FDA grants approval for Pfizer’s Prevnar 13 to prevent pneumococcal pneumonia

12 July 2016 (Last Updated July 12th, 2016 18:30)

American pharmaceutical company Pfizer has received the US Food and Drug Administration (FDA) approval for its Prevnar 13 (pneumococcal 13-valent conjugate vaccine [diphtheria CRM197 protein]) to prevent pneumonia and other invasive diseases.

American pharmaceutical company Pfizer has received the US Food and Drug Administration (FDA) approval for its Prevnar 13 (pneumococcal 13-valent conjugate vaccine [diphtheria CRM197 protein]) to prevent pneumonia and other invasive diseases.

With the FDA approval, Prevnar 13 can be used on adult patients of 18 years through to 49 years of age for the prevention of pneumococcal pneumonia and invasive disease caused by 13 Streptococcus pneumoniae (S. pneumoniae) serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F).

The treatment can also be administered on children aged just six weeks through to 17 years old for the prevention of invasive disease caused by 13 Streptococcus pneumoniae strains in the vaccine.

Also known as pneumococcus, S. pneumonia is the most common bacterial cause of community-acquired pneumonia.

"Prevnar 13 has already been approved for adults aged 50 and above and is the only pneumococcal vaccine approved across the lifespan."

Pneumococcal pneumonia can be classified into two groups, firstly non-invasive, when bacteria cause infection in the lungs but are not detected in the blood concurrently, and invasive, when bacteria enter the bloodstream (bacteremic pneumonia) or another normally sterile location in the body.

Pfizer Vaccines chief medical and scientific affairs officer Dr Luis Jodar said: “This expanded age indication in adults aged 18 to 49 offers an important public health benefit as appropriate vaccination against S. pneumoniae is critical to reducing the risk of pneumococcal disease, including in those with immunocompromising conditions.”

Prevnar 13 has already been approved for adults aged 50 and above and is the only pneumococcal vaccine approved across the lifespan.

The expanded age Prevnar 13 indication is currently in line with the 2012 US Centers for Disease Control and Prevention’s Advisory Committee on Immunisations Practices (ACIP) recommendations.


Image: Streptococcus pneumoniae in spinal fluid. FA stain (digitally colourised). Streptococci. Photo: courtesy of CDC / Dr. M.S. Mitchell.