It says Tamiflu remains highly effective against the vast majority of H1N1 cases.

Four cancer patients in a North Carolina hospital tested positive last week for a type of the flu that was resistant to Tamiflu. Five people at a British hospital also didn’t respond to the drug after contracting the flu.

WHO flu chief Dr. Keiji Fukuda said Thursday that investigations were under way, but that the American and British patients for whom Tamiflu did not work had severely weakened immune systems.

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The vaccine is subject to the same manufacturing and testing oversight as seasonal flu vaccines, the agency said in a news release. The expanded approval also includes CSL’s seasonal flu shots.

“Because children are among those most vulnerable to the 2009 H1N1 virus, having a broader range of children’s vaccines available is an important first step in responding to the H1N1 outbreak,” FDA commissioner of food and drugs Margaret Hamburg said in a statement.

As with any vaccine grown in eggs, people allergic to eggs or egg products shouldn’t get this vaccine, the FDA said.

Common adverse reactions include pain, redness and swelling at the injection site. Less common side effects may include irritability, loss of appetite and drowsiness.

CSL is based in Australia.

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Using anonymous data from MarketsSan databases (Thomson Reuters, Cambridge, Massachusetts), Dr. Pedro A. Piedra from Baylor College of Medicine, Houston and colleagues studied 1634 children prescribed oseltamivir and 3721 who received no antiviral drugs. Chronic conditions among the children included chronic lung disease, asthma, diabetes, HIV infection, cancer and transplants.

In the 14 days following influenza diagnosis, children treated with oseltamivir had about a rate of breathing-related illnesses (other than pneumonia) about one-quarter less than that of those not treated with antiviral medication, the authors report. Among the 1634 children with flu, there were 324 cases of such illnesses in those treated with oseltamivir; there were 885 cases among the 3721 who did not receive the treatment.

The rate of ear infections and its complications was also about a third less, compared with children not treated with antiviral medication, the authors report. Among the 1634 children with flu, there were 46 cases of such illnesses in those treated with oseltamivir; there were 184 cases among the 3721 who did not receive the treatment.

Children treated with oseltamivir were only one third as likely to require hospitalization for any reason as children not treated with antiviral medication. There were a total of 58 hospitalizations among both groups.

The results were similar for the 30 days following the influenza diagnosis, the researchers note, but the risk reductions were somewhat smaller.

The study, Piedra told Reuters Health via email, will be helpful in determining the best uses of oseltamivir for flu strains including H1N1, also known as swine flu.

Piedra has been a consultant to Tamiflu manufacturer Roche, and to other companies, and one of his co-authors is a Roche employee.

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The European Medicines Agency, the EU’s top drug regulatory body, is accelerating the approval process for swine flu vaccine, and countries such as Britain, Greece, France and Sweden say they’ll start using the vaccine after it’s greenlighted — possibly within weeks.

In an interview with The Associated Press, Dr. Keiji Fukuda, the World Health Organization’s flu chief, warned about the potential dangers of untested vaccines, although he stopped short of criticizing Europe’s approach outright.

“One of the things which cannot be compromised is the safety of vaccines,” he said Friday. “There are certain areas where you can make economies, perhaps, but certain areas where you simply do not try to make any economies.”

Flu vaccines have been used for 40 years, and many experts say extensive testing is unnecessary, since the swine flu vaccine will simply contain a new ingredient: the swine flu virus.

But European officials won’t know if the new vaccine causes any rare side effects until millions of people get the shots. Still, they say the benefit of saving lives is worth the gamble.

“Everybody is doing the best they can in a situation which is far from ideal,” said Martin Harvey-Allchurch, a spokesman for the European Medicines Agency. “With the winter flu season approaching, we need to make sure the vaccine is available.”

In Europe, flu vaccines are usually tested on hundreds of people for several weeks or months, to ensure the immune system produces enough antibodies to fight the infection.

But to ensure swine flu vaccine is available as soon as possible, the European Medicines Agency is allowing companies to skip testing in large numbers of people before the vaccine is approved.

The main issue is probably that without thorough testing it’s difficult to gauge the effective dosage — meaning Europeans might get too weak a vaccine. It’s unlikely the vaccine would endanger anyone, but until it is used in large numbers of people, no one will know for sure.

Europeans appear ready to use the vaccine widely before conducting any big studies to prove it is safe and effective. Neither the vaccine makers nor the European Medicines Agency would specify what basic safety tests are being done.

The U.S. is taking a more cautious approach: the government called Wednesday for several thousand volunteers to be injected with the swine flu vaccine in tests beginning in August to assess the vaccine’s safety. American officials said results should be ready by the time the U.S. plans to roll out a vaccination campaign in October.

Results from the U.S. tests will be of limited use to Europe, since countries like Britain plan to start vaccinating as early as August — before any American trial data is available. The vaccines used in the U.S. will also be different from those in Europe.

Some experts favor urgent action.

“The consequences of not having a vaccine if this virus gets worse are very high,” said Leonard Marcus, a public health expert at Harvard University. “If (regulatory authorities) took all the time that was necessary to make sure there are no side effects, ironically, in the effort to save a few lives, many lives could be lost.”

But critics say dangers lurk in any strategy to vaccinate without robust testing.

Scant information exists on flu vaccines with adjuvants, a component used to stretch the active ingredient that is commonly found in European flu vaccines. There are no licensed flu vaccines with the ingredient in the U.S.

There is also limited or no data on the safety and effectiveness of vaccines with adjuvants in children under 3 and pregnant women — two of the most vulnerable groups in a pandemic — a global outbreak.

Mass swine flu vaccination campaigns will also take place in the shadow of the 1976 swine flu disaster, when hundreds of people in the U.S. developed Guillain-Barre syndrome, a paralyzing disorder, after being vaccinated.

Experts don’t know why that happened, but say modern vaccine production techniques have improved since 1976. To avoid a similar episode, some say comprehensive testing before the vaccine is rolled out is essential.

“I can’t see any possible excuse to not test it for safety before it’s given to anyone,” said George Annas, a bioethics expert at Boston University.

If the vaccine turns out to have dangerous side effects, it could generate a public backlash, particularly in a country like Britain, where many people remain suspicious of vaccines because of unsubstantiated allegations linking the measles, mumps and rubella vaccine to autism. That could lead to millions of people refusing vaccination.

When the bird flu crisis hit several years ago, the European Medicines Agency designed a special protocol to approve a vaccine for use in a pandemic as soon as possible.

The agency let companies submit data for a “mock-up” vaccine, using H5N1 bird flu. The idea was to do most of the testing before the global epidemic hit so when it did, drugmakers could insert the pandemic virus into the vaccine at the last minute.

When the first swine flu vaccine doses are ready, the European Medicines Agency will approve them largely based on data from the bird flu vaccine, since both will have the same basic ingredients.

If the agency thinks the bird flu data predicts how the swine flu virus will work, they will approve it, said spokesman Harvey-Allchurch.

The agency will then require regular reporting of the vaccine’s effects as it is being administered — monitoring that is normally done beforehand.

WHO’s Fukuda said everyone involved in making the vaccine, from manufacturers to regulatory agencies, is looking at what steps can be taken to streamline the process.

“But there is no one who disagrees that one of the absolutes is that there can’t be any question whether the vaccine is safe or not,” he said.

WHO reported that the swine flu viruses aren’t producing enough of a key vaccine ingredient, which may limit how much vaccine is available. Its laboratory network is now working to produce a new set of viruses that it hopes will work better.

Drugmakers including Baxter International, GlaxoSmithKline PLC, Novartis and Sanofi-Pasteur, however, insist they will be able to start shipping the first batches of vaccine soon.

British health officials have repeatedly said they will start vaccinating in August, as soon as the vaccine is approved. Other European countries, including Greece, France, Sweden, say they will use the vaccine after it gets the green light from the European agency, but none other than Britain expect to start the shots next month.

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“We have already received proposals from people on behalf of countries in Latin America, Mexico and Israel,” the Mumbai-based company’s chief executive and joint managing director, Amar Lulla, was quoted as saying by Indian media.

“We have the capability to supply 1.5 million dosages of the drug within four to six weeks,” he added.

No approach had yet been made by either the World Health Organisation (WHO) or the Indian government, he added.

WHO on Monday raised its flu pandemic alert level from three to four amid global concern over swine flu. Mexico, the outbreak’s epicentre, has raised its probable death toll to 152 and cases have been confirmed across the world.

Cipla Limited is one of the big Indian drug firms that makes a generic version of Swiss group Roche’s Tamiflu to export to countries where it is not patented.

The Indian firm sells the drug at 1,000 rupees (20 dollars) for a 10-day course. Cipla and Ranbaxy supplied the antiviral drug to some Asian countries during the outbreak of bird flu in 2006.

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The United States advised Americans against most travel to Mexico and ordered stepped up border checks in neighboring states. The European Union health commissioner advised Europeans to avoid nonessential travel both to Mexico and parts of the United States.

The virus poses a potentially grave new threat to the U.S. economy, which was showing tentative early signs of a recovery. A widespread outbreak could batter tourism, food and transportation industries, deepening the recession in the U.S. and possibly worldwide.

The suspected number of deaths rose to 152 in Mexico, the epicenter of the outbreak with nearly 2,000 people believed to be infected.

The number of U.S. cases rose to 50, the result of further testing at a New York City school, although none was fatal. Other U.S. cases have been reported in Ohio, Kansas, Texas and California. Worldwide there were 79 confirmed cases, including six in Canada, one in Spain and two in Scotland.

The World Health Organization reported a slightly lower figure, 73. The WHO said it was still awaiting official reports from the U.K. about the Scottish cases, and it was reporting different numbers in the U.S. (40) and Mexico (26) from what those governments confirmed.

While the total cases were still measured in hundreds, not thousands, Mexican Health Secretary Jose Angel Cordova said the epidemic was entering an extremely dangerous phase, with the number of people infected mushrooming even as authorities desperately ramped up defenses.

“We are in the most critical moment of the epidemic. The number of cases will keep rising, so we have to reinforce preventative measures,” Cordova said at a news conference.

The WHO raised the alert level to Phase 4, meaning there is sustained human-to-human transmission of the virus causing outbreaks in at least one country.

Its alert system was revised after bird flu in Asia began to spread in 2004, and Monday was the first time it was raised above Phase 3.

“At this time, containment is not a feasible option,” as the virus has already spread to several other countries, said WHO Assistant Director-General Keiji Fukuda.

Putting an alert at Phases 4 or 5 signals that the virus is becoming increasingly adept at spreading among humans. That move could lead governments to set trade, travel and other restrictions aimed at limiting its spread.

Phase 6 is for a full-blown pandemic, characterized by outbreaks in at least two regions of the world.

It could take 4-6 months before the first batch of vaccines are available to fight the virus, WHO officials said.

Russia, Hong Kong and Taiwan said they would quarantine visitors showing symptoms of the virus amid global fears of a pandemic, an epidemic spread over a large area, either a region or worldwide.

President Barack Obama said the outbreak was reason for concern, but not yet “a cause for alarm.”

Dr. Richard Besser, acting director of the Centers for Disease Control and Prevention, said that so far the virus in the United States seems less severe than in Mexico. Only one person has been hospitalized in the U.S.

“I wouldn’t be overly reassured by that,” Besser told reporters at CDC headquarters in Atlanta, raising the possibility of more severe cases in the United States.

“We are taking it seriously and acting aggressively,” Besser said. “Until the outbreak has progressed, you really don’t know what it’s going to do.”

U.S. customs officials began checking people entering U.S. territory. Millions of doses of flu-fighting medications from a federal stockpile were on their way to states, with priority given to the five already affected and to border states. Federal agencies were conferring with state and international governments.

“We want to make sure that we have equipment where it needs to be, people where they need to be and, most important, information shared at all levels,” said Janet Napolitano, head of the Homeland Security Department.

“We are proceeding as if we are preparatory to a full pandemic,” Napolitano said.

She said travel warnings for trips to Mexico would remain in place as long as swine flu is detected.

Mexico canceled school at all levels nationwide until May 6, and the Mexico City government said it was considering a complete shutdown, including all public transportation, if the death toll keeps rising. Labor Secretary Javier Lozano Alarcon said employers should isolate anyone showing up for work with fever, cough, sore throat or other signs of the flu.

Even some of Mexico’s most treasured national holidays were affected by the swine flu alert.

Authorities announced Monday the cancellation of the annual Cinco de Mayo parade, in which people in period costumes celebrate Mexican troops’ defeat of a French army on May 5, 1862. The national labor umbrella group announced the cancellation of Mexico City’s traditional May 1 parade and the National Institute of Anthropology and History said all of its 116 museums nationwide would be closed until further notice.

Amid the warnings, the Mexican government grappled with increasing criticism of its response. At least two weeks after the first swine flu case, the government has yet to say where and how the outbreak began or give details on the victims.

The health department lacked the staff to visit the homes of all those suspected to have died from the disease, Cordova said.

Cordova said 1,995 people have been hospitalized with serious cases of pneumonia since the first case of swine flu was reported April 13. The government does not yet know how many were swine flu.

He said tests show a 4-year-old boy contracted the virus before April 2 in Veracruz state, where a community has been protesting pollution from a large pig farm.

The farm is run by Granjas Carroll de Mexico, a joint venture half owned by Virginia-based Smithfield Foods, Inc. Spokeswoman Keira Ullrich said the company has found no clinical signs or symptoms of the presence of swine flu in its herd or its employees working anywhere in Mexico.

Mexico’s Agriculture Department said Monday that its inspectors found no sign of swine flu among pigs around the farm in Veracruz, and that no infected pigs have been found yet anywhere in Mexico.

As if the country did not have enough to deal with, Cordova’s comments were briefly interrupted by a 5.6-magnitude earthquake in southern Mexico that rattled already jittery nerves and sent mask-wearing office workers into the streets of the capital.

Aside from the confirmed cases, 13 are suspected in New Zealand, and one is suspected in both France and Israel.

European Union Health Commissioner Androulla Vassiliou advised Europeans to avoid nonessential travel to Mexico and parts of the United States, although Besser said that including the U.S. in the advisory seemed unwarranted at this time.

State Department spokesman Robert A. Wood said Vassiliou’s remarks were his “personal opinion,” not an official EU position, and therefore the department had no comment.

“We don’t want people to panic at this point,” Wood said.

The U.S. stepped up checks of people entering the country by air, land and sea, and the State Department warned U.S. citizens to avoid nonessential travel to Mexico. It said those who live in Mexico should avoid hospitals or clinics there unless they have a medical emergency.

The best way to keep the disease from spreading, Besser said, is by taking everyday precautions such as frequent handwashing, covering up coughs and sneezes, and staying away from work or school if not feeling well. He said authorities are not recommending that people wear masks at work because evidence that it is effective “is not that strong.”

Besser said about 11 million doses of flu-fighting drugs from a federal stockpile have been sent to states in case they are needed. That’s roughly one quarter of the doses in the stockpile, he said.

There is no vaccine available to prevent the specific strain now being seen, he said, but some antiflu drugs do work once someone is sick.

If a new vaccine eventually is ordered, the CDC already has taken a key preliminary step — creating what’s called seed stock of the virus that manufacturers would use.

Many of the cases outside Mexico have been relatively mild. Symptoms include a fever of more than 100, coughing, joint aches, severe headache and, in some cases, vomiting and diarrhea.

European and U.S. markets bounced back from early losses as pharmaceutical stocks were lifted by expectations that health authorities will increase stockpiles of anti-viral drugs. Stocks of airlines, hotels and other travel-related companies posted sharper losses.

WHO spokesman Peter Cordingley singled out air travel as an easy way the virus could spread, noting that the WHO estimates that up to 500,000 people are on planes at any time.

Governments in Asia — with potent memories of previous flu outbreaks — were especially cautious. Singapore, Thailand, Japan, Indonesia and the Philippines dusted off thermal scanners used in the 2003 SARS crisis and were checking for signs of fever among passengers from North America. South Korea, India and Indonesia also announced screening.

In Malaysia, health workers in face masks took the temperatures of passengers as they arrived on a flight from Los Angeles.

China said anyone experiencing flu-like symptoms within two weeks of arrival had to report to authorities.

China, Russia and Ukraine were among countries banning imports of pork and pork products from Mexico and three U.S. states that have reported swine flu cases, while other countries, such as Indonesia, banned all pork imports.

The CDC says people cannot get the flu by eating pork or pork products.

Germany’s leading vacation tour operators were skipping stops in Mexico City as a precaution. The Hannover-based TUI said trips through May 4 to Mexico City were being suspended, including those operated by TUI itself and through companies 1-2 Fly, Airtours, Berge & Meer, Grebeco and L’tur.

Japan’s largest tour agency, JTB Corp., suspended tours to Mexico through June 30. Russian travel agencies said about a third of those planning to travel to Mexico in early May had already canceled.

HealthBr.com reminds that top medication for influenza (flu) treatment is Tamiflu.

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WHO swine flu page: http://www.who.int/csr/disease/swineflu/en/index.html

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