Swine Flu News
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Pennykay
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Production of Swine Flu Vaccine Is Way Behind
Published: October 22, 2009
SWIFTWATER, Pa. (AP) -- The federal government originally promised 120 million doses of swine flu vaccine by now. Only 13 million have come through. As nervous Americans clamor for the vaccine, production is running several weeks behind schedule, and health officials blame the pressure on pharmaceutical companies to crank it out along with the ordinary flu vaccine, and a slow and antiquated process that relies on millions of chicken eggs.
There have been other bottlenecks, too: Factories that put the precious liquid into syringes have become backed up. And the government itself ran into a delay in developing the tests required to assess each batch before it is cleared for use.
What effect the delays will have on the course of the outbreak is unclear, in part because scientists cannot say with any certainty just how dangerous the virus is, how easily it spreads, or whether it will mutate into a more lethal form. Since April, swine flu has killed more than 800 people in the U.S., including 86 children, 39 of them in the past month and a half, according to the Centers for Disease Control and Prevention. More than half of all hospitalizations since the beginning of September were people 24 and under.
''We're in this race against the virus, and only Mother Nature knows how many cases are going to occur over the next six to 10 weeks,'' said Michael Osterholm, a vaccine expert at the University of Minnesota.
In the meantime, many states have had to postpone mass vaccinations. Clinics around the country that managed to obtain doses of the vaccine have been swamped. And doctors are getting bombarded with calls from worried and angry parents. ''Nobody has it,'' said AnnMarie O'Connor, who waited more than four hours for the vaccine in Rockville, Md., standing in line with her two young children and about 1,000 other people. Health officials ''said the shots would be here in early October. But where are they?''
Federal officials counsel patience, saying that eventually there should be enough of both vaccines for everyone who wants them. ''We wish we had better ways to produce vaccines perfectly predictably, but this is how influenza vaccine production often goes,'' Dr. Anne Schuchat, who heads the CDC's immunization and respiratory disease section, said last week.
The delays have led to renewed demands for a quicker, more reliable way of producing vaccines than the chicken-egg method, which is 50-year-old technology and involves injecting the virus into eggs and allowing it to feed on the nutrients in the egg white. Federal officials initially projected that as many as 120 million doses of the vaccine would be ready to dispense by mid-October. They later reduced their estimate to 45 million. As of Tuesday, only 12.8 million were available. (Health officials say a single dose will protect adults, while children under 10 will need two doses.)
In a sign of how rapidly the virus is spreading, education officials said 198 schools in 15 states were closed Wednesday because of swine flu, with more than 65,000 students affected. That was up from 88 school closings the day before. ''Right now, the vaccine is in a race against the virus, and the virus is winning,'' Osterholm said.
The government now hopes to have about 50 million doses out by mid-November and 150 million in December, Dr. Nicole Lurie, assistant health and human services secretary for preparedness, told The Associated Press on Wednesday. ''By the end of November, I think we're going to be pretty well back on track,'' she said.
However, a study by Purdue University researchers said the vaccinations will probably come too late to significantly reduce the number of infections. The study, published last week, predicted that infections would peak in late October and that by the end of the year, 63 percent of the U.S. population will have caught the virus.
The blame for the delays has been placed in part on the chicken-egg technology. It is a slow process, and the pressure on manufacturers to produce two vaccines at the same time -- for both swine flu and ordinary flu -- has made it even slower. Also, the virus on which the swine flu vaccine is based was found to reproduce very slowly in eggs -- much more slowly than the ordinary flu virus. Health and Human Services Secretary Kathleen Sebelius, who on Wednesday was grilled about the delays by the Senate Homeland Security Committee, said the problem has been fixed.
The U.S. government is funding newer technologies that hold the promise of a more reliable and expandable vaccine supply. ''We need a man-to-the-moon effort for flu vaccine if we don't want to find ourselves in the same position in the future,'' Osterholm said. Flu vaccines are not nearly as profitable as other kinds of drugs, and most of the biggest vaccine makers have little incentive to switch from a method with which they are familiar.
At its two plants in the Pocono Mountains town of Swiftwater, Sanofi Pasteur, the top U.S. supplier of seasonal vaccine, is churning out more than 75 million doses of swine flu vaccine and 50 million doses of the winter flu variety. Sanofi spokeswoman Donna Cary said egg-based production of flu vaccine is ''tried and true'' and will probably remain the dominant method for years to come.
''If it weren't for the egg-based process, we wouldn't be able to respond to this pandemic,'' she said. More than 30 farms in the eastern United States are under long-term contract to provide eggs for vaccines, tending 9 million to 12 million chickens. Once the fertilized eggs arrive at the vaccine plant, the flu virus is injected into them and allowed to multiply for several days. Then the eggshells are cracked; the virus-laden fluid is extracted, the flu virus is killed and the substance is purified. The inactivated strain is tested to determine purity, potency and yield. From start to finish, the process takes about six months. In normal years, that is usually enough time to get the vaccine to anyone who wants it. But in an all-out epidemic, egg-based production is incapable of producing huge batches quickly.
The government has awarded a $487 million contract to Novartis for a plant in North Carolina that will make flu vaccine by growing the virus inside animal cells, preferably from mammals. The plant is expected to be up and running by 2011 or 2012. Also, Protein Sciences Corp. of Meriden, Conn., landed a five-year, $147 million contract to develop a vaccine using its recombinant technology -- flu proteins grown in insect cells. The hope is that the first doses would be available within 12 weeks of the beginning of a pandemic. That is about twice as fast as flu vaccine produced from eggs.
''I think you're going to see these new technologies come on board rapidly, especially given what's happened this year,'' said Paul Radspinner, president and chief executive of FluGen Inc., a Madison, Wis., company working on several new vaccine technologies of its own.
Published: October 22, 2009
SWIFTWATER, Pa. (AP) -- The federal government originally promised 120 million doses of swine flu vaccine by now. Only 13 million have come through. As nervous Americans clamor for the vaccine, production is running several weeks behind schedule, and health officials blame the pressure on pharmaceutical companies to crank it out along with the ordinary flu vaccine, and a slow and antiquated process that relies on millions of chicken eggs.
There have been other bottlenecks, too: Factories that put the precious liquid into syringes have become backed up. And the government itself ran into a delay in developing the tests required to assess each batch before it is cleared for use.
What effect the delays will have on the course of the outbreak is unclear, in part because scientists cannot say with any certainty just how dangerous the virus is, how easily it spreads, or whether it will mutate into a more lethal form. Since April, swine flu has killed more than 800 people in the U.S., including 86 children, 39 of them in the past month and a half, according to the Centers for Disease Control and Prevention. More than half of all hospitalizations since the beginning of September were people 24 and under.
''We're in this race against the virus, and only Mother Nature knows how many cases are going to occur over the next six to 10 weeks,'' said Michael Osterholm, a vaccine expert at the University of Minnesota.
In the meantime, many states have had to postpone mass vaccinations. Clinics around the country that managed to obtain doses of the vaccine have been swamped. And doctors are getting bombarded with calls from worried and angry parents. ''Nobody has it,'' said AnnMarie O'Connor, who waited more than four hours for the vaccine in Rockville, Md., standing in line with her two young children and about 1,000 other people. Health officials ''said the shots would be here in early October. But where are they?''
Federal officials counsel patience, saying that eventually there should be enough of both vaccines for everyone who wants them. ''We wish we had better ways to produce vaccines perfectly predictably, but this is how influenza vaccine production often goes,'' Dr. Anne Schuchat, who heads the CDC's immunization and respiratory disease section, said last week.
The delays have led to renewed demands for a quicker, more reliable way of producing vaccines than the chicken-egg method, which is 50-year-old technology and involves injecting the virus into eggs and allowing it to feed on the nutrients in the egg white. Federal officials initially projected that as many as 120 million doses of the vaccine would be ready to dispense by mid-October. They later reduced their estimate to 45 million. As of Tuesday, only 12.8 million were available. (Health officials say a single dose will protect adults, while children under 10 will need two doses.)
In a sign of how rapidly the virus is spreading, education officials said 198 schools in 15 states were closed Wednesday because of swine flu, with more than 65,000 students affected. That was up from 88 school closings the day before. ''Right now, the vaccine is in a race against the virus, and the virus is winning,'' Osterholm said.
The government now hopes to have about 50 million doses out by mid-November and 150 million in December, Dr. Nicole Lurie, assistant health and human services secretary for preparedness, told The Associated Press on Wednesday. ''By the end of November, I think we're going to be pretty well back on track,'' she said.
However, a study by Purdue University researchers said the vaccinations will probably come too late to significantly reduce the number of infections. The study, published last week, predicted that infections would peak in late October and that by the end of the year, 63 percent of the U.S. population will have caught the virus.
The blame for the delays has been placed in part on the chicken-egg technology. It is a slow process, and the pressure on manufacturers to produce two vaccines at the same time -- for both swine flu and ordinary flu -- has made it even slower. Also, the virus on which the swine flu vaccine is based was found to reproduce very slowly in eggs -- much more slowly than the ordinary flu virus. Health and Human Services Secretary Kathleen Sebelius, who on Wednesday was grilled about the delays by the Senate Homeland Security Committee, said the problem has been fixed.
The U.S. government is funding newer technologies that hold the promise of a more reliable and expandable vaccine supply. ''We need a man-to-the-moon effort for flu vaccine if we don't want to find ourselves in the same position in the future,'' Osterholm said. Flu vaccines are not nearly as profitable as other kinds of drugs, and most of the biggest vaccine makers have little incentive to switch from a method with which they are familiar.
At its two plants in the Pocono Mountains town of Swiftwater, Sanofi Pasteur, the top U.S. supplier of seasonal vaccine, is churning out more than 75 million doses of swine flu vaccine and 50 million doses of the winter flu variety. Sanofi spokeswoman Donna Cary said egg-based production of flu vaccine is ''tried and true'' and will probably remain the dominant method for years to come.
''If it weren't for the egg-based process, we wouldn't be able to respond to this pandemic,'' she said. More than 30 farms in the eastern United States are under long-term contract to provide eggs for vaccines, tending 9 million to 12 million chickens. Once the fertilized eggs arrive at the vaccine plant, the flu virus is injected into them and allowed to multiply for several days. Then the eggshells are cracked; the virus-laden fluid is extracted, the flu virus is killed and the substance is purified. The inactivated strain is tested to determine purity, potency and yield. From start to finish, the process takes about six months. In normal years, that is usually enough time to get the vaccine to anyone who wants it. But in an all-out epidemic, egg-based production is incapable of producing huge batches quickly.
The government has awarded a $487 million contract to Novartis for a plant in North Carolina that will make flu vaccine by growing the virus inside animal cells, preferably from mammals. The plant is expected to be up and running by 2011 or 2012. Also, Protein Sciences Corp. of Meriden, Conn., landed a five-year, $147 million contract to develop a vaccine using its recombinant technology -- flu proteins grown in insect cells. The hope is that the first doses would be available within 12 weeks of the beginning of a pandemic. That is about twice as fast as flu vaccine produced from eggs.
''I think you're going to see these new technologies come on board rapidly, especially given what's happened this year,'' said Paul Radspinner, president and chief executive of FluGen Inc., a Madison, Wis., company working on several new vaccine technologies of its own.
maroo
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Good Grief.
Why is this not national news? Why don't I hear about this every time I turn on the TV?
H1N1 has been "overblown" by the media? I don't think so.
LuvOrlando
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Good Grief.
Why is this not national news? Why don't I hear about this every time I turn on the TV?
H1N1 has been "overblown" by the media? I don't think so.
Isn't that the way everything is being played out these days though? Nothing but smoke and mirrors, and then when the farce gets called out, more smoke and mirrors and assurances our eyes are lying. I agree it's really getting old in a hurry.
sersee05
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definitely keep calling different health departments though..Because there is a shortage..but the states were all promised some. My county in NJ is just getting some shots in now. I kept calling last week and found out that only one county had the injections. It was only an hour and a half and there wasn't any mandate on who could come get them. I called and made an appointment and was able to get my asthmatic son vaccinated yesterday. I could have easily brought all three kids in and gotten them one..since they didn't ask..but I felt it wasn't the right thing to do..I am sure some did that though. They were only vaccinating young toddlers, 5-18 with underlying medical conditions and pregnant women. So definitely keep trying..they had just started setting up appts when I called ..and then that quickly there were done! I got lucky because I called at just the right time.
However, in speaking with my counties health department, they are requiring picture Id's to prove you live in the county and a doctor's note to prove there is an underlying condition.
However, in speaking with my counties health department, they are requiring picture Id's to prove you live in the county and a doctor's note to prove there is an underlying condition.
maroo
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The thing I took home from the hearing the other day was that only 28 States are even reporting deaths.
So how many people are REALLY dying?
How many children have we REALLY lost this year to this stupid flu?
Va-bear
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Joy, I really feel for you and quote the poster who mentoins calling the health dept over and over. One of my sons has asthma and I was so stressed trying to get him the shot too. We ended up enrolling him in a trial just to guarantee he get it. Then, today, they were offering the mist at the Health Dept near here for all children (who dont have asthma, etc.) - as I took my other son for it I heard the nurses saying they had JUST gotten the injectable form so if there were any kids/adults there w/ asthma, who were pregnant, etc. they could get it.
Just 1/2 hour earlier, if someone had called, they would have been told they didnt have any injectable vaccine. Sad to say, it will probably be gone by 6pm tonight - VERY happy for those that did get it.
So, do keep calling and calling. Good luck. 
Just talked to our ped as 3 of my 4 kids have been home all week with fever and flu symptoms. The labs are so backed up that they are treating everything as a suspected case and not testing unless demanded by the parents. Even if the test is positive, the treatment remains the same. I asked if they should get the vaccine and the response was that unless they were positively diagnosed by test, they should. There are many viruses around all the time so you never really know what you have 
OK, I just returned from our weekly Pediatric Faculty meeting, and our attending virologist gave this update:
Stocks of Tamiflu suspension (for young children) is out, here in Iowa.
However, compounding pharmacies can take capsules and make them into a solution for children under about 7 or 8 who cannot swallow capsules.
Overall, there are over 400,000 courses of Tamiflu in the state, so no statewide shortage, at least here.
Dosing recommendations have been too low. For children, it was recommended at 2 mg/kg/dose twice a day - now it should be 3 mg/kg/day. Adult treatment dose remains 75 mg twice a day. And prophylaxis dose is half that - same dose, given once a day.
For hospitalized patients, they get twice the treatment dose - 150 mg twice a day for adults.
And Tamiflu has to be started within 48 hours of onset of symptoms.
Again, Tamiflu is effective for H1N1, but not seasonal flu.
Stocks of Tamiflu suspension (for young children) is out, here in Iowa.
However, compounding pharmacies can take capsules and make them into a solution for children under about 7 or 8 who cannot swallow capsules.
Overall, there are over 400,000 courses of Tamiflu in the state, so no statewide shortage, at least here.
Dosing recommendations have been too low. For children, it was recommended at 2 mg/kg/dose twice a day - now it should be 3 mg/kg/day. Adult treatment dose remains 75 mg twice a day. And prophylaxis dose is half that - same dose, given once a day.
For hospitalized patients, they get twice the treatment dose - 150 mg twice a day for adults.
And Tamiflu has to be started within 48 hours of onset of symptoms.
Again, Tamiflu is effective for H1N1, but not seasonal flu.
Deb, I thought Tamiflu was used for seasonal flu before H1N1? What was it used for before this outbreak? Thanks so much for your updates. They are very informative.
Can you tell me what county? I am in Bergen and I called this week and they had no idea when they were getting them.
HOGFAN
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Our hospital's emergency room today called a "saturation two" which (I was told) means that there are so many people in the ER who need to be admitted that the floors have to 'empty' out any patients that might possibly be in good enough shape to be discharged.
In our hospital visitors have to be 18 or older,no kids.
In our hospital visitors have to be 18 or older,no kids.
themilesfamily
<font color=green>Wanna potty with Spongebob Squar
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Hi Deb! I'm in Linn County Iowa. Any word on when we're going to see availability for the Swine Flu vaccine? I have a 5-year old and she and I are heading to Disney in mid-November.
Do you think we'll be able to get our vaccine by then??? Just your opinion...I know nothing is set in stone.
AlexWyattMommy
<font color=deeppink>Okay, here I am, out of high
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The seasonal H1N1 - which is very different from the Novel Type A H1N1 - is resistant to Tamiflu. That means Tamiflu won't help reduce the duration of the seasonal flu.
Keep calling everyday. When we got our first shipment at work, there was no forewarning- except "soon". Then the next day we received 500 doses of the H1N1 mist. Same thing when we ran out very early of the seasonal flu shot. We were told it would be a few weeks. Then 2 days later we had 100 more doses being delivered.
I know in our area they are not having the schools give it. Nor are they doing clinics w/ the health department anytime soon. Essentially very limited clinics are getting it and that is it.
Ironically, we got the 500 doses 3 weeks ago and our supply is holding steady. Seems we are only going through about 100 doses a week, and we have 9000+ patients. If it holds out I'm getting it for my son next Friday (he had the seasonal flu mist so we're in that holding/waiting phase).
Today at work, we started making an emergency prep plan for dealing w/ an outbreak amongst staff. Only 3 employee's have been immunized so far (for varying reasons) and it's becoming a top concern. As we've seen increased cases in the last several days. Just a week ago we were getting no positive tests in the office, then it's been a sudden surge this week. So it's definetly arriving again in our area. We had a large outbreak in the spring and were hoping it wouldn't be as widespread this time due to the number of people who already had it.
I know in our area they are not having the schools give it. Nor are they doing clinics w/ the health department anytime soon. Essentially very limited clinics are getting it and that is it.
Ironically, we got the 500 doses 3 weeks ago and our supply is holding steady. Seems we are only going through about 100 doses a week, and we have 9000+ patients. If it holds out I'm getting it for my son next Friday (he had the seasonal flu mist so we're in that holding/waiting phase).
Today at work, we started making an emergency prep plan for dealing w/ an outbreak amongst staff. Only 3 employee's have been immunized so far (for varying reasons) and it's becoming a top concern. As we've seen increased cases in the last several days. Just a week ago we were getting no positive tests in the office, then it's been a sudden surge this week. So it's definetly arriving again in our area. We had a large outbreak in the spring and were hoping it wouldn't be as widespread this time due to the number of people who already had it.
I found the vaccine this afternoon at a Walgreens about 30 minutes from my house. I was really excited and jumped in the car with the kids when they got off the bus. We waited an hour and a half, but all got it.
But here's the kicker. My 8 year old this evening says he's getting a sore throat and feels achy. No fever yet. But now besides worrying if he's got swine flu, I'm worried that he got the vaccine while he was probably already sick. Should I be worried about that? I was reading where it says you shouldn't get the vaccine if you're sick.
I guess we'll be off to the pediatrician in the morning to see about Tamiflu.
What bad things can happen if you're vaccinated while you're sick? I'm a bit worried.
But here's the kicker. My 8 year old this evening says he's getting a sore throat and feels achy. No fever yet. But now besides worrying if he's got swine flu, I'm worried that he got the vaccine while he was probably already sick. Should I be worried about that? I was reading where it says you shouldn't get the vaccine if you're sick.
I guess we'll be off to the pediatrician in the morning to see about Tamiflu.
What bad things can happen if you're vaccinated while you're sick? I'm a bit worried.
taximomfor4
<font color=purple>Needs a few Ricola drops<br><fo
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I don't think I'd go for the Tamiflu. You don't want to negate the shot you just gave! Anyway, you'll expose him to even MORE illnesses out and about.
Thanks for the PM btw -- I got it too late, but will keep calling around here. I am desperately seeking EITHER flu shot -- I can't even get a seasonal one. They run out!
BibbidiBobbidiBOO
<font color=green>AKL is my new favorite<br><font
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I thought Tamiflu worked for seasonal B but not seasonal A last year. Perhaps this has changed. I think last year was the first year it did not work on seasonal A.
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