent pneumococcal conjugate vaccine (PCV13) vaccination program, or Vaxneuvance was used for catch-up in larger populations of children who had not received the pneumococcal vaccine or had previously received another incomplete PCV vaccination regimen
.

Data supporting approval include results
from the pivotal PNEU-PED-EU-1 study (NCT04031846).
The study, conducted in healthy infants (n = 1184), evaluated the safety, tolerability and immunogenicity
of Vaxneuvance 2-dose infant regimen followed by 1 toddler dose.

The results showed that 30 days after vaccination of young children, according to the geometric mean concentration (GMC) of serotype-specific immunoglobulin G (IgG): (1) for 13 common serotypes, Vaxneuvance elicited an immune response no less than the currently licensed 13-valent pneumococcal conjugate vaccine (PCV13); (2) For the two serotypes 22F and 33F unique to Vaxneuvance, the immune response triggered by Vaxneuvance is better than PCV13
.

Data from clinical programs also support the use of Vaxneuvance in conjunction with other commonly used routine pediatric vaccines, as well as in a variety of clinical settings, such as the use of Vaxneuvance as an interchangeable vaccine after initiation of the infant PCV13 vaccination program, or the catch-up
of Vaxneuvance in larger populations of children who have not received the pneumococcal vaccine or have previously received another incomplete PCV vaccination regimen 。 In addition, the data support the use of Vaxneuvance in special populations, such as premature infants and children
infected with HIV or with sickle cell disease (SCD).
(Bio Valley Bioon.
com)

European Commission Expands Merck's VAXNEUVANCE™ (Pneumococcal 15-valent Conjugate Vaccine) Indication to Include Infants, Children and Adolescents