Biological E Gets Govt Panel Nod To Manufacture 14-Valent Pneumococcal Conjugate Vaccine For Infants. All About It
Pneumococcal Conjugate Vaccine: The CDSCO's SEC on Thursday granted permission to Biological E to manufacture a vaccine against infection caused by the bacterium Streptococcus pneumoniae.
Pneumococcal Conjugate Vaccine: The Central Drugs Standard Control Organisation’s (CDSCO’s) Subject Expert Committee (SEC) on Thursday granted permission to Hyderabad-based biopharmaceutical company Biological E to manufacture a vaccine against infection caused by the bacterium Streptococcus pneumoniae. The vaccine will be a 14-valent investigational pneumococcal polysaccharide conjugate vaccine against pneumococcal disease, according to ABP News sources.
What Is A Pneumococcal Conjugate Vaccine?
A pneumococcal conjugate vaccine (PCV) helps protect against bacteria that cause pneumococcal disease, which refers to any disease caused by pneumococcal bacteria.
These bacteria cause diseases such as pneumonia, ear infections, sinus infections, meningitis, and bacteremia, which is infection of the blood.
PCV was launched in India in May 2017 to reduce infant mortality and morbidity caused by pneumococcal pneumonia.
A pneumococcal vaccine containing 14 different strains of Streptococcus pneumoniae is known as a 14-valent pneumococcal conjugate vaccine (PCV14). It is a paediatric vaccine, which means it is administered to children.
SEC Approves Phase III Clinical Trial Data
On Thursday, September 1, the CDSCO’s SEC reviewed and approved the data for the Phase III clinical trial conducted in infants. The SEC also recommended the manufacture of PCV14 against Streptococcus pneumoniae in single-dose and multi-dose presentations. PCV14 can be administered to infants at six, 10, and 14 weeks of age, ABP News reports.
How Can PCV14 Be Beneficial?
Infection caused by Streptococcus pneumoniae continues to be a leading cause of mortality in children aged below five years in India and in developing countries. Biological E hopes that the PCV14 vaccine can contribute to the prevention of invasive pneumococcal disease and protect millions of lives globally.
About Biological E’s 14-Valent Pneumococcal Conjugate Vaccine
According to an article published by Springer, the 14-valent pneumococcal conjugate vaccine being developed by Biological E is an intramuscular formulation that will be used for the prevention of pneumococcal disease, including childhood pneumonia, ear infections, meningitis, and bacteraemia infection caused by Streptococcus pneumoniae.
The PCV14 vaccine contains 14 serotypes of Streptococcus pneumoniae. Of these, 12 serotypes are the same as those used in Pfizer’s Prevnar13 vaccine. This is also a pneumococcal conjugate vaccine. The 12 serotypes are: 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F. In addition to these serotypes, PCV14 has serotypes 22F and 33F which have resulted in increased cases of Streptococcus pneumoniae infection globally.
How Will PCV14 Work?
In the Phase III clinical trials, the primary immunogenicity objectives of the vaccine were met. Immunogenicity is a measure of how well a vaccine works, and signifies the type of immune responses that the vaccine generates and their magnitude over time. In other words, it is defined as the ability of a substance to stimulate an immune response.
The primary immunogenicity objective of PCV14 is to demonstrate non-inferiority with anti-PncPS (pneumococcal capsular polysaccharide) IgG (Immunoglobulin G) antibody concentrations against each of the 12 common serotypes used in Biological E’s PCV14 vaccine. This means that in seropositive subjects, the vaccine was able to generate IgG antibodies which fight against the pneumococcal capsular polysaccharide present in each of the 12 common serotypes of Streptococcus pneumoniae.
PCV14 also demonstrated anti-PncPS IgG antibody concentrations against the unique serotypes 22F and 33F, which are specific to Biological E’s pneumococcal conjugate vaccine.
Pfizer’s Prevnar13 also contains the serotype 6A. This serotype is not present in Biological E’s PCV14. However, the serotype 6B present in PCV14 provided cross-protection against serotype 6A.
The PCV14 vaccine elicited functional immune responses, ABP News reports. One month after administration of the third dose of the vaccine, an adequate increase in serotype-specific OPA (opsonophagocytic activity) GMTs (geometric mean titers) was observed for all 14 serotypes included in PCV14. GMT is a logarithmic value and opsonophagocytic activity is a measure of the functional activities of antibodies in vitro (outside the body), and can be correlated with in-vivo protection (inside the body). In other words, an increased value of serotype-specific OPA means that the antibodies generated by PCV14 against the pneumococcal capsular polysaccharide of the 14 serotypes of Streptococcus pneumoniae exhibited functional immune responses.
Is PCV14 Safe?
The safety analysis conducted for PCV14 found that all the adverse events were mild to moderate in intensity. Also, no grade-3 (severe and undesirable adverse event) and grade-4 (life-threatening or disabling adverse event) events were reported. Based on the safety comparison analysis, PCV14 was found to be a well-tolerated and safe vaccine.
In terms of serotype coverage for infants, Biological E’s PCV14 is comparable to Pfizer’s Prevnar13 and Merck’s VAXNEUVANCE, both of which are pneumococcal conjugate vaccines approved globally.
According to ABP News sources, Mahima Datla, Managing Director, Biological E, said: “We are delighted with this remarkable development. BE’s PCV14 will protect millions of infants worldwide and contribute to the prevention of invasive pneumococcal disease. With this recommendation from SEC and the anticipated formal approval from DCGI thereafter, India will have yet another important lifesaving vaccine for paediatric use. Biological E. would be also working with WHO and other global regulatory agencies to make this vaccine available globally.”
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