MEDIA RELEASE

The state Department of Health (DOH) will be holding free H1N1 vaccination clinics on the Big Island throughout the month of April. The clinics will be at two locations, one in Hilo and the other in Kona, and anyone who has not yet received the 2009 H1N1 flu vaccine should make an appointment to get theirs.

West Hawaii residents can make an appointment to go to the Kona Health Center April 12, 16 and 28, from 9 a.m. to 3:30 p.m. each of those days and get vaccinated. The Kona Health Center is at 79-1015 Haukapila St., Kealakekua.

In Hilo, the East Hawaii Public Health Nursing Office will hold H1N1 clinics April 12, 15, 19, 22, 26 and 29, from 8:30 a.m. to 11 a.m. each of those days. The East Hawaii Public Health Nursing Office is located at 75 Aupuni St., Ste 106, Hilo.

There is no cost for the vaccination; anyone younger than 18 must be accompanied by a parent or guardian. Also, parents are reminded that children under 10 years old need two doses of the H1N1 vaccine.

As of March 31, 616,000 doses of H1N1 vaccine were allocated to Hawaii, and an estimated 570,000 doses had either shipped or were in transit to Hawaii.

Based on vaccinator reports, which continue to be received and processed, 294,241 people have been vaccinated in Hawaii. That number represents at least 23 percent of our state’s population, based on a 2008 Census Bureau estimate.

Of the 13 H1N1-related deaths that occurred in Hawaii, two were Big Island residents.

“It is still important for everyone in Hawaii to get an H1N1 flu vaccination. Complications from the flu can be very serious causing hospitalizations and deaths each year. Even a mild case of the flu often results in missed school days and lost work time,” said Dr. Chiyome Fukino, director of the state Department of Health. “Getting vaccinated protects you from the H1N1 flu virus and has the added benefit of indirectly protecting others around you, some of whom might be at risk for serious complications.”

H1N1 has been causing more disease recently in the Southeast on the Mainland. Several states are reporting regional or local activity. Hawaii has thus far been spared a second “wave” of H1N1 influenza activity and the DOH reminds the public that a key factor to fending off an uptick in flu activity is for people to get vaccinated.

“We want everyone in Hawaii County to know that it’s free and easy to get the H1N1 vaccine at our clinics,” said Dan Gushiken, Hawaii District Health Office health educator. “If you don’t have health insurance or if you have not been able to get the vaccine from your regular doctor, this is a great way to get maximum protection against the H1N1 flu.”

To schedule an appointment in Kona, or for more information about these clinics, call the Kona Health Center at 322-1500. In Hilo, call the East Hawaii Public Health Nursing Office at 974-6025.

Also, follow the Department of Health on Twitter at www.twitter.com/HIGov_…

MEDIA RELEASE

WASHINGTON, Dec. 17, 2009–A study conducted by U.S. Department of Agriculture (USDA) scientists provides additional confirmation that meat and tissue from pigs exposed to two strains of the 2009 novel pandemic H1N1 virus did not contain virus. The results were published today in the Public Library of Science’s online journal, PLoS ONE. The study was conducted by scientists with USDA’s Agricultural Research Service (ARS) at the agency’s National Animal Disease Center, part of the USDA National Centers for Animal Health in Ames, Iowa. ARS is the chief intramural scientific research agency of USDA.

“This research provides additional reassurance for consumers about the safety of pork,” said Edward B. Knipling, ARS administrator. “The information contained in the study will also benefit customers of U.S. pork products, both here and abroad.”

ARS scientists received samples of the 2009 novel pandemic H1N1 (H1N1) virus in May from the U.S. Centers for Disease Control and Prevention. The virus samples came from humans in California and Mexico who had become infected with this H1N1 virus.

Researchers inoculated a group of 30 five-week-old pigs with the virus to determine the pigs’ susceptibility to H1N1. Five pigs that were not inoculated with the virus served as a comparison or “control” group. The pigs were observed daily for clinical signs of illness and then were euthanized at three, five or seven days after inoculation.

Researchers tested tissue samples of the pigs’ lungs, liver, muscle, spleen and other vital organs using the most sensitive tools available to detect the presence of live virus and nucleic acids from the virus. The inoculated animals showed signs of upper respiratory disease consistent with influenza, however there was no evidence that the virus had spread to any other parts of the body.

These findings about the safety of pork from pigs previously infected with the 2009 novel pandemic H1N1 virus support recommendations of the World Health Organization that pork harvested from swine that had been infected previously and had recovered from the virus can be safely handled or eaten, following basic hygiene practices for handling of meat.
This research supports the USDA priority of ensuring food safety. Additional information about USDA’s H1N1 efforts is available at www.usda.gov/H1N1flu

MEDIA RELEASE

HONOLULU – The Hawaiʻi State Department of Health (DOH) is stepping up its statewide campaign to encourage college students to get vaccinated for the H1N1 virus. People 18-24 years old have been hit disproportionally hard by the virus in the United States. Targeting the week of January 10-16, the first week of the new term for most Hawaiʻi college campuses, the Lingle-Aiona Administration – led by the DOH – has partnered with the University of Hawaiʻi at Mānoa (UH Mānoa), Brigham Young University- Hawaiʻi (BYU- Hawaiʻi) and the U.S. Centers for Disease Control and Prevention to vaccinate potentially thousands of college students.

“Influenza is a highly contagious disease, and flu season in Hawai‘i requires our year-round vigilance,” said Lt. Governor James R. “Duke” Aiona, Jr. “Limiting the spread of seasonal flu and H1N1 influenza has been the result of unprecedented collaboration across various levels of government and the private sector.”

As of yesterday, 620,000 H1N1 vaccine doses have been allocated to Hawaiʻi. Of that amount, 418,040 doses have either shipped or are in transit to Hawaiʻi for providers, representing 67 percent of Hawaiʻi’s total allocation.

“The supply has finally caught up with the demand, and starting Monday, we will be able to offer the H1N1 vaccine to anyone who wants it,” said State Department of Health Director Chiyome Fukino, M.D.

Protecting Hawaiʻi’s keiki is a top priority for the DOH. Since the start of the current flu season, it has set aside 77,460 doses for school clinics. So far, 48,304 students in 285 schools have been immunized for the H1N1 virus.

Even though Hawaiʻi has not been hit by a “second wave” of H1N1-related illnesses and deaths as seen on parts of the mainland, health officials say it’s too early to breathe a sigh of relief.

“Many people think it’s over, but it isn’t,” said State Epidemiologist Sarah Park, M.D. “This is what we’ve been talking about in terms of pandemic. It’s not just a one point in time. It goes on and it comes back in waves.”

China, the world’s most populous nation, has seen a decrease in the number of H1N1 cases in major cities. But the virus continues to spread in villages and smaller communities, according to the China Health Ministry.

Because harsher winter months are approaching and many Chinese are expected to go home for the Lunar New Year holiday next month, health officials are expecting the virus to continue spreading in China.

Hawaiʻi remains vulnerable as long as the H1N1 virus continues to circulate among the international community. This is why Hawaiʻi health officials say the best way to protect the public from the H1N1 virus is to get vaccinated.

The DOH and the U.S. Centers for Disease Control and Prevention encourage everyone to get vaccinated for the H1N1 virus.

The Lingle-Aiona Administration also strongly believes that vaccination is the best way for the people of Hawaiʻi to stay healthy. Therefore, Governor Linda Lingle and Lt. Governor Aiona issued a proclamation today declaring the week of January 10-16 “Influenza Vaccination Week” in Hawaiʻi.

School clinics at UH Mānoa and BYU- Hawaiʻi next week will focus on vaccinating students. They will open it up to other members of the community the following weeks.

Anyone who wishes to get the H1N1 vaccine may do so by contacting your health care provider or call Aloha United Way’s 2-1-1 hotline for more information.

MEDIA RELEASE

The Centers for Disease Control and Prevention (CDC) is aware that pregnant women, parents of young children, and others may have questions about the safety of thimerosal in vaccines against 2009 H1N1 flu. Here is some information to help you in making decisions.

Thimerosal Use Prevents Vaccine Contamination
Thimerosal is a mercury-containing preservative that is added to multi-dose vials (vials containing more than one dose) of vaccine to prevent contamination and growth of potentially harmful bacteria. This may occur when a syringe needle enters a vial as a vaccine is being prepared for administration. Such contamination could cause serious local reactions, illness, or death.

Many Studies Have Found Thimerosal In Vaccines To Be Safe
Thimerosal is a very effective preservative that has been used since the 1930s to prevent contamination in a number of products including some multi-dose vials of vaccines.

Data from 19 studies show no convincing evidence of harm caused by the low doses of thimerosal in vaccines, except for minor local injection site reactions like redness and swelling at the injection site. For more information on thimerosal and its safety, visit: General Questions and Answers on Thimerosal

Some Flu Vaccines Against 2009 H1N1 Contain Thimerosal
Since influenza vaccines are produced in large quantities for annual immunization campaigns, some vaccines are produced in multi-dose vials. FDA licensed (approved) both multi-dose vials and single-dose units of the 2009 H1N1 flu vaccine. The multi-dose vials of 2009 H1N1 flu vaccine contain thimerosal, while injectable single-dose units do not. In addition, the live-attenuated version of the vaccine, which is called LAIV and administered as a nasal spray, is produced in single-units and does not contain thimerosal.

Thimerosal-free Flu Vaccines Against 2009 H1N1 May Be Limited
Some priority groups may not be able to find injectable thimerosal-free 2009 H1N1 flu vaccine due to a recent recall of pre-filled, single-dose syringes manufactured by Sanofi Pasteur. Since LAIV is only approved for people from 2 through 49 years of age who are not pregnant and do not have certain health conditions, this means pregnant women and children from ages 6 through 23 months may have difficulty obtaining a thimerosal-free 2009 H1N1 vaccine. Remember, it is safe for children and pregnant women to receive a flu vaccine that contains thimerosal.

Getting The Flu Vaccine Is Safer Than Getting The Flu
It is important to keep in mind that severe illness and possible death can be associated with influenza, and vaccination is the best way to prevent influenza infection and its complications. Currently, the 2009 H1N1 flu virus (sometimes called “swine flu”) seems to be causing serious health outcomes for the following priority groups:

• Healthy young people from birth through age 24
• Pregnant women
• Adults 25 to 64 who have certain underlying medical conditions

Children, especially those younger than 5 years of age and those who have high risk medical conditions are at increased risk of influenza-related complications.

Research Shows No Link Between Thimerosal And Autism
CDC places a high priority on vaccine safety, surveillance, and research. CDC is aware that the presence of the preservative thimerosal in some vaccines and misconceptions of a relationship to autism has raised concerns. These concerns make the decisions surrounding vaccinations confusing and difficult for some people, especially some parents. Most research done in the United States, and around the world, shows no link between thimerosal in vaccines and autism, a neurodevelopment disorder. In fact, sadly, autism rates have actually gone up since thimerosal was taken out of childhood vaccines in 2001, providing further evidence that thimerosal-containing vaccines are not related to autism.

MEDIA RELEASE

Why are some lots of the nasal spray 2009 H1N1 flu vaccine being recalled from the market?

First, it is important to point out that the recall is not safety-related. As part of its quality assurance program, the manufacturer of the nasal spray monovalent 2009 H1N1 flu vaccine, MedImmune, performs routine, ongoing stability testing of the vaccine. Stability testing means measuring the strength (also called potency) of the vaccine over time to make sure it does not go below a pre-specified limit during the vaccine’s “shelf life.” On December 18 and 21, the manufacturer notified CDC and FDA that the potency in 13 batches (called “lots”) of nasal spray vaccine had decreased below the pre-specified limit or were at risk of falling below that limit within the upcoming week. The vaccine was within the specified range at the time the vaccine was distributed. The slight decrease in potency should not affect how the vaccine works. However, the manufacturer will send providers directions for returning any unused vaccine from these lots.

What does potency mean for the nasal spray 2009 H1N1 vaccine?

Potency (or strength) is determined by the measurement of the concentration of the active component in the 2009 H1N1 vaccine.

Are there any concerns about safety of vaccines from these lots?

No. There are no safety concerns with these lots of 2009 H1N1 vaccine. All lots successfully passed pre-release testing for safety, purity and potency.

Should people who received vaccines from these lots be revaccinated?

No. The vaccine potency is or will soon be only slightly below the limit. In addition, much of this vaccine has already been administered while fully potent and within specifications. The vaccine in these lots is still expected to be effective in stimulating a protective response. There is no need to re-administer a dose to those who received vaccine from these lots.

What action(s) should persons who have received vaccine from the recalled lots take?

Persons who received vaccine from the recalled lots do not need to take any special actions. As is recommended for all 2009 H1N1 vaccines, all children younger than 10 years old should get the recommended two doses of 2009 H1N1 vaccine approximately a month apart for the optimal immune response. Therefore, children younger than 10 years old who have only received one dose of the nasal spray vaccine thus far should still receive a second dose of 2009 H1N1 vaccine. It is best to use the same type of vaccine for the first and second dose.

What are the affected lot numbers?
The affected lot numbers are:

* 500754P
* 500751P
* 500756P
* 500757P
* 500758P
* 500759P
* 500760P
* 500761P
* 500762P
* 500763P
* 500764P
* 500765P
* 500776P

How many doses are in these lots?

There were approximately 4.7 million doses in these lots that were distributed to providers. Most of the doses were shipped to vaccine providers in October and early November, during a time when the vaccine potency was still at or above the recommended level. The manufacturer is recalling any doses from these lots that may still be unused.

Is the potency issue related to this recall isolated to just the 13 lots of nasal spray vaccine?

The voluntary recall described here is specific to the 13 lots of nasal spray 2009 H1N1 flu vaccine noted above. Subsequent lots of the vaccine were produced with a slightly higher potency to decrease the chance that they would fall “below specification” before their expiration dates. As per their routine practice, the manufacturer will continue to monitor the potency of those lots, and will notify healthcare providers if the shelf life of any additional lots is shorter than expected.

This recall does not affect 2009 H1N1 vaccine produced by other manufacturers. However, a similar recall was conducted recently which involved lots of Sanofi Pasteur’s pediatric 2009 H1N1 vaccine in 0.25 mL pre-filled syringes.

What testing was performed on these lots of vaccine before they were released?

Before they were shipped, the lots being recalled now passed all quality controls and met all specifications for safety, purity, and potency.

What is being done to notify providers who received vaccine from the affected lots?

The manufacturer will send a notification to providers who received doses from any of the 13 lots of vaccine so that they can return any unused vaccine.

Where were the affected lots of vaccine distributed?

Vaccine from these 13 lots was distributed throughout the United States.

For more information visit: www.cdc.gov and www.flu.gov

MEDIA RELEASE

The Hawai‘i State Department of Health (DOH) announced that thanks to vaccine supplies gradually catching up with demand, Hawai‘i vaccination providers can now use the 2009 H1N1 nasal spray vaccine (LAIV — live attenuated influenza vaccine) to vaccinate any healthy, nonpregnant persons ages 2 through 49 years old. Vaccination providers were notified of the expanded eligibility for H1N1 nasal spray vaccine earlier this past week.

However, for the shots (MIV — injectable monovalent inactivated vaccine), vaccination providers should continue to adhere to the U.S. Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) recommended priority groups for vaccination:

• Pregnant women
• People who live with or care for infants younger than age 6 months
• Healthcare and emergency medical services personnel
• Children and young adults ages 6 months through 24 years
• Anyone ages 25 through 64 years old with underlying medical conditions that put them at a higher risk for influenza-related complications.

The CDC and DOH recommend the H1N1 nasal spray vaccine for all healthy people 2-49 years old who are not pregnant. Vaccination is voluntary and the best protection available against the 2009 H1N1 flu.

For more information on H1N1 influenza or the vaccine, call your doctor, visit flu.hawaii.gov, or call Aloha United Way at 2-1-1. The DOH also is on Twitter. Follow us at www.twitter.com/HIgov_…

For a list of where to get your flu vaccination in Hawaii visit: H1N1 vax provider Resource List.pdf

For vaccinations elsewhere check: www.flu.gov/individual…

MEDIA RELEASE

In fatal cases of 2009 H1N1 influenza, the virus can damage cells throughout the respiratory airway, much like the viruses that caused the 1918 and 1957 influenza pandemics, report researchers from the National Institutes of Health (NIH) and the New York City Office of Chief Medical Examiner. The scientists reviewed autopsy reports, hospital records and other clinical data from 34 people who died of 2009 H1N1 influenza infection between May 15 and July 9, 2009. All but two of the deaths occurred in New York City. A microscopic examination of tissues throughout the airways revealed that the virus caused damage primarily to the upper airway—the trachea and bronchial tubes—but tissue damage in the lower airway, including deep in the lungs, was present as well. Evidence of secondary bacterial infection was seen in more than half of the victims.

The team was led by James R. Gill, M.D., of the New York City Office of Chief Medical Examiner and New York University School of Medicine, and Jeffery K. Taubenberger, M.D., Ph.D., of the National Institute of Allergy and Infectious Diseases (NIAID) at NIH. The findings are reported in the Archives of Pathology & Laboratory Medicine, now available online and scheduled to appear in the February 2010 print issue.

“This study provides clinicians with a clear and detailed picture of the disease caused by 2009 H1N1 influenza virus that will help inform patient management,” says NIAID Director Anthony S. Fauci, M.D. “In fatal cases of 2009 H1N1 influenza, it appears the novel pandemic influenza virus produces pulmonary damage that looks very much like that seen in earlier influenza pandemics.”

The new report also underscores the impact 2009 H1N1 influenza is having on younger people. While most deaths from seasonal influenza occur in adults over 65 years old, deaths from 2009 H1N1 influenza occur predominately among younger people. The majority of deaths (62 percent) in the 34 cases studied were among those 25 to 49 years old; two infants were also among the fatal cases.

Ninety-one percent of those autopsied had underlying medical conditions, such as heart disease or respiratory disease, including asthma, before becoming ill with 2009 H1N1 influenza. Seventy-two percent of the adults and adolescents who died were obese. This finding agrees with earlier reports, based on hospital records, linking obesity with an increased risk of death from 2009 H1N1 influenza.

The researchers examined tissue samples from the 34 deceased individuals to assess how 2009 H1N1 influenza virus damaged various parts of the respiratory system. “We saw a spectrum of damage to tissue in both the upper and lower respiratory tracts,” says Dr. Taubenberger. In all cases, the uppermost regions of the respiratory tract—the trachea and bronchial tubes—were inflamed, with severe damage in some cases. In 18 cases, evidence of damage lower down in the finer branches of the bronchial tubes, or bronchioles, was noted. In 25 cases, the researchers found damage to the small globular air sacs, or alveoli, of the lungs.

“This pattern of pathology in the airway tissues is similar to that reported in autopsy findings of victims of both the 1918 and 1957 influenza pandemics,” notes Dr. Taubenberger.

The researchers also examined 33 of the 34 cases for evidence of pulmonary bacterial infections. Of these cases, 18 (55 percent) were positive for such infections. Not all of those individuals who had bacterial pneumonia along with 2009 H1N1 virus infection had been hospitalized, however, indicating that some had acquired their bacterial infections outside of a health-care setting. This raises the possibility, say the authors, that community-acquired bacterial pneumonia is playing a role in the current pandemic. “Even in an era of widespread and early antibiotic use,” write the authors, “bacterial pneumonia remains an important factor for severe or fatal influenza.”

Computerized tomography (CT) lung images were available in four cases of pulmonary bacterial infection. In all four cases, the CT scans showed an abnormality known as ground-glass opacity, which are patches of rounded haze not seen in normal lung images. It is not known, say the researchers, whether the abnormalities detected by CT in the four cases also occur in people who have milder H1N1 infections. They call for additional investigation into the utility of CT scans as a tool to help clinicians identify and better treat severe H1N1 infections.

Visit www.flu.gov for one-stop access to U.S. government information on avian and pandemic influenza. Also, visit NIAID’s flu Web portal at www3.niaid.nih.gov/top…

PHISHING SCAM – CDC Sponsored State Vaccination Program for H1N1

CDC has received reports of fraudulent emails (phishing) referencing a CDC sponsored State Vaccination Program for H1N1. The messages request that users create a personal H1N1 (swine flu) Vaccination Profile on the CDC.gov web site.

An example of the phishing email is below:

Users that click on the embedded link in the email are at risk of having malicious code installed on their system. CDC reminds users to take the following steps to reduce the risk of being a victim of a phishing attack:

• Do not open or respond to unsolicited email messages.
• Do not click links embedded in emails from unknown senders.
• Use caution when entering personal information online.
• Update anti-virus, spyware, firewall, and anti-spam software regularly.

For more info on this phishing scam visit: www.cdc.gov/hoaxes_rum…

MEDIA RELEASE

Pandemic (H1N1) 2009 briefing note 16

19 NOVEMBER 2009 | GENEVA — To date, WHO has received vaccination information from 16 of around 40 countries conducting national H1N1 pandemic vaccine campaigns. Based on information in these 16 countries, WHO estimates that around 80 million doses of pandemic vaccine have been distributed and around 65 million people have been vaccinated. National immunization campaigns began in Australia and the People’s Republic of China in late September.

Vaccination campaigns currently under way to protect populations from pandemic influenza are among the largest in the history of several countries, and numbers are growing daily. Given this scale of vaccine administration, at least some rare adverse reactions, not detectable during even large clinical trials, could occur, underscoring the need for rigorous monitoring of safety. Results to date are encouraging.

Common side effects

As anticipated, side effects commonly reported include swelling, redness, or pain at the injection site, which usually resolves spontaneously a short time after vaccination.

Fever, headache, fatigue, and muscle aches, occurring shortly after vaccine administration, have also been reported, though with less frequency. These symptoms also resolve spontaneously, usually within 48 hours. In addition, a variety of allergic reactions has been observed. The frequency of these reactions is well within the expected range.

Guillain-Barre syndrome

To date, fewer than ten suspected cases of Guillain-Barre syndrome have been reported in people who have received vaccine. These numbers are in line with normal background rates of this illness, as reported in a recent study. Nonetheless, all such cases are being investigated to determine whether these are randomly occurring events or if they might be associated with vaccination.

WHO has received no reports of fatal outcomes among suspected or confirmed cases of Guillain-Barre syndrome detected since vaccination campaigns began. All cases have recovered. WHO recommends continued active monitoring for Guillain-Barre syndrome.

Investigations of deaths

A small number of deaths have occurred in people who have been vaccinated. All such deaths, reported to WHO, have been promptly investigated. Although some investigations are ongoing, results of completed investigations reported to WHO have ruled out a direct link to pandemic vaccine as the cause of death.

In China, for example, where more than 11 million doses of pandemic vaccine have been administered, health authorities have informed WHO of 15 cases of severe side effects and two deaths that occurred following vaccination. Thorough investigation of these deaths, including a review of autopsy results, determined that underlying medical conditions were the cause of death, and not the vaccine.

Safety profile of different vaccines

Campaigns are using nonadjuvanted inactivated vaccines, adjuvanted inactivated vaccines, and live attenuated vaccines. No differences in the safety profile of severe adverse events among different vaccines have been detected to date.

Although intense monitoring of vaccine safety continues, all data compiled to date indicate that pandemic vaccines match the excellent safety profile of seasonal influenza vaccines, which have been used for more than 60 years.

Find information about the flu at: www.flu.gov

MEDIA RELEASE

The Iowa Department of Public Health (IDPH) and the Iowa Department of Agriculture and Land Stewardship (IDALS) remind Iowans that in addition to protecting their families, friends and neighbors from the spread of the 2009 H1N1 influenza virus, it’s important to remember to protect family pets from the illness, as well. People who are sick with H1N1 can spread the virus not only to humans, but to some animals.

The Departments are sharing this message following the confirmation of a case of H1N1 in an Iowa cat.

The 13-year-old indoor cat in Iowa was brought to the Lloyd Veterinary Medical Center at Iowa State University’s College of Veterinary Medicine, where it tested positive for the H1N1 virus. The diagnosis is the culmination of collaborative efforts between IDPH, Iowa State University College of Veterinary Medicine, Center for Advanced Host Defenses, Immunobiotics and Translational Comparative Medicine, USDA, and IDALS Animal Industry Bureau.

“Two of the three members of the family that owns the pet had suffered from influenza-like illness before the cat became ill,” said IDPH Public Health Veterinarian, Dr. Ann Garvey. “This is not completely unexpected, as other strains of influenza have been found in cats in the past.” Both the cat and its owners have recovered from their illnesses.

People can keep their pets healthy by washing hands, covering coughs and sneezes, and minimizing contact with their pets while ill with influenza-like symptoms. If your pet exhibits signs of a respiratory illness, contact your veterinarian.

“Indoor pets that live in close proximity to someone who has been sick are at risk and it is wise to monitor their health to ensure they aren’t showing signs of illness,” said Dr. David Schmitt, State Veterinarian for Iowa.

For more information about H1N1, visit www.idph.state.ia.us/h… or call the Iowa Influenza Hotline at 1-800-447-1985.

Contact Information: Polly Carver-Kimm at (515) 281-6693

MEDIA RELEASE

In an effort to proactively address the ongoing pandemic, the President signed a National Emergency Declaration on H1N1 that allows healthcare systems to quickly implement disaster plans should they become overwhelmed.

As experts expected, H1N1 flu is moving rapidly throughout the country and the majority of states now have widespread influenza activity. This declaration gives authority for the Department of Health and Human Services (HHS) to waive certain regulatory requirements for healthcare facilities in response the ongoing pandemic. Specifically, healthcare facilities will be able to submit waivers to establish alternate care sites, and modified patient triage protocols, patient transfer procedures and other actions that occur when they fully implement disaster operations plans.

Under Section 1135 of the Social Security Act [42 USC §1320b–5] healthcare facilities may petition for HHS approval of waivers in response to particular needs within the geographic and temporal limits of the emergency declarations. Before HHS has the authority to approve such “1135 Waivers” two conditions must be met: first, the Secretary must have declared a Public Health Emergency, and second, the President must have declared a National Emergency either through a Stafford Act Declaration or National Emergencies Act Declaration. 1135 Waivers still require specific requests be submitted to HHS and processed, and some State laws may need to be addressed as well.

The Secretary may tailor authorities granted under Section 1135 waivers to match the specific situational needs, but the requirements that may be waived include those related to Medicare, Medicaid or the Children’s Health Insurance Program (CHIP), the Emergency Medical Treatment and Active Labor Act (EMTALA), and the Health Insurance Portability and Accountability Act (HIPAA).

Past instances where authority to grant Section 1135 waivers was enabled include:

Hurricane Katrina (2005)
56th Presidential Inauguration (2009)
Hurricanes Ike and Gustav (2008)
North Dakota flooding (2009)
Learn more about this National Emergency Declaration and get information on H1N1 and seasonal flu at Flu.gov.

MEDIA RELEASE

HONOLULU – The Hawai‘i State Department of Health (DOH) announced that the inoculation (shot) version of the 2009 H1N1 Influenza vaccine has arrived in Hawai‘i. Last week, Hawai‘i was allocated 6,700 doses of injectable MIV (monovalent inactivated vaccine) by the U.S. Centers for Disease Control and Prevention (CDC). Orders from that first allocation began arriving in Hawai‘i today. Hawai‘i’s weekly allocation of 2009 H1N1 influenza vaccine continues to increase as orders are placed daily by the DOH.

The influenza nasal spray (LAIV ) version of the 2009 H1N1 vaccine began arriving in Hawai‘i on Oct. 5, 2009 and providers are continuing to administer this dosage to priority groups as defined by the CDC (see guidelines on page 2). The nasal spray vaccine can only be administered to children and adults ages 2 years to 49 years of age with no underlying medical conditions. The nasal spray vaccine is not recommended for pregnant women.

“Now that the injectable inactivated version of the vaccine is here, more people in priority groups can start receiving their vaccine,” said Health Director Chiyome Fukino, M.D. “The department is directing inactivated vaccine supplies to providers who serve priority groups which include healthcare workers, EMS and first responders involved in direct patient care, along with those at higher risk for developing serious complications from the 2009 H1N1 flu.”

“The LAIV availability allowed us to serve healthy members of priority groups under age 49,” said State Epidemiologist Sarah Park, M.D. “Now we will begin focusing on primarily pushing these H1N1 flu shotsthat have arrived to meet demand for pregnant women, and those with underlying health conditions such as asthma, diabetes, and other conditions that affect one’s lung function or immune system, as well as other priority persons who cannot receive the nasal-spray version.”

The LAIV (nasal spray) contains a live, weakened virus and should not be used in pregnant women or people with compromised immune systems. The shot version contains a portion of inactivated virus and can be given to everyone. Both are safe and have been produced the same way as regular flu vaccines except that this new vaccine protects against 2009 H1N1. Members of priority groups should contact their health care provider to determine the appropriate vaccine version to receive.

In accordance with CDC guidelines, the DOH will give first priority to the following high-risk groups for H1N1 vaccination:

• Healthcare and emergency medical services personnel with direct patient contact;
• Pregnant women;
• Household contacts and caregivers for children younger than age 6 months;
• All people from age 6 months through 24 years; and,
• Persons aged 25 through 64 years who have health conditions associated with higher risk of medical complications from influenza.

As part of statewide efforts in all counties, a total of 442 Honolulu firefighters and emergency medical services personnel were vaccinated over the weekend of Oct. 10-12, 2009 at Castle Medical Center, Hawaii Medical Center-West, Mililani fire station, The Queen’s Medical Center, and the Waikiki fire station.

Flu.hawaii.gov lists community providers offering the H1N1 vaccine to the public. The public may also receive updates on H1N1 vaccine availability by following the DOH on Twitter, at twitter.com/HIgov_Heal… Information on 2009 Novel H1N1 influenza is also available by calling Aloha United Way’s 2-1-1 helpline.

MEDIA RELEASE

The U.S. Food and Drug Administration today warned consumers to use extreme care when purchasing any products over the Internet that claim to diagnose, prevent, treat or cure the H1N1 influenza virus. The warning comes after the FDA recently purchased and analyzed several products represented online as Tamiflu (oseltamivir), which may pose risks to patients.

One of the orders, which arrived in an unmarked envelope with a postmark from India, consisted of unlabeled, white tablets taped between two pieces of paper. When analyzed by the FDA, the tablets were found to contain talc and acetaminophen, but none of the active ingredient oseltamivir. The Web site disappeared shortly after the FDA placed the order. At the same time, the FDA also purchased four other products purported to diagnose, prevent, treat or cure the H1N1 influenza virus from other Web sites.

These products contained various levels of oseltamivir but were not approved for use in the United States. Several of the products purchased did not require a prescription from a health care professional. Additionally, the products did not arrive in a timely enough fashion to treat someone infected with the H1N1 influenza virus, or with an immediate exposure to the virus.

“Products that are offered for sale online with claims to diagnose, prevent, mitigate, treat or cure the 2009 H1N1 influenza virus must be carefully evaluated,” said Commissioner of Food and Drugs Margaret A. Hamburg, M.D. “Medicines purchased from Web sites operating outside the law put consumers at increased risk due to a higher potential that the products will be counterfeit, impure, contaminated, or have too little or too much of the active ingredient.”

Consumers may not know exactly what they are getting when buying such antiviral products on the Internet from an unfamiliar company. Patients who buy prescription drugs from Web sites operating outside the law are at increased risk of suffering life-threatening adverse events, such as side effects from inappropriately using prescription medications, dangerous drug interactions, contaminated drugs, and impure or unknown ingredients found in unapproved drugs. This may particularly be the case in the event of a public health emergency, such as an influenza outbreak, where approved treatment options would be in high demand and expensive, and where drug shortages could occur.

Drugs that are in high demand are vulnerable to counterfeiting and diversion because buyers may be desperate to stock the product, and criminals capitalize on the situation.

The FDA urges consumers to only purchase FDA-approved products from licensed pharmacies located in the United States. Consumers should contact their health care provider if they have any questions or concerns about medical products or personal protective equipment.

The two antiviral drugs approved by the FDA for treatment and prophylaxis of the 2009 H1N1 influenza virus are Tamiflu (oseltamivir phosphate) and Relenza (zanamivir).

Tamiflu and Relenza, in addition to their approved label, have Emergency Use Authorizations that describe specific authorized uses during this public health emergency.

The FDA actively monitors the Internet, and where appropriate, will purchase and analyze drug products.

Consumers can also visit FDA’s Web site for tips about how to protect themselves when buying medicines online.

MEDIA RELEASE

HONOLULU – The Hawai‘i State Department of Health (DOH) has confirmed novel H1N1 influenza infection in an adult male in his 50s who died at Tripler Army Medical Center on O‘ahu. This brings the total number of deaths in Hawai‘i with laboratory confirmed 2009 H1N1 Influenza to 11.

The O‘ahu resident had a number of underlying medical conditions that contributed to his decline and death. No further information about patient medical conditions before death or identification will be released due to patient privacy considerations and federal law.
“The patient had multiple, additional co-morbidities and these conditions were contributing factors to his death,” said Dr. Sarah Park, Chief of the Disease Outbreak Division and State Epidemiologist. “We are continuing to monitor critical case testing and focused clusters to help identify if this pandemic virus changes into something that causes more severe disease.”

Similar to what has been observed nationally, underlying conditions such as obesity, smoking, asthma, heart disease, diabetes, and respiratory difficulties have been contributing factors in novel H1N1-related hospitalizations and deaths in Hawai‘i.

The U.S. Centers for Disease Control and Prevention has information at cdc.gov/h1n1flu/pregna… for pregnant women, who may also be at increased risk for complications from H1N1 influenza infection.

The public is urged to take the following steps to prevent spreading illness to others:

• Get a seasonal flu vaccination and the 2009 H1N1 flu vaccination when it becomes available. This is especially important for high-risk groups.
• If you become sick, stay at home; isolate yourself from others whenever possible;
• Cover your cough or sneeze with a tissue and dispose of used tissues;
• Wash your hands frequently, or use an alcohol-based hand sanitizer;
• Avoid touching your eyes, nose, and mouth;
• Seek care if you have flu-like illness (fever > 100°F plus cough or sore throat); and
• Stay healthy by eating a balanced diet, drinking plenty of water, and getting plenty of rest and exercise.

On October 5, Hawai‘i received its first shipment of H1N1 vaccine. DOH continues to place vaccine orders according to demand and allocation numbers. Initially, priority groups will be the first to receive the vaccine, and as more becomes available and demand is met, the entire public will be encouraged to receive the vaccine.

In accordance with CDC guidelines, the DOH will give first priority to the following high-risk groups for H1N1 vaccination:

• Healthcare and emergency medical services personnel with direct patient contact;
• Pregnant women;
• Household contacts and caregivers for children younger than age 6 months;
• All people from age 6 months through 24 years; and,
• Persons aged 25 through 64 years who have health conditions associated with higher risk of medical complications from influenza.

For more information on H1N1 influenza or the vaccine, please visit flu.hawaii.gov, or call Aloha United Way at 2-1-1. The DOH also is on Twitter. Follow us at www.twitter.com/HIgov_…

MEDIA RELEASE

The state Department of Health has begun placing orders with the U.S. Centers for Disease Control and Prevention for 2009 Novel H1N1 Influenza vaccine.  

The CDC has approximately 3 million initial doses of nasal-spray flu vaccine LAIV (FluMist®) available to the nation in this first series of shipments to all states that place orders.  

Shipments are expected to arrive during the week of Oct. 5. 

“These initial shipments of H1N1 vaccine will be used to protect emergency medical service personnel, first responders and healthcare workers,” said Health Director Chiyome Fukino, M.D. “The state will follow CDC guidance and give first priority to high-risk groups that may be more vulnerable to serious complications from the H1N1 flu.”

In accordance with CDC guidelines, the DOH will give first priority to the following high-risk groups for H1N1 vaccination: 

* Healthcare and emergency medical services personnel with direct patient contact; 

* Pregnant women; 

* Household contacts and caregivers for children younger than age 6 months; 

* All people from age 6 months through 24 years; 

* Persons aged 25 through 64 years who have health conditions associated with higher risk of medical complications from influenza. 

Hospital facilities will be some of the first to receive the novel H1N1 vaccine to immunize their healthcare workers. 

The DOH is also working on other avenues of distribution that will include pre-registered primary care physicians; community vaccinators such as retail pharmacy chains and community health clinics; and school-located vaccination clinics scheduled to begin in November. 

According to the CDC, the first H1N1 vaccine doses received by all states will be the nasal spray live attenuated influenza vaccine (LAIV) or FluMist®.  This form of vaccine is recommended for children two years of age or older and adults up to 49 years of age.  

It is not recommended for pregnant women or individuals with underlying medical conditions such as asthma. In addition to LAIV, injectable vaccine doses will be available in weekly shipments to states beginning in mid-October.   

The CDC estimates 10 million to 20 million doses of both forms of vaccine will be available for distribution nationwide each week after the first week in October.  

Hawaii was allocated 14,400 doses of vaccine to be able to draw from with its first order. H1N1 vaccine allocations can and most likely will come multiple times during the course of a week, so H1N1 allocation numbers will change frequently. 

Beyond the high-risk groups who will be targeted initially to receive the H1N1 vaccine, the DOH will be encouraging everyone to get vaccinated as it becomes more widely available. 

Meanwhile, everyone can continue to help stop the spread of influenza by getting their seasonal flu vaccination and through simple yet effective methods like covering your cough, washing your hands frequently, and staying home if you are sick. 

New influenza Web site

The DOH has launched a new website dedicated solely to information on influenza and the H1N1 vaccine in Hawaii.  

The Web site is accessible at www.hawaii.gov/health/… and will include the latest information available on the H1N1 vaccine, when and where it will be available.  

The public may also receive the updates on H1N1 vaccine availability by following the DOH on Twitter, at twitter.com/HIgov_Heal…  

Information on 2009 Novel H1N1 influenza is also available by calling Aloha United Way’s 2-1-1 helpline.

MEDIA RELEASE

Anyone with asthma is at higher risk for flu-related complications, such as pneumonia. Along with everyone else, if you have asthma you should:

* wash your hands often with soap and water, especially after coughing or sneezing;

* cover your nose and mouth with a tissue when coughing or sneezing and throw the tissue away. If you do not have a tissue, cough or sneeze into your elbow or shoulder not your bare hands;

* avoid touching your eyes, nose, or mouth (germs are spread that way); and

* stay home when you are sick, except to get medical care.

If you have asthma, you should follow an updated, written Asthma Action Plan developed with your doctor. Follow this plan for daily treatment and for controlling your asthma symptoms.

If your child has asthma, make sure that his or her updated, written Asthma Action Plan is on file at school or at the daycare center. Be sure that the plan and medication(s) are easy to get to when needed.

Everyone with asthma who is older than 6 months should get a shot every year to protect against the seasonal flu. Children aged 6 months to 8 years who never have had a seasonal flu shot will need two doses the first time. Children who have had a seasonal flu shot in the past only need one shot. Persons with asthma should not use the inhaled “FluMist®” vaccine.

Everyone with asthma who is aged 6 months to 64 years should get the 2009 H1N1 flu shot when it becomes available. The 2009 H1N1 flu shot is not the same as the shot for seasonal flu. If the H1N1 flu vaccine is in short supply, some persons may not be able to get the shot right away.

Certain antiviral drugs are prescription medicines that fight the flu virus by stopping it from growing in your body. They make you feel better faster and may prevent serious flu problems.

The antiviral drug Tamiflu (also known as oseltamivir) is recommended for treating 2009 H1N1 virus infection and may be prescribed for persons with asthma. Flu treatments work best if they start within two days of when you get flu-like illness.

Persons with flu infections might also get bacterial infections. These persons will also need to take antibiotics to fight the bacterial infection. Some signs of bacterial infection are severe or prolonged illness, or illness that seems to get better but then gets worse.

Do not give aspirin (acetylsalicylic acid) to children or teenagers who have the flu. This can cause a rare but serious illness called Reye’s syndrome.

To learn more about these recommendations and for updates, visit www.cdc.gov/flu/ or call CDC at 1-800-CDC-INFO.

MEDIA RELEASE

CDC’s health information is now available on your mobile device. 

Visit m.cdc.gov on your mobile phone or PDA for information on seasonal flu, H1N1 flu, public health emergencies, and more. Sign up now to have important CDC information about H1N1 flu and other topics delivered directly to your mobile phone. 

This site is designed to be easily read and navigated from mobile devices and will soon feature even more health and safety topics.

CDC this month launched a three-month text messaging campaign pilot to share important, timely health information directly to users. Your feedback is very important to us and we look forward to receiving your input during this pilot.

To subscribe to the pilot, text HEALTH to 87000. Once you sign up for this pilot, you will be asked a few questions and begin receiving short health tips from CDC. 

Subscribers can expect to receive about three health messages a week during the three-month pilot. 

CDC does not charge subscribers to participate, although standard text messaging rates will apply. You can opt out at any time by simply replying HEALTH QUIT.

MEDIA RELEASE

Approval Provides Important Tool to Fight Pandemic

The U.S. Food and Drug Administration announced today that it has approved four vaccines against the 2009 H1N1 influenza virus. The vaccines will be distributed nationally after the initial lots become available, which is expected within the next four weeks.

“Today’s approval is good news for our nation’s response to the 2009 H1N1 influenza virus,” said Commissioner of Food and Drugs Margaret A. Hamburg, M.D. “This vaccine will help protect individuals from serious illness and death from influenza.”

The vaccines are made by CSL Limited, MedImmune LLC, Novartis Vaccines and Diagnostics Limited, and sanofi pasteur Inc. All four firms manufacture the H1N1 vaccines using the same processes, which have a long record of producing safe seasonal influenza vaccines.

”The H1N1 vaccines approved today undergo the same rigorous FDA manufacturing oversight, product quality testing and lot release procedures that apply to seasonal influenza vaccines,” said Jesse Goodman, M.D., FDA acting chief scientist.

Based on preliminary data from adults participating in multiple clinical studies, the 2009 H1N1 vaccines induce a robust immune response in most healthy adults eight to 10 days after a single dose, as occurs with the seasonal influenza vaccine.

Clinical studies under way will provide additional information about the optimal dose in children. The recommendations for dosing will be updated if indicated by findings from those studies. The findings are expected in the near future.

As with the seasonal influenza vaccines, the 2009 H1N1 vaccines are being produced in formulations that contain thimerosal, a mercury-containing preservative, and in formulations that do not contain thimerosal.

People with severe or life-threatening allergies to chicken eggs, or to any other substance in the vaccine, should not be vaccinated.

In the ongoing clinical studies, the vaccines have been well tolerated. Potential side effects of the H1N1 vaccines are expected to be similar to those of seasonal flu vaccines.

For the injected vaccine, the most common side effect is soreness at the injection site. Other side effects may include mild fever, body aches, and fatigue for a few days after the inoculation. For the nasal spray vaccine, the most common side effects include runny nose or nasal congestion for all ages, sore throats in adults, and — in children 2 to 6 years old — fever.

As with any medical product, unexpected or rare serious adverse events may occur. The FDA is working closely with governmental and nongovernmental organizations to enhance the capacity for adverse event monitoring, information sharing and analysis during and after the 2009 H1N1 vaccination program. In the U.S. Department of Health and Human Services, these agencies include the Centers for Disease Control and Prevention.

Vaccines against three seasonal virus strains are already available and should be used (see information on the seasonal flu). However, they do not protect against the 2009 H1N1 virus (see information on H1N1 flu).

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