- The stock price of Merck & Co., Inc. (NYSE: MRK) increased by 4.03% in the most recent trading session. This is why.
The stock price of Merck & Co., Inc. (NYSE: MRK) increased by 4.03% in the most recent trading session. Investors responded positively to Merck announcing that the U.S. Food and Drug Administration (FDA) has approved an expanded indication for VAXNEUVANCE (Pneumococcal 15-valent Conjugate Vaccine) (pronounced VAKS-noo-vans) to include children 6 weeks through 17 years of age.
Now VAXNEUVANCE is indicated for active immunization for the prevention of invasive disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F and 33F in individuals 6 weeks of age and older. The approval follows the FDA’s Priority Review of Merck’s supplemental application. VAXNEUVANCE is contraindicated for individuals with a severe allergic reaction (e.g., anaphylaxis) to any component of VAXNEUVANCE or to diphtheria toxoid.
The U.S. Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) is expected to meet today to discuss and make recommendations on the use of VAXNEUVANCE in pediatric populations.
Invasive pneumococcal disease (IPD) is known as an infection caused by the bacterium Streptococcus pneumoniae, or pneumococcus. While there are approximately 100 different types of S. pneumoniae, called serotypes, a smaller number of serotypes are responsible for IPD in children. And Serotypes 3, 22F, and 33F are 3 of the top 5 serotypes causing childhood cases of IPD. IPD can lead to hospitalization or death. Some examples of IPD are bacteremia (an infection in the blood) and meningitis (an infection of the coverings of the brain and spinal cord), which can also result in long-term neurological complications. Children under the age of 2 are particularly vulnerable to IPD.
The FDA’s approval was based on data from seven randomized, double-blind clinical studies assessing the safety, tolerability, and immunogenicity of VAXNEUVANCE in infants, children and adolescents. The clinical data from the pivotal study showed that immune responses elicited by VAXNEUVANCE following a four-dose pediatric series were non-inferior to the currently available 13-valent pneumococcal conjugate vaccine (PCV13) for the 13 shared serotypes based on serotype-specific immunoglobulin G (IgG) geometric mean concentrations (GMCs).
In a secondary analysis, immune responses for VAXNEUVANCE following a 4-dose pediatric series were superior to PCV13 for shared serotype 3 and the 2 serotypes unique to VAXNEUVANCE, 22F and 33F. Randomized controlled trials assessing the clinical efficacy of VAXNEUVANCE compared to PCV13 have not been conducted.
The data from the clinical program also support the use of VAXNEUVANCE concomitantly with other commonly administered routine pediatric vaccines and in a variety of clinical settings, such as interchangeable use following initiation of an infant vaccination schedule with 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 PCV. Additionally, data support the use of VAXNEUVANCE in special populations, such as in preterm infants and children living with HIV infection or sickle cell disease.
“Despite decreases in incidence of invasive pneumococcal disease in children, certain key serotypes continue to cause serious illness that can lead to death in children under the age of 5, with serotypes 3, 22F and 33F responsible for more than a quarter of all invasive pneumococcal disease cases in this population. With the robust clinical data supporting VAXNEUVANCE and this FDA approval, VAXNEUVANCE will be an important new option to help advance protection for children.”
— Dr. Steven Shapiro, chairman, department of pediatrics, Jefferson Abington Hospital, and investigator for the PNEU-PED trial
“Our goal with VAXNEUVANCE is to expand coverage of key invasive disease-causing serotypes and provide a strong immune response to serotypes that pose substantial risk to infants and children. With this approval, we bring forward our first pediatric pneumococcal conjugate vaccine – and the first pediatric pneumococcal conjugate vaccine to be approved in almost a decade – building on our commitment to preventing invasive pneumococcal disease and on our legacy in pediatric vaccine development. We thank the investigators and the families of our clinical trial participants for participating in the research studies and the role they played in this milestone.”
— Dr. Eliav Barr, senior vice president, head of global clinical development and chief medical officer, Merck Research Laboratories
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