Novartis discloses clinical data of H1N1 vaccine
BASEL, Switzerland Novartis on Tuesday announced new interim data from ongoing clinical trials demonstrating that a single 7.5-µg dose of the company’s 2009 H1N1 influenza unadjuvanted vaccine, half of the currently approved U.S. dose, fulfilled immune response criteria associated with protection in adults and the elderly.
If confirmed and approved by the Food and Drug Administration, the discovery could increase the supply of H1N1 vaccine in the U.S. market.
Novartis has discussed these new data with FDA and is performing additional statistical analysis suggested by the agency, the company reported. It is still under evaluation whether the antigen content per dose can be reduced in the United States.
Current U.S. guidelines for 2009 H1N1 influenza vaccine use state that adolescents, adults and the elderly are required to receive one 15-µg dose to achieve adequate protective antibody levels against the H1N1 influenza virus, and children ages 9 years and under are required to receive two 15-µg doses four weeks apart.
“These promising data suggest that many more people could potentially be vaccinated with our current vaccines supply, protecting more people earlier against the current pandemic,” stated Andrin Oswald, CEO of Novartis Vaccines and Diagnostics.
FDA approves fifth H1N1 vaccine
ROCKVILLE, Md. The Food and Drug Administration on Monday announced that it has approved a fifth vaccine for protection against the 2009 H1N1 influenza virus, this one manufactured by ID Biomedical of Quebec, Canada, which is owned by GlaxoSmithKline.
As with the four previous H1N1 influenza vaccines licensed by the FDA on Sept. 15, ID Biomedical Corp. will manufacture its H1N1 vaccine using the established, licensed egg-based manufacturing process used for producing seasonal flu vaccine.
ID Biomedical’s H1N1 monovalent vaccine will be produced in multidose vials, in a formulation that contains thimerosal.
PCMA responds to drug price increase
WASHINGTON An article in The New York Times reporting that drug companies have dramatically increased the prices of drugs despite a decrease in the Consumer Price Index has prompted calls for biosimilars reform from an organization representing the nation’s pharmacy benefit managers.
The Pharmaceutical Care Management Association said that policy-makers should focus on creating a regulatory approval pathway for biosimilars instead of “shell games” to lower prescription drug costs. “Increased choice and competition generated by pharmacy benefit managers has been pivotal in driving prescription-drug trend to historic lows, while expanding consumers’ access to drug and pharmacy choices,” a statement by PCMA read.
The Times reported Sunday that while drug companies have promised to lower overall drug prices by $8 billion, wholesale prices of branded drugs increased by 9%, while the Consumer Price Index decreased by 1.3%.
The Pharmaceutical Research and Manufacturers of America criticized the article Monday, saying that drug companies determined drug prices independently based on such considerations as patent expirations and research and development costs, and that many PhRMA member companies had experienced flat or negative sales growth.