Friday, July 31, 2009

CDC Says Who Gets H1N1 Vaccine First

SOURCE: CDC

Novel H1N1 Vaccination Recommendations

With the new H1N1 virus continuing to cause illness, hospitalizations and deaths in the US during the normally flu-free summer months and some uncertainty and about what the upcoming flu season might bring, CDC's Advisory Committee on Immunization Practices has taken an important step in preparations for a voluntary novel H1N1 vaccination effort to counter a possibly severe upcoming flu season. On July 29, ACIP met to consider who should receive novel H1N1 vaccine when it becomes available.

Novel H1N1 Vaccine

Every flu season has the potential to cause a lot of illness, doctor’s visits, hospitalizations and deaths. CDC is concerned that the new H1N1 flu virus could result in a particularly severe flu season this year. Vaccines are the best tool we have to prevent influenza. CDC hopes that people will start to go out and get vaccinated against seasonal influenza as soon as vaccines become available at their doctor’s offices and in their communities (this may be as early as August for some). The seasonal flu vaccine is unlikely to provide protection against novel H1N1 influenza. However a novel H1N1 vaccine is currently in production and may be ready for the public in the fall. The novel H1N1 vaccine is not intended to replace the seasonal flu vaccine – it is intended to be used along-side seasonal flu vaccine.

CDC’s Advisory Committee on Immunization Practices (ACIP), a panel made up of medical and public health experts, met July 29, 2009, to make recommendations on who should receive the new H1N1 vaccine when it becomes available. While some issues are still unknown, such as how severe the virus will be during the fall and winter months, the ACIP considered several factors, including current disease patterns, populations most at-risk for severe illness based on current trends in illness, hospitalizations and deaths, how much vaccine is expected to be available, and the timing of vaccine availability.

The groups recommended to receive the novel H1N1 influenza vaccine include:

* Pregnant women because they are at higher risk of complications and can potentially provide protection to infants who cannot be vaccinated;

* Household contacts and caregivers for children younger than 6 months of age because younger infants are at higher risk of influenza-related complications and cannot be vaccinated. Vaccination of those in close contact with infants less than 6 months old might help protect infants by “cocooning” them from the virus;

* Healthcare and emergency medical services personnel because infections among healthcare workers have been reported and this can be a potential source of infection for vulnerable patients. Also, increased absenteeism in this population could reduce healthcare system capacity;

* All people from 6 months through 24 years of age

o Children from 6 months through 18 years of age because we have seen many cases of novel H1N1 influenza in children and they are in close contact with each other in school and day care settings, which increases the likelihood of disease spread, and

o Young adults 19 through 24 years of age because we have seen many cases of novel H1N1 influenza in these healthy young adults and they often live, work, and study in close proximity, and they are a frequently mobile population; and,

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

We do not expect that there will not be a shortage of novel H1N1 vaccine, but flu vaccine availability and demand can be unpredictable and there is some possibility that initially, the vaccine will be available in limited quantities. So, the ACIP also made recommendations regarding which people within the groups listed above should be prioritized if the vaccine is initially available in extremely limited quantities. For more information see the CDC press release CDC Advisors Make Recommendations for Use of Vaccine Against Novel H1N1.

Once the demand for vaccine for the prioritized groups has been met at the local level, programs and providers should also begin vaccinating everyone from the ages of 25 through 64 years. Current studies indicate that the risk for infection among persons age 65 or older is less than the risk for younger age groups. However, once vaccine demand among younger age groups has been met, programs and providers should offer vaccination to people 65 or older.

Total Wellness
Andrea Oster RN, BSN
aoster@totalwellnesshealth.com
888-434-4358
www.totalwellnesshealth.com
www.vsamerica.com

Monday, July 27, 2009

FDA Approves Vaccine for 2009-2010 Seasonal Influenza

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 & Availability
http://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

Total Wellness
www.vsamerica.com
888-434-4358

Novel H1N1 Influenza Vaccine Q&A

July 20, 2009 2:15 PM ET

Q. What are the plans for developing novel H1N1 vaccine?

A. Vaccines are the most powerful public health tool for control of influenza, and the U.S. government is working closely with manufacturers to take steps in the process to manufacture a novel H1N1 vaccine. Working together with scientists in the public and private sector, CDC has isolated the new H1N1 virus and modified the virus so that it can be used to make hundreds of millions of doses of vaccine. Vaccine manufacturers are now using these materials to begin vaccine production. Making vaccine is a multi-step process which takes several months to complete. Candidate vaccines will be tested in clinical trials over the few months.

Q. When is it expected that the novel H1N1 vaccine will be available?

A. The novel H1N1 vaccine is expected to be available in the fall. More specific dates cannot be provided at this time as vaccine availability depends on several factors including manufacturing time and time needed to conduct clinical trials



Q. Will the seasonal flu vaccine also protect against the novel H1N1 flu?

A. The seasonal flu vaccine is not expected to protect against the novel H1N1 flu.

Q. Can the seasonal vaccine and the novel H1N1 vaccine be given at the same time?

A. Clinical trial results will be necessary to confirm that novel H1N1 and seasonal vaccine will be safe and effective if given at the same time. We expect the seasonal vaccine to be available earlier than the H1N1 vaccine. The usual seasonal influenza viruses are still expected to cause illness this fall and winter. Individuals are encouraged to get their seasonal flu vaccine as soon as it is available.
Q. Who will be recommended as priority groups to receive the novel H1N1 vaccine?

A. Based on what we're currently seeing with respect to the virus and epidemiologic data, states, communities, and health care providers should begin planning strategies for how they will vaccinate younger people (children and younger adults), pregnant women, healthcare personnel, and people who have underlying health conditions. The Advisory Committee on Immunization Practices (ACIP) and other federal advisory bodies will continue to monitor the virus and review epidemiologic data over the summer. We'll be looking to the ACIP and other stakeholders, as well as the public, as we move forward in our planning. It is possible that vaccine priority groups will differ from earlier guidance as more data becomes available however it's very important for planning to continue based on information currently available.

Q. Where will the vaccine be available?


A. Every state is developing a vaccine delivery plan. Vaccine will be available in a combination of settings such as vaccination clinics organized by local health departments, healthcare provider offices, schools, and other private settings, such as pharmacies and workplaces.

Q. Are there other ways to prevent the spread of illness?

A. Take everyday actions to stay healthy.

•Cover your nose and mouth with a tissue when you cough or sneeze. Throw the tissue in the trash after you use it.
•Wash your hands often with soap and water, especially after you cough or sneeze. Alcohol-based hands cleaners are also effective.
•Avoid touching your eyes, nose or mouth. Germs spread that way.
•Stay home if you get sick. CDC recommends that you stay home from work or school and limit contact with others to keep from infecting them.


Follow public health advice regarding school closures, avoiding crowds and other social distancing measures. These measures will continue to be important after a novel H1N1 vaccine is available because they can prevent the spread of other viruses that cause respiratory infections.

Q. What about the use of antivirals to treat novel H1N1 infection?

A. Antiviral drugs are prescription medicines (pills, liquid or an inhaled powder) that fight against the flu by keeping flu viruses from reproducing in your body. If you get sick, antiviral drugs can make your illness milder and make you feel better faster. They may also prevent serious flu complications. This fall, antivirals may be prioritized for persons with severe illness or those at higher risk for flu complications.

Centers for Disease Control and Prevention
1600 Clifton Rd
Atlanta, GA 30333
800-CDC-INFO
(800-232-4636)
TTY: (888) 232-6348
24 Hours/Every Day
cdcinfo@cdc.gov

Total Wellness
www.vsamerica.com
888-434-4358

Monday, July 20, 2009

FDA Approves Vaccine for 2009-2010 Seasonal Influenza

FDA Approves Vaccine for 2009-2010 Seasonal Influenza
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 & Availability
http://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

Kristina Macklin
Total Wellness
kmacklin@totalwellnesshealth.com
888.434.4358
www.totalwellnesshealth.com

Tuesday, July 7, 2009

Seasonal Flu Vaccine Distribution

The CDC recommends getting your seasonal flu shot as soon as vaccine is available. We anticipate that vaccine will be available sooner this year than it has been in the past, making this a great time to reserve vaccine for your on-site flu clinic. We can provide your on-site shots as early as September. Give us a call today at 888.434.4358 or email us to set up your event.

Kristina Macklin
Total Wellness
kmacklin@totalwellnesshealth.com
888.434.4358
www.totalwellnesshealth.com