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Interview with Bruce Gellin, Director, National Vaccine Program Office (HHS)

by: DemFromCT

Sun Oct 25, 2009 at 22:00:00 PM EDT

As 2009 H1N1 (the virus formerly known as swine flu) continues to spread (that's what pandemic viruses do), vaccine remains in short supply but is starting to be administered to high risk patients and health care workers with direct patient contact. Among the weekend flu stories are the proactive administrative move of declaring swine flu a national emergency to give hospitals more flexibility with triaging patients to alternate care sites, and Mitch McConnell offering help from the GOP if the President requests it.
DemFromCT :: Interview with Bruce Gellin, Director, National Vaccine Program Office (HHS)
The CDC weekly update can be found here:

One of the power tools in the toolbox to combat the virus is vaccination (the other is communication), and with that in mind, I asked Bruce Gellin from the HHS National Vaccine Program Office a few timely questions about the country's vaccination program.

The National Vaccine Program Office (NVPO) has responsibility for coordinating and ensuring collaboration among the many federal agencies involved in vaccine and immunization activities. The NVPO provides leadership and coordination among Federal agencies, as they work together to carry out the goals of the National Vaccine Plan. The National Vaccine Plan provides a framework, including goals, objectives, and strategies, for pursuing the prevention of infectious diseases through immunizations.
I've known Dr. Gellin for some years from interactions at various flu conferences, and it would be fair to say he's a little busy these days. I'm grateful for his time and attention to detail in answering some commonly asked questions for us.

The new H1N1 vaccine will be appearing in various places over the next few weeks, but many patients are finding their doctors are not set up to give it. Is there is place people can go to in order to find out where the vaccine is being offered if their own doctor will not be doing so? ( flu.gov and the American Lung Association have seasonal flu info)

Bruce Gellin: As soon at the H1N1 flu virus was identified in April, public health laboratories began to develop a vaccine - in the same way that they do every year to make the seasonal flu vaccine.  From the beginning, the development of the H1N1 vaccine was a race against the virus and the federal government's goal has been to get the vaccine to every American who wants and needs it.

Based on an understanding of the disease patterns and severity, and, therefore, who would most benefit from the H1N1 vaccine, the CDC's Advisory Committee on Immunization Practices (ACIP) identified five target groups to receive the initial supply of vaccine. These recommendations were developed in July and reaffirmed just last Thursday at a meeting at the CDC.

These target groups include pregnant women, people who live with or care for children younger than 6 months of age, healthcare and emergency medical services personnel, persons between the ages of 6 months and 24 years old, and people ages of 25 through 64 years of age who are at higher risk for H1N1 because of chronic conditions or compromised immune systems.

The H1N1 vaccine was licensed by the FDA in mid-September and initial supplies became available in early October.  To protect people against the disease as soon as possible, we chose to distribute limited quantities of vaccine as it becomes available, rather than wait until we had large quantities.

As vaccine lots are approved by the FDA, they are shipped to four central distribution points.  From there, vaccine is sent to distribution sites, predetermined by state and local health officials, across the country.  There may be as many as 150,000 distribution sites where vaccine will be administered.  As supply grows, an increasing number of places will be able to provide vaccines including hospitals, clinics, doctor's offices, health departments, and other sites determined by local officials.

The federal website www.Flu.gov contains a Flu Shot Locator.  This interactive map includes information on where the H1N1 vaccine will be locally administered.  As information is being updated regularly on the vaccine situation as well as other aspects of H1N1, we encourage individuals to be familiar with the site and all that it has to offer and periodically check it as well as their individual state and local departments of health websites.    

Frankly, many people don't know as much about their state and local health departments as they should, so this would also be a good time to know more about all of the activities that health departments do to keep our communities healthy and safe as H1N1 is only a piece of all that they do.  Two good national sources of information about the role of local public health include the Association of State and Territorial Health Officers ( http://www.astho.org ), and the National Association of County and City Health Officers ( http://www.naccho.org ).  These two web sites provide  an in-depth look at the range of things that local and state public health officials do every day in communities across the country. ( ed. Your local health department can be found here. )

We are all frustrated that supplies are not what we had hoped they would be but we're encouraged that more and more vaccine will be available over the next few weeks.  In the mean time, now is the time to learn about the vaccines so that you can begin to answer any questions that you may have.  Visit www.Flu.gov and talk with your health care provider.  To learn more about H1N1 vaccine supply and distribution go to: Supply and Distribution.

The vaccine is a federal program and free but there's usually an administration charge. What if people can't afford that?  

Bruce Gellin: Vaccines don't deliver themselves.  While the federal government is providing vaccine to the states free of charge, some private health care providers may charge a small fee to administer the vaccine.  

However, cost should not be a barrier to those who want to be vaccinated against the H1N1 flu.  To ensure that as many individuals as possible can receive the vaccine, Medicaid will the cost of the vaccine as will Medicare.   For those without insurance or limited coverage, they can get the vaccine free-of-charge from their local health department.  For more information about vaccine financing and billing, go to: Vaccine Administration Billing.

Will this H1N1 be part of next year's seasonal flu vaccine?

Bruce Gellin:  At this time we don't know if next year's seasonal flu vaccine will contain the H1N1 virus strain.  Each year, the seasonal flu vaccine contains three influenza viruses. These viruses are selected based on the different types of viruses that are circulating around the world causing disease in people.  In February of each year, the FDA and the World Health Organization recommends which viruses should be included in the upcoming seasonal flu vaccine.  Production usually begins shortly thereafter.  

In fact, had H1N1 arrived earlier in the US we would likely have been able to include it in this year's seasonal flu vaccine. Unfortunately, it arrived after the seasonal flu vaccine had gone into production and attempting to add it in would have greatly slowed down the availability of the seasonal flu vaccine for this year.  That is why a separate vaccine was made against the H1N1 virus.

As we continue to monitor the situation around the world and see what pattern of influenza viruses are causing disease, note that the World Health Organization as already determined that the H1N1 virus will be recommended to be one of the vaccine strains for the Southern Hemisphere for their next flu season.  More information about this specific recommendation can be found at Recommended composition of influenza virus vaccines for use in the 2010 southern hemisphere influenza season .

Some people, including doctors, are counseling against getting this vaccine because it's "new". Can you comment on how it is made relative to the usual seasonal flu and any safety studies that have been done to date?

Bruce Gellin: As an infectious diseases physician and a parent of a young child, I'm personally concerned about the H1N1 threat. While many experience "mild" disease, we also know that for some, the infection is very serious.  H1N1 flu is widespread in nearly every state and, sadly, we have seen serious disease in children, but for all of those for whom vaccine is being recommended (see ACIP list of recommended groups) continue to be at risk for this infection and its complications.

We know that vaccination is the most effective defense against the H1N1 virus so I encourage parents, pregnant women, young adults and those with chronic conditions to talk with their health care provider so they can make the decision that's best for them and their loved ones.  

I recognize, however, that many people have reservations about getting vaccinated.  Vaccine safety is an important component of any immunization program and is a priority for the Department of Health and Human Services. The H1N1 vaccines that are now available have been reviewed by the Food and Drug Administration and are licensed according to the criteria that they license the seasonal flu vaccines every year.  In addition to the review of the data that was necessary to grant the license, H1N1 vaccine is being monitored very closely through a number of systems that are always monitoring vaccines when they are used broadly in the population.  

Each year, millions of Americans safely receive the seasonal flu vaccine.  The H1N1 vaccine is made the same way as the regular seasonal flu vaccine and by the same manufacturers using all of the same procedures and tests.  And, as I mentioned above, if the H1N1 virus had emerged earlier in the year, it most likely would have been included in this year's seasonal flu vaccine.

To be sure that the vaccine provides the protection we expect, the National Institutes of Health and all of the vaccine manufactures have been conducting clinical trials with the H1N1 vaccines.  In addition, these studies also give us a clear picture of potential side effects. These studies are being conducted in children, pregnant woman, and adults - as well as in a number of populations at high risk for disease and its complications.   This information has been factored into decisions about how to implement the H1N1 flu immunization program and the appropriate dosing for children. To learn more about these studies, go to:  NIAID Set to Launch Clinical Trials to Test 2009 H1N1 Influenza Vaccine Candidates.

This flu season, the federal government and health care professionals will work closely together to monitor the H1N1 vaccine for safety.  The government, in partnership with health care providers, state and local health departments, universities, health plans, and states will utilize new and existing vaccine monitoring and reporting systems to more rapidly identify and report rare side effects associated with the vaccine.   A panel of outside experts will help government officials in this process. See  Recommendations on 2009 H1N1 Influenza Vaccine Safety Monitoring.

How many people are usually vaccinated yearly, and why is there such a special encouragement for H1N1 vaccination?  

Bruce Gellin: There has been increased use of seasonal flu vaccines over the past several years as additional populations have been recommended to receive the vaccine. Over 100 million people, on average, are vaccinated each year against the seasonal flu and this year approximately 115 million doses of seasonal flu vaccine will be available.  To date, nearly 80 million doses have been distributed so there is more to come.

The H1N1 flu virus is different from typical flu viruses so a majority of the population is susceptible - which is why it's causing so much disease around the world.  But, we know that influenza vaccines are very effective so we have every reason to believe that the H1N1 vaccines will offer a great deal of protection and help reduce the spread of disease.  Systems are in place to make a very safe and effective vaccine in large quantities so we worked with vaccine manufacturers to develop these vaccines to protect as many people as possible from H1N1 infection and its consequences.

This is a voluntary program. Are there any changes anticipated at the federal level to make vaccine mandatory?

Bruce Gellin: As with all vaccines, recommendations made by the federal government are then put into place by the states.  The federal government's vaccination program for H1N1 flu is voluntary and there are no plans to make vaccination mandatory at the federal level.  

That said we do believe strongly that health care workers should get the H1N1 and the seasonal flu vaccine.  This is because they will have contact with people with H1N1 who may be suffering from complications from the disease.   Some hospitals and localities are requiring health care workers to get the H1N1 vaccine, but that is a local decision.  

Can seniors get this shot, even if they aren't at the head of the line to go first?

Bruce Gellin: The H1N1 virus has caused severe illness in pregnant women, children, and young adults.  Unlike seasonal flu, there has been very little illness in people 65 and older since the H1N1 virus emerged last spring.  We don't understand why this is true but it's possible that some time in the past a virus like H1N1 circulated and older people today have some level of protection against it.

Since seniors do not appear to be at high-risk for the H1N1 flu they were not included in the initial list of recommended populations to receive the first doses of the vaccine.  

However, people 65 and older, should get their seasonal flu shot and should talk with their doctor about the H1N1 vaccine.  The decision to administer the vaccine and get vaccinated is ultimately a personal decision and one that can be made with their doctor.  

In the UK and the US, questions have come up about the number of vaccines children get, and whether the sheer number of them matter (in some 'overload' way). Can you comment?

Bruce Gellin: I understand that many parents are concerned about the number of vaccines given to children and it's true that there more that more vaccines given today than even a few years ago.  That's because as science advances, we're able to protect children against more diseases than ever before.

Studies show, however, that children-even infants-can handle many vaccines at once.   This year, it's particularly important to consider the vaccinating children against both H1N1 flu and the seasonal flu.  

Thank you for the time and the expertise. For more information go to flu.gov and cdc.gov and check your local public health departments for local info on vaccine availability. You can find the American Lung Association's flu clinic locator here, and you can also try 211, your state's info line.

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h/t Nimbus

But only recently have U.S. health officials discovered why manufacturers can't deliver as much swine flue vaccine as expected.

Officials at the Centers for Disease Control and Prevention say for months, the companies didn't realize how far short their vaccine "yields" were falling. That's because they didn't have the chemicals - called reagents - that would have told them how much active ingredient they had in their vaccine production vats.

"To really understand how much product you have, you need to do potency tests," says Dr. Anne Schuchat, chief of the CDC's National Center for Immunization and Respiratory Diseases. She says reliable tests used to measure potency were delayed.

"When they were run, the manufacturers basically found out that the product they had was actually less than they thought they had," Schuchat said in an interview with NPR. "That wasn't something we knew a long time ago. That's relatively recent."


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