Fact Sheet: Safety of Thimerosal in Vaccines Against 2009 H1N1 Flu
"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..."

CDC Estimates of 2009 H1N1 Influenza Cases, Hospitalizations and Deaths in the United States, April – December 12, 2009
"...Updated Estimates from April – December 12, 2009

Using the same methodology CDC has updated the estimates to include the time period from April through December 12, 2009.

CDC estimates that between 39 million and 80 million cases of 2009 H1N1 occurred between April and December 12, 2009. The mid-level in this range is about 55 million people infected with 2009 H1N1.
CDC estimates that between about 173,000 and 362,000 2009 H1N1-related hospitalizations occurred between April and December 12, 2009. The mid-level in this range is about 246,000 H1N1-related hospitalizations.
CDC estimates that between about 7,880 and 16,460 2009 H1N1-related deaths occurred between April and December 12, 2009. The mid-level in this range is about 11,160 2009 H1N1-related deaths..."

2009 H1N1 Flu: Situation Update
"Key Flu Indicators
December 11, 2009, 1:30 PM

Each week CDC analyzes information about influenza disease activity in the United States and publishes findings of key flu indicators in a report called FluView. During the week of November 29-December 5, 2009, influenza activity decreased over the previous week across all key indicators except for deaths, but most indicators remain higher than normal for this time of year..."

2009 H1N1-Related Deaths, Hospitalizations and Cases: Details of Extrapolations and Ranges: United States, Emerging Infections Program (EIP) Data
"In order to provide a fuller and more accurate picture of the burden of the 2009 H1N1 pandemic on the United States, CDC has developed a methodology to estimate ranges of 2009 H1N1 cases and related hospitalizations and deaths. This method uses raw data on 2009 H1N1 hospitalizations collected through CDC’s Emerging Infections Program (EIP), which conducts surveillance for laboratory-confirmed influenza-related hospitalizations in children and adults in 62 counties covering 13 metropolitan areas of 10 states. The estimated ranges generated by this methodology provide a sense of scale in terms of the burden of disease caused by 2009 H1N1. It may never be possible to validate the accuracy of these figures. The true number of cases, hospitalizations and deaths may lie within the ranges provided or it’s also possible that they may lie outside the ranges.
This methodology is not predictive and cannot be used to forecast the number of cases, hospitalizations and deaths that will occur going forward over the course of the pandemic because they are based on actual surveillance data. More information about this methodology is contained in this document."

CDC Estimates of 2009 H1N1 Influenza Cases, Hospitalizations and Deaths in the United States, April – October 17, 2009
"..When the 2009 H1N1 flu outbreak began in April 2009, CDC began reporting the number of laboratory-confirmed cases, hospitalizations and deaths associated with 2009 H1N1 flu in the United States that were reported by states to CDC. These initial case counts, and subsequent ongoing laboratory-confirmed reports of hospitalizations and deaths, are thought to represent a significant undercount of the actual number of 2009 H1N1 flu cases in the United States. A paper in Emerging Infectious Diseases authored by CDC staff entitled “Estimates of the Prevalence of Pandemic (H1N1) 2009, United States, April–July 2009” reported on a study to estimate the prevalence of 2009 H1N1 based on the number of laboratory-confirmed cases reported to CDC. Correcting for under-ascertainment, the study found that every case of 2009 H1N1 reported from April – July represented an estimated 79 total cases, and every hospitalized case reported may have represented an average of 2.7 total hospitalized people. Since that time, CDC has been working to develop a way to estimate, in an ongoing way, the impact of the 2009 H1N1 pandemic on the U.S. in terms of 2009 H1N1 cases, hospitalizations and deaths...

CDC estimates that between 14 million and 34 million cases of 2009 H1N1 occurred between April and October 17, 2009. The mid-level in this range is about 22 million people infected with 2009 H1N1.

CDC estimates that between about 63,000 and 153,000 2009 H1N1-related hospitalizations occurred between April and October 17, 2009. The mid-level in this range is about 98,000 H1N1-related hospitalizations.

CDC estimates that between about 2,500 and 6,000 2009 H1N1-related deaths occurred between April and October 17, 2009. The mid-level in this range is about 3,900 2009 H1N1-related deaths."

FDA Publishes Guidance on Diagnostic Tests for 2009 H1N1 Influenza Virus
"The U.S. Food and Drug Administration today published a guidance document that should help manufacturers develop diagnostic tests for the 2009 H1N1 influenza virus. Although there are not any FDA-approved or cleared tests that diagnose this specific infection, during this pandemic, manufacturers can submit a request to the FDA for an Emergency Use Authorization (EUA). If granted, the EUA will allow the test to be used during the national public health emergency declared by Department of Health and Human Services Secretary Kathleen Sebelius in April. This guidance document outlines what information the FDA recommends that manufacturers include in these EUA requests.

The EUA authority allows the FDA to authorize use of unapproved or uncleared medical products or unapproved or uncleared uses of approved or cleared medical products following a declaration of emergency, when certain criteria are met. The authorization ends when the declaration of emergency is terminated or the authorization is revoked by the FDA.

The EUA authority is part of Project BioShield, which became law in July 2004.

While the FDA encourages manufacturers to submit appropriate premarket applications for these tests, the agency also recognizes that it may not be possible to generate complete clinical validation data that would normally be included in an application. However, this guidance outlines information the FDA recommends be included, and the FDA gives these requests thorough and careful review to protect the public health..."

Estimates of the Prevalence of Pandemic (H1N1) 2009, United States, April–July 2009
"Through July 2009, a total of 43,677 laboratory-confirmed cases of influenza A pandemic (H1N1) 2009 were reported in the United States, which is likely a substantial underestimate of the true number. Correcting for under-ascertainment using a multiplier model, we estimate that 1.8 million–5.7 million cases occurred, including 9,000–21,000 hospitalizations...

October 24, 2009- President Obama Signs Emergency Declaration for H1N1 Flu
"Authority

Section 1135 of the Social Security Act [42 USC §1320b–5] permits the Secretary of Health and Human Services to waive certain regulatory requirements for healthcare facilities in response to emergencies. Two conditions must be met for the Secretary to be able to issue such “1135 waivers”: first, the Secretary must have declared a Public Health Emergency; second, the President must have declared a National Emergency either through a Stafford Act Declaration or National Emergencies act Declaration. If these conditions are met, then healthcare facilities may petition for 1135 waivers in response to particular needs, and only within the geographic and temporal limits of the emergency declarations...'
Read the official Declaration

Flu Myths and Realities
"Vaccines that contain thimerosal are unsafe for children and pregnant women.”

It is safe for children and pregnant women to receive a flu vaccine that contains thimerosal.

Thimerosal is a very effective preservative that has been used since the 1930s to prevent contamination in some multi-dose vials of vaccines. There is no convincing evidence of harm caused by the low doses of thimerosal in vaccines, except for minor reactions like redness and swelling at the injection site.

The 2009-H1N1 influenza vaccines that FDA has licensed will be manufactured in several formulations, including pre-filled, single-dose syringes and nasal sprayers along with multi-dose vials. Only multi-dose vials of seasonal influenza vaccine will contain thimerosal to prevent potential contamination after the vial is opened. Single-dose units, however, will not require the use of thimerosal as a preservative. You may request this form of the vaccine if it is available. In addition, the nasal spray version of the 2009 H1N1 vaccine is produced in single-units and will not contain thimerosal..."

Preparing for the Flu: A Communications Toolkit for Federal Workers
"The purpose of Preparing for the Flu: A Communication Toolkit for the Federal Workforce is to provide information and communication resources to help federal agencies and employees implement recommendations from CDC in planning and responding to the 2009–2010 Influenza Season.

The toolkit includes:
Questions and answers about how federal agencies can respond to the 2009–2010
influenza season

Quick reference for federal agencies on 2009–2010 influenza season planning
and response

One fact sheet for federal agencies
Action Steps to Keep Your Federal Workforce Healthy

Two fact sheets for employees
Ten Ways You Can Stay Healthy at Work
Five Things You Can Do to Help Prevent the Spread of Flu

Three e-mail templates for federal agencies to send to employees
Flu Season is Starting. Get Ready Now!
If You Are Not Feeling Well
Staying Healthy

Additional communication resources for federal agencies
Additional Web resources for federal agencies"

FLUview
A weekly influenza survelliance report from the Centers for Disease Control and Prevention

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..."

Fraudulent 2009 H1N1 Influenza Products List
"Topics on this Page

Purpose of the Fraudulent Products List
Consumer Considerations about the Products List
View Products List
Purpose of the Fraudulent Products List

This list is intended to alert consumers about Web sites that are illegally marketing unapproved, uncleared, or unauthorized products in relation to the 2009 H1N1 Flu Virus (sometimes referred to as the “swine flu” virus). Note that until evidence to the contrary is presented to FDA, the owner of the listed Web site is considered responsible for promoting the unapproved, uncleared, or unauthorized products. The uses related to the 2009 H1N1 Flu Virus are not necessarily being promoted by the manufacturers of the products.

Consumer Considerations about the Products List

This list does not include every Web site that is marketing products related to the 2009 H1N1 Flu Virus without FDA approval, clearance, or authorization, only those Web sites to which FDA has issued a warning letter.
Even if a Web site is not included in this list, consumers should exercise caution before purchasing over the Internet any product purporting to diagnose, mitigate, prevent, treat, or cure the 2009 H1N1 Flu Virus.
Please note that some of these products may be approved or cleared by FDA for other medical uses. The fact that a product is listed on this page indicates ONLY that the products are not cleared, approved, or authorized for the diagnosis, mitigation, prevention, treatment, or cure of the 2009 H1N1 flu virus.
Once included, all Web sites and products will remain listed. After FDA has verified that the products or the objectionable claims related to the 2009 H1N1 Flu Virus have been removed from the Web site, this information will be added to the list.

The information is current as of the date indicated. If we learn that any information is not accurate, we will revise the list as soon as possible..."

QUESTIONS & ANSWERS: 2009 H1N1 Influenza Vaccine
"What are the plans for developing 2009 H1N1 vaccine?
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 2009 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.

When is it expected that the 2009 H1N1 vaccine will be available?
The 2009 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.."

2009-H1N1 National Preparedness and Response Overview
"The health and safety of the American people is the first priority of President Barack Obama. Since the novel 2009-H1N1 flu virus emerged in the United States during the third week of April, the President has received regular briefings and asked his Cabinet to spare no effort in addressing this national security challenge. The Secretary of Health and Human Services is leading the way on public health preparedness and response efforts, the Principal Federal Official for domestic incidents, the Secretary of Homeland Security, is coordinating the supporting activities of Federal departments and agencies and facilitating response actions with State, local and territorial governments and tribal and private sector partners, while other Cabinet officials are leading complementary initiatives in their area of responsibility. It is a well-coordinated, all hands on deck approach. All Federal efforts are aimed at reducing the impact of 2009-H1N1 on the health and well-being of Americans and on the economy and functioning of society. Key elements of our preparedness and response efforts include:

Preparing for a fall wave of H1N1 flu with great team work across the Nation

Implementing a National Framework for 2009-H1N1 preparedness and response, including the four pillars of surveillance, mitigation, vaccine, and communications

Partnering with Congress, governors, mayors, territorial and tribal officials, state and local health departments and emergency managers, the medical community, private-sector entities, and community-based groups for an effective response

Issuing medical, science-derived public guidance for K-12 schools, institutions of higher education, businesses and employers, and families across the country available 24/7 on http://www.flu.gov
Making steady progress on developing a safe, effective, and voluntary H1N1 flu vaccine

Preparing for a voluntary, but strongly recommended, H1N1 flu shot program to be available to all Americans that wish to participate over a period of time
Encouraging Americans to act on a shared responsibility to reduce the impact of H1N1 flu

Calling on individuals and families to plan for the fall flu season and to take steps to prevent the spread of the H1N1 flu."

Surveillance for Pediatric Deaths Associated with 2009 Pandemic Influenza A (H1N1) Virus Infection --- United States, April--August 2009
"Children aged <5 years or with certain chronic medical conditions are at increased risk for complications and death from influenza (1--3). Because of this increased risk, the Advisory Committee on Immunization Practices (ACIP) has prioritized influenza prevention and treatment for children aged <5 years and for those with certain chronic medical and immunosuppressive conditions (4,5). CDC monitors child influenza deaths through its influenza-associated pediatric mortality reporting system. As of August 8, 2009, CDC had received reports of 477 deaths associated with 2009 pandemic influenza A (H1N1) in the United States, including 36 deaths among children aged <18 years. To characterize these cases, CDC analyzed data from April to August 2009. The results of that analysis indicated that, of 36 children who died, seven (19%) were aged <5 years, and 24 (67%) had one or more of the high-risk medical conditions. Twenty-two (92%) of the 24 children with high-risk medical conditions had neurodevelopmental conditions. Among 23 children with culture or pathology results reported, laboratory-confirmed bacterial coinfections were identified in 10 (43%), including all six children who 1) were aged ≥5 years, 2) had no recognized high-risk condition, and 3) had culture or pathology results reported. Early diagnosis of influenza can enable prompt initiation of antiviral therapy for children who are at greater risk or severely ill. Clinicians also should be aware of the potential for severe bacterial coinfections among children diagnosed with influenza and treat accordingly. All children aged ≥6 months and caregivers of children aged <6 months should receive influenza A (H1N1) 2009 monovalent vaccine when available..."

Duncan, Sebelius Unveil Recommendations for Schools on How Learning Continues in Case of Flu Outbreak
"Today, Department of Education Secretary Arne Duncan, Department of Health and Human Services Secretary Kathleen Sebelius, District of Columbia Mayor Adrian Fenty and District of Columbia Chancellor of Public Schools Michelle Rhee joined with officials from Google, Apple, Microsoft, Scholastic Inc., Pearson, Curriki, and the International Association for Online Learning to announce new recommendations on the continuity of learning in the event of students absences or school closures due to seasonal or novel H1N1 flu.

The recommendations crafted by the Department of Education are designed to help education stakeholders start planning and acting now for the impact that seasonal and 2009 H1N1 influenza could have this fall and winter on schools and the learning process.

Government officials are especially concerned about the impact of H1N1 in schools because the virus appears to spread quickly among younger Americans. The Centers for Disease Control’s DC Advisory Committee on Immunization Practices recently found that younger Americans, specifically children ages 6 months to 24 years, are one of the top priority groups when it comes to the new H1N1 vaccine..."
View Recommendations

Guidance for Businesses and Employers to Plan and Respond to the 2009 – 2010 Influenza Season
"CDC is releasing new guidance that recommends actions that non-healthcare employers should take now to decrease the spread of seasonal flu and 2009 H1N1 flu in the workplace and to help maintain business continuity during the 2009–2010 flu season.1 The guidance includes additional strategies to use if flu conditions become more severe and some new recommendations regarding when a worker who is ill with influenza may return to work. The guidance in this document may change as additional information about the severity of the 2009-2010 influenza season and the impact of 2009 H1N1 influenza become known. Please check www.flu.gov periodically for updated guidance

Introduction

The U.S. Department of Health and Human Services’ (HHS) Centers for Disease Control and Prevention (CDC), with input from the U.S. Department of Homeland Security (DHS), has developed updated guidance for employers of all sizes to use as they develop or review and update plans to respond to 2009 H1N1 influenza now and during the upcoming fall and winter influenza season. Businesses and employers, in general, play a key role in protecting employees' health and safety, as well as in limiting the negative impact of influenza outbreaks on the individual, the community, and the nation’s economy. Employers who have developed pandemic plans should review and revise their plans in light of the current 2009 H1N1 influenza outbreak to take into account the extent and severity of disease in their community as outlined in this guidance..."

Flu.gov
A new federal government web site for keeping update-to-date on federal activities regarding H1N1, avian, and pandemic influenza.

Updated Federal Guidelines for 2009 H1N1 Influenza in Schools Offer Many Options
"Updated federal guidelines offer state and local public health and school officials a range of options for responding to 2009 H1N1 influenza in schools, depending on how severe the flu may be in their communities. The guidance says officials should balance the risk of flu in their communities with the disruption that school dismissals will cause in education and the wider community.

The guidance from the Centers for Disease Control and Prevention (CDC) was announced today at a joint news conference by Health and Human Services Secretary Kathleen Sebelius, Education Secretary Arne Duncan, Homeland Security Secretary Janet Napolitano, and CDC Director Thomas R. Frieden, M.D., M.P.H.

The school guidance is a part of a broader national framework to respond to novel H1N1 influenza, which includes encouraging people to be vaccinated against the virus and to take other actions to avoid infection. The CDC anticipates more illness after the school year starts, because flu typically is transmitted more easily in the fall and winter..."