
EU widens indications for Pfizer vaccine
pharmafile | March 4, 2015 | News story | Research and Development, Sales and Marketing |ย ย EC, EMA, Pfizer, pneumococcal polysaccharide conjugate vaccine, prevenarย
Pfizer has gained approval from the European Commission which has signed off on an EMA decision to recommend Prevenar 13 for the prevention of pneumonia in adults.
Prevenar 13 (pneumococcal polysaccharide conjugate vaccine) was launched in 2009 and is already indicated in Europe to prevent pneumonia caused by the bacteria Streptococcus pneumonia, in children and young adults aged six to 17 years.
The European indication has now been extended to include the prevention of pneumonia caused by 13 strains of the bacteria in adults aged over 18 years. In the UK the Joint Committee on Vaccination and Immunisation, the independent advisors to the Department of Health, is currently reviewing the adult pneumococcal immunisation programme in the NHS.
Streptococcus pneumonia is the most common bacterial cause of community-acquired pneumonia, which is one of the leading causes of death and hospitalisation worldwide according to figures from the US Centre for Disease Prevention and Control โ and the World Health Organization.
Rene Reinert who is the VP at Pfizer for its vaccines medical and scientific affairs in Europe, says the company has identified pneumococcal pneumonia as an area of unmet need.
โWe welcome the approval of this new indication for Prevenar 13 in the EU, which will enable healthcare professionals to help adults reduce their risk of pneumococcal pneumonia caused by the 13 serotypes in the vaccine.
โThis is particularly important for older adults and those with medical conditions that may make them more vulnerable to this serious, debilitating and potentially deadly disease. Pfizer looks forward to working with vaccine technical committees in Europe to discuss this new indication and the CAPiTA [clinical trial] data, as well as potential updates to recommendations for the use of Prevenar 13 in adults.โ
However, in the US Pfizerโs consumer health division has announced slightly less positive news. It will close a manufacturing plant in California in May, with 70 job losses. The facility produces Emergen-C vitamin supplements, the largest selling branded Vitamin C line in the US, and Pfizer will switch the production to a plant in Carlise, Pennsylania.
The company also recently backtracked on an earlier decision to earmark a plant in Cork County, Ireland, for closure after an upturn in demand for Lipitor (atorvastatin) in China and emerging markets.
Lilian Anekwe
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