By Rob Stein and Kimberly Kindy The new swine flu virus is spreading rapidly around the United States, and more than half of the states are reporting unusually high levels of flu-like illness at a time of year when the respiratory disease usually disappears, federal health officials said yesterday. About half of the people with flu are testing positive for the new virus, indicating it is playing a significant role in the unusual pattern of disease, officials said. "We would be expecting to see the season to be slowing down or almost completely stopped," said Daniel Jernigan of the federal Centers for Disease Control and Prevention. "But what we're seeing is there are some areas that actually have reports of the amounts of respiratory disease . . . that are equivalent to peak influenza season." The unusual activity comes as two more U.S. deaths were reported from swine flu, bringing the total in the United States to at least five. A 33-year-old man succumbed in Corpus Christi, Tex., May 6, bringing that state's total to three, while a woman in her late 40s died last week in Maricopa County in Arizona, marking that state's first death. Washington state had previously reported a death. At least 173 infected people have been hospitalized across the country, including a New York school official who fell ill in the midst of a new outbreak that prompted the closing of two schools. "We know the outbreak is not localized but is spreading and appears to be expanding throughout the United States," Jernigan said. "This is an ongoing public health threat." The CDC has officially reported 4,714 confirmed or "probable" swine flu cases in 47 states, and 22 states are reporting widespread flu, but there could be as many as 100,000 cases around the country, Jernigan said. "This is not something we would expect to see at this time," said Jernigan, adding that the rising count is not simply the result of doctors looking harder for cases. Despite the spread in the United States, the CDC lifted its warning against all unnecessary travel to Mexico. So far, that country has suffered the most severe outbreak, but Mexican officials predicted yesterday that they would bring it under control by the end of the month. The CDC said individuals with other health conditions should consult with their doctors before traveling to Mexico, because such people appear to be the most prone to serious complications from the virus. The infected New York school administrator remained on a ventilator at Flushing Hospital Medical Center, and his son told reporters that his father's condition had deteriorated over the previous 24 hours. After falling ill a week ago, Mitchell Wiener, assistant principal of Intermediate School 238 in Queens, had developed pneumonia and kidney failure, his son Adam Wiener told local television reporters. Wiener's fever was "much worse," and he was not responding to medicine, he said. Contrary to previous reports, Wiener, 55, had no preexisting medical conditions other than gout, the son said. Four students at one school had confirmed cases of the virus, and more than 50 have been sent home this month with flu-like symptoms. At a second school, 29 students had visited the nurse with flu-like symptoms on Thursday, and at a third, 241 students were absent on Thursday. Maintenance crews were cleaning all three schools, which were closed for a week on Thursday. Late yesterday, officials announced they were closing two more schools in Queens and another in Brooklyn for as many as five days beginning Monday after documenting unusually high levels of the flu. "The fact that we're seeing large clusters in schools is a little surprising," said New York City Health Commissioner Thomas R. Frieden, whom President Obama selected yesterday to lead the CDC. Meanwhile, vaccine manufacturer GlaxoSmithKline announced yesterday that four European countries have collectively placed orders for 127 million doses of a vaccine it will develop to combat the new flu strain. The four countries -- Britain, France, Belgium and Finland -- are ordering the doses as a precaution in the event of a widespread outbreak, said Sarah Alspach, a company spokeswoman. Production of the vaccine will take about four months and will begin as soon as the manufacturer receives "seed" samples of the virus from the World Health Organization, she said. The WHO is considering whether to ask drug manufacturers to begin producing a vaccine in case the virus returns in a more dangerous form in the fall. Already, there is controversy over the vaccine, which will include an ingredient called an adjuvant that boosts the body's immune response. The ingredient is not licensed by Food and Drug Administration, but the agency has the power to authorize the use of such products in an emergency. Some health officials and vaccine watchdog groups say the accelerants may cause a severe reaction -- specifically, swelling in the joints and in the liver -- in people with compromised immune systems. "It's a big issue. An adjuvant in vaccines given to soldiers is at the center of the debate with the Gulf War syndrome," said Vicky Debold, a public health nurse who serves on the FDA's vaccines advisory committee. "The FDA is very concerned about them, especially what happens when people are given multiple vaccines at once that use a combination of adjuvants that have not been tested together." A scramble among wealthy nations to guard against a swine-flu pandemic is raising concerns that billions of people in poorer countries could be left without adequate supplies of vaccine. An increasing number of Western countries are signing agreements with vaccine makers guaranteeing them a certain number of doses should a pandemic occur. By locking up the supply in advance, they are making it even tougher for poor countries to get access to the shots they would need, critics say. Leaders from the World Health Organization and the United Nations are set to meet with drug-company executives in Geneva starting Tuesday, in part to hash out possible solutions to the vaccine problem. The emerging battle between the haves and have-nots underscores a major weakness in the global health system: Pharmaceutical companies have severely limited capacity to produce flu vaccines in emergencies. The WHO estimates drug companies will be able to produce between one billion and two billion doses of vaccine a year for a pandemic, depending on how much active ingredient is needed per dose. That is far short of the world's population of 6.8 billion. Wealthy countries -- including the U.K., Canada, Sweden, Switzerland, Denmark and Austria -- have been moving quickly to snap up the available capacity, ordering enough shots to cover much of their populations. The U.K. says it has a four-year, £155.4 million ($236.62 million) contract with GlaxoSmithKline PLC and Baxter International Inc. that guarantees delivery of up to 132 million doses of vaccine. The Netherlands is considering placing an advance order for 34 million doses, a spokeswoman for the health minister said. The U.S. government has taken a slightly different approach, cutting deals with drug companies to boost capacity. The U.S. this year awarded Novartis AG $486 million toward the construction of a vaccine factory that will be able to produce 150 million doses within six months of a pandemic being declared -- a deal that gives the U.S. first dibs on the vaccine, according to Andrin Oswald, Novartis's head of vaccines and diagnostics. The WHO hasn't yet declared a swine-flu pandemic, nor have drug companies started producing pandemic vaccine in large quantities. Once they do, it will take four to six months for the first doses to become available. Meanwhile, developing nations are sounding alarms about their vulnerable position. In a recent statement, health ministers from the Association of Southeast Asian Nations, including Indonesia, Cambodia and Vietnam, said "access to effective pandemic vaccines is a major problem in this region," and called on the WHO for help. "There is no mechanism to make sure we will get the medicines to those who need them," says Sangeeta Shashikant, legal adviser to the Third World Network, a nonprofit group that promotes the interests of the developing world. WHO vaccine official Marie-Paule Kieny said the organization is talking to vaccine manufacturers "to try to ensure access for developing countries." Anders Tegnell, a director of Sweden's national board of health and welfare, said Swedish officials discussed the ethics of the issue before signing an accord with Glaxo for pandemic vaccine. "If we have advance purchase agreements or not, still the bulk of production will most likely go to rich countries, because that's the way the market works," he said. He said pandemic flu vaccines might not even be the best investment for poor countries, which are battling more pressing health problems, including HIV and malaria. Drug companies say they recognize the problem of getting vaccines to poorer nations. A Baxter spokesman said the company will "be taking our lead from global health authorities" about how to "manage multiple priorities." A Glaxo spokesman said the company is "absolutely committed" to providing pandemic vaccine to poor countries. Glaxo on Friday said it plans to start producing a pre-pandemic vaccine against the current strain of the A/H1N1 virus causing the swine-flu outbreak. There is no guarantee this vaccine would work during a pandemic if the virus mutates significantly. Glaxo said it plans to donate 50 million doses of this pre-pandemic vaccine to the WHO for use in the developing world. Albert Garcia, a spokesman for France's Sanofi-Aventis SA, one of the largest vaccine makers, said while the company has signed loose agreements with France, Italy, Australia and the U.S. to supply vaccine in the event of a pandemic, the deals don't specify the number of doses, the price or the timing of delivery. Sanofi feels it is "not ethical for us to sell vaccines that don't exist at the moment," he said. Access to antivirals such as Tamiflu, used to treat a person already infected with the flu, are also an issue. Roche Holding AG, which makes Tamiflu, has donated millions of doses to the World Health Organization and increased its production to meet rising demand. It has also authorized a handful of generic companies to make and sell the drug in the developing world, in order to increase overall supply. But it is facing pressure to allow more widespread generic production. Indian generic maker Cipla Ltd. threw down the gauntlet this week by saying it plans to sell a generic version of Tamiflu to buyers in Mexico, where the drug is protected by patent. The company will sell the drug for $10 per pack, less than Roche's price in Mexico of €15 ($20) a pack, under contracts that indemnify Cipla against lawsuits, Cipla Chief Executive Amar Lulla said in a phone interview. David Reddy, the head of Roche's pandemic flu business, said "we see no rationale for generic supply, given that we are able to meet all of the needs of" Mexican buyers. Write to Jeanne Whalen at jeanne.whalen@wsj.com
Washington Post Staff Writers
Saturday, May 16, 2009
Wall Street Journal
Rich Nations Lock in Flu Vaccine as Poor Ones Fret
Wednesday, May 27, 2009
Swine Flu Vaccine Info (Wash Post & Wall Street Journal)
Washington Post
New Virus Appears to Be a Factor in Extended Flu Season
[AND INFO ON A VACCINE]
Staff writer Robin Shulman in New York contributed to this report.
MAY 16, 2009
A flu-vaccination campaign in Panama City this month. Developing nations are sounding alarms about being left out in case of pandemic.
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