Why Weren't H1N1 Vacccines Available for Our Children Before School Started?

President Barack Obama declared H1N1 a national emergency last weekend, a status that will give the federal government greater flexibility and authority to contain the pandemic. But the current shortage of H1N1 vaccine underscores the severe lack of U.S. preparedness in responding to pandemics, whether through natural disease transmission or manmade bioterrorist attacks.

I am posting this in my capacity as the chair of the bipartisan Commission on the Prevention of Weapons of Mass Destruction Proliferation and Terrorism. Jim Talent, former Republican senator from Missouri, is the vice chair.

I'm posting this because I am worried.

Whether the threat is from naturally occurring disease or bioterrorism, the United States needs to be able to produce vaccines and other medicines faster and less expensively. We had six months of advance warning for the H1N1 pandemic. A bioterrorism attack will have no advance warning.

The answer is to create the infrastructure for rapid development of large quantities of safe vaccines and medicine. Modern methods will shave months off the typical six-to-nine months that current processes require. The newer methods can produce more vaccine and be quickly scaled-up, on demand. The investment in new technologies will generate benefits for both public health and national security.

Here's the scenario. A villain--whether an Al Qaeda operative or someone like Timothy McVeigh--uses a crop duster to spread just two-to-four pounds of anthrax spores over a major city. Let's say it's during an Independence Day celebration. Or the Thanksgiving Day parade. That action could kill more Americans than died in World War II. Clean-up and other economic costs could exceed $1.8 trillion.

A critical, on-the-ground, emergency response is to quickly have vaccines and medicine ready for the public, to reduce the impact of a terrorist attack and save lives.

It's not science fiction. Our bipartisan, congressional Commission unanimously concluded that unless the world community acts decisively and with great urgency, it is more likely than not that a weapon of mass destruction will be used in a terrorist attack somewhere in the world by the end of 2013--and that a biological attack is more likely than nuclear.

The United States--unlike the European Union and China--continues to use a 60-year old production method, using chicken eggs, to make H1N1 and other important vaccines. U.S. flu vaccines are safe and effective, but manufacturing can take six months, and is vulnerable to delays. The time it takes to make the vaccine is much longer than the time it takes for a flu virus to cause a pandemic. Right now, the H1N1 vaccine is being produced as quickly as possible, but millions of people will not have the chance to be vaccinated before they are exposed to the virus.

Part of the slowness is due to the fact that all six US manufacturers of flu vaccine use chicken eggs. A modern and faster method to make a safe flu vaccine uses a process called "cell culture." Cell culture does not require eggs. Vaccines for polio and the modern smallpox vaccine have been produced for decades using this technology.

Abandoning chicken eggs for cell culture has several advantages:

• Rapid scale-up in production would be possible.
• Egg-specific steps in the production process would be removed, saving time.
• Vaccine can be given to people who are allergic to eggs.
• Chickens are susceptible to avian influenza infections, which could disrupt the supply chain of eggs and cripple vaccine production.


The U.S. has invested in cell culture technologies, but none are yet available. The Commission released the two-minute video to engage the U.S. public on the need to improve the nation's capability to produce vaccines and medicine faster and less expensively. The video and resources are available on the website, which includes links to public discussions on Facebook, Twitter and MySpace.

Senator Talent and I want to hear what people have to think, to help inform our work on the Commission and our advocacy to help protect the United States from the threat of terrorism.

Consider this an invitation to join the conversation.

 

Comments

[Sheldon101]

THINGS ARE GETTING BETTER
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The H5N1 avian influenza scared governments around the world. The death rate from the 1918-1919 Spanish flu was 1 or 2% in the absence of antibiotics and medical The death rate from H5N1 is over 50% in humans.

That scared governments around the world and opened a new market for vaccine makers as they've been developing pre-pandemic and pandemic vaccines for H5N1 in cases it mutates to become contagious from human. http://en.wikipedia.org/wiki/Influenza_A_virus_subtype_H5N1

There's been a benefit from this as far as H1N1 is concerned. Vaccine makers are able to supply more vaccine than they would have a few years ago.

As well, the bugaboo of annual flu vaccination, that the vaccine doesn't work well on the elderly is solvable by some combination of a much higher dose of antigen (4x) or using the AS03 adjuvant (based on the Canadian experience with H1N1 this year) or even an older whole virus vaccine.

Flu vaccination: Safe, Effective and the Right Thing to Do.
www.vaccineswork.blogspot.com

[isjois]

Vaccine inserts from the pharmaceutical companies clearly outline the possible side effects of their products. No drug or medical intervention is 100% safe. Vaccines will never be completely safe for every person who receives them.

Some people can use antibiotics...while other people can die if they are used.
Some people can eat peanuts...while other people may die if they are exposed to them.
Some people can drive cars...while others will die in car accidents.

We need to be cautious in oversimplifying our statements or creating arguments based on fear.

"The Right Thing To Do" - Who decides what is right for you? Do you want a blogger deciding that we all must submit to vaccines? Do you want the government to force you or your loved ones to be vaccinated? There is a slippery slope in this comment.

[MicheleCA]

Good post.

[Sheldon101]

If it's mandatory, then government on behalf of the people has decided we cannot risk the damage caused by those who refuse to be vaccinated. Avian flu scared some governments to pass new laws allowing mandatory and forcible vaccination.

Because flu vaccination is voluntary each year, it's an ethics test for those who are willing to personally take the risk of influenza. Because by doing so, there's a large chance of harming others in their community compared to the almost zero risk of long term damage from the vaccination.

You should be willing to take a little risk for a very large benefit to others, some of them who are people you're close to and some who are strangers. If you could at practically zero risk, rescue a stranger from drowning, you'd do it. So why not do it for the stranger you don't see in front of you, but will still be harmed by your actions?

That's why it's the right thing to do.

[irishgawdess]

Prior to the K-12 school year starting, I asked this question (but who am I that anyone with the power to do anything about it would listen?) Anytime you get a bunch of kids w/ poor hygienic habits (sneezing w/o covering their mouths, picking their noses, and then touching everything, etc.) back together after spending their summers spread out all over the country, and bringing new germies back to school, you know there's gonna be an outbreak within a month of school starting. My school teacher friends have all gotten sick with some flu since early Sept.

Prior to the university system starting their academic year here in OR, I asked this question. A kid at my son's college died of the swine flu last spring. The school closed down for a week. The CDC knew that the H1N1 virus would be back again this fall. Why would people want to begin congregating in small spaces (class rooms) and risk catching the flu? You'd think someone in the state's public health office would have had a clue this season, and publicized this back in August, or early September. "People" just acted like waiting until both flus hit would be fine to finally receive the vaccine. How many people (both young and old) are going to have to die before more than just Bob Graham starts asking this question?

Are we just a nation of “wishers and a hopers?”

[GranE]

Senator Graham, thank you for your time serving on this committee. The general public needs to be made aware of these issues on a real time basis, and this is what you are trying to do here.

Aids was so mishandled by our country that it was allowed to spread into a epidemic, many people did not trust the science community when in fact it was the government who was wrong on the matter.
The leadtime from when the H1N1 was being investigated for its source until the manufacturing of a vaccine, has been short in comparison to seasonal flu shortages we saw last flu season, but the lasting effects are still not known. America has to get this right and we should not outsource our priorities.

The ability to act swiftly and produce a product that can be self-administered would seem to me to be a priorty. Our pharma companies cannot be trusted to do the right thing for the good of the people. Even though some Americans yell about government and taxes, they all want to drive on a paved road. Those of you who are trying to address the need must forge ahead with a deaf ear to the screamers and do what needs to be done. Just do it. We will do our best within our own communities to give you support.

[mizerello]

Every time we hear about various vaccines being produced, they are being produced either in Europe or China--never in this country. Are any vaccines actually manufactured in the U.S. any longer or, like everything else, are we now totally dependent upon foreign producers?

For some reason, rather than address the basic problem--the fact that we make nothing here anymore, we talk about improving the current situation, i.e., lead in our kid's toys--no politician ever says, we need to stop making our toys in China and bring back production to the U.S. Instead, they talk about fixing the situation in China.

From what I understand, there's not enough money in making vaccines to make it profitable for our lovely pharmaceutical industry to invest in better manufacturing techniques.

[Pierce Nichols]

What are you talking about? Half of this years pandemic flu vaccine production is in the US and half is in Europe. None is in China.

[digeridoo2]

Duh...because Cheney and his Republican minions are working night and day to undermine the government and a black president. Their racism is more important to them than vaccinating the country!

[julie1215]

This is also an excellent argument for having universal health care. What if there were a targeted biological weapons attack? Would we let the uninsured roam about spreading disease? A lot of them are workers with low wages that spend their days making our food, watching our children and taking care of our elderly. I have been on a waiting list to get my kids vaccinated for over a month. No vaccine anywhere, but we're awash in Viagra and Cialis. Way to be prepared. As long as grandpap can get it up, who cares if our kids succumb to pandemic?

[mergina]

It would be better to give our children vitamin supplements to boost their immune systems and keep them hydrated than to have that poison injected into them.

[PhilipB]

That is certainly something to consider. I am all over the place on this. It does seem that many medical professionals are skeptical of this. Hmmm, what is up with that? I mean really, I simply just want THE TRUTH.
Best regards to all!
:)

[Pierce Nichols]

So, do you have any actual evidence for your anti-vax claims? You know the type -- statistically significant, methodologically sound, and peer-reviewed? Also, not fraudulent.

[Areyoume2]

I'm a teacher for NYC and what a sham that vaccination program is. First - there was not a DOT of information until the PACKET came out this week, with instructions that it'd need to be signed or NOT within acouple or few days for vaccinations to begin next week. NYC Mayor Bloomberg saw this as a pro-active attempt to get his face OUT ahead of the curve (in his bid for an illegal third term) : A CRISIS Free Vaccines for ALL kids. But he is totally not prepared for this project. Let the lawsuits begin.

The rumors about the dangers of the vaccine so OUTSHINE any valid information. I hear teachers discussing the horror stories from what they've LEARNED on Facebook (come on, shouldn't educators be educated??). I've personally heard the principal discourage parents when they pop in for quick MIS-information about the danger of the vaccine. We're all at the mercy of this flu. And it's so easily resolved with a vaccination. The problem is that NYC Dept of Education is not qualified to handle anything BIG or REAL. If my kids were small I'd say YES to the vaccine NO to NYC DOE administrering it. And YES to figuring out a better system in time for something more seriousl!

[sposton]

This is the end result of a ideological dogma that says the government shouldn't own medicine producing capacity even when the pharmaceutical corporations aren't willing to provide this capacity because there just isn't as much money in vaccines as it is in Viagra. It is time to drop this kind of nonsense. Let's create a government owned and run state-of-the-art vaccine production capacity that this country deserves and badly needs. It is time we transcend the old fashioned chicken egg method of production of vaccines and move this field into the 21st century. Let capitalism reign elsewhere.

[wallyone]

Some of this complaining comes from those who ridiculed the government for overreacting to the flu outbreak in Mexico last summer. Fat chance they will admit how foolish they look now for the flat out stupid comments they made earlier this year.

[xlntcat]

You are right. They will never admit it they they are going to criticize regardless, They know that there is an element of the population who will always see the glass half empty and will resist anyone filling their glass, therefore, their complaints always get media traction.

[silqworm]

This is all hype and nonsense. We were and are right, look how easily they have worked you up over nothing.

[Pierce Nichols]

How many people have to die of H1N1 before you admit it's significant?

[DUSAA-1775]

the government said that by mid-October, there would be 120 million doses available. We are not even close to that number.
Obama lied....people died.

[wallyone]

They relied on the estimates supplied by the manufacturers. However, biologic processes are inherently somewhat unpredictable.

If you want to go to Bush lied, people died, then think about the cooked, stovepiped intelligence that lied us into the Iraq war for WMD's. There you are talking hundreds of thousands of deaths counting Iraqis, as well as untold additional damage.

[themeeg]

Amen!

[MED1025]

This is science. You can't push it into third gear to meet a time line. Crops don't grow faster even if you're hungry and vaccine can't be made faster just because you need it sooner.

[xlntcat]

It takes six months to nine months to manufacture a vaccine, but I am confident had we put you in charge you could have told us that the manufacturer overestimated their ability to supply the vaccine in the amount that was promised. This is one of the most ignorant complaints or the multiple ignorant complaints coming for a public that waited a decade or more for a polio vaccine and that after decades do not have an HIV/Aids vaccine. Perhaps if the previous administration had not cut funding to science, we would be having this discussion.

[Marnie1]

Before throwing rocks at the Obama administration over H1H1 just think back to how the Reagan administration reacted to HIV/AIDs.

It did nothing.
It spewed bigotry.

And did nothing.

It let people die. (Kind of reminds you of Dubhya reacting to Katrina, Rita, a huge tsunami.)

World wide most victims have always been women and children. Yet the Reaganites obsessed about homosexuality.

So the US did nothing while HIV grew into a world wide epidemic.

Other nations acted and the President of the United States, who claimed sole owner ship of being the only World Power, - did nothing.

[PhilipB]

Well, that is true.

[irishgawdess]

Let's hope that the Obama Admin. will do away with the conditional "abstinence only" edict in order for developing countries to accept our foreign aid directed towards AIDS/HIV.

[Marnie1]

Where was your leadership a year ago with the R&D for this year's flu was on going?

The shortage of flu vaccines has been an issue for at least 7 years. The shot I used to get at my asthma doctor’s office I now have to stand in long lines outside grocery stores and church basements to get. These shots were given without prescription, and with no medical supervision or oversight. And no screening to make sure that those who are at highest risk are protected first.

Every year a new vaccine has to be developed in anticipation of new strains of virus, that is a very time consuming, very high tech process. Growing virus in vitro is difficult and also very expensive. The lead time for this process is a year. Complaining about this year's supply is useless, because research now and the industry now is preparing for next year's flu.

This last minute CYA political blame game just makes the whiners look all the more ingorant.

[mamacita]

In a nutshell, the problem with the vaccine is our for-profit health care system. Low-profit margins on vaccine means less incentive to produce. The longer they wait, the more demand builds up, the more profit can be expected.

There is no incentive to invest in technology for a low-profit margin product. It would only cut into their profit margin more. Outsourcing is more likely, to increase the profit margin with cheaper production and less safety regulation. And it also leaves us at the discretionary good graces of another country.

You could also look into the cost comparison of producing the vaccine versus treating the disease. Is it more profitable to treat the disease?

Points to ponder while selling us out to the corporate healthcare profiteers....

[dobberdoss]

"But the current shortage of H1N1 vaccine underscores the severe lack of U.S. preparedness in responding to pandemics, whether through natural disease transmission or manmade bioterrorist attacks."

This vaccine IS bio- terrorism

[Marnie1]

The vaccine is man-made bio-protection.

The lack of our immunity to this virus is a result of its natural mutation.

[xlntcat]

The World Health Organization has been working on a vaccine for bird flu aggressively since 2005 and still do not have one. The world is unprepared for a pandemic and it is hard to see that changing unless we devote more resources to science including raising our miserable education rating in science.

[Sheldon101]

Wrong.

Research prepandemic and pandemic H5N1 vaccines.
http://getreadyforflu.blogspot.com/2008/06/pre-pandemic-h5n1-vaccine-may-help-ward.html
http://www.medicalnewstoday.com/articles/121877.php

Flu Vaccination: Safe, Effective and the Right Thing to Do
www.vaccineswork.blogspot.com