As USA Today reports, China captured world attention in 2009 when one of its companies developed the first effective vaccine against swine flu in just 87 days.

The way was opened for China to jump into the global vaccine business in a big way this March when the World Health Organization announced that the nation’s drug safety authority meets international standards for vaccine regulation. That means that Chinese vaccines can be submitted to the WHO for approval to be bought by United Nations agencies and the GAVI Alliance, which provides vaccines to children in poor countries.

Still, Chinese vaccines will continue to face skepticism, said a representative of Sinovac, the Chinese biotech firm that  developed the H1N1 swine flu vaccine. “We think the main obstacle is that we have the name of ‘made in China’ still. That is an issue,” she said.

As USA Today noted, China has endured repeated food and drug safety scandals. In 2007, Chinese cough syrup killed 93 people in Central America. A year later, contaminated blood thinner led to dozens of U.S. deaths, and tainted milk powder killed six Chinese babies and poisoned hundreds of thousands of others.

Last year, a Chinese newspaper report linked improperly stored vaccines to four children’s deaths in northern Shanxi province, raising nationwide concern, although the nation’s health ministry said the immunizations were not the cause of the fatalities.

STUART SILVERSTEIN

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Even so, according to an investigative report in the Los Angeles Times, the Obama administration over the last year has aggressively pushed a $433 million deal to buy an experimental smallpox drug called ST-246. Its purpose would be to treat people diagnosed with smallpox too late to be helped by the vaccine, which can reliably prevent death only when given within four days of exposure.

It’s not certain ST-246 would actually work — for ethical reasons the anti-viral drug can’t be tested in humans.

Senior Health and Human Services officials, however, have taken unusual steps to secure the contract for New York-based Siga Technologies Inc., whose controlling shareholder is billionaire Ronald O. Perelman, one of the world’s richest men and a longtime Democratic Party donor.

Those steps include replacing the government’s lead negotiator on the deal when the company complained that federal officials were resisting its financial demands. The cost per dose under the $433 million deal awarded in May is estimated at $255.

Some experts say spending large sums on the drug is a waste. “We’ve got a vaccine that I hope we never have to use — how much more do we need?” said Dr. Donald A. Henderson, the epidemiologist who led the global eradication of smallpox for the World Health Organization and later helped organize U.S. biodefense efforts under President George W. Bush. “The bottom line is, we’ve got a limited amount of money.”

While Health and Human Services officials have supported the drug deal, it could face a roadblock at the Food and Drug Administration. That agency’s stance is pivotal because the contract requires Siga to develop its drug “for ultimate approval by the FDA.”

The FDA has set a public meeting for next month to discuss ST-246 and a competing drug made by Chimerix. Yet since researchers are prohibited from infecting humans with the smallpox virus, the companies could face a tough battle in persuading the FDA their products are safe and effective.

STUART SILVERSTEIN

The recommendation by the panel  follows five years of efforts by health authorities to encourage girls ages 11 to 26 to receive the vaccine –a push that has been resisted by many American families.

HPV, or human papillomavirus, is the most common sexually transmitted disease. As The New York Times reports, between 75 percent and 80 percent of women and men in the U.S. will be infected by the virus at some point in their lives.

“Most will fight off the virus with no ill effects,” The Times said. “But in some people, infections lead to cellular changes that cause warts or cancer, including cervical, vaginal and vulvar cancers in women and anal cancer in men. A growing body of evidence suggests that HPV also causes throat cancers in men and women as a result of oral sex.”

The HPV shots have triggered concerns because, along with raising worries about vaccine safety in general, they call on parents to consider the sexual behavior of their children. As The Associated Press reports, some parents worry that the vaccine promotes promiscuous behavior.

Even though the vaccine is expected to prevent disease among females who have sex with vaccinated boys and young men, the males most likely to be shielded from disease tend to be homosexuals.

The vaccine has become an issue in the campaigns for the Republican presidential nomination. Texas Gov. Rick Perry has been criticized for trying to require vaccinations for girls in his state. U.S. Rep. Michele Bachmann, R-Minn., has wrongly suggested that the vaccine is linked to mental retardation.

HPV infections account for an estimated 22,000 cancers annually.  Anal cancer rates among men and women are on the increase, while cervical cancers have dropped dramatically since the 1970s.  Head and neck cancers, which are linked with oral sex, also have increased.

The three-dose HPV vaccination regimen costs pediatricians more than $300, and patients often are charged hundreds of dollars more. Most of the cost could be covered by private insurers, however, because the industry typically follows the panel’s recommendations.

The panel — known as the Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention — recommended the vaccinations for boys and young men ages 11 to 21.

“This is the first time we have a vaccine that is primarily designed to prevent cancer,” said Dr. Joseph Bocchini, a panel member and an infectious diseases expert with Louisiana State University. “It’s an important opportunity for the improvement of women’s health by reducing cervical cancer, and now we have the opportunity to prevent cancer in men.”

ROBERT T. NELSON

The trouble is, as the Los Angeles Times reports, influenza is a wily opponent — the strain posing the biggest threat can change every year, foiling the medical profession’s best efforts to design an effective shot. And given that some varieties of flu can cause a lot more harm than sniffles — in rare cases the virus can lead to deadly pandemics — there is a lot at stake.

So, to provide a more durable defense, scientists around the world are working to develop a universal flu vaccine that would train the immune system to  destroy flu — no matter what type it is. The key is to make a vaccine that combats the unchanging parts of the virus, which one immunologist described as its Achilles’ heel.

Dr. Francis Collins, the director of the National Institutes of Health, says that could happen by 2016, and British and Israeli companies are working on vaccines that they say could be ready in as soon as three years.

Other scientists say it will take longer, perhaps a decade.

Still, they aim to stop pandemics such as 2009′s swine flu outbreak, which was caused by a type of H1N1. The United Nations in August warned health authorities to be on alert for a possible resurgence of the sometimes deadly H5N1 bird flu, amid signs that a mutant strain is circulating in Asia.

“It’s almost inevitable that another pandemic will come,” said Dr. Antonio Lanzavecchia, a Swiss immunologist.

According to the World Health Organization, bird flu has killed at least 332 people since 2003. The death toll has remained low because people can pick up the virus only from a bird, but if it gains the ability to jump from person to person, “it has the potential to decimate the world population,” said Ian Wilson, a structural biologist at California’s Scripps Research Institute.

STUART SILVERSTEIN

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Early results show, The New York Times reports, that three doses of the vaccine protected 47 percent of 6,000 inoculated children, ages 5 months to 17 months, from severe malaria. The clinical trial, largely funded by the Bill and Melinda Gates Foundation, is scheduled to continue through 2014 and will include tests on more than 15,000 children.

As The Washington Post noted, controlling malaria has long been a top international public health goal. Caused by parasites transmitted by infected mosquitoes, malaria annually sickens more than 200 million people and kills about 780,000, mostly children in Africa.

While far less protective than immunizations against other diseases, the preliminary results of the experimental malaria vaccine were hailed as a major advance.

“This is remarkable when you consider that there has never been a successful vaccine against a human parasite,” Tsiri Agbenyega of the Komfo-Anokye Hospital in Ghana, who is leading the study, told reporters at a Seattle conference. “This potentially translates into tens of millions of cases of malaria in children being averted.”

Although most vaccines are not released until they protect more than 90 percent of the people inoculated, the malaria vaccine results were considered encouraging because the disease has been so difficult to combat. It is far harder to make a vaccine against parasites like malaria than to make one against a virus because the malaria parasite changes as it moves from blood to liver and back to the blood.

What’s more, the most pessimistic experts argue that making a long-lasting malaria vaccine is impossible. They say even the “perfect natural vaccine” — surviving repeated bouts of malaria — fades after a few years away from the malarial area.

The experimental vaccine — made by GlaxoSmithKline and currently known as RTS,S — has been in development for more than 25 years.

STUART SILVERSTEIN

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To cut SIDS fatalities further — as well as to combat the rise in sleep-related deaths from other causes, such as suffocation — the academy today issued issued new recommendations.  “Our goal is to ultimately eliminate these deaths completely,” said Dr. Rachel Moon, head of the academy’s SIDS task force, in a news release.

The new recommendations, among other things, urge parents to avoid using bumper pads in cribs. The academy said that they raise the risk of suffocation, strangulation and entrapment, and that there is no evidence that the pads prevent crib injuries.

In addition, the academy urged breastfeeding, saying it is linked to a reduction in SIDS. And the academy added an emphasis on infant immunizations, maintaining that vaccines lower the risk of SIDS by 50 percent. That recommendation comes at a time when many parents have qualms about potential harm from vaccinations and immunization regimens that typically call for babies to get five shots against seven diseases during their two-month and four-month visits.

As MyHealthNewsDaily reports, the academy also repeated previous recommendations such as keeping all loose bedding — including pillows and blankets — out of the crib and avoiding “bed-sharing” — having an infant sleep in the same bed as a parent or another child.

The recommendations follow a recent ban by the Consumer Product Safety Commission on the sale of traditional drop-side baby cribs, a move also intended to reduce crib deaths and injuries.

Separately, the academy issued other recommendations discouraging the viewing of TV or videos by children under age 2, saying that they should be as “screen-free” as possible.

STUART SILVERSTEIN

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