Merck announced the approval of VAXNEUVANCETM by the EU.

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Merck announced the approval of VAXNEUVANCETM by the EU.

Pharma Tech Outlook | Tuesday, January 04, 2022

For active immunization against Streptococcus pneumoniae-related invasive disease and pneumonia in people aged 18 and above, the European Commission (EU) has approved VAXNEUVANCETM (Pneumococcal 15-valent Conjugate Vaccine).

FREMONT, CA: The announcement that the European Commission (EC) has authorised VAXNEUVANCETM (Pneumococcal 15-valent Conjugate Vaccine) for active immunisation against Streptococcus pneumoniae-related invasive illness and pneumonia in people aged 18 and older was made by Merck, also known as MSD outside of the United States and Canada. The permission allows VAXNEUVANCE to be marketed in all 27 EU member states, as well as Iceland, Norway, and Lichtenstein, in accordance with official guidelines.

A positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) followed by the European Commission's decision, which reviewed data from seven randomized, double-blind clinical studies evaluating VAXNEUVANCE from various populations and clinical situations in 7,438 individuals. Healthy adults aged 50 and over, adults aged 18 to 49 with risk factors for pneumococcal illness, and immuno compromised persons living with HIV were among the participants. Furthermore, immunological responses to VAXNEUVANCE were superior to PCV13 for shared serotype 3 as well as the two VAXNEUVANCE-specific serotypes, 22F and 33F. There were no randomized controlled trials (RCTs) conducted that compared VAXNEUVANCE to PCV13.

Dr.Roy Baynes, senior vice president and head of global clinical development, Merck Research Laboratories chief medical officer stated that they are dedicated to aid more people become immune to the most common form of pneumococcal disease in adults, invasive pneumococcal disease (IPD) and pneumococcal pneumonia. With the help of VAXNEUVANCE, they have developed a combination vaccine that induces a high immune response that contributes significantly to one of the leading cause of IPD in the EU disease burden, against pneumococcal serotypes, particularly serotype 3. Furthermore, in the European Union  this approval gives physicians and patients a new option for protecting against pneumococcal serotypes, which causes around 40 percent of IPD cases in the EU's main member countries' for adults over 65.

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