Back to top

Image: Bigstock

Pfizer (PFE) Gets FDA Nod for Label Expansion of Prevnar 13

Read MoreHide Full Article

Pfizer Inc. (PFE - Free Report) announced that the FDA has approved a label expansion of vaccine Prevnar 13 (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]).

The vaccine can now be used for adults aged 18 to 49 years. The vaccine was previously approved for active immunization in the prevention of 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 – in adults aged 50 years or older.

The vaccine is also approved in the EU. Its uptake has been strong among adults so far. Pfizer’s vaccines division sales were up 18% to $1.6 billion in the first quarter of 2016. We believe that the latest label expansion of Prevnar will further boost sales. Moreover, the expanded age bracket aligns with the recommendations of the 2012 U.S. Centers for Disease Control and Prevention’s Advisory Committee on Immunizations Practices (ACIP) for use in adults 19 years of age and older with immunocompromising conditions (e.g., HIV, chronic renal failure, cancer), functional or anatomic asplenia (e.g., sickle cell disease), cerebral spinal fluid leak and Cochlear implants.

Pfizer has committed resources toward the development of treatments in the fields of oncology, cardiology, metabolic disorders, neuroscience, immunology, inflammation and vaccines. These are areas in which the company believes it can take leading positions. To this end, in Dec 2014, the company acquired Baxter’s portfolio of marketed vaccines comprising NeisVac-C and FSME-IMMUN/TicoVac.

Pfizer currently carries a Zacks Rank #2 (Buy). Other favorably placed stocks in the healthcare sector include Abbott Laboratories (ABT - Free Report) , Roche Holdings (RHHBY - Free Report) and Johnson & Johnson (JNJ - Free Report) . All the three stocks carry the same rank as Pfizer.

Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report >>

Published in