Thursday, October 29, 2009

Amherst Receives SWINE Flu (H1N1) Vaccine

The Town of Amherst has received two hundred doses of Swine Flu (H1N1) vaccine; one (100) hundred on October 21 and one (100) hundred on October 22, 2009. This first round of vaccine was distributed to pediatric and obstetric facilities in Amherst with some doses being reserved for first responders in the Town of Amherst. Further, we have received notification of another two (200) hundred doses to arrive in the near future. We will continue to maintain contact with the Amherst Public Schools, the University and Colleges, and obstetrical and pediatric facilities in an effort to make the vaccine available to those individuals that are at the very top of the Centers for Disease Control (CDC) program priority list.

Swine Flu (H1N1) continues to be a problem for the town of Amherst along with the Commonwealth of Massachusetts and the entire nation. We would recommend that citizens continue to follow advice from their health care professionals and take the necessary precautions as follows:

· Avoid hugging, holding, kissing or shaking hands with anyone who has a cold or the flu.
· Wash your hands often with soap and warm water or use an alcohol based hand sanitizer.
· Avoid touching your nose, mouth or eyes.
· Clean items that are touched often such as telephones and door handles.
· If you get sick, stay home and avoid contact with others.
· Severe symptoms should prompt you to contact your health care provider.
· Cover your mouth and nose with a tissue when sneezing or coughing.

For information, please see the Fact Sheet on the Town of Amherst web site www.amherstma.gov or Massachusetts Department of Public Health (MDPH) web site at www.mass.gov/dph/flu or the Centers for Disease Control (CDC) web site at www.cdc.gov/swineflu.

Questions may be answered by:

Epi Bodhi, Director, Amherst Health Department, Town of Amherst: 413-348-5107 or 413-259-3077

Thursday, October 8, 2009

Flu Vaccine Availability

On October 6th, the Amherst Health Department and Amherst Senior Center held a public seasonal flu vaccine clinic. The Public Health Nurse and volunteer nurses from the community and the Medical Reserve Corps administered over 200 doses of flu vaccine to area residents.

Due to complications related to the manufacturing and distribution of the new H1N1 vaccine, the balance of the town's allocated seasonal flu vaccine has been delayed. Therefore, our make-up flu clinic scheduled for October 14th from 8am to 10am has been postponed until further notice.

Please stay tuned for announcements regarding a seasonal flu vaccine make-up clinic, as well as H1N1 vaccination clinics which will be taking place later this fall.

Meanwhile, any resident seeking a flu shot can click here to search for available flu clinics in the area.

Thursday, October 1, 2009

FDA Informs Consumers of a Nationwide Voluntary Recall of Certain Tylenol Products

The U. S. Food and Drug Administration wants to make consumers aware of a voluntary recall conducted by McNeil Consumer Healthcare of certain lots of oral suspension Children's and Infants' TYLENOL products. This recall was done as a precautionary measure because of potential manufacturing problems. The voluntary recall does not include other Tylenol products.
The company initiated a recall of certain oral suspension products distributed between March 2008 and May 2008 due to the potential of bacteria in raw materials used to manufacture the finished product. The company’s analysis of the finished product did not reveal any bacterial contamination.

The full list of recalled product lots can be accessed on the company’s Web site at http://www.tylenol.com/generic.jhtml?id=tylenol/news/subpchildinfantnews.inc .

The FDA is working closely with the company to monitor this recall. There are no illnesses reported by patients using this product.

Tuesday, September 22, 2009

Early Results: In Children, 2009 H1N1 Influenza Vaccine Works Like Seasonal Flu Vaccine

For immediate release from the National Institutes of Health:

Early results from a trial testing a 2009 H1N1 influenza vaccine in children look promising, according to the trial sponsor, the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health. Preliminary analysis of blood samples from a small group of trial participants shows that a single 15-microgram dose of a non-adjuvanted 2009 H1N1 influenza vaccine — the same dose that is in the seasonal flu vaccine — generates an immune response that is expected to be protective against 2009 H1N1 influenza virus in the majority of 10- to 17- year-olds eight to 10 days following vaccination. These results are similar to those recently reported in clinical trials of healthy adults. Younger children generally had a less robust early response to the vaccine.

"This is very encouraging news," says NIAID Director Anthony S. Fauci, M.D. "As we had hoped, responses to the 2009 H1N1 influenza vaccine are very similar to what we see with routinely used seasonal influenza vaccines made in the same way. It seems likely that the H1N1 flu vaccine will require just one 15-microgram dose for children 10 to 17 years of age. The 2009 H1N1 influenza virus is causing widespread infections among children, so these are welcome results."

The ongoing NIAID-sponsored trial began in mid-August at five sites nationwide. The trial is assessing the safety and immune responses to one and two doses of either 15 micrograms or 30 micrograms of vaccine. Data from the trial is being compared for three age groups: children 6 months to 35 months old; 3 to 9 years old; and 10 to 17 years old.

The preliminary results are based on blood samples taken eight to 10 days after the first vaccination. Immune responses were strongest among the oldest children, those 10 to 17 years old. In this group of 25 children, a strong immune response was seen in 76 percent who received one 15-microgram dose of vaccine. The immune responses in children nine years old and younger were not as strong. Among 25 volunteers aged 3 to 9 years old, a strong immune response was seen in 36 percent of those given 15 micrograms of vaccine. In the youngest group, 20 children between 6 months to 35 months old, a single 15-microgram dose of vaccine produced a strong immune response in 25 percent of recipients.

"These results are not unexpected and are both similar to what is seen with seasonal influenza vaccines and consistent with what we and our colleagues at the Food and Drug Administration anticipated," notes Dr. Fauci.

Study investigators are also collecting blood samples from the volunteers approximately three weeks after both the first and second injections. It is anticipated that the immune response to the 2009 H1N1 influenza vaccine will be similar to that of seasonal influenza vaccination and will continue to rise for several weeks following vaccination, says Dr. Fauci. The study is being closely monitored by the trial physicians and staff as well as by an independent safety monitoring committee.

The vaccine being tested in this trial is manufactured by Sanofi Pasteur in Swiftwater, Pa., in the same manner as its licensed seasonal vaccine, which is used every year in millions of children, and is the same formulation recently licensed by the FDA to protect against 2009 H1N1 influenza. Like inactivated seasonal influenza vaccines, the vaccine contains a purified part of a killed virus and cannot cause flu.

NIAID is conducting trials of 2009 H1N1 influenza vaccines through its longstanding vaccine clinical trials network, the Vaccine and Treatment Evaluation Units. Additional information about the NIAID-sponsored clinical trials in children is available in an Aug. 18 Bulletin: http://www3.niaid.nih.gov/news/newsreleases/2009/H1N1pedvax.htm and a Q&A: http://www3.niaid.nih.gov/news/QA/qaH1N1pedvax.htm.

A detailed description of the trial protocol is at clinicaltrials.gov: http://clinicaltrials.gov/show/NCT00944073.

For more information on influenza, including pandemic influenza and avian influenza, visit www.flu.gov. Also, see NIAID’s Web portal at http://www3.niaid.nih.gov/topics/Flu/.
NIAID conducts and supports research — at NIH, throughout the United States, and worldwide — to study the causes of infectious and immune-mediated diseases, and to develop better means of preventing, diagnosing and treating these illnesses. News releases, fact sheets and other NIAID-related materials are available on the NIAID Web site at
http://www.niaid.nih.gov.

The National Institutes of Health (NIH) — The Nation's Medical Research Agency — includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. It is the primary federal agency for conducting and supporting basic, clinical and translational medical research, and it investigates the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.

Monday, September 21, 2009

CDC Influenza Update

According to the Centers for Disease Control and Prevention (CDC), the following indicators of the level of flu activity in the US are currently observed (taken from the CDC website):

Visits to doctors for influenza-like illness (ILI) are increasing nationally. Visits to doctors for influenza-like illness are higher than what is expected during this time of year and have increased for five consecutive weeks now. This is very unusual for this time of year.

Total influenza hospitalization rates for adults and children are similar to or lower than seasonal influenza hospitalization rates depending on age group, but are higher than expected for this time of year.

The proportion of deaths attributed to pneumonia and influenza (P&I) was low and within the bounds of what is expected at this time of year.

Twenty-one states are reporting widespread influenza activity at this time. They are: Alabama, Alaska, Arizona, Arkansas, Florida, Georgia, Illinois, Kansas, Kentucky, Louisiana, Maryland, Minnesota, Mississippi, Nevada, New Mexico, North Carolina, Oklahoma, Pennsylvania, South Carolina, Tennessee, and Virginia. Any reports of widespread influenza activity in September are very unusual.

Almost all of the influenza viruses identified so far are 2009 H1N1 influenza A viruses. These viruses remain similar to the viruses chosen for the 2009 H1N1 vaccine, and remain susceptible to the antiviral drugs oseltamivir and zanamivir with rare exceptions.


The Amherst Health Department will continue to stay abreast of the situation, using this blog and other means to communicate our findings and recommendations for staying healthy and safe during the flu season.

Wednesday, September 9, 2009

FDA Opens New Electronic Food Registry Portal

For Immediate Release: Sept. 8, 2009
Media Inquiries: Michael Herndon, Michael.Herndon@fda.hhs.gov, 301-796-4673
Consumer Inquiries: 888-INFO-FDA

FDA Opens the Reportable Food Registry Electronic Portal for Industry

Food facilities now required to report potentially dangerous products

The U.S. Food and Drug Administration has a new way to head off potential cases of foodborne illness – the Reportable Food Registry (RFR), where food industry officials must use to alert the FDA quickly, through an electronic portal when they find their products might sicken or kill people or animals. The requirement, a result of legislation, took effect with the launch of the portal.

Facilities that manufacture, process or hold food for consumption in the United States now must tell the FDA within 24 hours if they find a reasonable probability that an article of food will cause severe health problems or death to a person or an animal.

The reporting requirement applies to all foods and animal feed regulated by the FDA, except infant formula and dietary supplements, which are covered by other regulatory requirements. Some examples of reasons a food may be reportable include bacterial contamination, allergen mislabeling or elevated levels of certain chemical components.

The opening of the RFR electronic portal reflects a fundamental principle of the President’s Food Safety Working Group that “preventing harm to consumers is our first priority.”

"President Obama has pledged to strengthen food safety,” said Commissioner of Food and Drugs Margaret A. Hamburg, M.D. “The opening of the Reportable Food Registry electronic portal represents a significant step toward that pledge.”

"By fostering real-time submission to the FDA of information on food safety hazards, the registry enhances FDA's ability to act quickly to prevent foodborne illness," said Michael R. Taylor, senior advisor to the commissioner. "Working with the food industry, we can swiftly remove contaminated products from commerce and keep them out of consumers' hands."

The requirements apply to any person who has to submit registration information to the FDA for a food facility that manufactures, processes, packs, or holds food for human or animal consumption in the United States. These people are termed responsible parties.

A responsible party:


• Must investigate the cause of the adulteration if the adulteration of food may have originated with the responsible party
• Must submit initial information; followed by supplemental reports
• Must work with the FDA authorities to follow up as needed

A responsible party is not required to report if it found the problem before the food was shipped, and corrected the problem or destroyed the food.

The agency issued draft guidance on the RFR in June and sought comment. The FDA also held three public workshops across the country in which FDA representatives explained the RFR requirements and how the portal will work. A Federal Register notice was issued today announcing the opening of the RFR electronic portal and the availability of final guidance to assist the food industry in complying with the requirements of the RFR.

For more information:

The RFR Guidance
www.fda.gov/ReportableFoodRegistry

President Obama Proclaims National Preparedness Month

For Immediate Release

NATIONAL PREPAREDNESS MONTH, 2009
BY THE PRESIDENT OF THE UNITED STATES OF AMERICA


A PROCLAMATION:

Preparedness is an essential element of a resilient and secure Nation. My Administration has made preparedness a top priority, and we are working every day to ensure our country stands ready to respond to any disaster or emergency -- from wildfires and hurricanes, to terrorist attacks and pandemic disease. Our goal is to ensure a more resilient Nation -- one in which individuals, communities, and our economy can adapt to changing conditions as well as withstand and rapidly recover from disruption due to emergencies.

During National Preparedness Month, we underscore the responsibility of individuals, families, and communities -- including the private and nonprofit sectors -- to do their part before an emergency. I urge all Americans to take time to prepare an emergency supply kit and a family emergency plan, and to educate themselves about potential disasters. I also ask Americans to work within their own communities to coordinate emergency preparedness efforts. All Americans share this responsibility, and we must all work together to safeguard the Nation from harm.

The Federal Emergency Management Agency (FEMA) supports and promotes citizen education and grassroots preparedness efforts. FEMA's Ready Campaign provides simple and practical steps thatall Americans can take to protect themselves, their families, and their neighbors. Additionally, the Citizen Corps educates, trains, and coordinates volunteer activities that help make our communities safer and better prepared for emergencies. I encourage all Americans to learn more at www.ready.gov and www.citizencorps.gov.

NOW, THEREFORE, I, BARACK OBAMA, President of the United States of America, by virtue of the authority vested in me by the Constitution and laws of the United States, do hereby proclaim September 2009 as National Preparedness Month. I call upon the people of the United States to recognize the importance of preparing for potential emergencies beforehand and to observethis month with appropriate preparedness activities, events, and training to enhance our national resilience.

IN WITNESS WHEREOF, I have hereunto set my hand this fourth day of September, in the year of our Lord two thousand nine, and of the Independence of the United States of America the two hundred and thirty-fourth.

BARACK OBAMA