Pneumosil Pneumococcal Vaccine Description
Pneumosil is a sterile suspension of saccharides of the capsular antigens of Streptococcus pneumoniae serotypes 1, 5, 6A, 6B, 7F, 9V, 14, 19A, 19F, and 23F individually conjugated by using 1 cyano-4-dimethylamino pyridinium tetrafluoroborate chemistry (CDAP) to non-toxic diphtheria CRM197 protein.
The polysaccharides are chemically activated and then covalently linked to the protein carrier CRM197 to form the glycoconjugate. Individual conjugates are compounded, and then polysorbate 20 and aluminum phosphate are added to formulate the vaccine, said PATH.org.
PNEUMOSIL (Pneumococcal Conjugate Vaccine – adsorbed, 10 Valent), a well-designed vaccine with relevant serotypes, is more affordable than the existing PCVs comparable protection by targeting the most prevalent serotypes of the bacterium causing serious illness in developing countries. As a PCV, PNEUMOSIL is similar to the pediatric pneumococcal vaccine already on the market and targets serotypes 1, 5, 6A, 6B, 7F, 9V, 14, 19A, 19F & 23F.
“Pneumosil has been extensively evaluated in five randomized and controlled clinical trials, and has demonstrated comparable safety and immunogenicity against licensed pneumococcal vaccines across diverse populations of India and Africa, where Pneumosil was administered to adults, toddlers and infants using different vaccination schedules,” Vardhan was quoted as saying in the statement. “In fact, it is a matter of pride for our country for this historical milestone during COVID-19 pandemic because till now we are fully dependent on Pneumococcal Conjugate Vaccine manufactured by foreign manufacturers which are available at very high prices,” he added.
Serum Institute of India Pvt. Ltd. is now the world's largest vaccine manufacturer by several doses produced and sold globally (more than 1.5 billion doses), which includes Polio vaccine as well as Diphtheria, Tetanus, Pertussis, Hib, BCG, r-Hepatitis B, Measles, Mumps, and Rubella vaccines.
Pneumosil Pneumococcal Vaccine Indication
Pneumosil is indicated against invasive disease, pneumonia, and acute otitis media caused by Streptococcus pneumoniae serotypes 1, 5, 6A, 6B, 7F, 9V, 14, 19A, 19F, and 23F in infants and toddlers from 6 weeks up to 2 years of age.
Vaccines help prevent pneumococcal disease, an illness caused by Streptococcus pneumoniae bacteria, says the U.S. CDC. Pneumococcal disease is common in young children, but older adults are at the greatest risk of serious illness and death.
CDC recommends pneumococcal vaccination for all children younger than 2 years old and adults 65 years or older. In certain situations, older children and other adults should also get pneumococcal vaccines.
Pneumosil Pneumococcal Vaccine Dosage
The dosage of Pneumosil is 0.5 ml, given intramuscularly, with care to avoid Injection into or near nerves and blood vessels. The product is a suspension containing an adjuvant, which needs to be shaken vigorously immediately before obtaining a homogenous, whitish turbid liquid in the vaccine container.
The vaccine should be given by intramuscular injection only.
Pneumosil Pneumococcal Vaccine News
April 6, 2021 - The Serum Institute of India (SII) confirmed it would supply the first indigenously developed pneumococcal conjugate vaccine to the Centre. The doses will be sent to government medical stores depots in Kolkata, Mumbai, and Karnal. SII intends to supply 2.4 crore doses of the vaccine to the Health Ministry by December 2021. The supply order was issued on February 3, 2021, in the name of Prakash Kumar Singh, the Director of Government and Regulatory Affairs at the Pune-based SII.
December 28, 2020 - Serum Institute of India announced the launch of India's first indigenously developed pneumococcal vaccine -- Pneumosil -- in the Union's presence of Health Minister Harsh Vardhan. Pneumosil has been developed through collaboration spanning over a decade among the Serum Institute, PATH, and the Bill and Melinda Gates Foundation. This significant milestone aims to improve pneumococcal conjugate vaccine affordability and enable sustainable access for low-and middle-income countries.
December 19, 2019 - PNEUMOSIL®, a vaccine against a leading cause of deadly childhood pneumonia—the pneumococcus bacterium—has achieved prequalification by the World Health Organization. Developed through a collaboration spanning over a decade between Serum Institute of India, Pvt., Ltd. and PATH and with funding from the Bill & Melinda Gates Foundation, the vaccine is expected to protect children on par with other pneumococcal conjugate vaccines at a price that is more affordable for low- and middle-income countries.
March 6, 2019 - Pfenex Inc. announced that Serum Institute of India Private Limited had completed a pivotal Phase 3 study for Pneumosil®, a 10-valent pneumococcal conjugate vaccine. Serum Institute indicates all primary and secondary objectives were met. Following a review of the Complete Study Report and product dossier by the Drug Controller General of India, Serum Institute has received an export license for Pneumosil.
Pneumosil Pneumococcal Vaccine Clinical Trials
Clinical Trial NCT03197376: Phase 3 Study of 10-valent Pneumococcal Conjugate Vaccine (PNEUMOSIL) in Healthy Infants. Last Update Posted: July 14, 2020.
This study will examine the consistency of 3 batches of the Pneumosil vaccine by looking at infants' immune response. The study will also compare the immunogenicity of the Pneumosil vaccine to another WHO-prequalified vaccine, Synflorix.
Clinical Trial NCT03896477: Phase 3 Study of 10-valent Pneumococcal Conjugate Vaccine (PNEUMOSIL) Administered in a 2+1 Schedule to Healthy Infants. Last Update Posted: July 22, 2020.
The current Phase 3 descriptive study will provide data necessary to evaluate the safety and immunogenicity of PNEUMOSIL when administered in an alternative schedule to the 3 doses primary schedule (3+0) evaluated in Phase 3 pivotal trial (VAC-056) - namely in a 2 dose primary and booster (2+1) schedule - and compare immunogenicity to that of both currently licensed second-generation PCVs administered in the same 2+1 schedule.