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Swine flu vaccine manufacturers delivering September

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LONDON — Swine flu vaccine manufacturers are on track to start delivering the first batches of it in September, the World Health Organization said Thursday.

Marie-Paule Kieny, WHO's vaccine director, said several drug makers have started testing swine flu vaccine in humans, and that early safety results should be available next month, clearing the way for its use. Kieny also insisted that speeding the vaccine to the market will not compromise its safety.

WHO has recommended the first recipients of the vaccine be health care workers, perhaps followed by pregnant women and people with underlying health problems.


Kieny said WHO expects to see reports of side effects once the vaccine is given to millions of people, but that deadly side effects will be rare. Vaccines commonly provoke reactions such as nausea, fever, pain from the injection, and diarrhea.

She said the agency would work with country officials to detect any sign the vaccine might cause more worrying side effects, like Guillain Barre syndrome, a temporary paralysis disorder reported by hundreds of people after the U.S.'s disastrous 1976 immunization campaign against another variant of swine flu.

To fight the current pandemic , or global outbreak, half a dozen major pharmaceutical companies located in the United States, Europe and Australia are developing their own swine flu vaccines, which will have to be approved by drug regulatory authorities in each country where they are used.

It is the first time that companies have rushed to produce a vaccine within months to fight a flu pandemic. Health officials expect swine flu to surge in the fall, with the return of the regular flu season.

On Wednesday, Swiss drug maker Novartis said it had begun testing its swine flu vaccine in Europe, and would begin selling it long before completing its safety tests next year.

Last month, Australian pharmaceutical CSL started trials on its vaccine candidate.

Kieny said ongoing tests in Australia, China, Germany, the United Kingdom and the United States should inform officials how many doses of the vaccine are required. Many experts think people will need two shots to be protected.

Europe and the U.S. both have fast-track approval systems to make the swine flu vaccine available before extensive safety tests are completed.

In a statement on its Web site, WHO said Thursday "the public needs to be reassured" that procedures for approving swine flu vaccines "are rigorous and do not compromise safety or quality controls."

To increase the global supply of swine flu vaccines, WHO recommends that countries use ones containing adjuvants, a component that stretches the vaccine's active ingredient and boosts the body's immune response. Adjuvants are commonly used in flu vaccines in Europe, but there are no licensed flu vaccines with adjuvants in the U.S.

There is little or no information on how safe flu vaccines with adjuvants are in pregnant women and children — two of the groups most at risk in the pandemic.

Kieny dismissed concerns adjuvanted vaccines might not be ideal for groups such as pregnant women. "We see no apparent safety signal," she said. "There is no safety concern with using adjuvanted vaccine."

The U.S. may have as many as 160 million doses ofswine flu vaccine available sometime in October, even though manufacturers worldwide are having serious trouble brewing shots, federal health officials said Thursday.

The Food and Drug Administration may formally approve much of that vaccine before studies required to prove how well it works are completed, treating the new inoculations just like the recipe change that regular winter flu vaccine undergoes each year.

That doesn't mean mass vaccinations would start before key information from studies of thousands of volunteers is in, U.S. officials stressed Thursday. Most of those studies start next month to determine if people will need one shot or two for good protection and how high a dose should be in each shot. The earliest results should start arriving in September and October.

But the FDA told its scientific advisers it could finish the red tape of licensing much of that vaccine well before the use-it-or-not decision is made — because it's brewed exactly the same as regular winter flu vaccine, merely using the new swine influenza virus, part of the common H1N1 influenza family, as the chief ingredient. Companies just have to take the normal steps required for each year's regular winter flu vaccine, such as proving the inoculations are manufactured appropriately.

Taking the same path now will save some important time because "the virus is ahead of us," said FDA vaccine chief Dr. Norman Baylor. This "is not a rubber stamp. We do need to review some data to give us some comfort that that vaccine will provide some benefit and that it's manufactured properly."

Even if swine flu is not more dangerous than regular winter flu, "we have a population that's virtually 100 percent susceptible," said committee chairman Dr. John Modlin, a pediatrician at Dartmouth-Hitchcock Medical Center. "This is an entirely appropriate way of proceeding, one that to me seems both necessary and appropriate and prudent."

European regulators plan to license swine flu vaccine very similarly, although the U.S. is awaiting study data before deciding whether to use it.

Make no mistake: Vaccines containing immune-system boosters called adjuvants are not candidates for the easier strain-change approval, the FDA said. Flu vaccine with this extra ingredient is widely sold in Europe but never has been sold here, and there's little information about their safety in young children or pregnant women. While both adjuvant-free and adjuvant-added swine flu vaccine is being tested in the U.S. and abroad, using it outside of those studies would require a completely separate government decision.

Even if 160 million doses are in hand in October, at the expected two doses a person, that supply would cover only a fraction of the populations that this new influenza strain is sickening the most — school-age children, teenagers and young adults. More vaccine would trickle out over the following months.

Companies making swine flu shots are struggling. The chief ingredient for influenza vaccine is grown in chicken eggs, and companies are getting far fewer doses per egg — 30 percent of the normal yield for regular winter flu vaccine, said FDA's Dr. Jerry Weir.

One bright spot: The U.S. has the world's only nasal-spray flu vaccine, and maker announced Thursday that it's producing plenty — so many millions of doses a month that it can't keep up with putting them into the special sprayer required to use it. So Maryland-based MedImmune Inc. is working with the government to see if it can race out a different method for fall, simply dripping its swine flu vaccine into people's noses.

"A dropper instead of a sprayer works as well," said MedImmune vice president Dr. Ben Machielse.

The U.S. estimates for its October supply took that problem into account, said Robin Robinson of theDepartment of Health and Human Services, which is buying the nation's swine flu supply and will decide who receives it. But that estimate also assumes that two low-dose shots, about a month apart, will offer enough protection.

If studies show people need higher-dose shots, that will further cut the early available supply.

Not included in that calculation are MedImmune's potential extras. It used a different "seed virus" to grow vaccine than other manufacturers, because it's a different type of vaccine: Flu shots are made of killedinfluenza virus, while FluMist is a live but weakened strain. It comes in a set dose, and MedImmune said it will have 14 million swine flu nasal sprays available by October, and 40 million by year's end. But overall it's producing roughly 35 million doses a month, Malchielse said, if only it could turn that bulk product into a form easily administered to people.

The good news: Despite a brisk flu season in the Southern Hemisphere, the new swine flu isn't yet mutating to become more dangerous, said Dr. Nancy Cox of the Centers for Disease Control and Prevention.

Cox said "it's actually quite surprising" that the virus is showing so little genetic variation given its rapid spread. It has sickened more than a million people in the U.S. alone since April and circled the globe in a matter of weeks.

Swiss drugmaker Novartis has begun injecting its swine flu vaccine into people in the company's first human tests, a spokesman said.

The vaccine is being tested in a yearlong trial of 6,000 people of all ages in Britain, Germany and the United States, Novartis spokesman Eric Althoff told The Associated Press on Wednesday, adding that the vaccine will likely be on the market before the trial finishes.

A person in Britain became the first to get the swine flu vaccine about 10 days ago, he said.

Sanofi-Pasteur, which makes about 40 percent of the world's flu vaccines, expects to start testing its swine flu vaccine within days in the US and Europe, according to spokesman Benoit Rungeard. Sanofi-Pasteur is a unit of Paris-based Sanofi-Aventis SA.

Since swine flu was declared to be a pandemic, or global outbreak, by the World Health Organization in June, pharmaceuticals have been racing to get their vaccines ready. Last month, Australian drugmaker CSL became the first vaccine maker to start testing its vaccine in humans in Australia.

"We initiated clinical trials about 10 days ago," Althoff said.

Half of Novartis' vaccines being tested are grown in chicken eggs, the traditional way of making flu vaccines, while the other half use a new cell-based technology.

The trial will test the vaccine's safety and whether one or two shots are necessary.

"Our assumption is that two doses will be required," Althoff said.

The vaccines being tested in Europe have an adjuvant, an ingredient used to boost the body's immune response. In the US, Althoff said Novartis will be testing both vaccines with and without adjuvants.

WHO recommends that countries use vaccines with adjuvants, to stretch the global supply of swine flu vaccine. Flu vaccines in Europe often contain adjuvants. However there are no licensed flu vaccines with adjuvants in the United States.

Once Novartis AG has preliminary data from the trial, they will submit that to drug regulators including the European Medicines Agency. European and US regulators have a fast-track process for approving swine flu vaccine, to ensure it is available before the flu season starts in the fall, when swine flu is expected to surge.

The European Medicines Agency has previously said swine flu vaccines based on a pre-approved bird flu vaccine could be licensed within five days, even without extensive testing in humans.

Last month, WHO reported that the swine flu viruses being used to make the vaccine were not growing enough of a key ingredient, and said they were only producing half as much "yield" as regular flu viruses. The agency asked its laboratory network to produce a new set of viruses for vaccine makers to use.

Althoff confirmed that Novartis is only getting about 30 to 50 percent of the usual yield it gets from flu viruses to make vaccines. Novartis made its vaccines with WHO's original set of flu viruses, and hasn't yet started working with the new viruses.

The low virus yield could mean delays in when countries get their vaccine orders filled.

More than 35 countries have placed orders with Novartis for swine flu, or H1N1 vaccine, including France, the Netherlands, and Switzerland. The US has ordered $979 million worth of bulk vaccine and Novartis' adjuvant.

Althoff said the company expected to start shipping vaccine in the last quarter of 2009 and will continue the deliveries next year.

GlaxoSmithKline PLC, which has orders for 291 million doses of vaccine from countries including Britain, has not yet started testing its vaccine in humans. The US has also ordered $250 million worth of vaccine ingredients from Glaxo.

Since swine flu emerged in April, it has killed at least 1,154 people worldwide and is estimated to have infected millions.

In India on Wednesday, hundreds of anxious people crowded a hospital waiting to be tested for swine flu. Panic spread in the city of Pune and fights broke out at the city's top hospital after authorities reported the country's first swine flu fatality two days ago.

In other efforts to fight swine flu, a Saudi health ministry official said Wednesday that authorities will require religious pilgrims to have a medical certificate showing they don't suffer from chronic diseases.

Khaled al-Merghalani also said children and the elderly will be banned from the annual hajj pilgrimage. WHO officials have said swine flu appears to be striking younger people particularly hard, with the median age from 12 to 17.

Plenty of Swine Flu Vaccine?

By the end of October, officials expect to have 120 million doses of swine flu vaccine on hand. That's not enough for everybody -- especially if two doses are needed -- but that would be enough to add more people to the front of the line.

If projected vaccine supplies are on hand, otherwise healthy children 4 and older would be included in the first group to get the vaccine. People 25 to 64 with underlying medical conditions that put them at risk of severe flu disease would also be included, as would a larger group of health care workers and emergency medical technicians.

Once there's enough vaccine for these urgent groups, swine flu vaccine will be offered to healthy people 24 and older.

 But not everyone agrees that the vaccine should be doled out one group at a time. The 120 million doses of swine flu vaccine that should arrive by the end of October is more doses of flu vaccine than Americans have ever used in a single year.

"The only sin is vaccine left in the refrigerator. And this happens every time you prioritize flu vaccine," William Schaffner, MD, president-elect of the National Foundation for Infectious Diseases, told the committee.

Swine Flu Vaccine: Full Speed Ahead or Go Slow?

The recommendations came today in a special, urgently called meeting of the CDC's Advisory Committee on Immunization Practices, a group of vaccine and infectious disease experts from outside the CDC. The group's recommendations are almost always made official U.S. vaccine policy by the FDA and CDC.

The next wave of the H1N1 swine flu pandemic is expected to hit the U.S. this fall. Early vaccine supplies -- about 40 million doses -- could become available as early as September.

That will happen only if officials decide by mid-August to start packaging swine flu vaccine without waiting for initial safety and efficacy data from clinical trials. Those trials have just begun. The earliest information from those trials won't be available for six to eight weeks.

The new flu vaccine will be the second flu vaccination Americans will be urged to get. This year, even more than others, health officials will be urging us to get our annual flu vaccine to protect against seasonal flu. Soon after that, we'll be asked to line up to get our swine flu vaccination.

"This year our challenge has doubled," HHS Secretary Kathleen Sebelius said in a video feed to the meeting. "Like seasonal flu, the novel H1N1 flu is deadly. ... It has spread wide and disrupted communities across the U.S. While media attention has decreased over the summer, the threat from this virus has not."

We may very well be asked to get two shots of swine flu vaccine. CDC flu expert Anne Schuchat, MD, says the CDC expects immunization to require two shots, given three weeks apart. It's not yet clear whether the inhaled version of the swine flu vaccine will require two doses or just one.

A swine-flu vaccine is proving difficult to manufacture because the viruses used to make the shots aren't yielding a large amount of active ingredient, two large vaccine makers said Thursday.

Their comments echoed similar statements from the World Health Organization earlier this week, and mean that millions of vaccine doses ordered by many governments could arrive later than expected.

The WHO said Thursday the H1N1 pandemic virus has spread with "unprecedented speed," noting that past pandemic viruses have taken six months to spread as widely as this one has "in less than six weeks." The agency said it would no longer ask countries to report every laboratory-confirmed case, but would instead seek data on clusters of severe cases or deaths as it continues to monitor the disease's spread.

The warnings of a possible delay in bringing a vaccine to market comes as the health ministry of the U.K., one of the countries hardest hit by swine flu, released new calculations suggesting that, in a worst-case scenario, between 19,000 and 65,000 people could die in the U.K. during the first major wave of the H1N1 pandemic.

The U.K. has spelled out a number of stark scenarios for how the pandemic could play out; some experts have played down the projections, and the U.K.'s Department of Health warned that "this represents a 'reasonable worst case' for which to plan, not a prediction."

A growing list of countries is counting on vaccine doses to arrive in the coming months. The U.S., U.K., Canada, Australia and many other nations have ordered enough doses to cover much of their populations. France this week placed a 1 billion euros ($1.4 billion) order for 94 million doses.

To make vaccine against a flu virus, the virus is cultivated, inactivated and blended into antigen, the main ingredient used in the shots. But the H1N1 virus being used for swine-flu vaccine is so far yielding a "low" level of antigen, Swiss drug maker Novartis AG said Thursday. It said the yield so far is about 30% to 50% of what the company normally gets for seasonal flu vaccines.

Robert Parkinson, chief executive of Baxter International Inc. , also described "yield optimization" as a challenge.

The WHO said Monday it is attempting to tweak the H1N1 virus and send manufacturers a new copy that might yield more vaccine. In the meantime, Novartis said it is attempting to adjust its production process to improve the yield.

Experts aren't yet sure how much antigen will be needed per shot; human studies to be carried out later this summer will make that clear. The less antigen necessary, the more shots can be produced. Booster ingredients called adjuvants may also be used to increase the effectiveness of the antigen.

Under the worst-case scenario in Britain's new calculations, 30% of its population of 62.3 million could become infected and experience symptoms during the first major wave of the pandemic, and 0.1% to 0.35% of these 18.7 million people could die -- a fatality rate similar to that of seasonal flu each year, the health ministry said. The ministry said it was releasing the figures to help companies and organizations prepare.

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