Thursday, August 20, 2009

Swine Flu Cases Expected Slow...

Thursday 20th August 2009
By: Nursing In Practice
15 Minutes Ago

The latest swine flu patient figures are expected to show a slowing of new cases of the disease.

Chief Medical Officer Liam Donaldson's last update revealed there were 25,000 new cases, compared with 30,000 and 110,000 in the previous two weeks.

The number of new cases of swine flu should continue to decline while schools and universities are closed, according to experts, but numbers may rise sharply again when term time begins.

The eventual number of deaths is estimated to be between 55,000 and 750,000.

A total of 44 people in England have been confirmed as dying after contracting swine flu, while another five have died in Scotland.

Sir Liam revealed that people in priority groups would begin receiving vaccinations in October.

However, doctors have reportedly been alerted over fears that Tamiflu could put increase some patients' risk of suffering a stroke.

The Medicines and Healthcare products Regulatory Agency (MHRA) has raised concerns that the drug may interact with warfarin, which is taken to thin the blood.

Swine Flu Vaccine Order Questioned

ABC News

Posted 1 hour 1 minute ago
Updated
55 minutes ago

A company developing a swine flu vaccine has questioned the Federal Government ordering another vaccine before knowing whether it is effective.

The first batch of 21 million doses of the vaccine being developed by the pharmaceutical company CSL is expected to be delivered next week.

Adelaide-based company Vaxine is developing another swine flu vaccine.

The company's Professor Nikolai Petrovsky says data from his trials will be available within the next six weeks.

"The Government is clearly purchasing the CSL vaccine even while they are waiting for data to show the CSL vaccine is effective," he said.

"So in effect they are in a fortunate position of being able to sell their vaccine before they show it works, perhaps a slightly unusual situation, but that's where it's at.

"Obviously you wouldn't want the Government to make very large purchases of a vaccine and then have that vaccine turn out not to be effective, because then the money would have obviously been wasted."

Monday, August 17, 2009

US Expects Far Fewer Swine Flu Shots In October

By LAURAN NEERGAARD
The Associated Press August 17, 2009, 9:30PM ET

The U.S. won't have nearly as much swine flu vaccine ready by mid-October as long predicted -- 45 million doses instead of the anticipated 120 million.

Health and Human Services spokesman Bill Hall said Monday more will arrive rapidly after that. About 20 million more doses will be shipped every week until the governments gets its full order, 195 million doses in all.

But the now-anticipated delay, which is blamed on manufacturing issues, will extend by a month efforts to get people at highest risk vaccinated against the new flu strain.

Thursday, August 13, 2009

Farmers Work to Protect Pigs From Swine Flu

Wall Street Journal: August 13, 2009, 8:28 P.M. ET

WASHINGTON -- Hogs aren't spreading swine flu but they can catch it from people, requiring farmers to take extra care this fall and winter to prevent humans from sneezing on their livestock.

Because no vaccine has been developed yet to protect hog herds, the emphasis by producers will be on getting vaccinations for farm workers, veterinarians and others who come into contact with the animals.

It is "not so much to protect the workers, but to protect the pigs from the workers," said Jennifer Greiner, director for science and technology at the National Pork Producers Council.

Farmers would prefer, however, to vaccinate the pigs rather than the humans around them, Ms. Greiner said, but that isn't yet possible despite the efforts of the U.S. Department of Agriculture's Agriculture Research Service.

The agency's scientists haven't been able to develop a viable pig vaccine for the new swine flu, known as A/H1N1, according to an agency memo obtained by Dow Jones Newswires, although they are still "evaluating an experimental vaccine."

The government also has shared samples of the swine-flu virus with private drug companies in the hopes that they will produce a vaccine. Neither Ms. Greiner nor USDA officials believe success will come in time for this year's flu season.

Development of the vaccine isn't expected until well into winter, USDA spokesman Ed Curlett said.

That is bad news say industry and government officials because the hype surrounding this virus has hurt the pork business since April, and it could do further damage this fall when the flu season starts.

If pigs start getting sick, pork sales could take a hit even though there is no danger of meat contamination, USDA chief veterinarian John Clifford said.

The A/H1N1 virus was dubbed swine flu because it is an H1N1 type that traditionally has been found in pigs, but this particular strain contains swine, avian and human viral genes.

Pigs have contracted the virus, but for the most part it has been spread human to human. The first confirmed cases of the swine flu in pigs were found in Canada in early May and they got sick from exposure to an infected farm worker.

U.S. health and agriculture officials have repeatedly tried to assure consumers here and abroad that this "novel" H1N1 virus can't be transmitted in pork, but Mr. Clifford said there is still a danger to swine producers from baseless fear.

USDA scientists tried to detect the virus in pork produced from an infected pig, but couldn't find it, according to the Agriculture Research Service memo.

"The virus has only been isolated from the respiratory tract and not from other tissues," according to the document. "The virus was not isolated in meat and therefore the novel H1N1 is not a food safety issue."

Despite the science, meat packers may still refuse to buy pork from a swine operation at which the H1N1 virus has been detected, Mr. Clifford said. That concern has the USDA reaching out to processors and producers.

The USDA needs processors to keep buying swine in order to keep business flowing, but the agency also needs farmers to overcome the fear of stigma and report illnesses in their herds if they find them.

The flu isn't a "reportable" livestock illness, meaning farmers aren't compelled to tell the government if they find it, as opposed to a disease like foot-and-mouth.

If they report finding flu symptoms, veterinarians will be able to quickly tell if it is the new flu that has killed more than a thousand people world-wide, thanks to the work of USDA researchers.

The USDA's Mr. Clifford said the swine-flu virus is virulent, but not potent enough to kill the pigs nor mobile enough to jump easily from one herd to the next. He said close surveillance is necessary "because of the possibility that the virus could change into something more dangerous to swine."

Write to Bill Tomson at bill.tomson@dowjones.com

Monday, August 10, 2009

Vaccine Trials Off to Fast Start For Pandemic Flu

Nicholas Sarakas says his mother urged him not to take part in pandemic vaccine trials. "She was worried about me. She didn't want them guinea-pigging me," he says. "She made me promise never to be in another clinical trial."

Sarakas, 25, decided to volunteer anyway. A college student without health insurance at the University of Missouri in St. Louis, he reasoned that he'd rather take his chances with the vaccine, and its risks, than pandemic flu.

"There are people my age that are dying from this," he says.

Early Monday, Sarakas rolled up his sleeves for an injection in each arm, becoming one of dozens of adults enrolling in an unprecedented flurry of fast-track flu vaccine trials that will grow to include 11,131 adults and 5,740 children, with more trials planned.

The vaccine is designed to blunt the effect of a virus that, starting this fall, could infect 100 million people in the USA and cause 30,000 to 90,000 deaths based on scenarios drawn from past pandemics, says Arnold Monto of the University of Michigan, an adviser to the Centers for Disease Control and Prevention and the World Health Organization. About 36,000 people in the USA die each year of flu.

The virus, a new type of H1N1 strain also known as swine flu, has been linked to 6,506 hospitalizations and 436 deaths in the USA — up from 353 a week ago — since it emerged in Mexico in April.

Too many volunteers to count

The U.S. government has ordered roughly 195 million doses of pandemic flu vaccine, in addition to the 120 million doses of seasonal flu vaccine expected to be available by the end of September.

"Vaccine is a huge component of the public health response to influenza," says Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, which is sponsoring the trial that enrolled Sarakas at Saint Louis University and four other trials at eight federally funded vaccine research centers across the country.

The flurry of swine flu vaccine trials, some sponsored by the U.S. government and others by five vaccine manufacturers, began late last week. Now people are clamoring to take part.

"We've had over 1,000 people call wanting to participate," says Sharon Frey, lead investigator of the St. Louis study. "We've stopped counting."

Frey says she expects to meet her quota of 200 volunteers by next week, thanks to widespread publicity.

Side effects, dosages unknown

"I feel really lucky that I get to participate," says Karla Payne, 54, of Westchester, Ohio, who got her shots Monday in a study at Cincinnati Children's Hospital Medical Center. "I used to work in the public schools. So many students didn't have money for health care. When I saw in the paper that they would start using schools to vaccinate kids, I thought, gosh, this would be a good thing to do, because they need to get vaccine out there."

The studies are necessary because so little is known about the pandemic vaccine, though many researchers believe it is likely to act much like seasonal vaccines, says Bruce Gellin, director of theDepartment of Health and Human Services National Vaccine Program Office.

Flu vaccines historically have few side effects beyond redness and soreness at the infection site. Studies of several thousand volunteers aren't big enough to detect more subtle side effects such as Guillain-Barré syndrome, a rare nerve ailment that crops up in one of every million flu vaccine recipients. Federal health agencies have ramped up surveillance efforts to detect any severe side effects that might occur.

There are other uncertainties as well. For instance, vaccine makers don't know how big a dose to give, how many doses will be needed per person for protection and whether it will be necessary to add an immune-booster called an adjuvant.

Each one of those factors may affect how many people can be vaccinated. For instance, if the usual 15-microgram dose has to be doubled, the number of people who could be vaccinated would fall to 98 million. If two shots are required at double the dose, the number of people who could be vaccinated would drop further, to 50 million.

Andrin Oswald, CEO of Novartis vaccines and diagnostics, says vaccine makers also have found that the seed virus needed to make H1N1 vaccine produces just half the yield of seasonal vaccine viruses. The low yield may slow vaccine production so much that pandemic vaccine may be in short supply during the fall flu surge, he says.

"What we normally say in our orders to the government is that if the yield is 100%, we could deliver 10 million doses by December. If it's only 50%, it would take until March," Oswald says, adding that manufacturers now have a new seed strain that may boost yields.

"Timing is everything," Monto says. "We believe the second wave of flu will come in the fall. If vaccine doesn't arrive until November-December, it won't do as much good."

By the numbers:

The U.S. government and five companies on Monday began injecting volunteers to test a new vaccine to guard against the H1N1 flu strain. If effective, the vaccine will begin to be available to the general public in mid October.




Company

Number of adults in trials

Number of children in trials
Novartis2,7721,582
CSL Limited1540850
Sanofi Pasteur1300400
GlaxoSmithKline40111800
MedImmune300300
U.S. government sponsored17501300
Total116736232

Sources: Company data, Food and Drug Administration and the National Institutes of Health

Swine Flu Prep: Let The Safety Tests Begin

By: Deborah Franklin
7:30 pm August 10, 2009

Will shots against this virus work? Only tests will tell. ( CDC)

Vaccine makers have begun squeezing out the first drops of the new H1N1 flu vaccine and rushing them to several sites around the world for tests of safety and effectiveness in people. On Monday's All Things Considered, NPR's Joanne Silberner reports from Baltimore on how everything went on their first day -- why 400 people in the city have volunteered to get the experimental injections this week, and what sort of side effects they can expect. She'll be back on Tuesday's Morning Edition with an update on how the pandemic flu spent its summer vacation, and what to expect next month.

Meanwhile, ATC's Melissa Block talks tonight with Dr. David Fleming, the Director of Public Health for Seattle's King County. Dr. Fleming is charged with getting whatever vaccine is delivered to Seattle in mid-October or so into the arms of nearly a million of his county's 1.8 million residents as quickly as possible.

The best way to do that, he says, is to beef up the usual distribution systems -- adding extra volunteer docs and nurses to give shots in clinics, drug stores and maybe schools, too.

Though the H1N1 vaccine itself will be free, he says, people with health insurance will pay a small administrative fee that their insurer will pick up. Local and state government will pay for the shots of those without insurance.

Immunization, Dr. Fleming says, will be recommended but voluntary.

The ultimate decision whether or not someone receives it or not is their's. Or, in the case of a child, the decision is the parent's.

Fleming says what keeps him up at night is the unpredictable nature of the virus, in terms of severity. He's also thinking a lot about timing --- wondering when the next wave will hit.

I think it's likely that H1N1 will arrive from the Southern Hemisphere before October -- maybe as early as September when school starts back up.

That means King County and many other spots could have at least two months when pandemic flu will be freely circulating before there's vaccine to check it.

"We're trying to prepare for that," Fleming says.

Sunday, August 9, 2009

Swine Flu Should Not Close Most Schools, Federal Officials Say

By: Denise Grady of The New York Times
Published: August 8, 2009
Most schools should be able to stay open even if swine flu outbreaks occur again this fall, government officials said Friday as they issued recommendations for dealing with the illness when the school year starts.

Decisions about whether to close schools should be made locally, the officials said, and “should balance the goal of reducing the number of people who become seriously ill or die from influenza with the goal of minimizing social disruption and safety risks to children,” which sometimes occur when schools close.
The nation has 130,000 schools, 55 million students and 7 million staff members. Closing schools may mean that parents have to stay home or find child care, which some cannot afford. People in essential jobs, like health care, may be stuck at home during outbreaks when they are most needed. In some cases, children may wind up being left home alone or going to the mall, where they can spread the H1N1 flu virus.
The secretaries of education, homeland security and health and human services described the guidelines for schools with grades kindergarten through 12 on Friday at a news briefing in Washington, along with the director of the Center for Disease Control and Prevention. Guidelines for colleges and employers are set to be issued on Aug. 23.
“It’s now clear that closure of schools is rarely indicated, even if H1N1 is in the school,” said Dr. Thomas R. Frieden, director of the disease control centers, though he added that closings might be necessary if so many people were sick that the school could not function, or if parents persisted in sending sick children to school.
Education Secretary Arne Duncan said that some schools “will have to close,” and that administrators should be making plans to continue schooling at home, via telephones and the Internet.
Emphasizing that vaccination is the best way to prevent the spread of the flu, Health and Human Services Secretary Kathleen Sebelius said the vaccine against the H1N1 virus should be ready by October. People will probably need two shots of the new vaccine, in addition to one shot for seasonal flu. Children and young people ages 6 months to 24 years are to be given priority for the H1N1 vaccine, and vaccination clinics may be set up in some schools.
The advice to schools includes telling staff members and students to stay home when they are sick and not to return for at least 24 hours after the fever goes away. This differs from earlier guidelines, which advised staying home for seven days.
Schools are also urged to set up a separate room where students and staff members who do come to school sick can stay until they can be sent home. They should be given masks to wear, and so should the people looking after them.
Special schools for sick children or pregnant teenagers, both high-risk groups, may need to close, Dr. Frieden said.
The guidelines also say that if the flu becomes more severe, additional measures may be needed, like screening staff members and students daily, telling people at high risk and those with sick family members to stay home, and increasing the distance between people at school by moving the desks farther apart.