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Pfizer's 20-Valent Pneumococcal Vaccine Application Accepted EU Review

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  • The European Medicines Agency has accepted for review Pfizer Inc's (NYSE: PFE) marketing application seeking approval for the 20-valent pneumococcal conjugate vaccine (20vPnC).
  • The vaccine candidate is for preventing invasive disease and pneumonia caused by Streptococcus pneumoniae serotypes in adults ages 18 years and older.
  • The U.S. marketing application for 20vPnC is also currently under review, with the agency's goal date in June 2021.
  • In June 2020, Pfizer initiated two Phase 3 trials for 20vPnC evaluating the safety and efficacy of the investigational vaccine in infants.
  • Price Action: PFE is down 0.09% at $33.79 in premarket trading on the last check Friday.
 

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Posted-In: PneumoniaBiotech News Health Care FDA General

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