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NPRWhat You Need To Know About Swine Flu Vaccine

Try touching forearms instead of bumping fists in greeting to avoid flu.

The first doses of vaccine against swine flu — officially known as H1N1 of 2009 — will start arriving at hospitals, doctors' offices and clinics around the country this week. That's record time for a new vaccine — only a little more than five months after scientists discovered the now-pandemic virus.

The swine flu vaccination campaign is moving from planning to implementation, as Dr. Anne Schuchat of the Centers for Disease Control and Prevention puts it.

At this key stage, we turned to listeners and readers to answer their questions about this new flu vaccine.

I am concerned about the safety of the swine flu vaccine. Were shortcuts taken as it was rushed to the market? Was it subjected to the same testing as seasonal flu vaccine? — Dr. Ian Zlatkis, a pediatrician from New Orleans

"The H1N1 pandemic flu vaccine is made exactly the same way by the same manufacturers with the same processing, the same materials, as we make seasonal flu vaccine, which has an extraordinarily good safety record," says Dr. Anthony Fauci, director of the National Institute of Allergies and Infectious Disease. He is more responsible than any other single person for the fast-track development of this new flu vaccine.

The new H1N1 vaccine has gotten more scientific scrutiny than seasonal flu vaccines do, he adds. "We don't even do those [clinical trials] with the seasonal flu vaccine," he says. But in this case the tests were needed so scientists and manufacturers could know how big a dose would be necessary to get a protective immune response.

At the same time, Fauci acknowledges that it's just not possible — with any flu vaccine, and perhaps with any vaccine — to know in advance if it will cause rare side effects, such as the Guillain-Barre paralysis that a different, less purified swine flu vaccine may have touched off in 1976.

(Guillain-Barre syndrome normally strikes 1 person in every 100,000 in the population. The National Institute of Medicine says the 1976 swine flu vaccine was associated with a Guillain-Barre rate of 2 per 100,000.)

If such a rare reaction occurred once in every 100,000 vaccinated people, Fauci says, "you'd have to put millions of people on a clinical trial, and that's not how clinical trials work." Nor would there be enough time to do it.

The CDC is planning to watch more closely than ever for serious side effects among those who get the new vaccine, says Dr. Beth Bell of the agency. The CDC will use, among other things, its own Vaccine Adverse Events Reporting System. It will be augmented by surveillance in the military services, the Veterans Affairs system, and a new "real time" monitoring system that involves health plans covering 15 percent of the U.S. population.

I am pregnant and planning to get the swine flu vaccination. News reports keep saying that pregnant women will be first in line. However it's my understanding that the vaccine trials in pregnant women are not yet completed. — Erin Bolton of Baltimore

"Erin, you should take the flu vaccine," says Dr. Frank Witter, a specialist in maternal-fetal medicine at Johns Hopkins University in Baltimore. "Not only should you get the seasonal flu vaccine, but also the pandemic flu vaccine."

Since the new flu virus emerged last spring, pregnant women have been hospitalized and died from it at disproportionate rates — in fact, six times more often than the general population, says Witter.

This fall Erin Bolton's pregnancy will be in its final stages, the time of greatest risk. That's another reason she shouldn't wait, he says.

Some obstetricians worry that if they urge a woman to get vaccinated and she subsequently has a miscarriage — a common event that has not been linked to flu vaccination in the past — the doctor will get blamed.

"Some people will be thinking, well, the vaccine caused the problem," Witter acknowledges. "But I would feel much worse if one of my patients died from influenza that I was unable to vaccinate against."

As a young person with asthma, I am in the group of people who are supposed to get the first round of the vaccine. However, the nasal spray version of the vaccine, the only version available at first, is not supposed to be given to people with asthma. Should I risk it and get the nasal spray vaccine? — Meghan Guptill of Orinda, Calif.

You should wait, says Dr. Calman Prussin, an asthma specialist at the National Institutes of Health who's also an expert in vaccine side effects.

Prussin says the nation's estimated 21 million asthma patients should get the flu shot, which contains pieces of a killed flu virus, but not the nasal spray called FluMist, which contains a live but weakened flu virus. That's because earlier studies have shown that the live-virus vaccine might precipitate an asthma attack.

For asthma patients worried they might get the flu before they can get a flu shot with the killed-virus vaccine, Prussin recommends they plan with their doctor to get quick access to the antiviral drug oseltamivir, or Tamiflu, at the first sign of flu symptoms. "If it's taken in the first two days, it will decrease the severity of the flu," Prussin says.

Prussin says people with asthma might also consider taking Tamiflu to prevent flu if they have been exposed to someone with influenza.

What vaccine options will be available for children with egg allergy, the second-most-common food allergy among children? — Cathy Vesecky, Milburn, N.J.

People with egg allergies should not get flu vaccines in the regular way, says Prussin. But that doesn't mean they can't get vaccinated against flu. An allergist can determine the degree of egg sensitivity a person has and divide the vaccine dose into safe increments.

I've read online that people born before 1957 are already immune to swine flu. Is this true, and if so, why? — Lisa Radher, Chicago

Yes, pretty much so, says Dr. David Morens of the National Institutes of Health, who has studied the history of flu viruses.

People born before 1957 were exposed to ancestors of the new pandemic virus, which are in a lineage that goes back to the notorious H1N1 virus that touched off the raging pandemic of 1918-19. That's why people older than 52 are likely to have some protective antibodies that "cross-react" with the new H1N1 flu.

In 1957, for reasons flu experts don't fully understand, H1N1 viruses disappeared for 20 years. They were supplanted by other seasonal flu strains, such as the currently circulating H3N2. So younger Americans didn't get exposed to H1 viruses while they were growing up.

Then in 1977, H1N1 came back into circulation, possibly because of a laboratory accident in Russia that released an archived virus. Since then H1 viruses have evolved further away from earlier versions.

But Morens cautions that no age group is fully protected against the current H1N1 virus, so most doctors would urge people over 53 to get vaccinated after other, higher-priority groups, such as pregnant women, have had their chance.

Will there be thimerosal-free flu vaccines produced? — A concerned listener

Yes, you will be able to request a vaccine that does not contain this preservative, even though government experts do not believe that vaccines containing thimerosal pose a risk.

Are there or are there no adjuvants in the swine flu vaccine? — Unidentified listener

No, neither the swine flu vaccine nor seasonal flu vaccines in this country contain immune-boosting agents called adjuvants. The government ordered adjuvants in case the new H1N1 vaccine did not produce a high enough immune response. But in fact, tests showed the immune response was much better than expected, so the adjuvants will not be used. European countries use adjuvants in flu vaccines for older people, whose immune systems are not as robust.

Why is NPR still referring to this influenza as "swine flu" when the USDA wants it to be referred to as H1N1? — Several listeners

We use "swine flu" as one of several names, along with "pandemic flu," "the new H1N1" and "the new flu." We try not to refer to this new virus as simply "H1N1," although many do, because there are many H1N1 flu viruses, including a seasonal H1N1 that is still circulating.

Genetically, the flu virus discovered last April is made up of genetic elements that have most in common with swine flu viruses, but also have genetic sequences from human and bird flu viruses. Scientists believe the new virus has circulated in swine for a decade or more without having been detected as a new virus. It jumped into humans more recently, but no one knows exactly where or when.

The pork industry is concerned that the name "swine flu" implies to some people that they can catch it by eating pork products. There is no such risk.

Copyright 2012 National Public Radio. To see more, visit http://www.npr.org/.

Web Chat: Swine Flu Questions Answered

Not sure if you should get the vaccine? Nervous about safety?

Learn from our experts: NPR's swine flu czar Richard Knox and Dr. Richard Wenzel, a professor at the Medical College of Virginia, in Richmond answered your questions in a Web chat.

Transcript

STEVE INSKEEP, host:

It's MORNING EDITION from NPR News. I'm Steve Inskeep.

RENEE MONTAGNE, host:

And I'm Renee Montagne.

In Your Health, we look at swine flu. The first H1N1 vaccination will be given to the public this morning. Officials in Indiana and Tennessee say health workers there will get the nasal spray version of the vaccine. And millions of doses are headed to clinics, schools and offices nationwide.

We ask you to send us questions. Some of you asked where to get the vaccine. Others are wondering if they should get it.

STEVE INSKEEP: We're going to get some answers this morning from two of our science correspondents and a few other experts. And we begin with NPR's Joanne Silberner who's on the line. Joanne, where are you?

JOANNE SILBERNER: I am at the Centers for Disease Control and Prevention. They have something called the Emergency Operation Center, where they take an information on swine flu outbreaks and vaccine availability. And pretty much everything on swine flu is being collected and analyzed here in front of me. There's a dozen screens with maps. They've really drilled for this and they're taking this in stride,

INSKEEP: So if you can't answer a question sitting where you are, we should be very, very afraid, pretty much.

SILBERNER: Well, I have people here to help me answer questions. How's that?

INSKEEP: Well let's go through a couple. We'll start with our first question from Lisa K. - last initial, K. - of Malvern, Pennsylvania. She writes: The swine flu shot will not be offered by my family doctor. How exactly will this work and where can I get my shot? So, how will it work?

SILBERNER: Well, it's being run by the government. The government has already purchased essentially all the vaccine being made. And the states goes to the CDC to order it and each state gets a percentage of what's available based on how many people live in that state. Then it goes from the distributor directly to school districts, clinics, hospitals, pharmacies, about 90,000 places across the United States.

And last week, millions of vaccines went on their way to the distribution centers and to the states, and that includes both the regular injectable vaccine and a new nasal spray version that's based on one that's already used for seasonal flu.

INSKEEP: So that's the first part of her question, how will this work, and then her next part is where do I get my shot?

SILBERNER: Well, in Lisa's case, she - her doctor could apply to the state and get vaccine from the state, or she can call up her state health department, the Pennsylvania Department of Health, by its Web site or phone in. I think that's going to be true of most states.

INSKEEP: We've also got questions from listeners who've written in with very specific questions about safety, Joanne. And we're going to get to those specific questions in a moment. But for right now, I just want to ask are some of the people on those computer screens that you're looking at monitoring safety issues?

SILBERNER: Yes. They're monitoring everything there is about this infection. And one of the people who's considering all the information that's being gathered is sitting right next to me, and her name is Dr. Beth Bell. She's with the National Center for Immunization and Respiratory Diseases at the CDC. And I'm just going to hand her off to you.

Dr. BETH BELL (Associate Director for Science, National Center for Immunization and Respiratory Diseases, CDC): Hi, Steve.

INSKEEP: Hi, Dr. Bell. How are you today?

Dr. BELL: Fine. How are you?

INSKEEP: Doing fine. Thanks for taking the time to speak with us here. I'd like to know how you think you're going to know if this vaccine starts to become a problem as you distribute it to those 90,000 sights across the country.

Dr. BELL: We're working very hard to make sure that we can closely monitor for adverse events once the vaccine is distributed. For example, we're working with a number of managed care organizations to track any adverse events that occur in their populations very quickly and to decide whether it's something to be worried about or not.

INSKEEP: Are the side effects from the swine flu vaccine any different from the seasonal flu vaccine that many people get at the same time?

Dr. BELL: So far the side effects are actually very similar. People will get a sore arm sometimes; some people might feel a little bit tired, have a little bit of headache. The kinds of side effects that one can expect to have in sometimes with various kinds of vaccines.

INSKEEP: Dr. Bell, thanks very much. If you'd hand the phone back to Joanne Silberner, I'd appreciate it.

Dr. BELL: I certainly will.

SILBERNER: Hi, Steve.

INSKEEP: Just one other quick question. This emergency operation center that you're in the middle of, did they set this up just for the swine flu?

SILBERNER: Oh, no. This is a place that's opened 24/7. They deal with things like hurricane response, food-borne outbreaks, any other major public health event they can deal with it here.

INSKEEP: NPR's Joanne Silberner is at the Centers for Disease Control, the Emergency Operation Center there. And we're going to hear next from NPR's Rickard Knox, who is monitoring developments from our studios here. Richard, good morning.

RICHARD KNOX: Good morning.

INSKEEP: He's our health and science correspondent. And how widespread are the safety concerns about this vaccine?

KNOX: There seems to be a lot of worries out there. There was a poll the other day from the magazine Consumer Reports that found that two-thirds of parents are saying that they are either holding off on getting their kids vaccinated or they've decided not to have their kids vaccinated. Their main concern is that they think the vaccine may not have been tested well enough.

INSKEEP: Let's listen to one of the questions that people have sent in.

Dr. IAN ZLATKIS (Pediatrician, New Orleans): Was it subjected to the same testing as the regular seasonal flu vaccine or were shortcuts taken as it was rushed to market?

INSKEEP: This gentlemen is identified as Dr. Ian Zlatkis, somebody who has questions himself even though he is a doctor.

KNOX: That's right. I think he's not alone out there. And for the answer to that, I'd like to go to Dr. Anthony Fauci. He's the director of the National Institute of Allergies and Infectious Diseases.

Dr. ANTHONY FAUCI (Director of the National Institute of Allergies and Infectious Diseases): The H1N1 pandemic flu vaccine is made exactly the same way with the same processing, with the same materials, as we make seasonal flu vaccine, which has an extraordinarily good safety record.

KNOX: He makes another point. He says the new vaccine really shouldn't be considered a new vaccine, a brand-new vaccine at all. It's like what they do every year with ordinary flu vaccines; they make little changes, they tweak it, they call them strain changes. It's just that this is a very big strain change.

INSKEEP: We had a question also from Erin Bolton(ph) of Baltimore, and she's in a group of people that has been strongly urged to get this vaccination. She writes: I'm pregnant. My baby is due in December. I'm planning to get vaccinated, she writes, but she's concerned that results of vaccine studies in pregnant women aren't in yet and she wonders whether she should wait.

KNOX: I put Erin Bolton's question to Dr. Frank Witter. He's at Johns Hopkins Medical School in Baltimore, and he's an expert in maternal fetal medicine.

Dr. FRANK WITTER (Johns Hopkins University, School of Medicine, Baltimore): Erin, you should take the flu vaccine. Not only should you take the seasonal flu vaccine, but you should also take the pandemic flu vaccine. Pregnant women have gotten very, very sick from this new virus and have actually died. So you should take the vaccine.

INSKEEP: Strong warning there, Richard Knox, but this is something that a lot of women may be reluctant to do when they're pregnant.

KNOX: I think a lot of pregnant women are very reluctant to take anything. But we already know that pregnant women are much more likely to get swine flu. If they get it, they're like six times more likely to die from it and that's really what Dr. Witter is emphasizing. A lot of his obstetrically colleagues worry that if they urge a woman to get vaccinated then she happens to miscarry, it may have nothing to do with the vaccine because we have no evidence that the flu vaccines do cause women to miscarry, but they may blame it on the doctor.

He says: well, you know, if that happens, I'd rather be blamed for a miscarriage than see a woman die from a flu that I might have helped her prevent.

INSKEEP: We're taking listeners questions about swine flu, and here's another one from Meghan Guptill(ph) of Orinda, California. She writes: As a young person with asthma, I am in the group of people who are supposed to get the first round of the vaccine. But, apparently she is hesitating, Richard Knox.

KNOX: Yes. And by the way, people with asthma are a really big group. They're about - more than 20 million Americans have it. The reason Meghan is hesitating, I understand, is because she's wondering if she should get the first vaccine out of the bloc, which will be the nasal spray type. It's called FluMist. But people with asthma aren't supposed to get FluMist because it might touch off asthma attacks, so she's worried about getting swine flu while she's waiting for the regular vaccine to be available. Asthma experts are saying she should wait until she can get the regular flu shot, not FluMist.

INSKEEP: We've been hearing, Richard Knox, about people who are worried about the vaccine. But let's talk a little bit here about people who say they are not that worried about swine flu. They wonder if it's really not that serious.

KNOX: A lot of people have been asking that. I hear it all the time. For that answer, let's go back to Dr. Tony Fauci of the NIH. He's really the government's top flu specialist.

Dr. FAUCI: Although, for the most part, it is a relatively mild infection. In the younger individuals who are getting infected, there's a small percentage, but a disturbing percentage who go on to develop serious disease and even some deaths. About 30 percent of the deaths are in people who are otherwise young, vigorous and healthy. You rarely, rarely see that with seasonal influenza.

KNOX: You might ask the question the other way around really, wouldn't there be a lot of anger if the government had not developed this vaccine and a number of people, especially young healthy people had died?

INSKEEP: Richard, thanks very much.

KNOX: You're welcome.

INSKEEP: NPR's Richard Knox.

RENEE MONTAGNE, host:

And if you have more questions, we'll have an expert answer them in a live Web chat today at noon Eastern Time. Go to npr.org/health.

(Soundbite of music)

MONTAGNE: It's MORNING EDITION from NPR News. Transcript provided by NPR, Copyright National Public Radio.

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