MHRA Approves First New Vaccine in a Decade to Protect Children Against Pneumococcal Diseases, including Pneumonia.

MHRA Approves First New Vaccine in a Decade to Protect Children Against Pneumococcal Diseases, including Pneumonia.

• MSD's VAXNEUVANCE▼™ (15-valent Pneumococcal Conjugate Vaccine (PCV15)) indication expanded to include infants, children, and adolescents

• The approval is the first pneumococcal vaccine for paediatrics in 10 years and is the first in what is hoped to be a new generation of vaccines to protect against pneumococcal diseases

• Historically cases like these have risen during winter which can lead to increased pressures on the public health system

LONDON, November 09, 2022 – MSD (tradename of Merck & Co., Inc., Rahway, N.J., USA (NYSE: MRK)) announced today that the Medicines and Healthcare products Regulatory Agency (MHRA) has approved a Type II variation, to extend the indication for VAXNEUVANCE (PCV15) in the UK to include active immunisation for the prevention of invasive disease, pneumonia and acute otitis media caused by Streptococcus pneumoniae (S. pneumoniae) in infants, children, and adolescents from 6 weeks to less than 18 years of age. The vaccine is already indicated for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae in individuals 18 years of age and older.1 The approvals were supported by eight randomised, double-blind clinical studies that enrolled approximately 8,400 individuals, including 5,400 who received PCV15. The studies evaluated the use of the product in various paediatric populations at risk for pneumococcal disease, including healthy infants, children and adolescents, pre-term infants and children living with HIV infection or sickle cell disease. The vaccine was also evaluated across a variety of clinical circumstances, such as interchangeable use following initiation of an infant vaccination schedule with the currently licensed 13-valent pneumococcal conjugate vaccine (PCV13) or in a catch-up setting for older children who are either pneumococcal vaccine-naïve or who previously received an incomplete series of another pneumococcal conjugate vaccine (PCV).1 The data supporting the approval included findings from the pivotal PNEU-PED-EU-1 study which evaluated the safety, tolerability and immunogenicity of a two-dose infant series followed by a toddler dose in healthy infants (n=1,184). Results showed that immune responses were noninferior to PCV13 for the 13 serotypes shared between the two vaccines and superior for the two additional serotypes in PCV15, 22F and 33F, as assessed by serotype-specific anti-pneumococcal polysaccharide immunoglobulin G (IgG) response rates and geometric mean concentrations (GMCs) at 30 days post-toddler dose.2 Pneumococcal disease is an infection caused by the bacterium S. pneumoniae, a World Health Organization Global Priority Pathogen.3 Invasive pneumococcal disease (IPD) can cause serious and potentially life-threatening infections such as bacteremia (infection in the bloodstream); bacteremic pneumonia (pneumonia with bacteremia); and meningitis (infection of the linings of the brain and spinal cord).4,5 Historically cases like these have risen during winter which can lead to increased pressures on the public health system.5 Vaccinations to protect children and families against preventable diseases can play a critical role in reducing the burden on the NHS and other parts of the public health system. With continued vaccine innovation, MSD is committed to working closely with healthcare system decision makers to ensure all vaccines are assessed holistically, whether as part of a national immunisation programme or in response to outbreaks.

Professor Andrew Cant of the Paediatric Immunology team at the Great North Children’s Hospital said: "Immunisation plays a vital role in protecting children from Pneumococcal Meningitis and Pneumonia. However, our very success in preventing infection with dangerous strains of Pneumococcus creates an opportunity for other strains of Pneumococcus to emerge and take their place as new dangerous strains. This ongoing struggle between microbes and immunity means, that despite our best efforts, we can never take it for granted that our current vaccines will remain wholly effective, but must continually innovate and improve our pneumococcal vaccines if we are to save children from these diseases and their life threatening and life changing consequences. I therefore very much welcome the news of the licensure of PCV15 for the paediatric population which gives protection against further strains of Pneumococcus and adds to the range of vaccines available".

Dr. Dilruwan Herath, Executive Medical Affairs Director, MSD UK & Ireland said: “Infants less than one year of age typically experience the highest rates of disease, therefore this approval provides an important new option to protect and reassure families across the UK. As the first new PCV in over a decade, we hope to see the new generation of pneumococcal vaccines assessed holistically by the UK health system.”

Date of preparation: November 2022

GB-PVC-00074

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Summary of PCV15 safety profile:

The safety of Vaxneuvance in healthy infants, including preterm infants (from 6 weeks of age at first vaccination) and children (11 through 15 months of age) was assessed as a 3 dose or 4 dose regimen in 5 clinical studies with a total of 7,229 participants.

The most frequent adverse reactions were pyrexia ≥38 °C (75.2%), irritability (74.5%), somnolence (55.0%), injection-site pain (44.4%), injection-site erythema (41.7%), decreased appetite (38.2%), injection-site induration (28.3%) and injection-site swelling (28.2%) based on results in 3,589 participants, excluding participants who received a mixed dose regimen. The majority of solicited adverse reactions were mild to moderate (based on intensity or size) and of short duration (≤3 days). Severe reactions (defined as being extremely distressed or unable to do usual activities or size >7.6 cm) occurred in ≤3.5% of infants and children following any dose, with the exception of irritability which occurred in 11.4% of participants.1

The safety of Vaxneuvance in healthy children and adolescents was assessed in a study that included 352 participants, aged 2 to less than 18 years of age, of whom 177 received a single dose of Vaxneuvance. In this age cohort, 42.9% of all participants had a history of previous vaccination with a lower valency pneumococcal conjugate vaccine.

The most frequent adverse reactions were injection-site pain (54.8%), myalgia (23.7%), injection-site swelling (20.9%), injection-site erythema (19.2%), fatigue (15.8%), headache (11.9%), injection-site induration (6.8%), and pyrexia ≥38 °C (5.6%). The majority of solicited adverse reactions were mild to moderate (based on intensity or size) and of short duration (≤3 days); severe reactions (defined as being extremely distressed or unable to do usual activities or size >7.6 cm) occurred in ≤4.5% of children and adolescents.1

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For more information, please see the Summary of Product Characteristics for this medicine, available online at www.medicines.org.uk/emc/product/13754/smpc

This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side-effects you may get. See https://yellowcard.mhra.gov.uk/ for how to report side effects.

Note to editors

Date of preparation: November 2022

GB-PVC-00074

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About PCV15

PCV15, MSD’s 15-valent pneumococcal conjugate vaccine, consists of purified capsular polysaccharides from S. pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F and 33F individually conjugated to CRM197 carrier protein.1

PCV15 is indicated in the UK for active immunisation for the prevention of invasive disease, pneumonia and acute otitis media caused by Streptococcus pneumoniae in infants, children, and adolescents from 6 weeks to less than 18 years of age. PCV15 is also indicated for active immunisation for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae in individuals 18 years of age and older.1

The MHRA’s decision means PCV15 can now be marketed in the UK. PCV15 is not currently included within existing national immunisation programmes. MSD understands the Joint Committee on Vaccination and Immunisation (JCVI) will be looking to undertake an assessment of the pneumococcal national immunisation programmes in the coming months to assess whether any changes are warranted. Only upon ministerial approval of a JCVI recommendation will any new vaccine be included within a national immunisation programme.

The approval follows the positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) and European Commission (EC) decision.6

About Pneumococcal Disease Pneumococcal disease is an infection caused by the bacterium S. pneumoniae, or pneumococcus. While there are more than 100 different types of S. pneumoniae, called serotypes, a selected number of serotypes are responsible for the majority of pneumococcal infections. During July–December 2021, IPD cases increased among children <15 years of age, compared to previous years with an incidence of 1.96 (cases per 100,000 children), among whom incidence was highest in <1-year-olds.7 Invasive pneumococcal disease (IPD) can cause serious and potentially life-threatening infections such as bacteremia (infection in the bloodstream); bacteremic pneumonia (pneumonia with bacteremia); and meningitis (infection of the linings of the brain and spinal cord).4,5