It is a tridecavalent vaccine and thus contains thirteen serotypes of pneumococcus (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). These serotype sugars are conjugated to diphtheria carrier protein because this makes the antigenic and protective effect stronger (in most cases). Prevnar 13 was approved for use in the European Union in December 2009. In February 2010, Prevnar 13 was approved in the United States to replace Prevnar, the pneumococcal 7-valent conjugate vaccine (PCV7). After waiting for the outcome of a trial underway in the Netherlands, the Centers for Disease Control and Prevention (CDC) recommended the vaccine for adults over age 65 in August 2014.Prevnar (PCV7) was a heptavalent vaccine, meaning that it contains the cell capsule sugars of seven serotypes of the bacteria S. pneumoniae (4, 6B, 9V, 14, 18C, 19F, and 23F) conjugated with diphtheria proteins. It was manufactured by Wyeth (which was acquired by Pfizer). Prevnar (PCV7) was approved for use in the United States in February 2000, and vaccination with Prevnar was recommended for all children younger than two years and for unvaccinated children between 24 and 59 months old who were at high risk for pneumococcal infections.Prevnar was produced from the seven most prevalent strains of Streptococcus pneumoniae bacteria in the U.S. The bacterial capsule sugars, a characteristic of these pathogens, are linked (conjugated) to CRM197, a nontoxic recombinant variant of diphtheria toxin (from cultures of Corynebacterium diphtheriae). This produces a more robust immune response (in most healthy persons).
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.