Are you planning a novel H1N1 flu vaccination program here in the U.S.?
Yes, we are preparing for an H1N1 vaccination campaign. Working with Congress, governors, mayors, state and local health departments, the medical community and our private sector partners, the administration has been actively preparing for a range of H1N1 virus outbreak scenarios that may develop over the next few months and will prepare action plans based on the best scientific information available to help our nation respond aggressively to H1N1.
As we prepare for the fall flu season, we will be working closely with our partners in the medical community to develop, test, purchase and distribute vaccines as well as medicines to treat those who may contract the H1N1 virus.
We are making every effort to have a safe and effective H1N1 vaccine available for distribution as soon as mid-October, but it is possible, even probable, that epidemics may begin in different parts of the country before then. This makes prevention even more critical.
Over the course of the next few months, with the assistance of our partners in the private and public sector and at every level of government, we will move aggressively to prepare the nation for the possibility of a more severe outbreak of the H1N1 virus. We will do all we can to plan for different scenarios. We ask the American people to become actively engaged with their own preparation and prevention. It’s a responsibility we all share.
Who will be recommended as priority groups to receive the novel H1N1 vaccine?
On July 29, 2009, the Advisory Committee on Immunization Practices (ACIP)—an advisory committee to CDC—recommended that novel H1N1 flu vaccine be made available first to the following five groups:
- Pregnant women
- Health care workers and emergency medical responders
- People caring for infants under 6 months of age Children and young adults from 6 months to 24 years
- People aged 25 to 64 years with underlying medical conditions (e.g. asthma, diabetes)
- Combined, these groups would equal approximately 159 million individuals.
Why are these priority groups different than those listed in your previous pandemic plans?
Our pandemic plans developed over the past several years were just that—plans. Our previous planning guidance was intended to provide strong advice to support planning an effective and consistent pandemic response by States and communities. Nevertheless, it is important that plans are flexible as the guidance may need to be modified based on the status of vaccine technology, the characteristics of pandemic illness, and risk groups for severe disease – factors that will remain unknown until a pandemic actually occurs.
It is recognized that the supply of the novel H1N1 vaccine will not be available all at once, but rather, be produced at a rate that depends on both efficiency of production and manufacturing capacity. Given that the novel H1N1 influenza vaccine supply will continue to be available over time, allocation decisions needed to be made.
The priority groups identified during that planning process were based on what we projected might occur with a hypothetical virus in a future influenza pandemic. Now that an actual flu pandemic has arrived, we must be flexible and adjust our response based on the nature of the actual virus that has emerged, is circulating and causing disease around the world. Based on what we know now about the novel H1N1 virus and the most vulnerable groups that are being affected most by this virus and those most likely to encounter it —younger people, pregnant women, healthcare personnel, and people who have underlying health conditions—it is necessary to revise and refine our vaccine prioritization guidance based on real world events
Where will the vaccine be available?
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.
How are you going to vaccinate everyone in this country and how are we going to pay for it?
The President and the Congress are committed to doing everything we can to keep the American people safe and have allocated funding that can be used to produce vaccine components necessary to protect Americans. To date, HHS has have already invested more than $1 billion to produce a bulk supply of vaccine and to prepare pilot lots of potential vaccine for use in clinical studies.
In addition Congress passed and President Obama recently signed a supplemental appropriation for $7.5 billion to cover the costs of preparing for H1N1 including a vaccination campaign.
As we prepare for the fall flu season, we will be working closely with our partners in the medical community to develop, test, distribute and produce flu vaccines for prevention and anti-virals administer an H1N1 flu vaccine and to distribute and dispense antiviral medications for those who may require treatment.
We will make every effort to have a safe and effective H1N1 vaccine available for distribution to those who are identified as target audiences as soon as possible, but our current estimate is that a vaccine for H1N1 won’t be ready for distribution until mid-October. This fact makes prevention even more critical.
The process of making and testing a vaccine is already underway and decisions regarding vaccine formulation and dosing will be informed by the clinical studies that will start later this summer. Not everyone in the country may need an H1N1 vaccine. We will know more once the clinical trials are complete.
Will HHS be providing liability protection for vaccine manufacturers? And will HHS compensate eligible individuals who might be injured by a vaccine?
On June 15, 2009, HHS Secretary Sebelius signed a declaration under the Public Readiness and Emergency Preparedness (PREP) Act to extend liability immunity against tort claims (except for willful misconduct) to individuals and entities involved in all stages of 2009 H1N1 influenza vaccine development, testing, manufacture, distribution, prescribing, administration, and use. Liability immunity means that there is no legal tort claim that can be pursued in state or federal court. Individuals and entities that receive liability immunity under the declaration include manufacturers, distributors, States, locals, Tribes, and other entities that supervise or administer a vaccination program, and healthcare professionals or others authorized under State law to prescribe, administer, and dispense vaccines, when they are carrying out activities in accordance with the conditions stated in the declaration. One condition of the declaration is that the vaccination activities must relate to a present or future federal contract, grant, cooperative agreement, interagency agreement, or memorandum of understanding. Vaccines procured by the federal government for distribution are included. PREP Act declarations are intended to encourage manufactures to produce vaccine, and other entities to participate in distribution, dispensing, administration, and use of the vaccine.
The PREP Act also authorizes the Department to establish a compensation program when a declaration is issued under the Act. Funds for a compensation program were provided under the June 24 Supplemental Appropriations Act. The Department is currently working on developing a compensation program for eligible individuals who sustain covered injuries following vaccination.
