Pfizer Inc. (NYSE:PFE) shares were up 0.25% on Tuesday and an additional 0.33% in after-hours trading to $36.36 as the company received approval from the U.S. Food and Drug Administration for its pneumonia vaccine. Pfizer has a market cap of $219.97 billion at 6.06 billion shares outstanding. Shares have been trading in a 52-week range of $28.25 to $36.46 so a break past the resistance could be in order.
Thanks to the FDA approval, Pfizer’s Prevenar 13 is currently the only treatment available for all ages in the market. Prior to this, the pneumonia vaccine was able to get regulatory clearance for the treatment of pneumococcal disease in adults aged 50 or older. Prevanar 13 has now gotten FDA approval for adults aged 18 to 49.
This expanded age indication in adults 18 to 49 offers an important public health benefit as appropriate vaccination against S. pneumoniae is critical to reducing the risk of pneumococcal disease, including in those with immunocompromising conditions,” said Dr. Luis Jodar, Chief Medical and Scientific Affairs Officer, Pfizer Vaccines.
In 2015, Prevanar products had gross annual sales of $6.25 billion, up 40% from a year ago. This vaccine has also been previously approved for children aged 3 weeks to young adults aged 17 years. The FDA’s decision to also approve it for adults aged 18 to 49 is based on data from a late-stage study in adults who had not been vaccinated against the disease in the past.
Prevanar is already included in immunization programs for 102 countries so the approval for use in a larger age bracket could lend significant upside for the Pfizer revenues. Also, the expanded age indication more closely aligns with the 2012 U.S. Centers for Disease Control and Prevention’s Advisory Committee on Immunizations Practices (ACIP) recommendations for adults 19 years of age and older with immunocompromising conditions.
Pfizer is a a research-based global biopharmaceutical company that is engaged in discovering, developing and manufacturing of healthcare products. Its portfolio includes medicines, vaccines and medical devices, as well as consumer healthcare products.
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