Marketing approval for 13 valent pneumococcal vaccine Prevnar 13 could be delayed in US, according to Pfizer.
US Food and Drug Administration has not yet completed its review of the Biologics License Application (BLA) for Prevnar 13, Pfizer Inc announced.
Prevnar 13 review will continue beyond the prescription drug user fee (PDUFA) action date of December 30, 2009.
Prevnar 13 is pneumococcal 13-valent conjugate vaccine which contains diphtheria CRM197 protein.
In May 2009, Prevnar 13 was designated for priority review.
Priority review status is given to products that, if approved by the Center for Biologics Evaluation & Research (CBER), would be a significant improvement in the safety or effectiveness of the treatment, diagnosis or prevention of a serious or life-threatening disease.
In August 2009, US FDA extended its review by 90 days from the original action date of September 30, 2009, to December 30, 2009, based on the submission of additional manufacturing data requested by the FDA.
Pfizer is seeking an indication for Prevnar 13 for active immunization of infants and toddlers for the prevention of invasive disease and otitis media caused by the 13 Streptococcus pneumoniae (S. pneumoniae) serotypes in the vaccine.
On November 18, 2009, US FDA’s Vaccines and Related Biological Products Advisory Committee voted 10 to 1 that the data presented from the BLA for Prevnar 13 support its safety and efficacy for the prevention of invasive pneumococcal disease in infants and young children.
On December 11, 2009, the European Commission granted marketing authorization for Prevenar 13 (Pneumococcal polysaccharide conjugate vaccine [13-valent, adsorbed]) – as it is known outside the United States – for active immunization for the prevention of invasive disease, pneumonia, and acute otitis media caused by 13 S. pneumoniae serotypes in infants and children from 6 weeks to 5 years of age.
To date, Prevnar 13 has been approved for use in infants and young children in 34 countries.
Further pediatric regulatory filings for Prevnar 13 are in advanced stages of review in various countries spanning six continents, a Pfizer release said.
Prevnar 13 is also being studied in global Phase 3 clinical trials in adults, with regulatory submissions expected in 2010.
Prevnar 13 includes the seven serotypes (4, 6B, 9V, 14, 18C, 19F, and 23F) in Prevnar (Pneumococcal 7-valent Conjugate Vaccine [Diphtheria CRM197 Protein]), plus six additional serotypes (1, 3, 5, 6A, 7F, and 19A). Together, these 13 serotypes are responsible for the majority of remaining invasive pneumococcal disease in infants and young children in the United States. Serotype 19A is now the most common serotype in the United States.
The review of Prevnar 13 is based on data from 13 core Phase 3 studies involving more than 7,000 children.
According to a World Health Organization (WHO) 2002 estimate, pneumococcal disease is the leading cause of vaccine-preventable death worldwide in children younger than 5 years.
Pneumococcal disease is complex and describes a group of illnesses caused by the bacterium S. pneumoniae. It affects both children and adults and includes invasive infections such as bacteremia/sepsis and meningitis, as well as non-invasive disease including pneumonia and acute otitis media.
Prevnar is indicated for active immunization of infants and toddlers against serious invasive disease caused by Streptococcus pneumoniae, including bacteremia (bloodstream infection) and meningitis (infection of the membranes surrounding the brain and spinal cord) caused by the seven serotypes in the vaccine.
The seven serotypes (strains) of S. pneumoniae included in the vaccine (4, 6B, 9V, 14, 18C, 19F, and 23F) were the strains that most commonly caused these serious diseases in children prior to the introduction of the vaccine. The routine schedule is 2, 4, 6, and 12 to 15 months of age.
Prevnar is also indicated for immunization of infants and toddlers against otitis media (ear infections) caused by the seven serotypes in the vaccine. Protection against ear infections is expected to be less than that for invasive disease.
Prevnar is one of the most widely used vaccine in the world and generated sales of $2.7 billion in 2008.
In November, on batch of Prevenar (Prevnar is sold under the brand name Prevenar in EU countries), has been pulled out the Netherland’s market after three infants died within two weeks of getting the vaccine, Dutch health institute RIVM said.
Prevnar is marketed by Wyeth, which has just been acquired by the world’s largest drug maker Pfizer, worldwide.
Wyeth has ordered the suspension of Prevenar vaccines with batch number D66977, following the reports of infant deaths.
Last year, clinical trials of an advanced version of Prevanar by the domestic unit of Wyeth Inc. have been suspended by India’s drug regulator after reports of death of an infant on whom the vaccine was tested in a trial site in Bangalore.
Wyeth. however, had maintained that the child who died had been administered Prevenar and not the new 13-strain variant.
“The event occurred in the control group, which used the current worldwide standard vaccine for prevention of pneumococcal disease and which has been administered safely more than 200 million times worldwide during the past seven years,” a company spokesperson had said.
Hower, the ban on Prevnar trials was lifted in May this year and allowed Wyeth and its CRO GVK Biosciences Pvt. Ltd, the Hyderbad-based clinical research organization to carry on with the trials.