Pfizer receives FDA approval for Prevnar 13 vaccine

Pfizer on Wednesday announced that the FDA granted approval to Prevnar 13 (pneumococcal 13-valent conjugate vaccine) for the immunisation of children 6 weeks through 5 years of age to prevent pneumococcal disease and otitis media. The drugmaker said the new vaccine would be available in the first quarter.

Separately, Pfizer stated that the US Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices recommended the use of Prevnar 13 for routine vaccination of children aged 2 months through 59 months, as well as a supplemental dose for children through 59 months of age who were already vaccinated with Pfizer's currently marketed pneumococcal vaccine, Prevnar 7 (pneumococcal 7-valent conjugate vaccine).

Commenting on the news, Credit Suisse analyst Catherine Arnold estimated that Prevnar 13, which is approved for infants and young children in 38 other countries, will have $5.9 billion in sales in 2015. "We think it is the most important value driver for the future of Pfizer," she remarked. Prevnar 7 has annual sales of approximately $3 billion.

In addition, Emilio Emini, Pfizer's chief scientific officer of vaccine research, said the company is currently evaluating use of Prevnar 13 in adults, including a trial of 85 000 adults to prevent pneumonia acquired outside of the hospital. The drugmaker may ask the FDA to approve the product for use in adults by the end of the year, according to Geno Germano, president of Pfizer's specialty care business unit. Pfizer has forecast that if Prevnar 13 is approved for adults, it could add $1.5 billion in sales.

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