Regulatory Merck granted approval for pneumococcal vaccine for children by...

Merck granted approval for pneumococcal vaccine for children by the FDA

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The US Food and Drug Association (FDA) has approved Merck’s pneumococcal 15-valent conjugate vaccine (PCV15) called Vaxneuvance for children between the age of 6 weeks and 17 years.

Merck’s Vaxneuvance’s FDA approval had been in the works for a little while. The approval is based on the outcomes of seven randomized, double-blind clinical trials of the vaccine, in children, infants and adolescents. The trial evaluated the tolerability, immunogenicity and safety of the vaccine in the test groups.

The purpose of this vaccine is active immunization, to avoid invasive disease that prevails at the hands of Streptococcus pneumonia serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F and 33F in children over 6 weeks.

In pediatric populations, this is the first pneumococcal conjugate vaccine that has been granted approval for invasive pneumococcal disease (IPD) in almost a decade. Merck had submitted a priority review for the supplemental application of the vaccine, which the FDA granted. The approval for expanded indication was granted following the review.

According to the outcomes of a critical study, a four-dose pediatric regimen of Vaxneuvance prompted immune responses that were not less compared to the currently available 13-valent pneumococcal conjugate vaccine (PCV13) for the 13 serotypes.

A different assessment found that a four-dose pediatric regimen of Vaxneuvance prompted superior immune responses compared to PCV13 for shared serotype 3 and the additional Vaxneuvance-specific serotypes 22F and 33F. No randomized controlled trials have been conducted that evaluate the clinical efficacy of PCV15 in comparison with PCV13.

The head and chief medical officer, global clinical development senior vice-president of Merck Research Laboratories Dr. Eliav Barr said: “Our goal with Vaxneuvance is to expand coverage of key invasive disease-causing serotypes and provide a strong immune response to serotypes that pose a 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.”

The clinical program data also supports the parallel use of PCV15 with other frequently used routine pediatric vaccines, in different clinical settings. These could include starting the vaccine dosage of an infant with PCV13, and older children who received an incomplete dosage of another PCV. Another advantage of PCV15 is that according to the data, it can be used in special cases as well, such as children with sickle cell disease, HIV infection, or preterm infants.

 Steven Shapiro, Managing Director Jefferson Abington Hospital, Pennsylvania, said that even though the occurrence of invasive pneumococcal disease in children has reduced, there are some significant serotypes that still cause serious illness that can be fatal to children under five years of age. He also said that serotypes 3, 22F and 33F are accountable for over 25% of all the cases of invasive pneumococcal disease in the aforementioned children population. He believes this approval will enable Vaxneuvance to be a key new option in the protection of children.

Even though there are over 100 different kinds of serotypes, three of the top five serotypes that cause childhood cases of IPD are serotypes 3, 22F and 33F. Meningitis and bacteremia can be caused by IPD and may lead to hospitalization or in worst cases, death. Children under 2 years of age are particularly vulnerable to IPD, making the FDA-approved pneumococcal vaccine for children a welcome addition for this specific demographic. 

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