WHO Gives Approval to Pfizer's Pediatric Vaccine Prevnar 13

The World Health Organization has granted prequalification to Pfizer's (PFE) Prevnar 13 pediatric vaccine, which protects against an array of pneumococcal diseases. Pfizer's shares rose more than 1% in Monday's trading.

According to the WHO, pneumococcal disease is the leading cause of vaccine-preventable death worldwide in children younger than 5. Pneumococcal disease describes a group of illnesses including sepsis, infections of the blood, meningitis and pneumonia, all caused by the bacterium Streptococcus pneumoniae. The vaccine, which has already been approved in over 60 countries, including the U.S., and the European Union, protects against 13 varieties of the Streptococcus pneumoniae bacteria.

Pfizer is approaching a patent cliff: Several of its drugs are will lose patent protection soon, including the world's best-selling cholesterol fighting drug, Lipitor, which generates $12 billion a year in sales. In its search for drugs to replace the revenue that will be lost to generic competition, Pfizer has high hopes for the Prevnar vaccine. The previous version of Prevnar, which protects against seven varieties of the bacteria, generated $2.7 billion in sales in 2008. Analysts have estimated sales of Prevnar 13 will be between $5 billion and $6 billion in 2014 and 2015.

In March 2010, Pfizer entered into a 10-year Provisional Supply Agreement to provide Prevenar 13 to infants and young children in the world's poorest countries under the terms of the Advance Market Commitment for pneumococcal disease, Pfizer said in a statement. In order to participate in the AMC program, vaccines must receive WHO prequalification.

The WHO's global-use prequalification also allows United Nations agencies, including the UN Children's Fund (UNICEF), governments and other organizations that take part in national immunization programs, to procure the drug.

"This is an important step towards our goal of making Prevenar 13, which offers the broadest serotype coverage of any pneumococcal conjugate vaccine, available to infants and young children globally," said Dr. Emilio Emini, chief scientific officer of vaccine research at Pfizer.

Pfizer said that to meet the growing global demand for Prevenar 13, it is increasing its manufacturing capabilities through a combination of capital investment, process improvements and efficiency measures.