Posts Tagged ‘H1N1’
CDC Says Pregnant Women With Flu Symptoms Should Receive Anti-Viral Drugs
 
JULY 29, 2009, 12:18 P.M. ETÂ Â
WASHINGTON — The Centers for Disease Control and Prevention said Wednesday pregnant women suspected of having the flu should be promptly treated with antiviral medications.
The CDC, in a study set to be published in the medical journal Lancet, said pregnant women are more severely impacted by the H1N1 virus. CDC said pregnant women had higher rates of hospitalization and a greater risk of death compared to the general population.
The study looked at the impact of H1N1 flu on pregnant women from mid-April, when the new virus was first discovered, to June 16. Of 45 U.S. deaths from the H1N1 flu, six were in pregnant women, which represented 13% of deaths at the time. CDC said of the 34 cases of pandemic H1N1 in pregnant women were reported to the agency from April 15 to May 18, 11 women, or 32% were admitted to the hospital.
The CDC has said more than one million Americans have likely been sickened by the H1N1 flu and more than 300 people have died as of July 24.
The lead author of the study, Denise Jamieson, said doctors who treat pregnant women shouldn’t delay in starting antiviral treatment with Tamiflu, made by Roche Holding AG, or GlaxoSmithKline PLC’s Relenza.
“Some clinicians hesitate treating pregnant women with antiviral medications because of concerns for the developing fetus, but this is the wrong approach,” she said.
All of the pregnant women who died from H1N1 complications flu were healthy prior to infection of H1N1. They subsequently developed viral pneumonia, and later died. CDC said they did not receive antivirals soon enough to benefit their treatment. It’s recommended that antiviral treatment be started within 48 hours after symptoms begin.
CDC’s Advisory Committee on Immunization Practices meets later Wednesday to discuss which groups should be vaccinated if government officials decide to move forward with an H1N1 influenza vaccination campaign. Pregnant women, school-age children and health-care workers are expected to be at the top of the list. The earliest an H1N1 vaccine would be available would be mid-October.
Most companies making the vaccines for the U.S. market, including Sanofi Aventis, Novartis AG, GlaxoSmithKline PLC and CSL Ltd, have said the viruses used to make the active ingredient are producing yields of just 30% of what’s typically seen with seasonal vaccines.
Write to Jennifer Corbett Dooren at jennifer.corbett-dooren@dowjones.com
New Push in H1N1 Flu Fight Set for Start of School
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July 18, 2009
U.S. health officials are preparing intensively to combat an anticipated wave of outbreaks of the new H1N1 flu when children return to school and the pace of cases picks up.
Zuma PressKenya Bell, left, stands with daughter, Nyeree, who along with several others came down with the flu at an American Lung Association camp in California.
Anne Schuchat, chief of immunization and respiratory diseases at the U.S. Centers for Disease Control and Prevention, said Friday that the agency expects an increase in cases before the normal start of the flu season in mid-autumn, because children are likely to spread it to one another once they go back to school. Infectious diseases normally spread readily among children, and this virus has hit children and young adults harder than the elderly, who normally suffer the heaviest toll from flu.
“We’ve seen it in camps and military units,” Dr. Schuchat said. “I’m expecting when school reopens and kids are all back together, in some communities at least we may see an increase.”
The number of confirmed U.S. infections is now 40,617, with 263 deaths, the CDC said Friday. But the agency believes that more than one million people have been infected and weren’t tested for the virus or didn’t visit a doctor. The disease has become so widespread that the agency will probably suspend tallying individual case counts within the next few weeks and focus instead on tracking clusters, severe cases, deaths and other unusual events — a more traditional approach to tracking diseases, Dr. Schuchat said.
![[flu]](http://s.wsj.net/public/resources/images/OB-EB991_WFLUAc_NS_20090717222557.gif)
The CDC would be following the WHO, which said on Thursday that it is abandoning individual case counts.
Most of those who have the new flu get only mildly ill for a few days and don’t need treatment. But officials are concerned about the virus because it is new and could easily mutate and become more virulent as it spreads through the population. Argentina declared a nationwide animal-health emergency Friday after finding the virus possibly jumped from humans to two pig herds, a development that flu experts say could potentially spur mutations. The country’s death toll from the virus stands at 137.
Global officials are also concerned because the new H1N1 virus has caused severe illness in some children and young people. Some recently published studies suggest it can cause more severe illness than seasonal flu. Deaths from flu are normally rare among children and young adults, who account for the bulk of the U.S. deaths from the pandemic strain. Nor is it clear why the virus is striking pregnant women, as well as people with asthma, diabetes and other conditions hard.
To combat the virus, federal officials are preparing to mount a massive immunization campaign, and are also urging communities, businesses and individuals to make contingency plans for possible school closures, multiple employee absences for illness, surges of patients in hospitals and other effects of potentially widespread outbreaks.
Clinical trials are expected to begin later this month to test whether a vaccine developed to combat the virus is safe and effective, and the CDC is working with state and local public-health authorities to figure out how to get as many as 600 million doses, or two for every U.S. resident, into people’s arms. Results of the trials aren’t expected until early October, but officials say they expect to have the first 100 million doses of vaccine ready by mid-October.
The WHO and some vaccine manufacturers reported this week that the vaccine was proving difficult to manufacture because the viruses used to make the shots are yielding only 25% to 50% of the active ingredient they normally get for flu vaccines.
But Dr. Schuchat said that wasn’t affecting the U.S. government’s plans. “We haven’t heard news that has changed our expectations for vaccine availability in the fall,” she said. “Based on what has been described to us so far, it’s within the range of our planning assumptions, but that doesn’t mean we won’t have more surprises.”
Key Facts About Swine Influenza – CDC/Control & Prevention
http://www.cdc.gov/h1n1flu/key_facts.htm
Swine Flu
What is Swine Influenza?
Swine Influenza (swine flu) is a respiratory disease of pigs caused by type A influenza virus that regularly causes outbreaks of influenza in pigs. Swine flu viruses cause high levels of illness and low death rates in pigs. Swine influenza viruses may circulate among swine throughout the year, but most outbreaks occur during the late fall and winter months similar to outbreaks in humans. The classical swine flu virus (an influenza type A H1N1 virus) was first isolated from a pig in 1930.
How many swine flu viruses are there?
Like all influenza viruses, swine flu viruses change constantly. Pigs can be infected by avian influenza and human influenza viruses as well as swine influenza viruses. When influenza viruses from different species infect pigs, the viruses can reassort (i.e. swap genes) and new viruses that are a mix of swine, human and/or avian influenza viruses can emerge. Over the years, different variations of swine flu viruses have emerged. At this time, there are four main influenza type A virus subtypes that have been isolated in pigs: H1N1, H1N2, H3N2, and H3N1. However, most of the recently isolated influenza viruses from pigs have been H1N1 viruses.
Swine Flu in Humans
Can humans catch swine flu?
Swine flu viruses do not normally infect humans. However, sporadic human infections with swine flu have occurred. Most commonly, these cases occur in persons with direct exposure to pigs (e.g. children near pigs at a fair or workers in the swine industry). In addition, there have been documented cases of one person spreading swine flu to others. For example, an outbreak of apparent swine flu infection in pigs in Wisconsin in 1988 resulted in multiple human infections, and, although no community outbreak resulted, there was antibody evidence of virus transmission from the patient to health care workers who had close contact with the patient.
How common is swine flu infection in humans?
In the past, CDC received reports of approximately one human swine influenza virus infection every one to two years in the U.S., but from December 2005 through February 2009, 12 cases of human infection with swine influenza have been reported. For information on the number of probable and confirmed cases of novel H1N1 flu in humans see Novel H1N1 Flu Situation Update.
Can people catch swine flu from eating pork?
No. Swine influenza viruses are not transmitted by food. You can not get swine influenza from eating pork or pork products. Eating properly handled and cooked pork and pork products is safe. Cooking pork to an internal temperature of 160°F kills the swine flu virus as it does other bacteria and viruses.
How does swine flu spread?
Influenza viruses can be directly transmitted from pigs to people and from people to pigs. Human infection with flu viruses from pigs are most likely to occur when people are in close proximity to infected pigs, such as in pig barns and livestock exhibits housing pigs at fairs. Human-to-human transmission of swine flu can also occur. This is thought to occur in the same way as seasonal flu occurs in people, which is mainly person-to-person transmission through coughing or sneezing of people infected with the influenza virus. People may become infected by touching something with flu viruses on it and then touching their mouth or nose.
What do we know about human-to-human spread of swine flu?
In September 1988, a previously healthy 32-year-old pregnant woman was hospitalized for pneumonia and died 8 days later. A swine H1N1 flu virus was detected. Four days before getting sick, the patient visited a county fair swine exhibition where there was widespread influenza-like illness among the swine. In follow-up studies, 76% of swine exhibitors tested had antibody evidence of swine flu infection but no serious illnesses were detected among this group. Additional studies suggest that one to three health care personnel who had contact with the patient developed mild influenza-like illnesses with antibody evidence of swine flu infection.
How can human infections with swine influenza be diagnosed?
To diagnose swine influenza A infection, a respiratory specimen would generally need to be collected within the first 4 to 5 days of illness (when an infected person is most likely to be shedding virus). However, some persons, especially children, may shed virus for 7 days or longer. Identification as a swine flu influenza A virus requires sending the specimen to CDC for laboratory testing.
What medications are available to treat swine flu infections in humans?
There are four different antiviral drugs that are licensed for use in the US for the treatment of influenza: amantadine, rimantadine, oseltamivir and zanamivir. While most swine influenza viruses have been susceptible to all four drugs, the most recent H1N1 influenza viruses isolated from humans are resistant to amantadine and rimantadine.
What other examples of swine flu outbreaks are there?
Probably the most well known is an outbreak of swine flu among soldiers in Fort Dix, New Jersey in 1976. The virus caused disease with x-ray evidence of pneumonia in at least 4 soldiers and 1 death; all of these patients had previously been healthy. The virus was transmitted to close contacts in a basic training environment, with limited transmission outside the basic training group. The virus is thought to have circulated for a month and disappeared. The source of the virus, the exact time of its introduction into Fort Dix, and factors limiting its spread and duration are unknown. The Fort Dix outbreak may have been caused by introduction of an animal virus into a stressed human population in close contact in crowded facilities during the winter. The swine influenza A virus collected from a Fort Dix soldier was named A/New Jersey/76 (Hsw1N1).
Swine Flu in Pigs
How does swine flu spread among pigs?
Swine flu viruses are thought to be spread mostly through close contact among pigs and possibly from contaminated objects moving between infected and uninfected pigs. Herds with continuous swine flu infections and herds that are vaccinated against swine flu may have sporadic disease, or may show only mild or no symptoms of infection.
What are signs of swine flu in pigs?
Signs of swine flu in pigs can include sudden onset of fever, depression, coughing (barking), discharge from the nose or eyes, sneezing, breathing difficulties, eye redness or inflammation, and going off feed.
How common is swine flu among pigs?
H1N1 and H3N2 swine flu viruses are endemic among pig populations in the United States and something that the industry deals with routinely. Outbreaks among pigs normally occur in colder weather months (late fall and winter) and sometimes with the introduction of new pigs into susceptible herds. Studies have shown that the swine flu H1N1 is common throughout pig populations worldwide, with 25 percent of animals showing antibody evidence of infection. In the U.S. studies have shown that 30 percent of the pig population has antibody evidence of having had H1N1 infection. More specifically, 51 percent of pigs in the north-central U.S. have been shown to have antibody evidence of infection with swine H1N1. Human infections with swine flu H1N1 viruses are rare. There is currently no way to differentiate antibody produced in response to flu vaccination in pigs from antibody made in response to pig infections with swine H1N1 influenza.
Is there a vaccine for swine flu?
Vaccines are available to be given to pigs to prevent swine influenza. There is no vaccine to protect humans from swine flu. The seasonal influenza vaccine will likely help provide partial protection against swine H3N2, but not swine H1N1 viruses.
WHO Chief declares Swine Flu Speading with ‘Unprecedented Speed’
By Shirley S. Wang
July 16, 2009
The World Health Organization says it’s going to stop counting cases of the new H1N1 flu, according to a note posted on its website.
The virus is spreading with “unprecedented speedâ€, wrote the WHO. “At this point, further spread of the pandemic, within affected countries and to new countries, is considered inevitable.â€
But countries need to continue to closely monitor “unusual events†like clusters of severe virus infections or unusual patterns of these serious cases. These signals might come from noticing an increase in the number of people staying home from work or school, or by an increase in emergency room visits.
H1N1 pandemic spreading too fast to count – WHO
 
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Thu Jul 16, 2009 1:10pm EDT
 * H1N1 virus has spread more quickly than other pandemics
* WHO says pointless to count individual cases
* But countries should track deaths, unusual patterns
By Stephanie Nebehay
GENEVA, July 16 (Reuters) – The World Health Organisation (WHO) said on Thursday that the H1N1 flu pandemic was the fastest-moving pandemic ever and that it was now pointless to count every case.
The United Nations agency, which declared an influenza pandemic on June 11, revised its requirements so that national health authorities need only report clusters of severe cases or deaths caused by the new virus or unusual clinical patterns.
“The 2009 influenza pandemic has spread internationally with unprecedented speed. In past pandemics, influenza viruses have needed more than six months to spread as widely as the new H1N1 virus has spread in less than six weeks,” it said in a statement on the new strain, commonly known as swine flu.
It has become nearly impossible for health authorities and laboratories to keep count of individual cases — which have mostly been mild — as the virus spreads, according to the 193 member-state agency.
Flu experts say at least a million people are infected in the United States alone, and the WHO says the pandemic is unstoppable.
“It is very much agreed that trying to register and report every single case is a huge waste of resources,” WHO spokesman Gregory Hartl said.
Such tracking has limited authorities’ capacity to investigate serious cases and is no longer essential to monitor the level or nature of the risk posed by the virus, WHO said.
However, all countries should still closely monitor unusual clusters of severe or fatal infections from the pandemic virus, clusters of respiratory illness requiring hospitalisation or unexplained or unusual clinical patterns.
“Signals to be vigilant for include spikes in rates of absenteeism from schools or workplaces, or a more severe disease pattern, as suggested by, for example, a surge in emergency department visits,” it said.
Britain reported on Thursday that 29 people had died to date after contracting the virus. Health Minister Andy Burnham said this month the government was projecting more than 100,000 new cases a day of the flu in the country by the end of August.
The WHO will no longer issue global tables showing the numbers of confirmed cases for all countries — which stood at 94,512 cases with 429 deaths as of its last update on July 6.
Instead, it will issue regular updates on the situation in newly affected countries, which should report the first confirmed cases, weekly figures and epidemiological details.
Countries should still test a limited number of virus samples weekly to confirm that disease is actually due to the pandemic virus and to monitor any virological changes that may be important for the development of vaccines, it said.
At least 50 governments have placed orders for vaccines against the new H1N1 strain or negotiating with drug makers, WHO vaccine chief Marie-Paule Kieny told Reuters. [ID:nLG225946]
The WHO does not report figures for cases of seasonal influenza, which it says is linked to 250,000 to 500,000 deaths a year globally. (For the WHO statement go to: here) (Additional reporting by Peter Griffiths in London)
Stop Smoking & Get Active – Prepare for Flu Pandemic this Fall
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Personalize pandemic planningBy: Staff Writer 14/07/2009 1:00 AM | Stop smoking and get active — not just good advice for a long life. It is the best way to prepare for what might be a serious flu pandemic this fall. With disease experts worrying that H1N1 may mutate into something more ferocious in the coming flu season, even efforts by veteran nicotine addicts to cut the amount of smoking will make a difference, perhaps keeping a smoker out of the hospital or leading to a faster recovery. Each cigarette smoked does a little more damage to lung tissue, placing them at elevated risk from the H1N1 virus circulating. To date, disease experts have stressed the fundamentals of infection protection for the public, romper room basics such as washing your hands often, and also covering your cough and sneezes to prevent spreading your germs to others. Workplaces should be telling employees to stay home if they are sick, to nip in the bud infections within the office. Not a lot of attention has been paid to what those with underlying health conditions, such as chronic illnesses, can do to protect themselves. H1N1 has spread in Canada for months, and as the summer wends on, the virus may change into a more powerful foe. Unlike seasonal flus, which usually hit babies and the elderly hardest, H1N1 is hitting the stronger, healthier population. General health vigilance took on greater weight this week with news that manufacturers at work on a vaccine are getting less yield from the H1N1 seeds. That could reduce the amount available globally in November, the predicted ready date for a vaccine. People with diabetes, lung conditions (such as asthma or emphysema), heart conditions and those taking corticosteroids for serious inflammatory diseases, such as severe arthritis, are at higher risk of getting seriously sick with H1N1, which infects the respiratory tract. Pregnant women, particularly in later stages, are inclined to pick up flu viruses, as well, and are at higher risk from H1N1. People who drink to excess also put themselves at risk from infections. The best piece of advice for those with compromised health, like everyone, is to get physically active — walking is an easy form of exercise — and eat well. Keeping weight in check and losing extra pounds relieve stress on the body. Those with chronic diseases ought to take their medications appropriately; those suffering with asthma, for example, should be taking the daily preventive drugs as prescribed now to keep the lungs strong for the flu season. Those at higher risk should call their family doctors for advice and, if they get sick, should check in with primary health providers early to avoid falling serious ill. Medical specialists can help with advice tailored to individuals with specific health concerns, such as hepatitis or HIV. Governments are working on protocols for hospitals which could see resources such as staff, beds and equipment — particularly ventilators — taxed to serve all those who may get seriously sick. A severe pandemic would force medical personnel to make tough decisions on who gets what level of care. The best personal strategy is to stay out of the hospital, away from the line ups where someone is deciding what a strained health system can offer. Get healthy, master the bad habits and keep the chronic disease in check — routine advice that has extra currency in the personal planning for the pandemic. |
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How Fast Could a Swine Flu Vaccine Be Produced?
A doctor at the Centers for Disease Control examines specimens of the 1918 pandemic influenza virus, part of an effort to develop new vaccines and treatments for future pandemic influenza viruses
With the first reported death from the 2009 H1N1 flu, or swine flu, in the U.S., the Federal Government and flu-vaccine manufacturers are preparing for the possibility that a new vaccine will be necessary to control the outbreak. Should the call for vaccine production come from health officials, both traditional and newer, faster vaccine-making methods could be employed.
Dr. Richard Besser, acting director of the Centers for Disease Control and Prevention (CDC), said the agency has begun cultivating the seed stock of virus needed for a swine flu vaccine. (The current seasonal flu vaccine would not be effective against the swine flu.) “We’re moving forward aggressively so that if a decision is made that we need to rev up production to make that vaccine, we would be ready to do so,” he said.
But even if the CDC’s seed stock of virus were to be released to vaccine makers today, it would take the companies anywhere from four to six months before the first inoculation could be ready for public use. That’s because flu-vaccine production — whether for swine or seasonal flu — is time-consuming and laborious, requiring vaccine makers to grow millions of copies of the flu virus in chicken eggs, then purify those bugs into a ready-to-inject formula safe for patients. “We are moving things around to accommodate this and getting our raw materials ready and having our scientists ready. We are on alert, waiting on the CDC. We’re in daily contact with them,” says Donna Cary, spokeswoman for Sanofi Pasteur, which currently makes 50 million doses of the seasonal flu vaccine used in the U.S. each year.
But if and when the CDC gives the go-ahead, companies such as Sanofi will have to do an about-face, scrapping their current vaccine projects to switch to swine flu. Sanofi and other vaccine makers received the seed stock for the upcoming flu season last January and are now in the midst of culturing and purifying that virus for this fall’s flu season.
History teaches us, however, that it won’t be easy. The last time the U.S. recommended nationwide vaccination against a suspected swine flu was in 1976, with less than successful results, to say the least. Under orders from President Gerald Ford, a vaccine was rushed into production and administered to 45 million Americans, at a cost of $135 million. But within weeks, people started developing Guillain-Barré syndrome, a paralyzing immune-system disorder that can result from the vaccine. Some experts estimated the risk of Guillain-Barré as being seven times higher in those who were immunized vs. those who were not. After the immunization program was terminated nine months after it began, government officials paid $90 million in damages to patients who were injured by the vaccine. The widely feared swine flu epidemic never emerged.
Much has changed since then. Genetic advances have given researchers entirely new ways of developing vaccines. For example, instead of using the entire virus or bacterium to activate the human immune system, new strategies rely on genetic snippets from infectious bugs, which can trigger immunity without the risk of infection.
At the biotech company Novavax, researchers are testing the use of virus-like particles (VLP), instead of the virus itself, to stimulate a flu immune response. Using this method, a vaccine for the 2009 H1N1 virus could be in production in 10 to 12 weeks, rather than the usual four to six months. “We have made vaccines against multiple flu strains and tested them in humans and gotten relevant and robust immune responses, which checks off the major boxes that the technology works against flu,” says Rahul Singhvi, president and CEO of Novavax.
Novavax’s strategy involves isolating three proteins from the virus that flag the human immune system, which then churns out neutralizing antibodies against the proteins. These antibodies are robust enough to fight off the actual virus should an immunized person become infected. This is the same way the recently developed vaccine against human papilloma virus, Gardasil, works. “It provides the look and feel of the flu virus but does not have the genetic materials to cause disease,” Singhvi says.
A VLP vaccine may also prove easier to develop since all it requires is an accurate genetic sequence of three critical virus genes. That could especially help with swine flu, since researchers found back in the 1970s that the virus doesn’t grow well in chicken eggs; that could slash the yield and slow production of a potential new vaccine. “As long as we get the genetic sequence of some viral proteins, it doesn’t matter where the virus came from — human, swine or bird,” says Singhvi. So far, Novavax’s shot is still in the testing phase, but its VLP-based vaccines against seasonal and bird flu are providing good results. The company stands ready to try its strategy against swine flu if needed. “The CDC is aware of what we are doing, and we have offered to help both the Department of Health and Human Services and the CDC,” says Singhvi.
Other companies are taking an entirely novel approach and hoping to pick off influenza viruses in the nasal passages before they get deeper into the body and infect other cells. At NanoBio Corporation, a biotech company in Michigan, scientists are perfecting a topical nasal spray that would destroy any single-celled particles, like viruses, bacteria or fungi, on contact, while leaving our multicelled tissues intact. (Blood cells would be fair game for the destructive emulsion, however, so the solution could not be injected into the body.) In animal studies, says Dr. James Baker, the company’s chairman of the board, the spray protected 90% of mice from a lethal dose of influenza. The company is also testing a combination of the traditional flu vaccine with the emulsion, which, says Baker, provides a 50-times-greater immune response than the vaccine alone, even if using only one-sixth the usual vaccine dose. This technique is still too experimental to be helpful against the current swine flu outbreak, however.
So far, 10 states have confirmed cases of swine flu, including a death in Texas, but all 50 have already requested their portion of the Strategic National Stockpile (SNS) of antiviral medications, according to the CDC. (The SNS, maintained jointly by the Department of Homeland Security and the Department of Health and Human Services, is the nation’s emergency medicine chest, containing critical drugs and medical equipment to be used in a public-health emergency.) Although the stockpiled antiviral drugs can treat existing cases of flu, a vaccine is the only way to protect people who are uninfected and halt further spread of the virus.
The CDC, the only agency that possesses the virus needed to make a vaccine, says it is still “looking very intently” at a swine flu vaccine, but it has not yet given the green light to scale up production. In the event that it does, either in response to the current outbreak or down the road when the next pig-to-people flu causes massive illness, they may have better ways than they did in ’76 to battle the bug.
FDA Warns Consumers about Fraudulent H1N1 Flu Virus Claims
FDA NEWS RELEASE
For Immediate Release: June 15, 2009
The U.S. Food and Drug Administration is enforcing the laws that protect consumers from illegal products marketed through the Internet that claim to diagnose, prevent, mitigate, treat or cure the 2009 H1N1 flu virus.
On May 1, 2009, the FDA warned consumers regarding products related to the 2009 H1N1 flu virus offered on the Internet. The products involved are those that are promoted and marketed to diagnose, mitigate, prevent, treat, or cure the 2009 H1N1 flu virus but are not approved, cleared, or authorized by the FDA. The agency advised operators of offending Web sites that they must take immediate action to ensure that they are not marketing products intended to diagnose, mitigate, prevent, treat, or cure the 2009 H1N1 flu virus that have not been cleared, approved, or authorized by the FDA.
Since then, the FDA has issued more than 50 warning letters to offending Web sites and as a result, more than 66 percent of these Web sites have removed the offending claims and/or products.
“We are committed to aggressively pursuing those who attempt to take advantage of a public health emergency by promoting and marketing unapproved, uncleared, or unauthorized products,†said Margaret A. Hamburg, M.D., Commissioner of Food and Drugs. “We have achieved some success and will remain vigilant in our efforts to protect consumers from these fraudulent, potentially dangerous products.â€
Examples of unapproved, uncleared, or unauthorized products targeted by the FDA include:
–A shampoo that claimed to protect against the H1N1 flu virus;
–A dietary supplement that claimed to protect infants and young children from contracting the H1N1 flu virus;
–A “new†supplement that claimed to cure H1N1 flu infection within four to eight hours;
–A spray that claimed to leave a layer of ionic silver on one’s hands that killed the virus;
–Several tests that have not been approved to detect the H1N1 flu virus; and
–An electronic instrument costing thousands of dollars that claimed to utilize “photobiotic energy†and “deeply penetrating mega-frequency life-force energy waves†to strengthen the immune system and prevent symptoms associated with H1N1 viral infection.
The FDA’s warning letters are consistent with an aggressive strategy the agency put into place to protect consumers from individuals or businesses that promote fraudulent claims for products in an attempt to take advantage of the public’s concerns about the 2009 H1N1 flu virus.
Unapproved, uncleared, or unauthorized products that claim to diagnose, mitigate, prevent, treat or cure the 2009 H1N1 flu are illegal and a potentially significant threat to the public health.
These warning letters were the result of daily Internet surfs conducted by the FDA’s Office of Enforcement, Office of Criminal Investigations, and staff from the Center for Devices and Radiological Health, the Center for Drug Evaluation and Research, and the Center for Food Safety and Applied Nutrition. The warning letters issued by e-mail and the FDA requested a response within 48 hours.
In addition, the FDA posted the offending Web sites and products on the agency’s Web site.
“Taking swift action to inform unsuspecting consumers about products that could be dangerous to their health is a major priority for the FDA,†said Hamburg.
The FDA will consider further civil or criminal enforcement action against those Web sites that fail to resolve the violations cited in warning letters. Actions could include seizure, injunction, and criminal prosecution
WHO recommendations on pandemic (H1N1) 2009 Vaccines
13 JULY 2009 | GENEVA — On 7 July 2009, the Strategic Advisory Group of Experts (SAGE) on Immunization held an extraordinary meeting in Geneva to discuss issues and make recommendations related to vaccine for the pandemic (H1N1) 2009.
SAGE reviewed the current pandemic situation, the current status of seasonal vaccine production and potential A(H1N1) vaccine production capacity, and considered potential options for vaccine use.
The experts identified three different objectives that countries could adopt as part of their pandemic vaccination strategy:
Protect the integrity of the health-care system and the country’s critical infrastructure; reduce morbidity and mortality; and reduce transmission of the pandemic virus within communities.
Countries could use a variety of vaccine deployment strategies to reach these objectives but any strategy should reflect the country’s epidemiological situation, resources and ability to access vaccine, to implement vaccination campaigns in the targeted groups, and to use other non-vaccine mitigation measures.
Although the severity of the pandemic is currently considered to be moderate with most patients experiencing uncomplicated, self-limited illness, some groups such as pregnant women and persons with asthma and other chronic conditions such as morbid obesity appear to be at increased risk for severe disease and death from infection.
Since the spread of the pandemic virus is considered unstoppable, vaccine will be needed in all countries. SAGE emphasized the importance of striving to achieve equity among countries to access vaccines developed in response to the pandemic (H1N1) 2009
The following recommendations were provided to the WHO Director-General:
All countries should immunize their health-care workers as a first priority to protect the essential health infrastructure. As vaccines available initially will not be sufficient, a step-wise approach to vaccinate particular groups may be considered. SAGE suggested the following groups for consideration, noting that countries need to determine their order of priority based on country-specific conditions: pregnant women; those aged above 6 months with one of several chronic medical conditions; healthy young adults of 15 to 49 years of age; healthy children; healthy adults of 50 to 64 years of age; and healthy adults of 65 years of age and above.
Since new technologies are involved in the production of some pandemic vaccines, which have not yet been extensively evaluated for their safety in certain population groups, it is very important to implement post-marketing surveillance of the highest possible quality. In addition, rapid sharing of the results of immunogenicity and post-marketing safety and effectiveness studies among the international community will be essential for allowing countries to make necessary adjustments to their vaccination policies.
In view of the anticipated limited vaccine availability at global level and the potential need to protect against “drifted” strains of virus, SAGE recommended that promoting production and use of vaccines such as those that are formulated with oil-in-water adjuvants and live attenuated influenza vaccines was important.
As most of the production of the seasonal vaccine for the 2009-2010 influenza season in the northern hemisphere is almost complete and is therefore unlikely to affect production of pandemic vaccine, SAGE did not consider that there was a need to recommend a “switch” from seasonal to pandemic vaccine production.
WHO Director-General Dr Margaret Chan endorsed the above recommendations on 11 July 2009, recognizing that they were well adapted to the current pandemic situation. She also noted that the recommendations will need to be changed if and when new evidence become available.
SAGE was established by the WHO Director-General in 1999 as the principal advisory group to WHO for vaccines and immunization. It comprises 15 members who serve in their personal capacity and represent a broad range of disciplines from around the world in the fields such as epidemiology, public health, vaccinology, paediatrics, internal medicine, infectious diseases, immunology, drug regulation, programme management, immunization delivery, and health-care administration.
Additional participants in the SAGE meeting included members of the ad hoc policy advisory working group on influenza A(H1N1) vaccine, chairs of the regional technical advisory groups and external experts. Observers included industry representatives and regulators who did not take part in the recommendation process in order to avoid conflicts of interest.
CDC – Weekly Influenza Activity Estimates
Novel H1N1 Flu Situation Update
July 10, 2009, 11:00 AM ET>
Map: Weekly Influenza Activity Estimates Reported by State and Territorial Epidemiologists
(Activity levels indicate geographic spread of both seasonal and novel influenza A [H1N1] viruses)
(Posted July 10, 2009, 4:30 PM ET, for Week Ending July 4, 2009)
For Weekly Influenza Updates for your State
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