Good News, Pfizer's PCV13 Vaccine Age Range Is Now Expanded

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JAKARTA - PT Pfizer Indonesia said the 13-valence Pneumococcal Conjugate Vaccine (PCV 13) has received approval from the Indonesian Food and Drug Administration (BPOM) for an extended user age indication.

The vaccine can now be used for infants, children and adolescents from 6 weeks to 17 years of age and adults 18 to 49 years of age. This is in addition to the use of vaccines that have been approved to prevent pneumonia in children 6 months to 5 years of age and adults over 50 years of age.

According to Pfizer, the age range approval for the use of the PCV 13 vaccine marks the first pneumococcal vaccine that can be used for all age groups.

"We are very pleased with this approval as a significant step forward, as it continues our mission to expand protection against disease-causing bacterial serotypes to help prevent potentially serious respiratory infections, such as pneumococcal pneumonia at all ages," said Country Manager PT Pfizer Indonesia. dr. Nora T. Siagian quoted from Antara, Thursday.

Nora said children and adolescents aged 6 to 17 with underlying medical conditions were at a higher risk of pneumococcal disease.

The extended age indication in the age group of children and adolescents as well as adults provides benefits as an appropriate vaccination against S. pneumoniae to reduce the risk of pneumococcal disease, including those with immunocompromised conditions, Nora said.

Pfizer PCV13, which has been administered to millions of people worldwide, provides the broadest serotype coverage of all pneumococcal conjugate vaccines currently available for the prevention of invasive disease, pneumonia and acute otitis media caused by the bacterium Streptococcus pneumoniae.

The 13 pneumococcal serotypes at PCV 13 (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) are one of the most common invasive disease-causing strains in children. children around the world.

It has also been approved for use in adults 50 years of age and older in more than 120 countries, and is the first pneumococcal vaccine to be prequalified by the World Health Organization (WHO) in the older adult population.

The BPOM decision to approve the expanded indication is a continuation of the submission and review of clinical studies from start to finish throughout the entire process, demonstrating immunogenicity and establishing a safety profile in children and adolescents aged 6 to 17 years consistent with the safety profile established in the trial. previously in infants and young children, and adults aged 18 to 49 years.

Nora said BPOM's approval to extend the lifespan of Pfizer PCV13 is a form of Pfizer's ongoing commitment to developing innovative vaccines that can help prevent serious – and sometimes fatal – disease at every stage of life.

"We will continue to work closely with health authorities in efforts to provide access to PCV13 to those who are at risk of developing the disease," said Nora.