FDA approves CSL’s H1N1 vaccine for use in children
SILVER SPRING, Md. The Food and Drug Administration on Thursday approved the use of CSL Limited’s 2009 H1N1 influenza vaccine to include children ages 6 months and older. This vaccine previously was approved only for use in adults ages 18 years and older.
“Because children are among those most vulnerable to the 2009 H1N1 virus, having a broader range of children’s vaccines available is an important step in responding to the H1N1 outbreak,” stated Margaret Hamburg, FDA commissioner.
The approval was based on a study of the company’s seasonal flu vaccine in children showing the vaccine’s safety and efficacy in inducing antibodies to protect against influenza. Common adverse events experienced by children after administration of seasonal and H1N1 vaccines typically include pain, redness and swelling at the injection site, as well as, in some cases, irritability, loss of appetite and drowsiness.
Because CSL’s seasonal and H1N1 monovalent vaccines contain a small amount of egg protein, they should not be administered to anyone allergic to eggs or egg products.
The vaccines will be available in single-dose, preservative-free, pre-filled syringes, and in multi-dose vials that contain thimerosal, a mercury derivative, as a preservative. Both vaccines are manufactured by CSL of Australia.
Sanofi Pasteur releases data on H1N1 vaccine
SWIFTWATER, Pa. Sanofi Pasteur, the vaccines division of the Sanofi-Aventis Group, on Wednesday announced the final analyses of data from clinical trials of the U.S. licensed influenza A(H1N1) 2009 monovalent vaccine in adults and children.
The data confirm the immunogenicity and safety profile of the vaccine, with no serious vaccine-related adverse events reported during the 42 days of follow-up in the two trials.
“These are extremely important data,” stated Wayne Pisano, president and CEO of Sanofi Pasteur, “because they once again make clear not only the immunogenicity of the influenza A(H1N1) 2009 monovalent vaccine manufactured by Sanofi Pasteur, but also the fact that this vaccine has a safety profile similar to that typically observed with seasonal influenza vaccine in all age groups studied.”
The trials also confirm that one dose of influenza A(H1N1) 2009 monovalent vaccine induces a robust antibody response in adults — but two doses of vaccine are needed to assure a robust antibody response in children 9 years of age and younger. The two-dose regimen for these younger children is similar to the recommendations for seasonal influenza immunization in this age group.
CVS Caremark, NCOA kick off Medicare Part D educational events
WOONSOCKET, R.I. CVS Caremark and the National Council on Aging announced on Thursday the kick-off of Medicare Part D educational events in an effort to urge older adults and their caregivers to review their Medicare Part D options to find the lowest cost plan to meet their needs.
“Plan review can seem cumbersome, but completing a plan comparison each year is an essential step toward saving,” stated Mitch Betses, VP retail pharmacy operations at CVS Caremark. “Tools like the Medicare Part D Calculator are designed to simplify the process to help older adults and their caregivers select a plan that provides them with the greatest value and peace of mind.”
A CVS/pharmacy analysis of more than 10,000 older Americans using the Medicare Part D Savings Calculator last year revealed plan participants could save an average of $612 in annual drug costs by just switching to their optimal Medicare Part D plan.
CVS/pharmacy is launching a campaign to assist seniors and their caregivers realize savings on 2010 prescription costs through education and assistance on plan comparison. Starting Thursday, CVS/pharmacy and the NCOA are offering Medicare Part D educational events throughout the annual enrollment period at senior centers nationwide. They are urging patients to consider the Three C’s when evaluating plans: Cost, Coverage and Convenience.
Customers can also go online at CVS.com/medicare to use the free Medicare Part D Savings Calculator. In addition, CVS pharmacists are available throughout the enrollment period to provide plan comparison in stores for those who would like assistance.