More swine flu vaccine recalled: FDA
Julie Steenhuysen
CHICAGO
Wed Dec 23, 2009 12:35pm EST
CHICAGO (Reuters) - The U.S. Food and Drug Administration said on Tuesday AstraZeneca's MedImmune unit is voluntarily recalling some of its H1N1 swine flu vaccine because it was not as potent as it should be. Norman Baylor, director of the office of vaccines research and review at the FDA, said the recall involves a total of 4.7 million doses of the company's nasal spray vaccine, but only about 3,000 of those doses are left in warehouses.
The rest of the doses were given out in October and November, when the vaccine was still at full potency, Baylor told reporters on a conference call. The FDA said people who had already received the vaccine do not need another dose. The company is the second to recall H1N1 swine flu vaccine in the past month. Sanofi-Aventis SA on December 15 recalled 800,000 doses of its pediatric H1N1 swine flu vaccine because it is not as potent as it should be. MedImmune said in a statement the recall involves unused doses of 13 specific lots of 2009 H1N1 nasal spray vaccine, because of a slight decrease in potency that was detected during regular checks.
"The doses were well within potency specifications at the time of distribution," said Tor Constantino, a spokesman for the unit of AstraZeneca. He said the recall was not for safety issues, but was intended to notify any healthcare providers who may still have some of the recalled vaccine in their refrigerators. "The cause of the loss of potency is being investigated," Constantino said by telephone, adding that this has not been an issue in the past with the company's seasonal flu vaccine.
MedImmune is recommending that all lots marked with an expiration date of between January 19 and January 26, 2010 not be used. Constantino said the company has delivered 23 million of the total 40 million doses on its contract with the U.S. government. He said the recalled doses were some of the earliest the company made, and most have already been given to people.
The U.S. Health and Human Services Department has contracts with five companies to make 251 million doses of H1N1 vaccine as well as seasonal flu vaccine -- Sanofi Aventis, CSL of Australia, AstraZeneca unit MedImmune and GlaxoSmithKline. The CDC's Dr. Anne Schuchat said on Tuesday 111 million doses of H1N1 vaccine have been made available so far.
Scientists discover natural flu-fighting proteins
Thu Dec 17, 2009 10:46pm GMT
By Julie Steenhuysen
CHICAGO (Reuters) - U.S. researchers have discovered antiviral proteins in cells that naturally fight off influenza infections, a finding that may lead to better ways to make vaccines and protect people against the flu. They said a family of genes act as cell sentries that guard cells from an invading influenza virus, the team reported on Thursday in the journal Cell. "This prevents the virus from even getting into the cell," said Stephen Elledge of Harvard Medical School and a Howard Hughes Investigator at Brigham & Women's Hospital. "It is out there fighting the flu all of the time," Elledge said in a telephone interview.Elledge and colleagues used a new research technique called RNA interference in which they systematically turned off individual genes and then exposed cells to the flu virus.
Using this method, they discovered a small family of flu-fighting proteins called interferon-indicible transmembrane proteins that boost the body's natural resistance to viral infection. "If you get rid of it (the protein), the virus can replicate 5 to 10 times faster. What that means is your cells have a mechanism that can block 80 to 90 percent of the virus that gets in," Elledge said. They also showed that if they make the cell overproduce the protein, they become more resistant to the flu. "If you crank it up, it really shuts down the flu," he said.
The team showed that a specific protein in the family -- IFITM3 -- protected against several viruses, including strains of influenza A now found in seasonal flu, the West Nile virus and dengue virus. The proteins did not offer any protection against HIV or the hepatitis C virus, but lab tests suggested they may defend against other viruses, including yellow fever virus.
The team showed that if the virus evades this first-line protein defense and makes it inside the cell, this activates an alarm system called the interferon immune response that gets pumped out of cells and alerts the rest of the body to make more of the natural antiviral proteins. The findings offer new insights into the body's natural defenses against influenza and other viruses, Elledge said. "We really did not know how our bodies were stopping the flu." They also may lead to better ways to protect people from influenza and other viral infections.
"By making this protein be expressed in poultry or pigs, we can make them resistant to the flu. That can help protect people by protecting animals from the flu," he said. It also may lead to more reliable vaccine production by creating a more friendly environment for the virus to grow in chicken eggs, he said. "If we take our gene away from the cells in which the virus is growing, it will grow much faster. You can actually produce vaccines much faster," he said.
© Thomson Reuters 2009. All rights reserved.
Thu Dec 17, 2009 10:46pm GMT
By Julie Steenhuysen
CHICAGO (Reuters) - U.S. researchers have discovered antiviral proteins in cells that naturally fight off influenza infections, a finding that may lead to better ways to make vaccines and protect people against the flu. They said a family of genes act as cell sentries that guard cells from an invading influenza virus, the team reported on Thursday in the journal Cell. "This prevents the virus from even getting into the cell," said Stephen Elledge of Harvard Medical School and a Howard Hughes Investigator at Brigham & Women's Hospital. "It is out there fighting the flu all of the time," Elledge said in a telephone interview.Elledge and colleagues used a new research technique called RNA interference in which they systematically turned off individual genes and then exposed cells to the flu virus.
Using this method, they discovered a small family of flu-fighting proteins called interferon-indicible transmembrane proteins that boost the body's natural resistance to viral infection. "If you get rid of it (the protein), the virus can replicate 5 to 10 times faster. What that means is your cells have a mechanism that can block 80 to 90 percent of the virus that gets in," Elledge said. They also showed that if they make the cell overproduce the protein, they become more resistant to the flu. "If you crank it up, it really shuts down the flu," he said.
The team showed that a specific protein in the family -- IFITM3 -- protected against several viruses, including strains of influenza A now found in seasonal flu, the West Nile virus and dengue virus. The proteins did not offer any protection against HIV or the hepatitis C virus, but lab tests suggested they may defend against other viruses, including yellow fever virus.
The team showed that if the virus evades this first-line protein defense and makes it inside the cell, this activates an alarm system called the interferon immune response that gets pumped out of cells and alerts the rest of the body to make more of the natural antiviral proteins. The findings offer new insights into the body's natural defenses against influenza and other viruses, Elledge said. "We really did not know how our bodies were stopping the flu." They also may lead to better ways to protect people from influenza and other viral infections.
"By making this protein be expressed in poultry or pigs, we can make them resistant to the flu. That can help protect people by protecting animals from the flu," he said. It also may lead to more reliable vaccine production by creating a more friendly environment for the virus to grow in chicken eggs, he said. "If we take our gene away from the cells in which the virus is growing, it will grow much faster. You can actually produce vaccines much faster," he said.
© Thomson Reuters 2009. All rights reserved.
Kids' swine flu vaccines recalled due to fading potency
By Steve Sternberg, USA TODAY
Sanofi Aventis is voluntarily recalling 800,000 doses of pediatric swine flu vaccine in prefilled syringes because routine tests disclosed that its potency has diminished, federal officials said today. The Centers for Disease Control and Prevention issued an alert about the recall Tuesday morning, noting that the vaccine was fine when it was shipped, but its potency apparently faded during a month of storage. Anne Schuchat, director of the CDC's National Center for Immunization and Respiratory Diseases, says there's no reason for parents to worry, because demand for the vaccine is so great that the doses were most likely administered before its potency faded. "There's no need for parents to call pediatricians. We think the doses given are protective and safe," Schuchat says. The manufacturer is now notifying health providers who received the affected lots to discard the syringes, meant for children from 6 to 35 months of age. The agency recommends that children in that age group get two doses, about a month apart. Injectable vaccine is licensed to be stable for 18 months, while the nasal spray should last for 18 weeks. Seasonal flu vaccine is typically dated to expire in June of the year after it was produced, but Shuchat says that "month to month" its potency may drop, but usually not enough to limit its effectiveness.
British Researchers: Little Evidence Tamiflu Works
British researchers say little evidence Tamiflu works, but WHO says the drug is useful
By MARIA CHENG
The Associated Press
LONDON
British researchers say there is little evidence Tamiflu stops complications in healthy people who catch the flu, though public health officials contend the swine flu drug reduces flu hospitalizations and deaths.
Researchers at the Cochrane Review, an international nonprofit that reviews health information, looked at previously published papers on Tamiflu as used for seasonal flu. They found insufficient data to prove whether the antiviral reduces complications like pneumonia in otherwise healthy people but concluded the drug shortens flu symptoms by about a day. The papers were published online Tuesday in the British journal, BMJ.
The researchers said the benefits of Tamiflu were small and that authorities should consider its side effects before using the drug in healthy people. While the reviewed studies only looked at Tamiflu use for seasonal flu, the experts said their conclusions raised questions about the widespread use of the drug in people with any flu-like illness, including swine flu.
Fiona Godlee, BMJ's editor, said the papers cast doubt not only on how safe and effective Tamiflu is, but on the drug regulatory system that approved it. "Governments around the world have spent billions of pounds (dollars) on a drug that the scientific community now finds itself unable to judge," she said in a statement.
But the World Health Organization disagreed. They said data from countries around the world show that when given early, Tamiflu can reduce the severity of swine flu symptoms, though the agency recommends the drug be saved for people at risk of complications, like pregnant women, the elderly, children, and those with underlying medical problems.
"This will not change our (Tamiflu) guidelines," said Charles Penn, a WHO antivirals expert. Penn said that while past studies show Tamiflu only has a modest benefit, when patients with severe illness or at risk of complications are treated early, there are fewer hospitalizations and deaths.
And Roche, the maker of Tamiflu, defended the drug, saying in a statement that they "firmly believe in the robustness of the data."
Both the British researchers and WHO said there is little evidence to support the widespread use of Tamiflu in otherwise healthy people — precisely the policy Britain has adopted to fight swine flu.
In addition to recommending Tamiflu be saved for at-risk groups, WHO recommends Tamiflu only be used on a doctor's recommendation.
In Britain, however, Tamiflu is regularly dispensed to healthy people who catch the flu. The drug is given out via a national swine flu hotline by call center workers with no medical training.
Copyright 2009 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.
Copyright © 2009 ABC News Internet Ventures
British researchers say little evidence Tamiflu works, but WHO says the drug is useful
By MARIA CHENG
The Associated Press
LONDON
British researchers say there is little evidence Tamiflu stops complications in healthy people who catch the flu, though public health officials contend the swine flu drug reduces flu hospitalizations and deaths.
Researchers at the Cochrane Review, an international nonprofit that reviews health information, looked at previously published papers on Tamiflu as used for seasonal flu. They found insufficient data to prove whether the antiviral reduces complications like pneumonia in otherwise healthy people but concluded the drug shortens flu symptoms by about a day. The papers were published online Tuesday in the British journal, BMJ.
The researchers said the benefits of Tamiflu were small and that authorities should consider its side effects before using the drug in healthy people. While the reviewed studies only looked at Tamiflu use for seasonal flu, the experts said their conclusions raised questions about the widespread use of the drug in people with any flu-like illness, including swine flu.
Fiona Godlee, BMJ's editor, said the papers cast doubt not only on how safe and effective Tamiflu is, but on the drug regulatory system that approved it. "Governments around the world have spent billions of pounds (dollars) on a drug that the scientific community now finds itself unable to judge," she said in a statement.
But the World Health Organization disagreed. They said data from countries around the world show that when given early, Tamiflu can reduce the severity of swine flu symptoms, though the agency recommends the drug be saved for people at risk of complications, like pregnant women, the elderly, children, and those with underlying medical problems.
"This will not change our (Tamiflu) guidelines," said Charles Penn, a WHO antivirals expert. Penn said that while past studies show Tamiflu only has a modest benefit, when patients with severe illness or at risk of complications are treated early, there are fewer hospitalizations and deaths.
And Roche, the maker of Tamiflu, defended the drug, saying in a statement that they "firmly believe in the robustness of the data."
Both the British researchers and WHO said there is little evidence to support the widespread use of Tamiflu in otherwise healthy people — precisely the policy Britain has adopted to fight swine flu.
In addition to recommending Tamiflu be saved for at-risk groups, WHO recommends Tamiflu only be used on a doctor's recommendation.
In Britain, however, Tamiflu is regularly dispensed to healthy people who catch the flu. The drug is given out via a national swine flu hotline by call center workers with no medical training.
Copyright 2009 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.
Copyright © 2009 ABC News Internet Ventures
CDC: Few Serious Reactions After Swine Flu Vaccine
Chances of Neurological Disorder Seen in 1976 "Vanishingly Remote"
By Cathryn Meurer
WebMD Health News
Reviewed by Louise Chang, MDDec. 4, 2009 -
Serious reactions after receiving the H1N1 swine flu vaccine are rare and not significantly higher than those seen from the seasonal flu vaccine, according to a briefing at the CDC today. Director Thomas Frieden, MD, MPH, presented preliminary safety data and confidence that the H1N1 vaccine will not be dogged by Guillain-Barre syndrome, the neurological disorder that was associated with the 1976 swine flu vaccine.
“The likelihood that we’ll have a 1976-like problem with this year’s H1N1 influenza vaccine is vanishingly remote,” said Frieden. H1N1 flu cases fell off somewhat during the Thanksgiving week, with widespread activity reported in 25 states, a drop from 32 states in the previous week. Still, 17 children died last week of laboratory-confirmed H1N1 flu, bringing the number of child deaths to 210. That’s three times the number of flu deaths expected in children at this point in a normal flu season. “This virus is a much worse virus for younger people. The number of people, not just children, but young adults under age 50 who will get severely ill or die from this virus is much higher than it is from seasonal flu," said Frieden.
Tamiflu Shortage Coming to an End
Liquid forms of the antiviral drug Tamiflu should be easily available now, according to CDC. The agency distributed the drug from the strategic national stockpile until manufacturers could catch up with demand. Frieden says the agency is seeing a dramatic improvement in the treatment of children who are severely ill with influenza, due to the use antivirals like Tamiflu. In most years, only one in five sick children arriving at a hospital have been started on an antiviral. This year, 80% are getting early treatment, which helps prevent severe illness. The vaccine supply is increasing as well, with 73 million doses of the H1N1 swine flu vaccine available this week and another 10 million coming next week. Top priority for getting the shot should still go to people in the high-risk groups. “Vaccination is the single best thing you can do to protect yourself and your family against the flu,” Frieden said.
Insurers to expand flu vaccine funding
Tuesday, December 1, 2009, 5:35pm EST
Boston Business Journal - by Julie M. Donnelly
A group of private health insurers has agreed to foot the bill for the H1N1 vaccination clinics that are going on at public health clinics around the state. It’s expected to cost $25 million and will alleviate some pressure on cities and towns, which have sustained multiple budget cuts.
The H1N1 vaccine is free and is distributed by the federal government to local health departments and physicians’ offices around the country. But it’s not free to staff the clinics, and to pay for the needles and other consumables.
The Patrick Administration held a news conference Tuesday to announce the deal.
Mary Lou Buyse of the Massachusetts Association of Health Plans said it was the right thing to do. “This is a really bad pandemic - millions of people need to be immunized and if we don’t do it, it will get worse,” Buyse said in a interview. She agreed that a failure to provide widespread immunizations would also cost insurers more since more people would get sick.
Blue Cross Blue Shield cited higher costs from the flu as a reason for worsened financial performance in the third quarter. Other insurers said it was one of many factors that has caused their costs to rise over the past year.
Commonwealth Medicine, a non-profit health care consulting organization affiliated with UMass Medical Center, will act as the third party administrator to bill insurers so they can reimburse the municipalities.
The Massachusetts Department of Public Health has also issued a separate RFP asking organizations to step forward who might be able to come up with a pilot program to help arrange reimbursements for vaccinations that take place in school-based clinics. Proposals were due Nov 30 and the winning organization stands to gin $100,000 in federal stimulus money
All contents of this site © American City Business Journals Inc. All rights reserved.
Tuesday, December 1, 2009, 5:35pm EST
Boston Business Journal - by Julie M. Donnelly
A group of private health insurers has agreed to foot the bill for the H1N1 vaccination clinics that are going on at public health clinics around the state. It’s expected to cost $25 million and will alleviate some pressure on cities and towns, which have sustained multiple budget cuts.
The H1N1 vaccine is free and is distributed by the federal government to local health departments and physicians’ offices around the country. But it’s not free to staff the clinics, and to pay for the needles and other consumables.
The Patrick Administration held a news conference Tuesday to announce the deal.
Mary Lou Buyse of the Massachusetts Association of Health Plans said it was the right thing to do. “This is a really bad pandemic - millions of people need to be immunized and if we don’t do it, it will get worse,” Buyse said in a interview. She agreed that a failure to provide widespread immunizations would also cost insurers more since more people would get sick.
Blue Cross Blue Shield cited higher costs from the flu as a reason for worsened financial performance in the third quarter. Other insurers said it was one of many factors that has caused their costs to rise over the past year.
Commonwealth Medicine, a non-profit health care consulting organization affiliated with UMass Medical Center, will act as the third party administrator to bill insurers so they can reimburse the municipalities.
The Massachusetts Department of Public Health has also issued a separate RFP asking organizations to step forward who might be able to come up with a pilot program to help arrange reimbursements for vaccinations that take place in school-based clinics. Proposals were due Nov 30 and the winning organization stands to gin $100,000 in federal stimulus money
All contents of this site © American City Business Journals Inc. All rights reserved.
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