Q&A

See below for questions and answers related to fastervaccines.org.  Questions?  Post them on Facebook, Twitter, MySpace, or contact us.

• What’s wrong with how we make flu vaccine?
• What’s the connection between vaccines and weapons of mass destruction (WMD)?
• What government programs are important to speeding the vaccine process?
• Why aren’t these programs enough?
• What are the new vaccine technologies?
• If better technologies are in use elsewhere in the world, is this just a problem for the United States?
• What can I do?
• What’s the WMD Commission?
  
  

What’s wrong with how we make flu vaccine?

Influenza—or “flu”— can be a dangerous respiratory virus causing severe illness or death. There are some therapies available that reduce the severity of illness, but vaccination is the cornerstone of all efforts to reduce the impact of the flu.

The flu vaccines available in the United States 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, 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 use of chicken eggs in production. All six licensed, US manufacturers of flu vaccine use eggs—as they have done for decades.  A modern and faster method to make a safe flu vaccine uses a manufacturing 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.

What’s the connection between vaccines and WMD?

Last year, the Commission on the Prevention of Weapons of Mass Destruction Proliferation and Terrorism issued the World at Risk, a report on how America and the world can better prevent and prepare for terrorism. The report noted that it was more likely that a terrorist intent on mass destruction would use a bioweapon, rather than a nuclear weapon.

One of the most important ways the United States can be prepared is by having the capability to quickly produce vaccines and medicines. The good news:  having this capacity not only makes America more secure, it makes Americans healthier.
The United States is currently unprepared to make lifesaving vaccines and drugs in a timely manner, for either naturally occurring diseases (such as SARS in 2003) or a deliberate attack.

What government programs are important to speeding the vaccine process?

Two US government programs are designed to prevent and respond to biological, radiological, or nuclear attacks as well as naturally occurring emerging diseases.

One is the Biomedical Advanced Research and Development Authority (BARDA), part of the Department of Health and Human Services. It leads an integrated, systematic approach to the development and purchase of the necessary vaccines, drugs, therapies, and diagnostic tools for public health medical emergencies.

BARDA was created in 2006, with unanimous support in both chambers of Congress. Its mission is to make sure that the nation is prepared with drugs and medical countermeasures not only for influenza, but for other emerging diseases, as well as chemical, biological, radiological and nuclear public health threats. BARDA has been working hard to prepare the nation for flu, hiring top talent, and partnering effectively with the private sector. However, it has received little funding for the rest of its mission.

The other is Project BioShield, which funds medical countermeasures against biological, chemical, radiological, and nuclear agents.

Why aren’t these programs enough? 

The two programs are underfunded and have weathered attempts to raid their funding. 

The Obama Administration’s request for BARDA in FY 2010 was only $305 million. That is insufficient by a factor of 10. Drugs and vaccines needed for emerging, biological, chemical, and radiological threats will not be developed solely by the private sector without governmental support.

The Center for Biosecurity at the University of Pittsburgh Medical Center recently estimated that $3.39 billion per year in medical countermeasure development support would be required to achieve a 90 percent probability of developing an FDA-licensed countermeasure for each of those requirements. The cost estimates of developing these pharmaceuticals were based on in-depth surveys of historical vaccine and drug development data, and reflect the high failure rate of biopharmaceutical development. It now falls to the US government to fund the development of medical countermeasures based upon the level of risk that is deemed tolerable.

An amount of $1.7 billion per year would meet roughly half the estimated need to provide a significant and necessary down-payment on the nation’s preparedness. Given the threat, $1.7 billion per year for prevention and consequence management is a reasonable and comparatively sound investment. Despite limited funding to date, BARDA has developed the infrastructure, workforce, and expertise to manage the necessary portfolio of new medical countermeasures. What remains now is for the program to be funded.

What are the new vaccine technologies?

Key technologies are cell-culture production, virus-like particles, recombinant antigen, and DNA vaccines.

1. Cell-culture production is a proven technology, already used in the European Union. Polio and modern smallpox vaccines are made using cell culture.
   
   Cell culture is faster than eggs and offers greater surge capacity: Instead of growing the vaccine virus in eggs, it is grown in cultured cells. This eliminates several egg-specific manufacturing steps, potentially cutting months from manufacturing process. This approach can be rapidly scaled up, no need to have additional 15-day old fertilized eggs available. The vaccine can be given to people who are allergic to eggs.
   
   US facilities being built, but it is a slow process: In 2005, the US Department of Health and Human Services awarded $97 million to build a US-based cell culture facility that can produce 300 million doses/year.  HHS also awarded $487 million for a facility in Holly Springs, NC, to be completed in 2010.
   
   
2. Another proven technology is to use virus-like particles. This approach was used for the vaccine now in use to prevent cervical cancer. Production methods are relatively cheap and fast; it could cut egg-production flu vaccine from six months to three.
   
3. Recombinant antigen is a proven technology already used to develop the Hepatitis B vaccine. Typically these vaccines are made by putting genes from the virus into a vector, usually a much weaker virus. Either the vector is used as a vaccine, or parts are purified from that to make the vaccine (this is called a subunit vaccine).  This approach is faster and cheaper than current technologies.
4. DNA vaccines are still in development.  They contain only portions of the genetic material of the virus (without protein shell), but cannot cause infection. The approach has been demonstrated to be effective for vaccines in several animals, but not yet in humans.  With more investment, DNA vaccines could be a fast, flexible technology that could also accommodate new viruses in addition to influenza.

 

If better technologies are in use elsewhere in the world, is this just a problem for the United States? 

The manufacturing capacity for seasonal influenza vaccine is only about 300 million doses per year, globally. Vaccine development only takes place in a few countries, so many countries do not have vaccine manufacturers within their borders or even under contract—including Indonesia, Thailand, and all of Africa. In order for people in these countries to have vaccine, vaccine manufacturers will need to ramp up production of safe, effective vaccines without delay. There needs to be enough vaccine not only for the US population, but for the world.

What can I do?

Voice your support for greater government investment to ensure that the country is prepared to respond to naturally occurring diseases, as well as deliberate biological attacks. As a nation, we should be investing in:

• New vaccine and drug technologies for influenza.
• The capability to rapidly produce drugs and vaccines against an emerging disease, whether it is naturally occurring or deliberately introduced.
• Surveillance systems, including point-of-care diagnostic tests, so that doctors can tell if you are sick and what you have. This will help to track diseases, determine who needs care, and allow diseases to be stamped out faster.
  
  

What’s the WMD Commission?

Congress, acting on the recommendation of the 9/11 Commission,  established the bipartisan Commission for the Prevention of Weapons of Mass Destruction Proliferation and Terrorism to address the grave threat that the proliferation of weapons of mass destruction poses to the United States. In its first year, the Commission assessed the nation’s current activities aimed at preventing the proliferation of weapons of mass destruction and terrorism then provided a clear, comprehensive strategy with concrete recommendations in its December 2008 report, World at Risk.

World at Risk found 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.” The Commission also found that the greater threat was a biological attack, rather than a nuclear attack.

The Director of National Intelligence publicly agreed with the Report’s threat assessment, saying “we [the intelligence community] assess biological as the more likely and it’s better than an even chance in the next five years that an attack by one of those weapons systems will be conducted in some place on the globe…”

During its second year of activity, the Commission is working to improve understanding of its findings--and to turn those concrete recommendations into actions.

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