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Pandemic (H1N1) 2009 - update 86
Weekly update
5 February 2010 -- As of 31 January 2010, worldwide more than 209 countries and overseas territories or communities have reported laboratory confirmed cases of pandemic influenza H1N1 2009, including at least 15174 deaths.
WHO is actively monitoring the progress of the pandemic through frequent consultations with the WHO Regional Offices and member states and through monitoring of multiple sources of information.
Situation update:
In the temperate zone of the northern hemisphere, overall pandemic influenza activity continues to decline or remain low in most regions since peaking during late October and November 2009. Several areas continue to have evidence of active but declining transmission, particularly in North Africa and in limited areas of Eastern Europe and East Asia.
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News Release
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FOR IMMEDIATE RELEASE
Thursday, December 31, 2009 |
Contact: HHS Press Office
(202) 690-6343 |
HHS Secretary Sebelius Unveils New H1N1 Advertisement That Will Air During New Year’s College Football Bowl Games
Advertisement to be available via satellite TODAY 2:00 – 2:30 p.m. EST
WASHINGTON – The U.S. Department of Health and Human Services (HHS) today announced a new H1N1 flu vaccination advertisement that will air during four College Football Bowl Games held over the New Year's holiday. The ad is aimed at encouraging young people and all Americans to get vaccinated against the H1N1 flu.
The spot will run during the Outback Bowl, Gator Bowl, Valero Alamo Bowl, and the GMAC Bowl and can be seen at www.Flu.gov. It will also be available via satellite TODAY, Thursday, December 31, 2009 from 2:00 – 2:30 p.m. EST.
“Young Americans have been especially hard hit by the 2009 H1N1 flu,” said HHS Secretary Sebelius. “Sports events are important opportunities to encourage fans, athletes, young adults, and all Americans to protect themselves by getting the H1N1 vaccine. We hope that college athletic teams across the country will continue to join us in the fight against the H1N1 flu by getting vaccinated and encouraging others to get vaccinated too.”
Sports teams, colleges and universities have been important partners in the fight against the H1N1 flu. To build on sports teams’ and colleges’ success in raising awareness about the importance of getting the H1N1 flu vaccine, Secretary Sebelius and Education Secretary Arne Duncan recently sent a letter asking college athletic directors and university presidents to air H1N1 flu public service announcements during games and make short announcements over the public address systems in stadiums, field houses and athletic fields about the need to fight the flu through vaccination and basic preventative measures.
While older people are typically hit the hardest by the seasonal flu, the 2009 H1N1 flu has severely impacted younger Americans, including young adults under age 25 who were otherwise healthy. The Centers for Disease Control and Prevention estimates that among people under age 18, there were over 1,000 deaths, 71,000 hospitalizations, and a total of 16 million cases of H1N1 flu between mid-April and November 14, 2009.
HHS also released an online video on YouTube and www.Flu.gov that features Secretary Sebelius getting the H1N1 vaccine and urging Americans to do the same. With more than 110 million doses of the 2009 H1N1 vaccine now available, all Americans are encouraged to get vaccinated and protect themselves and their loved ones during flu season, which typically lasts from October until May.
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- CDC estimates that between 34 million and 67 million cases of 2009 H1N1 occurred between April and November 14, 2009. The mid-level in this range is about 47 million people infected with 2009 H1N1.
- CDC estimates that between about 154,000 and 303,000 2009 H1N1-related hospitalizations occurred between April and November 14, 2009. The mid-level in this range is about 213,000 H1N1-related hospitalizations.
- CDC estimates that between about 7,070 and 13,930 2009 H1N1-related deaths occurred between April and November 14, 2009. The mid-level in this range is about 9,820 2009 H1N1-related deaths.
Non-Safety-Related Voluntary Recall of Certain Lots of Sanofi Pasteur H1N1 Pediatric (0.25 mL, for 6-35 month olds) Vaccine in Pre-Filled Syringes Questions & Answers
December 15, 2009, 9:00 AM ET
What are the lot numbers affected by this recall?
Vaccine doses with the following lot numbers are included in the recall:
0.25 ml pre-filled syringes, 10-packs (NDC # 49281-650-25, sometimes coded as 49281-0650-25):
UT023DA
UT028DA
UT028CB
0.25 ml pre-filled syringes, 25-packs (NDC # 49281-650-70, sometimes coded as 49281-0650-70):
UT030CA
Why are some lots of pediatric H1N1 vaccine manufactured by Sanofi Pasteur in pre-filled syringes being recalled from the market?
As part of its quality assurance program, the manufacturer, Sanofi Pasteur, performs routine, ongoing stability testing of its influenza A (H1N1) vaccine after the vaccine has been shipped to providers. Stability testing means measuring the strength (also called potency) of a vaccine over time. It is performed because sometimes the strength of a vaccine can go down over time. On December 7, Sanofi Pasteur notified CDC and FDA that the potency in one batch (called a “lot”) of pediatric syringes that had been distributed was later found to have dropped below a pre-specified limit. As a result of this finding, Sanofi Pasteur tested additional lots and found that three other lots that had been distributed also had an antigen content that, while properly filled at the time of manufacturing, was later measured to be below pre-specified limits. This means that doses from these four vaccine lots no longer meet the manufacturer’s specifications for potency. Sanofi Pasteur will send providers directions for returning any unused vaccine from these lots.
What does potency mean for the H1N1 vaccine?
Potency (or strength) is determined by the measurement of the concentration of the active ingredient (also called antigen) in the H1N1 vaccine.
Are there any concerns about safety of vaccines from these lots?
No. There are no safety concerns with these lots of H1N1 vaccine. All lots successfully passed pre-release testing for purity, potency and safety.
Should infants and children who received vaccines from these lots be revaccinated?
No. The vaccine potency is only slightly below the “specified” range. The vaccine in these lots is still expected to be effective in stimulating a protective response despite this slight reduction in the concentration of antigen. There is no need to re-administer a dose to those who received vaccine from these lots. However, as is recommended for all 2009 H1N1 vaccines, all children less than 10 years old should get the recommended two doses of H1N1 vaccine approximately a month apart for the optimal immune response. Therefore, children less than 10 years old who have only received one dose of vaccine thus far should still receive a second dose of 2009 H1N1 vaccine
Window of Opportunity
December 7, 2009
Good news came out of last Friday’s CDC briefing that H1N1 vaccine supplies continue to increase. Dr. Frieden announced that there is twice as much H1N1 vaccine available now than was available last month, and ten million more than was available the previous week. In addition, another 10 million doses will be made available this week – providing Americans with an excellent window of opportunity to get vaccinated. Today, there are more than 81 million doses of the 2009 H1N1 vaccine available.
Vaccination is the best way to protect yourself and your family from influenza. As the supplies of vaccines are growing, we encourage people in priority populations to get vaccinated including kids who are historically under-vaccinated (about 1 out of every 5 school kids typically get vaccinated). Some states, such as Arkansas, Rhode Island, and Maine, are responding to this creatively by initiating school-based vaccination programs. The vaccination rate for kids in these states is as high as 50%, if not higher, in some places. This community response helps to protect kids and families, while building an infrastructure to respond to influenza outbreaks.
“Vaccination not only prevents severe illness, it also protects us from a disruption in society,” Dr. Frieden said. By reducing the number of people out of school and out of work due to influenza, the more productive we can be now and in the future.
The number of states with widespread H1N1 has declined, down to 25 states, yet there is still more activity than normal. It is uncertain whether there will be additional waves of influenza or what they will look like, but the CDC is monitoring the activity.
This uncertainty is why it is so critical that priority groups get vaccinated, particularly now when there are additional supplies of H1N1 vaccine available. Greater quantities of supplies mean greater access.
2009 H1N1 and Seasonal Influenza Infections and Invasive Pneumococcal Disease
November 24, 2009 6:00 PM ET
Some of CDC's Active Bacterial Core surveillance (ABCs) sites have seen an increase in serious cases of pneumococcal disease coincident with increases in influenza-associated hospitalizations. CDC has been working with state and local public health officials in Colorado for example concerning its ABCs site in the Denver Metro area to collect additional data on pneumococcal disease cases.
There is good evidence that 2009 H1N1 influenza may be responsible for this increase in invasive pneumococcal disease (IPD) cases in the Denver Metro area. (5-year average number of cases in October, ~20; total number in October 2009, 58).
WASHINGTON (AFP) – The United States will not donate swine flu vaccine to poor countries until at-risk Americans have been inoculated against H1N1, an official said Wednesday.
FDA NEWS RELEASE
For Immediate Release: Sept. 15, 2009
"FDA Approves Vaccines for 2009 H1N1 Influenza Virus
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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Additional Information
Influenza A (H1N1) 2009 Monovalent
RSS Feed for FDA News Releases [what is RSS?]
Sept. 17, 2009..........
Seasonal Flu Vaccine shipments from manufacturers are slow in coming this year. It appears there will be far less seasonal flu vaccine than expected.
August 12, 2009......
*The CDC has asked all Influenza providers to begin their clinics early this year. They would like all seasonal Flu vaccinations to be completed prior to the start of the H1N1 vaccination program later this fall.
Go to CDC.gov to see the "Priority" list of groups to receive the H1N1 vaccine first.
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