new 15valent pneumococcal vaccine recommended in the pediatric population

DIn the vaccination strategy against pneumococcal infections (PI), VAXNEUVANCE suspension for injection in pre-filled syringe is a new vaccine indicated in active immunization for the prevention of:

• invasive infections, pneumonia and acute otitis media caused by Streptococcus pneumoniae in infants, children and adolescents from 6 weeks to less than 18 years;
• invasive infections and pneumonia caused by Streptococcus pneumoniae in people aged 18 and over.

VAXNEUVANCE should be used according to official recommendations [1, 2].

A formulation targeting 15 pneumococcal serotypes

One dose (0.5 mL) of VAXNEUVANCE contains 15 pneumococcal serotypes, two more than PREVENAR 13. The additional serotypes are serotypes 22F and 33F:

• Pneumococcal polysaccharide serotype 1;
• Pneumococcal polysaccharide serotype 3;
• Pneumococcal polysaccharide serotype 4;
• Pneumococcal polysaccharide serotype 5:
• Pneumococcal polysaccharide serotype 6A;
• Pneumococcal polysaccharide serotype 6B;
• Pneumococcal polysaccharide serotype 7F;
• Pneumococcal polysaccharide serotype 9V;
• Pneumococcal polysaccharide serotype 14;
• Pneumococcal polysaccharide serotype 18C;
• Pneumococcal polysaccharide serotype 19A;
• Pneumococcal polysaccharide serotype 19F;
• Pneumococcal polysaccharide serotype 22F;
• Pneumococcal polysaccharide serotype 23F;
• Pneumococcal polysaccharide serotype 33F.

Like PREVENAR 13, VAXNEUVANCE is a conjugated pneumococcal vaccine (PCV) and adjuvant (aluminum phosphate). Each serotype is conjugated to the CRM 197 vector protein.

An alternative to PREVENAR 13 in pediatrics

A few months before the marketing of VAXNEUVANCE, the High Authority for Health (HAS) clarified the place of this new 15-valent vaccine (PCV 15) in the vaccination strategy for children. [1] :

• VAXNEUVANCE is an alternative to PREVENAR 13 (VPC 13) for the prevention of invasive pneumococcal infections (IIP), pneumonia and acute pneumococcal otitis media in infants, children and adolescents from 6 weeks to less than 18 years of age.

In its July 2023 evaluation report [1]the HAS notes that the 22F and 33F serotypes added to VAXNEUVANCE were respectively responsible for 5.1% and 1.71% of bacteremia and 0% and 5.88% of pneumococcal meningitis in 2020.

However, serotypes 24F, 10A and 23B frequently isolated in IIP in children under 15 years of age in 2020 remain not covered by VPC 13 and VPC 15, while they represented 16.24%, 10.26% respectively. and 10.26% of bacteremia and 11.76%, 13.73% and 5.88% of meningitis.

Important SMR but no ASMR for VAXNEUVANCE

The request for treatment of VAXNEUVANCE in the pediatric population was the subject of an opinion from the Transparency Commission (CT) in September 2023 [3]. The CT attributed a significant medical benefit (SMR) based on the available data, including:

• the data demonstrating the non-inferiority of the immune response induced by VAXNEUVANCE compared to PREVENAR 13 in terms of serological response rate and geometric means of antibody titers for the 13 common serotypes;
• the data demonstrating the superiority of the immune response induced by VAXNEUVANCE compared to PREVENAR 13 in terms of serological response rate and geometric means of antibody titers for the 2 additional serotypes 22F and 33F.

However, the CT considers that “the potential additional impact on the reduction of morbidity and mortality conferred by the addition of 2 serotypes (22F and 33F) cannot be assessed in the absence of clinical effectiveness data and due to the low representation of these circulating serotypes in France ». It concludes that VAXNEUVANCE does not provide any improvement in actual benefit (ASMR V).

The indication of VAXNEUVANCE in adults has not been the subject of a CT opinion. According to the new recommendations, vaccination of adults (from 18 years old) at risk of contracting IP is now based on the new PREVENAR 20 vaccine according to a one-dose schedule replacing the PCV 13 – PPV 23 sequence. [vaccin pneumococcique polyosidique non conjugué 23-valent – PNEUMOVAX] (see. our article of May 7, 2024).

Vaccination recommendations for infants and special cases in children

Primary vaccination against pneumococcus is compulsory for all children born from 1^er January 2018.
VAXNEUVANCE is cited in the 2024 edition of the vaccination calendar [2] as an alternative to PREVENAR 13 (VPC 13), according to the same vaccination schedule in infants:

• primary vaccination with 2 injections spaced 2 months apart, at the age of 2 months (8 weeks) and at 4 months;
• booster dose at 11 months.

VAXNEUVANCE is also an alternative to PREVENAR 13 for the vaccination of children in a specific situation, taking into account pneumococcal vaccinations already received:

• premature and infants at high risk of PI:
  • primary vaccination with 3 doses (carried out at 2, 3 and 4 months),
  • followed by 1 booster dose at 11 months;
• children aged 2 to less than 5 years at high risk of PI:
  • without previous pneumococcal vaccination: 2 doses of VPC 13 or 15 2 months apart, then 1 dose of VPP 23 (PNEUMOVAX) at least 2 months after the previous dose of VPC;
  • if previous vaccination with PCV 13 or 15 (before 24 months): 1 dose of PCV 23 (PNEUMOVAX) at least 2 months after the previous dose of PCV;
• children aged 5 to 17 at high risk of PI:
  • without previous pneumococcal vaccination: 1 dose of VPC 13 or 15 then 1 dose of VPP 23 (PNEUMOVAX) at least 2 months after the dose of VPC;
  • previous vaccination with the sequence VPC 13 or 15 – VPP 23: new injection of VPP 23 respecting a period of 5 years after the previous injection of VPP 23;
  • previous vaccination with VPP 23 only: 1 dose of VPC 13 or 15 if the previous vaccination was more than 1 year ago. The subsequent injection of VPP 23 will be carried out with a minimum delay of 5 years from the date of injection of this same vaccine.

VAXNEUVANCE in practice

VAXNEUVANCE comes in a pre-filled syringe containing 0.5 mL of injectable suspension, i.e. 1 dose.

The injection is carried out intramuscularly (IM). The recommended site is:

• the anterolateral aspect of the thigh in infants
• the deltoid muscle in the upper arm in children and adults.

It should be stored in the refrigerator between 2°C and 8°C. Once released, the vaccine should be administered as soon as possible.

Shake before injecting

Before injection, it is recommended to shake the pre-filled syringe until an opalescent suspension is obtained.

The injection needle is provided in the package. It must be attached to the pre-filled syringe just before injection.

When administered concomitantly with other vaccines

In infants, VAXNEUVANCE can be administered concomitantly (different injection sites) with the following vaccines, in the form of monovalent vaccines or combined vaccines:

• diphtheria, tetanus, whooping cough, poliomyelitis (serotypes 1, 2 and 3);
• hepatitis A, hepatitis B;
• Haemophilus influenzae type b;
• Measles Mumps Rubella ;
• varicella ;
• rotavirus (oral vaccine).

VAXNEUVANCE can also be administered concomitantly with the quadrivalent seasonal influenza vaccine (inactivated, split virion).

Administrative identity

• List I
• Box of 1 pre-filled syringe of 0.5 mL + 1 needle, CIP 3400930244371
• Refundable at 65% (see. Boxed) [4]
• Public price including tax = 48.82 euros [5]
• Approval for communities (see. Boxed) [6]
• MSD France Laboratory