April 29, 2005

Anthrax Vaccine Purchase for National Stockpile Is Imminent, Says Top U.S. Health Emergency Official

By Joe Fiorill
Global Security Newswire

WASHINGTON — The U.S. Health and Human Services Department expects within days to complete talks on a 5 million-dose purchase of anthrax vaccine for the Strategic National Stockpile, the official in charge of the effort said yesterday (see GSN, April 6).

“My office will complete negotiations for 5 million doses of the currently licensed anthrax vaccine in the next few days to support immediate requirements,” Health and Human Services Assistant Secretary Stewart Simonson said in testimony submitted to the Senate Appropriations Homeland Security Subcommittee.

When asked last evening by Global Security Newswire to elaborate on that projection, department spokesman Marc Wolfson said Simonson’s office is “down to the final negotiations with” drug maker BioPort.

“We are hopeful negotiations will wrap up soon,” BioPort spokeswoman Kim Root concurred in an e-mail today. “We are prepared to deliver licensed anthrax vaccine to the Strategic National Stockpile within days of signing the contract.”

The department in November announced its intention to buy the vaccine from BioPort, which makes the only existing U.S.-licensed vaccine. The United States has contracted with a second company, VaxGen, to provide 75 million doses of a newly developed vaccine within two years.

U.S. Senator Chuck Grassley (R-Iowa) wrote Health and Human Services early this month expressing concern that the agency had not completed the BioPort purchase. Grassley said the U.S. anthrax vaccine stockpile had not been augmented since the September 2001 al-Qaeda attacks.

Simonson indicated yesterday that a 5 million-dose increase was around the corner.

“Delivery of the product to the stockpile will begin very soon after the contract award and will have a direct impact on our preparedness,” said the assistant secretary, who heads the department’s Public Health Emergency Preparedness Office.

In his wide-ranging statement on the state of U.S. anti-WMD treatments, vaccines and countermeasures, Simonson also said the department expects next month to begin taking delivery of a supply of liquid potassium iodide to protect children’s thyroids from the effects of radiation.

Health and Human Services also recently issued requests for information from the drug industry to help the department project the timeline for development of countermeasures against nerve agents and acute radiation syndrome and of new anthrax treatments, he said.

April 25, 2005

Anthrax Vaccine Treatment Funding Remains Uncertain

By David Ruppe
Global Security Newswire

WASHINGTON — A Senate effort to ensure full funding of special U.S. military centers for treating soldiers suffering side effects from anthrax and other vaccinations failed last week, leaving open the question of whether the clinics will be fully funded in this fiscal year (see GSN, Jan. 13).

Senate leaders negotiated away an amendment to the supplemental appropriations bill for fiscal 2005 that would have provided $6 million for four regional Vaccine Healthcare Centers in the United States that offer treatment and advice on rare but serious side effects from the vaccine.

The Senate instead included a nonbinding statement of support for full funding in the bill, which was approved Thursday.

The Army earlier this year said it would transfer $5.7 million to the centers from another account, but Senator Joseph Biden (D-Del.) in a speech Wednesday on the Senate floor expressed concern that the absence of confirmed funding could hurt personnel in other military services.

“The centers are in danger of losing part of their funding this fiscal year,” he said when he introduced the amendment Wednesday.

“I am very concerned that the funding this year is being redirected because other services have not budgeted for the centers’ work, despite the fact that 46 percent of their cases were related to Air Force, Navy, and Marines personnel,” Biden added.

The main Vaccine Healthcare Center, located at the Walter Reed Army Medical Center in Washington, D.C., was created in 2001. Three additional satellite centers were opened at U.S. bases last year, at the Naval Medical Center in Portsmouth, Va., the Womack Army Medical Center at Ft. Bragg, N.C., and the Air Force’s Wilford Hall Medical Center in San Antonio, Texas. Together they received $5 million for fiscal year 2004 and sought $5.7 million for this fiscal year, which began Oct. 1, 2004, and ends on Sept. 30.

Praised last year by two senior defense officials, the centers have not been included in the Army’s long-term budget plans or in congressional appropriations bills. They have relied instead on funding transfers in recent years from other Army programs.

A statement released in January by the Walter Reed Army Medical Center said the U.S. Army Medical Command, through its North Atlantic Regional Medical Command, would “underwrite the $5.7 million operation” this fiscal year. Biden’s amendment would have appropriated an additional $6 million to the centers by taking the money out of other defense-wide funding in the bill, for the “Global War on Terror Partners Fund,” which provides economic assistance to some countries allied in counterterrorism efforts.

“Clearly, force protection in this time of war demands a good vaccination program. Equally clear, that program must include quality care for those who suffer adverse events in every service, not just the Army,” he said.

Anthrax vaccinations were required for military personnel until last October, when a federal judge banned mandatory vaccinations, ruling the Food and Drug Administration had not properly reviewed the drug when it licensed it as safe and effective against inhalation anthrax. The judge reiterated last month that the vaccines could be administered voluntarily, though the military so far has not resumed inoculations (see GSN, April 1).

April 18, 2005

Pentagon to participate in international plague vaccine effort

By David McGlinchey

The Defense Department has unveiled an international effort to develop a vaccine that would protect against the plague.

Defense officials announced the project Friday and said Pentagon scientists will collaborate with military biologists from Canada, Great Britain and Northern Ireland.

Federal health officials classify plague among the deadliest biological pathogens, along with smallpox, botulism, tularemia, hemorrhagic fever and anthrax.

"Under this agreement, the three nations will work together to develop and produce a plague vaccine that will ultimately be licensed for human use," the Pentagon announcement said.

The United States and the United Kingdom have operated separate plague vaccine development programs for more than five years. In 2000, both countries and Canada signed a memorandum of understanding to share vaccine development information.

According to the Centers for Disease Control and Prevention, a terrorist attack with plague in an aerosol gas could cause an outbreak of the pneumonic form of the disease, which affects the lungs and can be transmitted by the breath of infected victims. Plague infections can be fatal if victims are not treated promptly.

A spokesman from the Pentagon's Joint Program Executive Office for Chemical and Biological Defense said the arrangement would help all the participating nations.

"This international collaboration would be beneficial to the DoD, UK and Canada as it would result in a vaccine licensed in all three countries," the spokesman said. "As all three participating countries would support the effort, DoD would realize some cost savings."

Last year, Congress passed Project Bioshield, with $6 billion in federal funding designed to spur private companies to develop vaccines and treatments for dangerous biological weapons. Experts and former government officials have said, however, that the program is falling short of its goals.

Last year, Jerome Hauer, former HHS acting assistant secretary for the office of public health emergency preparedness, said that Project Bioshield was designed to "stimulate the industry.... But it appears to have had just the opposite effect." Officials have proposed a Project Bioshield II program to generate more industry initiatives, but most biological defense research is still in the hands of the federal government.

Defense officials plan to test the two plague vaccines currently in development and select one to receive additional attention and resources. The vaccine that is being researched in the United States was developed by the Army Medical Research Institute of Infectious Diseases. Researchers began testing the vaccine early this year at the University of Kentucky.

The British plague vaccine candidate is expected to begin testing in the United States in late 2005 under guidelines set out by the Food and Drug Administration. After results are in from those tests, officials will determine which vaccine to continue developing. The Defense spokesman said there are no concerns about meshing the two tracks of scientific research because the technical collaboration is scheduled to begin after one vaccine is chosen.

April 11, 2005

U.S. Lawmakers Press for Greater Incentives for Development of Biological Weapons Treatments

U.S. lawmakers are preparing legislation that would extend patents on brand-name drugs and reduce the potential liability of drug companies working to produce treatments for biological weapons attacks and natural outbreaks of infectious diseases, the Philadelphia Inquirer reported yesterday (see GSN, Oct. 12, 2004).

“There is no question that if terrorists are able to get their hands on a weaponized biological agent … they will use it in a place where Americans gather in their daily lives,” said Senator Judd Gregg (R-N.H.). “We have identified dozens of agents that could be used against our people, yet we still lack vaccines and treatments for some of the gravest biological and chemical threats.”

Funding and tax breaks under the 2004 Bioshield legislation are not adequate incentives to invest a drug that might never be needed, some pharmaceutical companies say. Bioshield also does not offer protections from lawsuits, according to the Inquirer.

Senators Joe Lieberman (D-Conn.) and Orrin Hatch (R-Utah) are preparing legislation that would allow drug companies to extend patents on biodefense-related medicine beyond the general 10-year useful patent life. Their proposal would also give companies patent extensions on other lucrative drugs if they agree to produce medicine for the biodefense effort, the Inquirer reported.

A bill from Gregg, Senate Majority Leader Bill Frist (R-Tenn.) and Senator Rick Santorum (R-Pa.) would also include patent extensions and liability protection to companies preparing drugs to counter biological attacks or infections such as SARS (Chris Mondics, Philadelphia Inquirer, April 10).

April 1, 2005

Judge to Allow Voluntary Anthrax Vaccinations

By David Ruppe
Global Security Newswire

WASHINGTON — The U.S. Defense Department can resume vaccinations for anthrax, but should make additional efforts to inform potential recipients that the shots are not mandatory, a federal judge said in a ruling read today but held until Monday (see GSN, March 30).

U.S. District Court Judge Emmet Sullivan said the vaccinations could occur under an “emergency use authorization” issued by senior government officials in January, which allows for voluntary vaccinations using drugs not licensed by the Food and Drug administration — without soliciting the informed consent of the potential recipients.

Lawyers representing six unidentified soldiers and civilian contractors who sued the government to stop the mandatory vaccinations have argued that soldiers could more readily be pressured to take the vaccine under the emergency use authorization.

U.S. law allows the government to conduct vaccinations with unlicensed drugs after obtaining either the recipient’s informed consent or a presidential waiver of the consent requirement. There has been no such waiver. Citing that law, Sullivan in October issued an injunction to stop a Defense Department program of mandatory mass anthrax vaccinations without informed consent.

However, a law passed last year after that ruling allows unlicensed drugs to be administered voluntarily, without informed consent, in the event of an emergency. Senior government officials declared a state of emergency in January.

Soliciting informed consent includes providing extensive information on the drug’s possible side effects to the potential recipient prior to the vaccination. The emergency use authorization law, lawyers for the plaintiffs said, allows officials to provide less information about potential side effects and is not specific about when such information should be provided.

A U.S. government lawyer, Andrew Tannenbaum, told Sullivan today that he anticipated that the Defense Department would give potential recipients a brochure describing some of the possible side effects prior to vaccination.

Under questioning, though, Tannenbaum conceded that the brochure did not inform potential recipients about Sullivan’s October ruling that the vaccinations could not be compulsory.

Sullivan delayed activation of the ruling until Monday to give the Bush administration time to say first what additional measures it would take to inform potential recipients of the judge’s injunction last year forbidding mandatory vaccinations.

Sullivan suggested posting the ruling prominently at each of the hundreds of military vaccination sites around the world.

“Service-people may not know they have a choice to make,” he said.

The Defense Department has posted the October ruling on a Web page. Sullivan rebuked the department for previously compelling vaccinations for some military personnel after his ruling went into effect.