Pfizer Pneumococcal Polysaccharide Conjugate Vaccine gets CDSCO panel okay
New Delhi: Pharmaceutical major, Pfizer Limited has got a go-ahead from the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organization (CDSCO) to import Pneumococcal Polysaccharide Conjugate Vaccine (13 Valent Adsorbed) for use in the 18 to 49 years age group.
However, the permission has been granted based on a condition that the firm shall submit Phase IV clinical trial protocol in the proposed age group within 3 months from the date of approval.
The recommendation came following a proposal presented by the firm for granting the permission to import Pneumococcal Polysaccharide Conjugate Vaccine (13 valent Adsorbed) for use in 18 to 49 years age group as an additional indication without conducting a clinical trial in the country.
Prevnar 13 (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]) is a vaccine approved for adults 18 years of age and older for the prevention of pneumococcal pneumonia and invasive disease caused by 13 Streptococcus pneumoniae strains (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). Prevnar 13 will only help protect against S. pneumoniae serotypes in the vaccine. Severe allergic reaction (eg, anaphylaxis) to any component of Prevnar 13 or any diphtheria toxoid–containing vaccine is a contraindication.
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 the pneumococcal 7-valent conjugate vaccine.
After reviewing the proposal, the committee noted that the vaccine is already approved in children as well as adults 50 years or older. Further, the vaccine is approved in this age group in the US, EU and many Asian countries.
Responding to the firm's proposal, the committee recommended for grant f approval of Pneumococcal Polysaccharide Conjugate Vaccine (13 Valent Adsorbed) for use in 18 to 49 years age group with the condition that the firm shall submit Phase IV clinical trial protocol in the proposed age group within 3 months from the date of approval.