Swine Flu Vaccine Trials begin–160M Shots ordered

Although the effects of the "swine flu" have been shown to be rather mild compared to the avian flu–which killed 70% of those infected–the World Health Organization declared it a pandemic, thereby lending an air of urgency to quickly vaccinate millions of people.

Public health agencies around the world have taken their cue from the WHO and embarked on an aggressive campaign to vaccinate against the swine flu–EVEN BEFORE THE VACCINE’S SAFETY HAS BEEN TESTED, or the safety of the vaccine adjuvants have been tested.

Such a policy could lead to a public health catastrophe.

"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."

A signal underscoring the justified safety concern is the fact that the US Secretary of the Dept. of Health and Human Services has issued flu vaccine manufacturers immunity from liability. The need for such legal immunity for manufacturers surely raises doubt about the safety of these experimental vaccines. While adults are being asked to voluntarily test the vaccine, children will become non-consenting test subjects.

"If you’re going to ask people to do this for the common good, then let’s make sure for the common good that these people will be taken care of if something goes wrong."

Australia is the first to begin testing the safety of the swine flu vaccine, and the US government is calling for volunteers to test the vaccine.

US vaccine test sites are listed below.

Posted by Vera Sharav

Associated Press
Gov’t calls for volunteers to test swine flu shots
By LAURAN NEERGAARD (AP)
July 24, 2009

WASHINGTON — The government called Wednesday for several thousand volunteers to start rolling up their sleeves for the first swine flu shots, in a race to test whether a new vaccine really will protect against the virus before its expected rebound in the fall.

The first shots should go into volunteers’ arms by the second week of August. A network of medical centers around the country is enrolling for the series of studies directed by the National Institutes of Health.

First, doctors will test different doses of the swine flu vaccine in healthy adults, including the elderly — two shots, given 21 days apart. If there are no immediate safety concerns, such as allergic reactions, the same testing quickly will begin in babies and children, said Dr. Anthony Fauci, head of NIH’s National Institute of Allergy and Infectious Diseases.

Will the results come in time to guide the government’s debate on whether to roll out a mass vaccination campaign starting in mid-October, one expected to target mostly school-age children and young adults?

"It’s going to be very, very close," Fauci told The Associated Press.

By early September, scientists should have the first clue — how much immune protection that initial dose triggers. How much protection the second dose adds won’t be known for yet another month.

As for safety, the new vaccine is expected to be similar to shots already given each year for seasonal flu. "It ought to be extremely safe," said Dr. William Schaffner, a vaccine specialist at Vanderbilt University, where a colleague will help test the vaccine.

Included in the government studies are vaccines made by Sanofi-Pasteur and CSL Ltd. Also Wednesday, CSL began a much smaller study of its vaccine in Australia, where the company is based.

Soon, vaccine from additional manufacturers — including the only non-shot version, a nasal spray — will begin separate, company-led studies in several thousand more volunteers.

But the NIH studies are specifically designed to test how the swine flu vaccine might be used by average Americans, with a set of tests to see how it reacts if given before, with or after the regular winter flu vaccine — which people are supposed to get as usual this fall.

The NIH’s main study sites:

_University of Maryland School of Medicine, Baltimore.

_University of Iowa, Iowa City, Iowa.

_St. Louis University, St. Louis, Mo.

_Baylor College of Medicine, Houston.

_Children’s Hospital Medical Center, Cincinnati.

_Emory University, Atlanta.

_Group Health Cooperative, Seattle.

_Vanderbilt University, Nashville, Tenn.

Children’s Mercy Hospital in Kansas City and Duke University Medical Center partner with two of those hospitals and also will participate in part of the research.
On the Net:

    * To search for "H1N1 influenza vaccine" trials: http://www.clinicaltrials.gov

Copyright © 2009 The Associated Press. All rights reserved.
~~~~~~

Associated Press
US: 160M doses of swine flu vaccine due in Oct.
By LAURAN NEERGAARD
Fri Jul 24

WASHINGTON – The U.S. may have as many as 160 million doses of swine 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 the Department 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 killed influenza 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.

~~~~~~~~~~
Legal immunity set for swine flu vaccine makers
By MIKE STOBBE (AP) – Jul 17, 2009

ATLANTA — The last time the government embarked on a major vaccine campaign against a new swine flu, thousands filed claims contending they suffered side effects from the shots. This time, the government has already taken steps to head that off.

Vaccine makers and federal officials will be immune from lawsuits that result from any new swine flu vaccine, under a document signed by Secretary of Health and Human Services Kathleen Sebelius, government health officials said Friday.

Since the 1980s, the government has protected vaccine makers against lawsuits over the use of childhood vaccines. Instead, a federal court handles claims and decides who will be paid from a special fund.

The document signed by Sebelius last month grants immunity to those making a swine flu vaccine, under the provisions of a 2006 law for public health emergencies. It allows for a compensation fund, if needed.

The government takes such steps to encourage drug companies to make vaccines, and it’s worked. Federal officials have contracted with five manufacturers to make a swine flu vaccine. First identified in April, swine flu has so far caused about 263 deaths, according to numbers released by the Centers for Disease Control and Prevention on Friday.

The CDC said more than 40,000 Americans have had confirmed or probable cases, but those are people who sought health care. It’s likely that more than 1 million Americans have been sickened by the flu, many with mild cases.

The virus hits younger people harder that seasonal flu, but so far hasn’t been much more deadly than the strains seen every fall and winter. But health officials believe the virus could mutate to a more dangerous form, or at least contribute to a potentially heavier flu season than usual.

"We do expect there to be an increase in influenza this fall," with a bump in cases perhaps beginning earlier than normal, said Dr. Anne Schuchat, director of the CDC’s National Center for Immunization and Respiratory Diseases.

On Friday, the Food and Drug Administration approved the regular winter flu vaccine, a final step before shipments to clinics and other vaccination sites could begin.

The last time the government faced a new swine flu virus was in 1976. Cases of swine flu in soldiers at Fort Dix, N.J., including one death, made health officials worried they might be facing a deadly pandemic like the one that killed millions around the world in 1918 and 1919.

Federal officials vaccinated 40 million Americans during a national campaign. A pandemic never materialized, but thousands who got the shots filed injury claims, saying they suffered a paralyzing condition called Guillain-Barre Syndrome or other side effects.

"The government paid out quite a bit of money," said Stephen Sugarman, a law professor who specializes in product liability at the University of California at Berkeley.

Vaccines aren’t as profitable as other drugs for manufacturers, and without protection against lawsuits "they’re saying, ‘Do we need this?’" Sugarman said.

The move to protect makers of a swine flu didn’t go over well with Paul Pennock, a prominent New York plaintiffs attorney on medical liability cases. The government will likely call on millions of Americans to get the vaccinations to prevent the disease from spreading, he noted.

"If you’re going to ask people to do this for the common good, then let’s make sure for the common good that these people will be taken care of if something goes wrong," Pennock said.

AP Medical Writer Lauran Neergaard contributed to this report from Washington.
On the Net:    * CDC: http://www.cdc.gov/H1N1flu/

FAIR USE NOTICE: This may contain copyrighted (© ) material the use of which has not always been specifically authorized by the copyright owner. Such material is made available for educational purposes, to advance understanding of human rights, democracy, scientific, moral, ethical, and social justice issues, etc. It is believed that this constitutes a ‘fair use’ of any such copyrighted material as provided for in Title 17 U.S.C. section 107 of the US Copyright Law. This material is distributed without profit.