FDA Approves Vaccine for 2009-2010 Seasonal Influenza

For immediate release: The U.S. Food and Drug Administration today announced that it has approved a vaccine for 2009-2010 seasonal influenza in the United States.

The seasonal influenza vaccine will not protect against the 2009 H1N1 influenza virus that resulted in the declaration of a pandemic by the World Health Organization (WHO) on June 11, 2009. The FDA continues to work with manufacturers, international partners and other government agencies to facilitate the availability of a safe and effective vaccine against the 2009 H1N1 influenza virus.

Although this year’s seasonal vaccine is directed against other strains of influenza expected to be circulating and will not provide protection against the 2009 H1N1 influenza virus, it is still important for those Americans for whom it is recommended to receive the seasonal influenza vaccine. No vaccine is 100 percent effective against preventing disease, but vaccination is the best protection against influenza and can prevent many illnesses and deaths.

“The approval of this year’s seasonal influenza vaccine is an example of the FDA’s important responsibility to assure timely availability of vaccine to help protect the health of the American public,” said Margaret A. Hamburg, M.D., commissioner of food and drugs. “A new seasonal influenza vaccine each year is a critical tool in protecting public health.”

The six vaccine brand names and manufacturers are: Afluria, CSL Limited; Fluarix, GlaxoSmithKline Biologicals; FluLaval, ID Biomedical Corporation; Fluvirin, Novartis Vaccines and Diagnostics Limited; Fluzone, Sanofi Pasteur Inc.; and FluMist, MedImmune Vaccines Inc.
Each year, experts from the FDA, WHO, U.S. Centers for Disease Control and Prevention (CDC), and other institutions study virus samples and patterns collected from around the world in an effort to identify strains that may cause the most illness in the upcoming season.

Based on those forecasts and on the recommendations of the FDA’s Vaccine and Related Products Advisory Committee, the FDA determines the three strains that manufacturers should include in their vaccines for the U.S. population. The closer the match between the circulating strains and the strains in the vaccine, the better the protection against the disease.

The vaccine for the 2009-2010 seasonal influenza contains:

• an A/Brisbane/59/2007 (H1N1)-like virus
• an A/Brisbane/10/2007 (H3N2)-like virus
• a B/Brisbane/60/2008-like virus

There is always a possibility of a less than optimal match between the virus strains predicted to circulate and the virus strains that end up causing the most illness. Even if the vaccine and the circulating strains are not an exact match, the vaccine may reduce the severity of the illness or may help prevent influenza-related complications.

According to the CDC, between 5 percent and 20 percent of the U.S. population develops influenza each year. More than 200,000 are hospitalized from its complications and about 36,000 people die. Older people, young children, and people with chronic medical conditions are at higher risk for influenza-related complications. Vaccination of these groups is critical.

Additionally, influenza immunization of health care personnel is important in protecting them and others from influenza.

For more information:

FDA Web Page on Influenza Vaccine Safety & Availabilityhttp://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/VaccineSafety/ucm110288.htm

FDA List of Strains Included in the 2009-2010 Influenza Vaccine http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Post-MarketActivities/LotReleases/ucm162050.htm

U.S. Centers for Disease Control and Prevention Web Page on Seasonal Influenza Resources for Health Professionals http://www.cdc.gov/flu/professionals/vaccination/

U.S. Centers for Disease Control and Prevention Web Page with Key Fact About Seasonal Flu Vaccine http://www.cdc.gov/flu/protect/keyfacts.htm

Swine Flu Update

The Amherst Public Health Department would like residents, business owners, and town employees to know that we are monitoring the current swine flu outbreak very closely and will keep the public informed of changes and new alerts as they happen.

Yesterday, Health Department staff participated in a conference call with the Massachusetts Department of Public Health in which we were given updates on the current situation, as well as the response being mounted by the state. We are confident that DPH, the CDC, and other players in the public health arena are responding appropriately and swiftly, and we are in frequent contact with state officials as they disseminate new information to local boards of health, schools, and municipal governments.

While this is not a time for panic, it is indeed a time for vigilance and circumspectful caution, and we encourage residents, visitors and business owners to practice the same precautions that would be in place during the regular flu season. Avoid holding, hugging, kissing, or shaking hands with anyone who has a cold or the flu. Avoid touching your nose, mouth or eyes without first washing your hands. Also avoid touching things like doorknobs, door handles, faucets and telephones that infected individuals might also use. Remember, when coughing or sneezing, do so into your sleeve, elbow or a tissue, and wash your hands regularly with warm soap and water. Antibacterial soap is not necessary---simple hand soap, warm water and friction are best.

If you or someone you know exhibits signs of flu (fever, shortness of breath, cough, sore throat, headache, body aches, or other symptoms), do not go to work, school or public recreational activities. Call your health care provider, describe your symptoms, and stay home for at least 7 days to rest and keep hydrated. If your fever rises or symptoms worsen, cover your nose and mouth with a mask and seek attention at a doctor's office or emergency room.

Children, the elderly and the chronically ill can be especially vulnerable to flu-like illnesses, so take extra precautions with these family members. If any ill person develops chest pain, purple or blue discoloration of the lips, vomiting, signs of dehydration (like dizziness, absence of urination, or lack of tears in infants), or seizures, seek medical attention immediately.

For more information about swine flu, visit the Centers for Disease Control and Prevention's swine flu website at http://www.cdc.gov/swineflu/, or call the Health Department at 259-3077.

Flu Activity Continuing to Decline

According to the Massachusetts Department of Public Health, influenza activity continues to decline statewide. As of the week ending March 7th, there were 10,640 lab-confirmed cases of influenza - approximately 3,400 (25%) fewer than at this time last season.

Nationally, during the week of March 1 - 7, influenza activity in the United States remained high, but is at approximately the same level as in the previous week. National Influenza Activity for the preceding week can be found at: http://www.cdc.gov/flu/weekly/fluactivity.htm.

Influenza Activity Declining in Massachusetts

According to current reports from the Massachusetts Department of Public Health, flu activity in Massachusetts peaked in the 2nd and 3rd weeks of February and is now in decline.

To date, 9 pediatric deaths from influenza have been identified by the Centers for Disease Control for the 2008-2009 flu season, 6 of those deaths reported between February 8th and 14th. These deaths occurred in Arkansas, Colorado, Florida, North Carolina, and Pennsylvania. Comparatively, there were 78 pediatric deaths during the 2006-2007 flu season.

The CDC strongly recommends vaccination for all children aged 6 months to 18 years, as well as any household contacts of children in that age group. Children between the ages of 6 months and 8 years should receive two doses of vaccine if they have never been previously vaccinated. Otherwise, studies have shown little to no efficacy or protection for this population if only one dose is received.

As always, public health officials would like to remind the public that although flu season does indeed begin to taper off in March, it is still possible to be infected with influenza throughout the year. While immunization does peak in November and December, it is still not too late to be vaccinated. The Amherst Health Department has approximately 8 doses of vaccine for children and adults over the age of 4 years, so please contact Keith Carlson at 259-3161 if you are interested.

We wish you a safe and healthy Spring!

Antiviral Resistance and Flu Vaccine

With the flu season not quite at its seasonal peak, public health officials across the country are still urging the public to seek vaccination against influenza. Even though this year's vaccine is not 100% protective against every strain of influenza currently circulating, it can still offer considerable protection within two weeks of vaccination.

Recent reports demonstrate that common strains of influenza are becoming increasingly resistant to Tamiflu, previously the most effective antiviral medication used to combat acute cases of influenza. And according to numerous public health and medical officials, that resistance to antiviral drugs is yet another reason for the majority of susceptible Americans to seek vaccination if at all possible.

While deaths from influenza are not excessively high this year, the recent deaths of two otherwise healthy Maryland teenagers from acute influenza infection underscore the need for more vigilance, surveillance, and prevention.

Whether or not you have already been vaccinated against influenza, frequent handwashing is a very important means to staying healthy. Encourage children, friends, colleagues and family members to practice good hygiene, including sneezing and coughing into a sleeve rather than into one's hand. And if you are not feeling well, staying home and avoiding exposure to others who might be ill is advisable if at all possible.

The Amherst Health Department still has some doses of free flu vaccine available for the public. Please refer any resident in need of vaccination to Keith Carlson, Amherst's Public Health Nurse, at 259-3161.

Flu Vaccine Still Available in Amherst

The Amherst Health Department currently has approximately 8 doses of flu vaccine available for any citizen (4 years of age and older) who is seeking vaccination. With the influenza season still not at its peak, we continue to recommend vaccination even into late February or early March. If demand should spike, we will most likely have access to more vaccine from the State of Massachusetts.

Please call the Health Department at 259-3161 if you are interested in receiving a flu vaccine.

Sniffle or Sneeze? No Antibiotics Please

CDC advises parents about colds, flu and antibiotics

The Centers for Disease Control and Prevention (CDC) has news for parents this cold and flu season: antibiotics don’t work for a cold or the flu.

Antibiotics kill bacteria, not viruses. And colds, flu and most sore throats are caused by viruses. Antibiotics don’t touch viruses — never have, never will. And it’s not really news. It’s a long-documented medical fact. But tell that to parents seeking relief for a child’s runny nose. Research shows that most Americans have either missed the message about appropriate antibiotic use or they simply don’t believe it. It’s a case of mistaken popular belief winning out over fact. According to public opinion research, there is a perception that “antibiotics cure everything.”

Americans believe in the power of antibiotics so much that many patients go to the doctor expecting to get a prescription. And they do. Why? Physicians often are too pressured for time to engage in lengthy explanations of why antibiotics won’t work. And, when the diagnosis is uncertain — as many symptoms for viral and bacterial infections are similar — doctors are more likely to yield to patient demands for antibiotics.

Risk of antibiotic-resistance

The problem is, taking antibiotics when they are not needed can do more harm than good. Widespread inappropriate use of antibiotics is fueling an increase in drug-resistant bacteria. And sick individuals aren’t the only people who can suffer the consequences. Families and entire communities feel the impact when disease-causing germs become resistant to antibiotics.

The most obvious consequence of inappropriate antibiotic use is its effect on the sick patient. When antibiotics are incorrectly used to treat children or adults with viral infections, such as colds and flu, they aren’t getting the best care for their condition. A course of antibiotics won’t fight the virus, make the patient feel better, yield a quicker recovery or keep others from getting sick.

A less obvious consequence of antibiotic overuse is the boost it gives to drug-resistant disease-causing bacteria. Almost every type of bacteria has become stronger and less responsive to antibiotic treatment when it really is needed. These antibiotic-resistant bacteria can quickly spread to family members, school mates and co-workers — threatening the community with a new strain of infectious disease that is more difficult to cure and more expensive to treat.

According to the CDC, antibiotic resistance is one of the world’s most pressing public health problems. Americans of all ages can lower this risk by talking to their doctors and using antibiotics appropriately during this cold and flu season.


What to do for colds and flu

• Children and adults with viral infections recover when the illness has run its course. Colds caused by viruses may last for two weeks or longer.
• Measures that can help a person with a cold or flu feel better:
– Increase fluid intake
– Use a cool mist vaporizer or saline nasal spray to relieve congestion
– Soothe throat with ice chips, sore throat spray or lozenges (for older children and adults)
• Viral infections may sometimes lead to bacterial infections. Patients should keep their doctor informed if their illness gets worse or lasts a long time.


Reproduced with the kind permission of the Centers for Disease Control and Prevention

Federal Contract Awarded to Build First U.S. Manufacturing Facility for Cell-Based Influenza Vaccine

For Immediate Release:

The U.S. Department of Health and Human Services (HHS) today announced a $487 million multiple year contract with Novartis Vaccines and Diagnostics, Inc., to build the first U.S. facility to manufacture cell-based vaccine for seasonal and pandemic flu. Because cell-based influenza vaccine can be made faster and in greater quantities than traditional vaccine, the new facility is expected to increase the U.S. capacity to make pandemic influenza vaccine by at least 25 percent.

Cell-based vaccine production could more easily meet surge capacity needs because cells could be frozen and stored in advance of an epidemic or developed rapidly in response to an epidemic. Cell-based vaccine production also dramatically reduces the possibility for contamination and promises to be more reliable, flexible, and expandable than egg-based methods.

Currently, influenza vaccines licensed by the U.S. Food and Drug Administration (FDA) are made in specialized chicken eggs using a process that has changed little in over 50 years. In place of eggs, cell-based vaccine production uses laboratory-grown cells that are capable of hosting a growing virus. The virus is injected into the cells where it multiplies. The cells’ outer walls are removed, harvested, purified, and inactivated. Using this technology, a vaccine can be produced in a matter of weeks.

“Today we are taking an important step in our ongoing commitment to pandemic preparedness,” said Dr. Robin Robinson, director of the HHS Biomedical Advanced Research and Development Authority (BARDA), which will oversee the contract. “In a pandemic we would need vaccine ready within six months. That’s why the National Strategy for Pandemic Influenza set domestic surge capacity as a goal in preparing the nation for a pandemic. That goal could not be accomplished using the traditional egg-based method of producing flu vaccine.”

New cell-based influenza vaccines provides an option for people who are allergic to eggs and, therefore, unable to receive current flu vaccines. Cell-based production avoids other problems that egg-based production has, such as a potential shortage of eggs due to poultry-based diseases.

The cell-based vaccine technology can also be used to make vaccines for seasonal influenza and other major emerging infectious diseases.

Under the contract, Novartis and HHS share the cost of the new cell-based influenza vaccine manufacturing facility in Holly Springs, N.C., with the HHS contract covering 40 percent of the cost and Novartis bearing 60 percent.

Also under the contract, Novartis will provide two new flu vaccines for seasonal flu or for pre-pandemic use. The contract builds on progress made through a previous HHS contract award to Novartis to accelerate the development of cell-based influenza vaccine.

The new contract also will fund scientific studies, called clinical bridging studies, to compare existing Novartis vaccines to new ones, including those developed in the new facility, to show that these new ones are also safe and effective. By comparing new and existing vaccines, the company can provide information quickly to the FDA to request licenses for the new vaccines.
If licensed by the FDA, the new cell-based vaccines made in the United States could be purchased for by the federal government for vaccine stockpiles.

The original version of this press release can be found here.

Tracking Influenza

If you would like to follow the progress of the flu season on a user-friendly website, Google has created "Google Flu Trends", a website which purports to offer up-to-the-minute information on the state of influenza in the United States.

To read about how Google is able to track such data and offer it to you with a fair amount of certainty as to its accuracy, click here. If you would rather trust the Centers for Disease Control (whose data, by the way, is always two weeks behind Google's), click here. Another resource for the globally-oriented would be the World Health Organization's Global Atlas of Infectious Disease, which tracks infectious diseases worldwide.

Lastly, if your interest is the threat of pandemic influenza, try visiting PandemicFlu.gov, a treasure trove of information for those interested in what some say is an inevitable worldwide pandemic which could very well occur in the 21st century.

The internet affords a great deal of information regarding the tracking and surveillance of disease, emerging diseases, and other global threats to public health. Feel free to visit these resources at your leisure, and use the knowledge that you glean to prepare yourself and your family in whatever way seems sensible to you.

If you have any questions about influenza--or any other disease, please feel free to contact the Amherst Health Department at 413-259-3077 for information.
Here's to a healthy winter!

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Keith Carlson, RN, BS