New Delhi: The drug major Biological E has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDCSO) to conduct the Phase IV clinical study of the 14-valent pneumococcal polysaccharide conjugate vaccine (Adsorbed).
This came after Biological E presented the Phase IV clinical trial protocol titled “A Phase IV multicentre follow-up study to assess the continued safety of Biological E’s 14-valent pneumococcal polysaccharide conjugate vaccine in subjects, who received 3-dose (3+0) primary PCV vaccination as part of BECT051 and BECT061 studies”.
Pneumococcal polysaccharide vaccine can prevent pneumococcal disease. Pneumococcal disease refers to any illness caused by pneumococcal bacteria. These bacteria can cause many types of illnesses, including pneumonia, which is an infection of the lungs.
Biological E’s PCV14 contains 14 serotypes (1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F and 33F). Biological E’s PCV14 contains the largest number of serotypes in India and offers expanded protection against two new serotypes 22F and 33F. These new serotypes have been reported recently to be causing infections.
At the recent SEC meeting for vaccines held on 30th April 2024, the expert panel reviewed the Phase IV clinical trial protocol titled “A Phase IV multicentre follow-up study to assess the continued safety of Biological E’s 14-valent pneumococcal polysaccharide conjugate vaccine in subjects, who received 3-dose (3+0) primary PCV vaccination as part of BECT051 and BECT061 studies”.
After detailed deliberation, the committee recommended the grant of permission to conduct a Phase IV clinical trial as presented protocol.
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