European Medicines Agency Accepts Pfizer’s Marketing Authorization Application for Its Investigational 20-valent Pneumococcal Conjugate Vaccine for Adults 18 Years

If approved, the vaccine would help protect adults against 20 serotypes responsible for the majority of invasive pneumococcal disease and pneumonia

NEW YORK–(BUSINESS WIRE)– Pfizer Inc. (NYSE:PFE) today announced that the European Medicines Agency (EMA) accepted for review the Marketing Authorization Application (MAA) for its 20-valent pneumococcal conjugate vaccine (20vPnC) candidate, as submitted for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae serotypes in the vaccine in adults ages 18 years and older. With the MAA acceptance, the formal review process by the EMA’s Committee for Medicinal Products for Human Use (CHMP) begins.

“The epidemiology of pneumococcal serotypes causing disease has been changing due to the success of pneumococcal conjugate vaccines targeting pediatric and adult populations. In many countries across Europe and around the world, more than half of all cases of invasive pneumococcal disease in older adults are due to the 20 serotypes covered in 20vPnC, including seven serotypes (8, 10A, 11A, 12F, 15B, 22F, and 33F) that are not included in any currently licensed pneumococcal conjugate vaccine,” said Kathrin U. Jansen, Ph.D., Senior Vice President and Head of Vaccine Research and Development, Pfizer. “20vPnC builds on the legacy of Prevenar and Prevnar 13 and our more than two decades of experience and innovation in developing pneumococcal conjugate vaccines. Today’s acceptance of the 20vPnC application in the European Union is a significant step forward in our continuing efforts to potentially provide adults with robust and meaningful protection against more pneumococcal disease-causing serotypes.”

The 20vPnC MAA submission encompasses data from Pfizer’s clinical program in adults, which includes Phase 1 and 2 trials and three Phase 3 trials (NCT03760146, NCT03828617, and NCT03835975) describing the safety and evaluating the immunogenicity of the vaccine candidate to support licensure for an indication to prevent invasive pneumococcal disease and pneumococcal pneumonia caused by Streptococcus pneumoniae serotypes in the vaccine in adults 18 years or older. The three Phase 3 trials have enrolled more than 6,000 adult subjects, 18 years and older, including adults 65 years of age and above, vaccine-naïve adults, and adults with prior pneumococcal vaccination.i,ii

ABOUT 20vPnC

Pfizer’s 20vPnC vaccine candidate includes capsular polysaccharide conjugates for the 13 serotypes in Prevenar 13®1 (pneumococcal polysaccharide conjugate vaccine [13 – valent, adsorbed]). The vaccine also contains capsular polysaccharide conjugates for seven additional serotypes that cause invasive pneumococcal disease (IPD),iii,iv,v,vi,vii and have been associated with high case-fatality rates,viii,ix,x,xi antibiotic resistance,5,xii,xiii and/or meningitis.xiv,xv Together, the 20 serotypes included in 20vPnC are responsible for the majority of currently circulating pneumococcal disease globally.xvi,xvii,xviii,xix,xx,xxi,xxii

The U.S. FDA has accepted for priority review the biologics license application of 20vPnC in adults 18 years of age and older with a Prescription Drug User Fee Act goal date in June 2021. In June 2020 Pfizer announced initiation of two Phase three trials for 20vPnC evaluating the safety and efficacy of the investigational vaccine in infants.

INDICATIONS FOR PREVNAR 13® (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein])

  • Prevnar 13® is a vaccine approved for adults 18 years and older for the prevention of pneumococcal pneumonia and invasive disease caused by S. pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F
  • Prevnar 13® is also approved for children 6 weeks through 17 years of age (prior to the 18th birthday) for the prevention of invasive disease caused by the 13 strains of Streptococcus pneumoniae in the vaccine, and for children 6 weeks through 5 years (prior to the 6th birthday) for the prevention of ear infections caused by 7 of the 13 strains in the vaccine
  • Prevnar 13® is not 100% effective and will only help protect against the 13 strains in the vaccine

U.S. IMPORTANT SAFETY INFORMATION

  • Prevnar 13® should not be given to anyone with a history of severe allergic reaction to any component of Prevnar 13® or any diphtheria toxoid-containing vaccine
  • Children and adults with weakened immune systems (eg, HIV infection, leukemia) may have a reduced immune response
  • In adults, the most common side effects were pain, redness, and swelling at the injection site, limitation of arm movement, fatigue, headache, muscle pain, joint pain, decreased appetite, vomiting, fever, chills, and rash
  • A temporary pause of breathing following vaccination has been observed in some infants born prematurely
  • The most commonly reported serious adverse events in infants and toddlers were bronchiolitis (an infection of the lungs) (0.9%), gastroenteritis (inflammation of the stomach and small intestine) (0.9%), and pneumonia (0.9%)
  • In children 6 weeks through 17 years, the most common side effects were tenderness, redness, or swelling at the injection site, irritability, decreased appetite, decreased or increased sleep, and fever
  • Ask your healthcare provider about the risks and benefits of Prevnar 13®. Only a healthcare provider can decide if Prevnar 13® is right for you or your child

For the full prescribing information for Prevnar 13®, please visit https://labeling.pfizer.com/showlabeling.aspx?id=501

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