H1N1 Vaccines ... Coming soon !

Four Vaccines Approved for Treating the 2009 H1N1 Influenza

On September 15, the FDA announced that it has approved 4 vaccines against the 2009 influenza A (H1N1) virus, formerly known as "swine flu." The vaccine lots are expected to be available and distributed within the next 4 weeks.

FDA Commissioner of Food and Drugs Margaret A. Hamburg, MD, said she thought the approval was good news for the nation's response to the H1N1 influenza virus. "This vaccine will help protect individuals from serious illness and death from influenza," she said.

The approval comes at a time when the Centers for Disease Control and Prevention (CDC) is reporting that visits to physicians around the country for influenza-like illness are increasing and are higher than expected at this time of year. The vaccines that are currently available against 3 seasonal influenza virus strains will not protect against the 2009 H1N1 virus.

The FDA said that the vaccines, based on early data, effectively elicit an immune response in most healthy adults about 8 to 10 days after vaccination. Clinical studies are still underway to produce an optimal dose for children, with results expected in the near future.

Meanwhile, the CDC stresses that influenza is primarily spread through person-to-person contact, by the coughing or sneezing of infected people, and recommends that infected people stay home and limit their contact with others to keep from infecting them.

The newly approved vaccines are being made by CSL Limited, MedImmune LLC, Novartis Vaccines and Diagnostics Limited, and Sanofi Pasteur Inc. All 4 firms reportedly use the same processes to manufacture the H1N1 vaccines. As with the seasonal influenza vaccine, some lots of the H1N1 vaccine will contain the preservative thimerosal and others will not. The FDA has been continuing its efforts toward reducing thimerosal use in vaccines.

The FDA warns that persons with known allergies to chicken eggs or any other substance in the vaccine should probably not be vaccinated, although in the ongoing clinical trials, the vaccines have been well tolerated. The most common adverse effect is soreness at the injection site; other adverse effects can include a mild fever, body aches, and fatigue for a couple of days after vaccination. For the nasal spray delivery system, the most common adverse effects were runny nose, nasal congestion in all ages, sore throats in adults, and fever in children aged 2 to 6 years.

The FDA is working with different organizations regarding adverse event monitoring, information sharing, and an overall analysis during and after the 2009 H1N1 vaccination program, according to the news release. "As with any medical product, unexpected or rare serious adverse events may occur," the FDA notes.

More information is available on the CDC's H1N1 Web site.

Blood Test Approved to Help Detect Ovarian Cancer

The FDA has approved a novel blood test (OVA1, Vermillion Inc and Quest Diagnostics) to help detect ovarian cancer in adult women with pelvic tumors that are known to need surgery.

The test consolidates immunoassay results for 5 proteins known to change with ovarian cancer, rating the likelihood of malignancy on a scale of 1 to 10.

"OVA1 is the first FDA-cleared laboratory test that can indicate the likelihood of ovarian cancer with high sensitivity prior to biopsy or exploratory surgery, even if radiological test results fail to indicate malignancy," the company said in a news release.

Identifying potentially malignant cases before surgery allows involvement of a gynecologic oncologist, which can improve patient outcome.

According to the FDA, ovarian cancer patients have demonstrated improved survival when the surgery is performed by gynecologic oncologists rather than general gynecologists or surgeons.

"Tests such as OVA1 personalize and improve public health by providing patients and health care providers with more information to support medical decisions that impact survival rates and reduce surgical complications," noted Jeffrey Shuren, MD, JD, acting director of the FDA's Center for Devices and Radiological Health.

OVA1 should only be used to compliment other diagnostic and clinical procedures; the test is not indicated for screening purposes or to achieve a definite diagnosis of ovarian cancer.

Telavancin Approved for Treating MRSA Skin Infections

The FDA has approved telavancin injection (Vibativ, Theravance, Inc, and Astellas Pharma US, Inc) for the once-daily treatment of adults with complicated skin and skin structure infections (cSSSI) caused by susceptible gram-positive bacteria, including methicillin-resistant (MRSA) and methicillin-susceptible strains of Staphylococcus aureus.

The injectable lipoglycopeptide antibiotic is a synthetic derivative of vancomycin, the current standard of care for cSSSI. Telavancin and vancomycin both inhibit bacterial cell wall synthesis by interfering with the polymerization and cross-linking of peptidoglycan; telavancin also binds to the bacterial membrane, disrupting its barrier function.

Approval of telavancin was based on data from 2 double-blind, randomized phase 3 studies (ATLAS I and II) of 1867 patients, showing that its use was statistically noninferior to vancomycin (1 g intravenously every 12 hours) for curing cSSSI caused by gram-positive bacteria, including MRSA.

"Vibativ has demonstrated its efficacy and safety in clinical trials for the treatment of gram-positive complicated skin and skin structure infections which included the largest cohort of patients with methicillin-resistant Staphylococcus aureus studied to date," said Ralph Corey, MD, professor of medicine at the Duke University Medical Center, Durham, North Carolina, and the principal investigator in the ATLAS program, in a company news release. "I believe Vibativ will be a welcome addition for physicians treating this serious infection."

The recommended dose of telavancin is 10 mg/kg administered by intravenous infusion once every 24 hours for 7 to 14 days. An infusion period of at least 60 minutes is recommended to reduce the risk for infusion reactions ("red man syndrome").

Women of childbearing potential should have a serum pregnancy test before treatment with telavancin; use during pregnancy should be avoided unless the potential benefit to the mother outweighs fetal risk.

Because of the potential for new-onset or worsening renal impairment, renal function should be monitored during treatment; dose adjustments are recommended for those with creatinine clearance of 50 mL/minute or less, and caution is advised when treating elderly patients.

Although telavancin does not interfere with coagulation, it does affect laboratory tests such as prothrombin time, international normalized ratio, and activated partial thromboplastin time. Blood samples for these tests should be collected as closely as possible before the patient's next dose of telavancin.

Because of the potential for QTc prolongation, caution is advised when treating patients taking other drugs known to have this effect.

Adverse reactions most commonly reported with use of telavancin in clinical studies included taste disturbance, nausea, vomiting, and foamy urine.