It is a decavalent vaccine and thus contains ten serotypes of pneumococcus (1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, and 23F) which are conjugated to a carrier protein. Synflorix received a positive opinion from the European Medicines Agency (EMA) for use in the European Union in January 2009, and GSK received European Commission authorization to market Synflorix in March 2009. Vaxneuvance
Vaxneuvance is a pneumococcal 15-valent conjugate vaccine created by Merck that was approved for medical use in the United States in July 2021. The vaccine was developed under the code name "V114". It is identical to PCV13, except that it adds serotypes 22F and 33F. These two serotypes are particularly important because, after "widespread use of the PCV13…[vaccine] in many countries," these two serotypes are now "among leading serotypes causing IPD in children and adults. "Vaxneuvance is indicated for the active immunization for the prevention of invasive disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F and 33F in adults 18 years of age and older.On 14 October 2021, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Vaxneuvance, intended for prophylaxis against pneumococcal pneumonia and associated invasive disease. The applicant for this medicinal product is Merck Sharp & Dohme B.V. Vaxneuvance was approved for medical use in the European Union in December 2021.
GAVI continues this work and as of March 2013, 25 GAVI-eligible and supported countries have introduced the pneumococcal conjugate vaccine. Further, 15 additional GAVI countries have plans to introduce the vaccine into their national immunization program and 23 additional countries have approved GAVI support to introduce the vaccine. Society and culture
Legal status
On 16 December 2021, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Apexxnar, intended for prophylaxis against pneumococcal pneumonia and associated invasive disease. The applicant for this medicinal product is Pfizer Europe MA EEIG. Apexxnar was approved for medical use in the European Union in February 2022. Economics
Prevnar 13 is Pfizers best-selling product. It had annual sales of US$5.85 billion in 2020. Brand names
The vaccines are marketed under several brand names including Prevnar 20, Prevnar 13, Synflorix, Pneumosil, and Vaxneuvance. Research
Merck is investigating a 21-valent vaccine (code named V116) against pneumococcus serotypes. The vaccine is geared towards persons living with HIV. References
Further reading
Centers for Disease Control and Prevention (2015). "Chapter 17: Pneumococcal Disease". In Hamborsky J, Kroger A, Wolfe S (eds.). Epidemiology and Prevention of Vaccine-Preventable Diseases (13th ed.). Washington, D.C.: Public Health Foundation. External links
"13-Valent Pneumococcal Vaccine". Drug Information Portal. U.S. National Library of Medicine. "Heptavalent pneumococcal conjugate vaccine". Drug Information Portal. U.S. National Library of Medicine. "Pneumococcal Conjugate (PCV13) Vaccine Information Statement". Centers for Disease Control and Prevention (CDC). 10 August 2021.