The U.S. Food and Drug Administration (FDA) has approved four vaccines for use against the 2009 H1N1 influenza virus. The vaccines—made by CSL Limited, MedImmune LLC, Novartis Vaccines and Diagnostics Limited, and sanofi pasteur Inc.—will be distributed nationally after the initial lots become available. This is expected to occur within the next four weeks.
Merck’s Garasil vaccine, promoted to prevent cervical cancer and genital warts, roared onto the market in 2006, but since then has decelerated sharply. Merck has been lobbying to increase its potential market to boys and mature women. It failed to persuade FDA to broaden use to older women–up to the age of 45–but now has convinced an agency advisory committee that Gardasil would be useful for boys and young men.
Gardasil® is the only HPV vaccine to have clinical efficacy and safety for women up to 45 years added to its product information. Gardasil® is a four-type (6,11,16,18) HPV vaccine. In addition to unsurpassed and sustained cervical cancer protection, Gardasil® can protect from cervical, vulvar and vaginal pre-cancer, and from genital warts caused by HPV types 6, 11, 16 and 18. These four types together cause the vast majority of HPV-related genital diseases.1,3,4,5
Vical Incorporated (Nasdaq:VICL) announced today that the company’s DNA vaccine against A/H1N1 pandemic influenza (swine flu) has demonstrated robust immune responses in 100% of vaccinated animals against virus strains isolated from recent outbreaks in three distinct geographic locations — California, Texas and Mexico.
In twin votes likely to add considerable force to U.S. marketing efforts for HPV vaccines, an FDA expert panel has voted to back GlaxoSmithKline’s long delayed application to market its HPV vaccine Cervarix to women and soon after supported Merck’s application to extend the use of Gardasil to males. Glaxo shares gain 0.5 pct, Merck shares gain 1.9 pct.
With two new swine flu vaccines approved for use and five million doses scheduled for delivery this month, China is set to become the first country to begin a mass vaccination campaign against the H1N1 pandemic. But officials with the World Health Organization say that there are some concerns about potential side effects.
A study conducted at the California Pacific Medical Center Research Institute indicated that elderly with low muscle density have a higher likelihood of being hospitalized than those with a more moderate ratio andsuggests it may be a better predictor of the risk of hospitalization than muscle mass or size
The Australian Infection Control Association this week warned the government against proceeding with the programme, saying that the planned use of multidose vials (used to vaccinate several people) posed a “significant potential risk to patient safety.” The association’s president, Claire Boardman, said that use of multidose vials would contravene national infection control guidelines (www.safetyandquality.gov.au/internet/safety/publishing.nsf/Content/02A94EEE98D72244CA25740F00251B98/$File/NationalInfectionControlGuidelines.pdf) and that numerous adverse events related to their use had been well documented.
The review of these new applications is only likely to heat up the HPV Vaccine controversy. Both vaccines have been harshly criticized by social conservatives in the U.S. And some medical experts have joined in as well, arguing that screening can be an equally effective method in stopping cancer. Nevertheless, more than 100 countries have approved the vaccines and many strongly support their use, noting high rates of efficacy.
As manufacturers work furiously to make a vaccine to protect against 2009 influenza A (H1N1) virus, a Rice University bioengineer is trying to improve the process for future flu seasons. The goal is to shorten the time it takes to identify targeted flu strains and manufacture the vaccines for them.
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