WASHINGTON - PFIZER Inc's new version of a blockbuster vaccine that fights pneumonia, meningitis and other diseases caused by pneumococcus bacteria won approval from US health officials on Wednesday.
Government vaccine advisers recommended the new Prevnar 13 vaccine for infants who have not been immunised with the original version. They also urged one shot of Prevnar 13 for children up to age 5 who have already received all four doses of the earlier vaccine.
Prevnar 13 was the most important experimental product the company acquired in last year's purchase of Wyeth. It fights 13 strains of Streptococcus pneumoniae bacteria. The original Prevnar, which targeted seven strains, was introduced in 2000 and has annual sales around US$3 billion (S$4.24 billion).
Infections caused by pneomococcus greatly declined after the original Prevnar was launched. At the time, the seven targeted strains accounted for 80 per cent of invasive pneumococcal infections in young children in North America. By 2007, cases had dropped 99 per cent in children younger than 5 years old, according to the Food and Drug Administration (FDA). Studies also showed disease rates fell in unvaccinated people, especially the elderly.
'Although the rates of invasive pneumococcal disease have declined dramatically, there are still children in the United States who are suffering with this serious illness,' Dr. Karen Midthun, acting head of the FDA's unit that reviewed Prevnar 13, said in a statement. The new version 'will help prevent pneumococcal disease caused by' the six additional strains, she said.
Pfizer has estimated that the added protection from Prevnar 13 could reduce deaths from pneumococcus by an extra 9,800 over 10 years. The new vaccine targets a strain called 19A that has emerged as the most common cause of pneumococcal infection in the United States. That strain is becoming harder to treat as it develops resistance to antibiotics, said Dr. Emilio Emini, Pfizer's chief scientific officer for vaccine research. -- REUTERS