Merck’s Pneumococcal Immunisation Approved for Priority Evaluation

The experimental pneumococcal conjugate immunisation from Merck, V116, has been granted a biologics license application by the Food and Drug Administration for priority evaluation. 

Pneumococcal disease is an infection caused by the bacterium Streptococcus pneumoniae, leading to various illnesses such as pneumonia, meningitis, and septicaemia. 

Individuals who get the vaccination are expected to be protected against pneumococcal illness and pneumococcal pneumonia. 

MSD’s submission draws on data from the late-stage study, which assessed the risks, antigenicity, and potential side effects of V116 in comparison to the PCV20 pneumococcal conjugate immunisation, focusing on individuals without prior pneumococcal immunisation. 

The leading medical executive of MSD, Dr Eliav Barr, commented, “Invasive pneumococcal disease poses a greater risk to older adults or those with weakened immune systems, in part due to disease-causing serotypes not covered by currently licensed pneumococcal conjugate vaccines. 

Dr Barr continued by stating, “If approved, V116 would be the first pneumococcal conjugate vaccine specifically designed to address the serotypes that cause most adult invasive pneumococcal disease.” 

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