" Citing a lack of cardiovascular benefit, the FDA is taking the unusual step of withdrawing approvals it had previously given for use of niacin and fenofibric acid with statins to treat high cholesterol.
The decision affects niac"...
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Clinical studies of 73 double seronegative children 12 months to 2 years of age demonstrated that BIAVAX (rubella and mumps virus vaccine live) II is highly immunogenic and generally well tolerated. In these studies, a single injection of the vaccine induced rubella hemagglutination-inhibition (HI) antibodies in 100 percent, and mumps neutralizing antibodies in 97 percent of the susceptible children.
The RA 27/3 rubella strain in BIAVAX (rubella and mumps virus vaccine live) II elicits higher immediate post-vaccination HI, complement-fixing and neutralizing antibody levels than other strains of rubella vaccine and has been shown to induce a broader profile of circulating antibodies including anti-theta and anti-iota precipitating antibodies. The RA 27/3 rubella strain immunologically simulates natural infection more closely than other rubella vaccine viruses. The increased levels and broader profile of antibodies produced by RA 27/3 strain rubella virus vaccine appear to correlate with greater resistance to subclinical reinfection with the wild virus, and provide greater confidence for lasting immunity.
Vaccine induced antibody levels following administration of BIAVAX (rubella and mumps virus vaccine live) II have been shown to persist for at least two years without substantial decline. Antibody levels after immunization with BIAVAX (Rubella and Mumps Virus Vaccine Live), containing the HPV-77 strain of rubella, have persisted for 10.5 years without substantial decline. If the present pattern continues, it will provide a basis for the expectation that immunity following vaccination will be permanent. However, continued surveillance will be required to demonstrate this point.
Last reviewed on RxList: 12/8/2004
This monograph has been modified to include the generic and brand name in many instances.
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