Source: HealthNews

As the number of H1N1 flu cases continues to rise, government health officials continue to urge the public to consider getting vaccinated against both swine flu and seasonal flu. “Unfortunately we are seeing more illness, more hospitalizations, and more deaths,” Dr. Anne Schuchat, director of the CDC’s National Center for Immunization and Respiratory Diseases, said in a recent H1N1 briefing. “We are now up to 76 children having died” from swine flu this year; many more already, she said, than the typical toll from influenza in years past.

At the briefing, Schuchat also addressed concerns she knows exist about the new vaccine. “Some people have reservations, they aren’t really sure about this vaccine,” she said. But a recent Associated Press-GfK poll suggests that a large majority of Americans have concerns about the vaccine. The AP poll, conducted October 1-5, found 72 percent of those surveyed are worried about side effects, although more than half say that wouldn’t stop them from getting the vaccine to protect their kids from the new flu. And 38 percent of parents said they were unlikely to give permission for their kids to be vaccinated at school.

“I would say there is moderate concern about the safety of it (H1N1 vaccine),” says Wally Ghurabi, DO, chief of emergency services at Santa Monica-UCLA and Orthopedic Hospital in California and a member of the H1N1 Steering Committee for the University of California Los Angeles. He says “someone always brings up Guillain-Barre,” a neurological condition that was linked with a previous swine flu vaccine manufactured in 1976. However, experts argue that the link was not clear and point out that vaccine production has greatly improved since then, as has testing for contaminants, which may have explained the link. Ghurabi’s advice is for patients to weigh the pros and cons, taking their risk into account. For instance, “if you are caring for a two-month old baby or are pregnant, you are in a high risk group,” he says.

But federal officials say the H1N1 vaccine is made the same way as seasonal flu vaccines that have been used for years. “This isn’t a new vaccine,” Schuchat said. “The vaccine is being manufactured exactly the same way as the seasonal flu vaccine. It is basically a vaccine made against the H1N1 instead of the seasonal viruses (expected to circulate in the upcoming season). Based on everything we know now, we are expecting a good safety record for H1N1.”

The federal government has purchased 250 million doses of the 2009 H1N1 vaccine at a cost of $2 billion, and as of Friday 3.7 million doses have been ordered by states and the District of Columbia, according to Schuchat. She says in all, 6.8 million doses are now available and production is continuing, but exactly when the H1N1 vaccine will be available in a given community is hard to predict. The CDC has recommended that certain at-risk populations, including pregnant women, health care providers and individuals with underlying chronic medical conditions such as asthma, receive the new H1N1 vaccine as a priority before the general population.

Source: HealthNews

At Wednesday’s meeting for the advisory committee, pharmaceutical giant Merck & Co., maker of the Gardasil vaccine, presented data from three clinical trials that the company claims supports broadening the distribution of the vaccine to include boys and young men. The three trials included more than 5,400 boys and men that were from 23 countries and 6 continents.

According to Anna Giuilano, who is an independent scientist at Moffit Cancer Center located in Tampa, Florida, and the trials’ principal investigator, “The data clearly demonstrates that there was a benefit to men in receiving Gardasil. Overall, we saw a 90 percent reduction in disease—genital warts and pre-cancerous lesions—caused by HPV in men and an 89 percent reduction in genital warts incidence. Essentially, we have a really fantastic opportunity to extend the benefit of the vaccine to men. This is a sexually transmitted infection’ if we can reduce infection and related diseases in men, we have the potential to have a much broader public health impact by reducing the overall burden of infection and disease in the community at large.”

Guiliano stated that there were no serious adverse events that were related to the vaccine. There were some minor side effects such as running a low grade fever and pain at the injection site. The Gardasil vaccine would be administered in boys and young men exactly the same way it has been given to girls and young women: three doses over a span of six months. Pan Eisele, who is a spokeswoman for Merck, said that the cost will be $130 dollars per dose.

According to the Centers for Disease Control and Prevention, approximately 20 million Americans are infected with HPV. There are approximately 6.2 million new infections annually. The CDC states that at least 50 percent of women and men that are sexually active get an HPV infection at some point in their life. The American Social Health Association said that HPV is the most common sexually transmitted virus and puts that number at 75 percent or above.

The CDC says that although HPV is very common for both sexes, most men will not develop symptoms or any serious health problems, and there is no test that will detect the virus in men. The only test that is approved for HPV on the market is for women, for the use in cervical-cancer screening.

The advisory committee has also voted that Cervarix, which is new HPV vaccine that is made by GlaxoSmithKline, appeared to be safe and effective for girls and young women between the ages of 10 and 25. Cervarix has already been approved for us in Europe.

Barbara Howe, who is the vice president and director of North American vaccine development for GlaxoSmithKline, said, “This is an important step in cancer prevention for the millions of girls and young women at risk for cervical cancer. If approved, Cervarix will provide protection against cervical cancer, a devastating disease that is responsible for thousands of deaths in U.S. women each year.”

Still, the panel recommend that GlaxoSmithKline do more studies that would closely monitor miscarriages and other problems that were reported by patients. In a final review of this proposal, both of the applications will be considered by the FDA, which usually—but not always—follows the recommendations of its advisory committees.

Source: HealthNews