October 12, 2008

Policy Prevents Shipments Of Bird Flu Vaccine

Calling it the "nuttiest thing" he'd ever heard, Defense Secretary Robert Gates laughed off claims by Indonesia's health minister that shipments of bird flu virus to a U.S. research laboratory had been halted for fear Washington might use them to make biological weapons.

However, buried deep inside an 86-page supplement to the United States' export regulations is a single sentence that prohibits U.S. exports of vaccines for avian bird flu to five countries designated as state sponsors of terrorism.  The ban is based on concern the viruses might be used to make biological weapons.

The policy means that countries such as Iran, North Korea, Syria, Cuba and Sudan may not get the vaccines without first receiving special export licenses, which could be granted or refused at the discretion and timing of the United States. Additionally, under a general U.S. embargo, Cuba, Iran and Sudan are also subject to a ban on all human pandemic influenza vaccines.

The policy, quietly enacted more than a decade ago to include vaccines for everything from the Ebola virus to Dengue fever, has raised concerns among the medical and scientific communities.  Officials from the U.S. Department of Health and Human Services and the Centers for Disease Control and Prevention (CDC) said they were not aware of the regulations until contacted by The Associated Press last month. Privately, they expressed alarm, with recent worries about the threat of a bird flu pandemic making the matter even more relevant.    

Peter Palese, chairman of the microbiology department at Mount Sinai School of Medicine in New York, said the policy made "no scientific sense".  The bird flu vaccine, he said, can be used to contain outbreaks in poultry before they mutate to a form more easily transmitted among people.

"The more vaccines out there, the better," he told the Associated Press.

"It's a matter of protecting ourselves, really, so the bird flu virus doesn't take hold in these countries and spread," he said.

Christopher Wall, the U.S. Commerce Assistant Secretary, did not elaborate on the specific threat posed by vaccines for chickens infected with bird flu, but told the AP there were "valid security concerns" that they "do not fall into the wrong hands."

"Legitimate public health and scientific research is not adversely affected by these controls," he said.

However, some experts call the notion of using vaccines to make bioweapons "far-fetched", and worry how quickly authorities could cut through the bureaucracy and red tape to distribute vaccines during a true health emergency.

Typically it would take at least six weeks to approve an export licenses for any vaccine on the list, according to Thomas Monath, former head of a CIA advisory group on countering biological attacks. Such decisions would follow negotiations at a "very high level" of government, he told the AP. 

That could make it more difficult to contain bird flu outbreak among chickens in, for example, North Korea, which is in the region hardest hit by the virus.   Sudan and Iran have already seen documented cases of the virus in poultry, and countries impacted by the virus surround Syria.  

University of Toronto's Kumanan Wilson, whose research centers on health protection policy, said it would be ironic if the bird flu virus mutated into a more dangerous form in one of those countries.

"That would pose a much graver threat to the public than the theoretical risk that the vaccine could be used for biological warfare," he told the AP.

The danger posed by biological warfare depends upon the specific virus or bacteria being used.    Most experts believe the bird flu vaccines cannot be genetically altered to create bioweapons since they contain an inactivated virus that cannot be resuscitated, and that it's unlikely they would be used to make resistant strains of the virus to wreak havoc within global poultry stocks.

If enemy states wanted to do that, they could simply make their own vaccines or turn to a less hostile country such China, said Ian Ramshaw, a vaccine immunology and biosecurity expert at the Australian National University.

"I can think of no scientific reason how a terrorist organization could use such a vaccine for malicious intent," he told the AP.

"I personally think it's a rather silly attitude and the U.S. is probably going overboard as it has in the past with many of its bioterrorism initiatives."

Some bioethicists believe limiting vaccines raises moral questions of whether some countries should be denied because of their foreign policy positions.
And they point to inconsistent export controls, citing countries such as Iraq, Libya and others the U.S. suspects of having bioweapons programs but yet do not face export restrictions.

"If there really is a serious threat, to be consistent we'd have to more heavily regulate who has access to the vaccine,"  Michael Selgelid, co-author of the book "Ethical and Philosophical Consideration of the Dual Use Dilemma in the Biological Sciences".

"There are malevolent actors in the U.S. just like there might be in all these other countries," he told the AP.

The policies were enacted amid biosecurity fears during the mid-1990s, which were then heightened in the aftermath of the September 11 2001 terrorist attacks and the anthrax mailings that followed shortly thereafter.  The vaccines are among a long list of items that are prohibited from being sent to rogue states out of concern they could be used to make weapons of mass destruction.

Bird flu has killed more than 240 people worldwide in the last five years, nearly in Indonesia.  Siti Fadilah Supari, Indonesia's health minister, gained widespread attention last year when she boycotted the World Health Organization's virus sharing system, claiming that pharmaceutical companies were using viruses from developing nations without their knowledge to make costly vaccines.   Since then, she has called for the creation of a global stockpile of drugs.


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