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

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.
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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.

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