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Industry an Effective Partner in Preparing for Biological Threats | Commentary

Recently, news emerged that six vials of smallpox were discovered in an old storage room at the National Institutes of Health campus in Bethesda, Maryland. Fortunately, the vials were quickly isolated and secured, and the Centers for Disease Control and Prevention says that onsite personnel have not identified any infectious exposure risk to lab workers or the public. The week prior, workers at a CDC lab were exposed to anthrax, though thankfully none became ill.

But what would happen if we were not so fortunate? What if workers had been exposed or had exposed others? Smallpox is extremely contagious, and because it was eradicated in America in 1980, individuals today are no longer routinely vaccinated for it. Because of this, we would rely upon the government’s stockpile of smallpox medical countermeasures — antivirals and vaccines developed and procured to protect Americans against an accidental or intentional release of smallpox.

Thanks to federal biodefense programs that partner with industry to develop and stockpile medical countermeasures against chemical, biological, radiological and nuclear threats, each year our country is better equipped to respond to such threats, including a potential smallpox outbreak or anthrax event. The Biomedical Advanced Research and Development Authority works with biotech and pharmaceutical companies to develop and stockpile medical countermeasures. Through development and purchases under the Project BioShield Special Reserve Fund, managed by BARDA, our government has stockpiled several different vaccines and drugs to help the nation recover from a smallpox or anthrax event, whether accidental or as part of a terrorist attack.

Several recent examples demonstrate the success of the partnership between BARDA and industry. BARDA provides funds for the development of new medical countermeasures that help to address specific issues or special populations. For this reason, the U.S. government began a program to develop and procure a smallpox vaccine suitable for certain populations which do not respond well to the traditional vaccine. That project came to fruition in 2010, when Bavarian Nordic, a biotechnology company, began deliveries of IMVAMUNE, a new smallpox vaccine for specific sub-populations, to the Strategic National Stockpile.

BARDA funds also played a key role in the development of an innovative antiviral treatment for smallpox, SIGA Technologies’ Arestvyr. SIGA received a BARDA advanced development contract for Arestvyr in 2008. Deliveries to the Strategic National Stockpile began last year.

We have also made tremendous progress in our readiness to respond to any possible anthrax emergency thanks to BARDA funds. Last September, BARDA signed a four year agreement to replenish its stockpile of GSK’s Raxibacumab, the first FDA approved anti-toxin for treatment of inhalational anthrax.

The risk of a bioterrorist attack on the U.S. is an uncertain reality. Biological weapons could inflict serious harm on our nation equal to, or possibly greater than, that of nuclear weapons.

The success of the stockpile programs shows that government-industry partnerships are effective ways to prepare for such threats. Since 2004, twelve medical countermeasures have been procured with Project BioShield funds, with 12 more expected through 2019. There is also a promising pipeline of future products, with over 150 medical countermeasures under development with BARDA contracts.

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