U.S. Health and Human Services Retracts Statement on New Anthrax Vaccine after Inquiry by Senator
By David Francis
Global Security Newswire
WASHINGTON — An inquiry from a U.S. senator prompted the Health and Human Services Department last month to retract a statement about the advantages of a new anthrax vaccine being developed to replace the existing licensed vaccine (see GSN, May 6).
Senate Finance Committee Chairman Charles Grassley (R-Iowa), in a series of letters obtained by Global Security Newswire, questioned whether a statement in a March 2004 press release about VaxGen’s recombinant anthrax vaccine was true. The HHS press release said the treatment, being developed under a Project Bioshield contract, “has already been shown to be stronger and more effective than the vaccine being used today.”
Assistant Secretary for Public Health Preparedness Stewart Simonson wrote in a May 4 response to Grassley that the department’s claim that the new vaccine is more effective than BioPort’s licensed treatment had been removed from the agency’s Web site.
“The statement in question was based on preliminary test data,” said department spokesman Marc Wolfson. “It was decided that the statement was premature and could be misleading. So in response to Senator Grassley’s request [the Health and Human Services Department] decided to remove the release from its Web site.”
Grassley sent a letter to Secretary Michael Leavitt in January, expressing concerns that the country was inadequately prepared for an anthrax attack.
After meeting with agency officials, Grassley followed up with a second letter in April asking why additional doses of the licensed anthrax vaccine had not been added to the Strategic National Stockpile and whether the statement in the press release was misleading.
Simonson admitted in the May 4 letter to Grassley that the press release touting VaxGen’s vaccine as more effective than the licensed vaccine was unsupported by current science.
Department officials believe the new vaccine will prove superior to BioPort’s vaccine because the recombinant DNA technology used to produce the drug is expected to result in more consistent immunity from batch to batch. It would be administered in a three-shot cycle, as opposed to BioPort’s vaccine, which requires six shots. In addition, BioPort’s vaccine is manufactured using a decades-old process, and questions have been raised by Defense Department personnel about the vaccine’s safety and effectiveness (see GSN, May 6).
In his letter, Simonson also noted that the department was adding 1.5 million doses of the licensed vaccine to the stockpile by the end of this month, with an additional 6 million doses to be added in fall 2006.
Unsatisfied with the agency’s response, Grassley sent a letter May 5 asking why it has taken so long after the 2001 anthrax attacks to procure licensed vaccine for the stockpile.
In a May 13 response, Simonson attributed contractual difficulties between the Health and Human Services Department, the Defense Department and vaccine manufacturer BioPort, for the delay.
“The transfer of 5 million doses of AVA from DoD to HHS was delayed and eventually abandoned because of issues connected with the passage of the Homeland Security Act and the Project Bioshield Act as well as the usual problem inherent in negotiating a complex interagency agreement (e.g. pricing, indemnification, etc),” Simonson wrote. “In the end, it was clear that a direct contractual relationship between HHS and BioPort was preferable to the interagency process.”
Grassley does not plan to send additional letters or schedule hearing on the vaccine issues, said spokeswoman Jill Kozeny.
“Senator Grassley will continue to monitor the situation but no hearings or additional letters of inquiry are planned right now,” Kozeny wrote in an e-mail.
VaxGen is scheduled to deliver the first 25 million doses of the new vaccine in 2006. The remaining 50 million doses would be delivered by 2009. The product is not scheduled for Food and Drug Administration licensure review until 2007 (see GSN, Nov. 5, 2004).
Lance Ignon, VaxGen’s vice president of corporate affairs, said during a June 6 webcast that congressional questions about the vaccine are to be expected and would not delay licensure.
“We’re happy and have been happy to speak with any number of legislatures to bring them up-to-speed on this because while we’ve been intimately familiar with the workings of this program now for quite a few years, many in Washington have not. The award of the contract in November was sort of the first [time] they really started thinking about how Project Bioshield works,” Ignon said.
Meanwhile, two key House panels are planning hearings this summer on the country’s preparedness for a biological attack.
House Democratic sources said the House Homeland Security Subcommittee on Emergency Preparedness, Science and Technology is planning a hearing on Bioshield tentatively scheduled for the end of June.
A majority spokeswoman refused to confirm whether the hearing would occur, saying nothing has been officially placed on the calendar.
However, Democratic sources said ranking Homeland Security Committee Democrat Bennie Thompson (Miss.) is concerned that the contract with VaxGen for an unapproved vaccine detracts from preparedness. Thompson sent nearly identical letters to Homeland Security Secretary Michael Chertoff and Leavitt in May outlining his concerns.
“The new type of anthrax vaccine under development in Project Bioshield has some unique benefits, but is offered by only one manufacturer and is not yet approved by the Food and Drug Administration,” Thompson wrote. “I know Project Bioshield’s purpose is to develop vaccines from an experimental stage, and I support effort to develop new anthrax vaccines such as those offered buy this unique technology. However, I am concerned about the possibility that if this new technology is not ultimately successful, or does not receive FDA approval, the [Strategic National Stockpile] may be left without an adequate supply of anthrax vaccine in the case of an emergency.”
Thompson asks for details on efforts to secure additional vaccines and for progress on the development of the new anthrax vaccine. He has not received a response yet, and plans to address these issues at the upcoming hearing, according to the Democratic sources.
The House Government Reform Committee is also planning a Bioshield hearing in July, according to a Republican committee source. The committee plans to invite industry representatives and government officials to testify, the source said.
According to the source, Representative Chris Shays (R-Conn.) plans to ask questions about the use of Bioshield’s emergency use authorization authority. This power allows the Health and Human Services Department at the request of the Pentagon to approve the use of unlicensed countermeasures.
The authority has been granted once, when the Food and Drug Administration last year approved BioPort’s anthrax vaccine to combat inhalation anthrax, an approved indication. The move prompted a series of letters from Shays to Leavitt and Central Intelligence Agency chief Porter Goss, questioning the legality of the request and whether the application of this power was intended under Bioshield (see GSN, Dec. 17, 2004).
“Congressman Shays is going to make a point to talk about that,” the source said.
The Senate Health, Education, Labor and Pensions Committee’s bioterrorism preparedness subcommittee is in the middle of a series of hearings to review a bill introduced by Republican leadership and another by Senators Joe Lieberman (D-Conn.), Orrin Hatch (R-Utah) and Sam Brownback (R-Kan.). Both pieces of legislation would provide incentives, such as liability shields and patent exclusivity, to encourage big drug makers to enter the vaccine market.
Senator Richard Burr (R-N.C.), subcommittee chairman, plans to review the bills and has pledged to consider both before combining them into a single piece of legislation.
Global Security Newswire
WASHINGTON — An inquiry from a U.S. senator prompted the Health and Human Services Department last month to retract a statement about the advantages of a new anthrax vaccine being developed to replace the existing licensed vaccine (see GSN, May 6).
Senate Finance Committee Chairman Charles Grassley (R-Iowa), in a series of letters obtained by Global Security Newswire, questioned whether a statement in a March 2004 press release about VaxGen’s recombinant anthrax vaccine was true. The HHS press release said the treatment, being developed under a Project Bioshield contract, “has already been shown to be stronger and more effective than the vaccine being used today.”
Assistant Secretary for Public Health Preparedness Stewart Simonson wrote in a May 4 response to Grassley that the department’s claim that the new vaccine is more effective than BioPort’s licensed treatment had been removed from the agency’s Web site.
“The statement in question was based on preliminary test data,” said department spokesman Marc Wolfson. “It was decided that the statement was premature and could be misleading. So in response to Senator Grassley’s request [the Health and Human Services Department] decided to remove the release from its Web site.”
Grassley sent a letter to Secretary Michael Leavitt in January, expressing concerns that the country was inadequately prepared for an anthrax attack.
After meeting with agency officials, Grassley followed up with a second letter in April asking why additional doses of the licensed anthrax vaccine had not been added to the Strategic National Stockpile and whether the statement in the press release was misleading.
Simonson admitted in the May 4 letter to Grassley that the press release touting VaxGen’s vaccine as more effective than the licensed vaccine was unsupported by current science.
Department officials believe the new vaccine will prove superior to BioPort’s vaccine because the recombinant DNA technology used to produce the drug is expected to result in more consistent immunity from batch to batch. It would be administered in a three-shot cycle, as opposed to BioPort’s vaccine, which requires six shots. In addition, BioPort’s vaccine is manufactured using a decades-old process, and questions have been raised by Defense Department personnel about the vaccine’s safety and effectiveness (see GSN, May 6).
In his letter, Simonson also noted that the department was adding 1.5 million doses of the licensed vaccine to the stockpile by the end of this month, with an additional 6 million doses to be added in fall 2006.
Unsatisfied with the agency’s response, Grassley sent a letter May 5 asking why it has taken so long after the 2001 anthrax attacks to procure licensed vaccine for the stockpile.
In a May 13 response, Simonson attributed contractual difficulties between the Health and Human Services Department, the Defense Department and vaccine manufacturer BioPort, for the delay.
“The transfer of 5 million doses of AVA from DoD to HHS was delayed and eventually abandoned because of issues connected with the passage of the Homeland Security Act and the Project Bioshield Act as well as the usual problem inherent in negotiating a complex interagency agreement (e.g. pricing, indemnification, etc),” Simonson wrote. “In the end, it was clear that a direct contractual relationship between HHS and BioPort was preferable to the interagency process.”
Grassley does not plan to send additional letters or schedule hearing on the vaccine issues, said spokeswoman Jill Kozeny.
“Senator Grassley will continue to monitor the situation but no hearings or additional letters of inquiry are planned right now,” Kozeny wrote in an e-mail.
VaxGen is scheduled to deliver the first 25 million doses of the new vaccine in 2006. The remaining 50 million doses would be delivered by 2009. The product is not scheduled for Food and Drug Administration licensure review until 2007 (see GSN, Nov. 5, 2004).
Lance Ignon, VaxGen’s vice president of corporate affairs, said during a June 6 webcast that congressional questions about the vaccine are to be expected and would not delay licensure.
“We’re happy and have been happy to speak with any number of legislatures to bring them up-to-speed on this because while we’ve been intimately familiar with the workings of this program now for quite a few years, many in Washington have not. The award of the contract in November was sort of the first [time] they really started thinking about how Project Bioshield works,” Ignon said.
Meanwhile, two key House panels are planning hearings this summer on the country’s preparedness for a biological attack.
House Democratic sources said the House Homeland Security Subcommittee on Emergency Preparedness, Science and Technology is planning a hearing on Bioshield tentatively scheduled for the end of June.
A majority spokeswoman refused to confirm whether the hearing would occur, saying nothing has been officially placed on the calendar.
However, Democratic sources said ranking Homeland Security Committee Democrat Bennie Thompson (Miss.) is concerned that the contract with VaxGen for an unapproved vaccine detracts from preparedness. Thompson sent nearly identical letters to Homeland Security Secretary Michael Chertoff and Leavitt in May outlining his concerns.
“The new type of anthrax vaccine under development in Project Bioshield has some unique benefits, but is offered by only one manufacturer and is not yet approved by the Food and Drug Administration,” Thompson wrote. “I know Project Bioshield’s purpose is to develop vaccines from an experimental stage, and I support effort to develop new anthrax vaccines such as those offered buy this unique technology. However, I am concerned about the possibility that if this new technology is not ultimately successful, or does not receive FDA approval, the [Strategic National Stockpile] may be left without an adequate supply of anthrax vaccine in the case of an emergency.”
Thompson asks for details on efforts to secure additional vaccines and for progress on the development of the new anthrax vaccine. He has not received a response yet, and plans to address these issues at the upcoming hearing, according to the Democratic sources.
The House Government Reform Committee is also planning a Bioshield hearing in July, according to a Republican committee source. The committee plans to invite industry representatives and government officials to testify, the source said.
According to the source, Representative Chris Shays (R-Conn.) plans to ask questions about the use of Bioshield’s emergency use authorization authority. This power allows the Health and Human Services Department at the request of the Pentagon to approve the use of unlicensed countermeasures.
The authority has been granted once, when the Food and Drug Administration last year approved BioPort’s anthrax vaccine to combat inhalation anthrax, an approved indication. The move prompted a series of letters from Shays to Leavitt and Central Intelligence Agency chief Porter Goss, questioning the legality of the request and whether the application of this power was intended under Bioshield (see GSN, Dec. 17, 2004).
“Congressman Shays is going to make a point to talk about that,” the source said.
The Senate Health, Education, Labor and Pensions Committee’s bioterrorism preparedness subcommittee is in the middle of a series of hearings to review a bill introduced by Republican leadership and another by Senators Joe Lieberman (D-Conn.), Orrin Hatch (R-Utah) and Sam Brownback (R-Kan.). Both pieces of legislation would provide incentives, such as liability shields and patent exclusivity, to encourage big drug makers to enter the vaccine market.
Senator Richard Burr (R-N.C.), subcommittee chairman, plans to review the bills and has pledged to consider both before combining them into a single piece of legislation.
