CIDRAP News Headlines - Dec. 2006

[sharon sanders]

CIDRAP News Headlines
Thursday, December 14, 2006


IOM says community measures may help in a pandemic
The Institute of Medicine (IOM) weighed in with a clear "maybe" this week on whether community interventions such as school closures, quarantine, and respiratory etiquette could help blunt the impact of an influenza pandemic. Read article...
Studies support flu vaccination in children, adults
Two studies reported in today's issue of the New England Journal of Medicine provide additional support for seasonal influenza immunization while shedding some light on questions about vaccination strategies and the efficacy of the vaccines. Read article...

 

[sharon sanders]

Re: CIDRAP News Headlines - Dec. 2006

Congress passes public health preparedness bill

Lisa Schnirring and Robert Roos

Staff Writers

Dec 15, 2006 (CIDRAP News) ? Just before adjourning on Dec 9, the US Congress passed a bill to establish a new biodefense research and development agency and tune up the nation's public health emergency preparedness programs in a number of other ways.
The legislation sets up an agency called the Biodefense Advanced Research and Development Authority (BARDA) within the Department of Health and Human Services (HHS). The agency represents an attempt to revive the languishing Project BioShield, established in 2004 to develop countermeasures against biological weapons and other threats.
The legislation, called the Pandemic and All-Hazards Preparedness Act (S 3678), was passed by the Senate Dec 5 and cleared the House in the early morning hours of Dec 9. It now awaits President George W. Bush's signature.
"We're anticipating that he will sign it," Marc Wolfson, a spokesman for the HHS Office of Public Health Emergency Preparedness, told CIDRAP News today.
"I think people were surprised it made it through in the last hours there," Wolfson said. "There was a lot of negotiation that went into seeing it happen."
The final version combines a wide-ranging bill introduced in the Senate in July with a House measure calling for the BARDA. The House unanimously passed the BARDA bill, offered by Reps Anna G. Eshoo, D-Calif., and Mike Rogers, R-Mich., in September. The Senate added the house measure to its bill (S 3678) before passing it Dec 5; the House passed the combined bill just before adjournment.
Sen. Richard Burr, R-S.C., author of the original Senate bill, praised his colleagues of both political parties who worked for 2 years on the legislation. "This bill will help improve our preparedness and response to emergencies and disasters be they a terrorist attack or caused by Mother Nature," Burr said in a Dec 9 press release. "It will also help improve our ability to create new drugs and vaccines to fight against emergencies like a flu pandemic."
The bill reauthorizes the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, passed after the terrorist attacks of 2001. Besides setting up the BARDA, the legislation does the following, among other things:

• <LI class=body>Clarifies that HHS, not the Department of Homeland Security, is the lead federal agency for health and medical response to public health emergencies <LI class=body>Requires HHS to set general preparedness standards and pandemic influenza preparedness standards for states and to penalize states financially for failure to meet them <LI class=body>Requires states to match federal preparedness grants at the 5% level initially and at 10% in later years <LI class=body>Calls for establishing within 2 years a nationwide electronic information-sharing system to enhance detection of and response to disease outbreaks and other public health emergencies <LI class=body>Requires HHS to study the possibility of providing local communities with additional medical surge capacity in an emergency <LI class=body>Makes political subdivisions of states and groups of states eligible for federal assistance for public health preparedness
• Codifies and expands the Medical Reserve Corps, a community-based network of volunteers who provide assistance in public health emergencies

The BARDA aims to boost Project BioShield, which was set up to nurture the development of vaccines and other medical countermeasures against biological, chemical, radiological, and nuclear agents. Major pharmaceutical companies have shown little interest in pursuing BioShield projects.
An online report this week by Government Executive magazine said past efforts to create a BARDA were hamstrung by controversies about whether it would be subject to the Freedom of Information Act and other disclosure laws. Most provisions to circumvent those laws were stripped from the bill, except for one that allows HHS to withhold information that might expose public health weaknesses, the report said.
Eshoo, coauthor of the House version of the BARDA bill, said in a Dec 9 statement that the lack of commercial demand for drugs to counter bioterrorism-related diseases creates a funding gap known as the "valley of death." She said the BARDA will bridge the gap by making interim payments at key development milestones, which will give companies incentives to pursue products that show promise in early research.
HHS Secretary Mike Leavitt, in a Dec 5 statement after the Senate approved S 3678, said the legislation complements work that is already being done to improve the BioShield program. He said HHS is taking steps to streamline countermeasure development by making the process more transparent and predictable. The new legislation will allow HHS to make milestone-based advance payments to companies, rather than withholding payment until the product is delivered, Leavitt said.
The text of the bill says that the HHS secretary can pay up to 10% of a contract amount in advance if it appears necessary to ensure the project's success. Also, a contract can provide for additional advance payments of up to 5% each for meeting milestones specified in the contract, up to a total of 50%.
Lance Ignon, vice president of corporate affairs at VaxGen Inc., a Brisbane, Calif., company that has been struggling to fulfill an $877.5 million government contract to supply anthrax vaccine, told CIDRAP News that the legislation is a step in the right direction. "But what's needed is a fundamental cultural shift to a more open and transparent dialogue between government and industry," he said. "Unless that happens, this won't succeed."
VaxGen's anthrax vaccine has been delayed because of potency problems, and in May, the Government Accountability Office said the government's contract with VaxGen was too rigid and might discourage other biotechnology companies from pursuing Project BioShield contracts. Developing new vaccines is expensive, difficult, and often hampered by testing and production delays.
"Getting across the valley of death is not necessarily about money, but involves a true partnership between government and industry," Ignon said.
The new legislation authorizes spending of $1.07 billion for BARDA for fiscal years 2006 through 2008.
In an August report, the Congressional Budget Office estimated that the original Senate bill?which did not include the BARDA provision?would cost $297 million in fiscal year 2007 and about $6 billion for the period 2007 through 2011.
See also:
Access to text of Pandemic and All-Hazards Preparedness Act on Library of Congress site (Search "S 3678")
http://www.thomas.gov
Government Printing Office text of bill
http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=109_cong_bills&docid=f:s3678enr.txt.pdf
Dec 9 press release from Sen. Richard Burr
Dec 9 statement from Rep. Anna Eshoo
Dec 5 HHS press release
Jul 19 story CIDRAP News story "Broad health preparedness bill advances in Senate"
Congressional Budget Office estimate of cost of original Senate bill
http://www.cbo.gov/showdoc.cfm?index=7479&sequence=0&from=6

 

[sharon sanders]

Re: CIDRAP News Headlines - Dec. 2006

CIDRAP News Headlines
Thursday, December 21, 2006


HHS seeks advice on allocating pandemic vaccine
The Department of Health and Human Services is seeking help from the public in figuring out how to allocate scarce supplies of influenza vaccine in the event of a flu pandemic. Read article...
Canada reaches dead end in BSE probe
Government investigators were unable to determine where Canada's latest cow infected with bovine spongiform encephalopathy (BSE) was born, making it impossible to tell how the animal was exposed to the disease or find other cows that might have been exposed, the Canadian government said this week. Read article...

 

[sharon sanders]

Re: CIDRAP News Headlines - Dec. 2006

CIDRAP News Headlines
Friday, December 22, 2006


Vietnam, South Korea, Nigeria battle avian flu
More poultry have died of H5N1 avian influenza in Vietnamese provinces where the virus recently re-emerged, and the disease has spread to another province in South Korea and 3 more Nigerian states, according to news reports. Read article...
Study: 1918-like pandemic now would kill 62 million
Scientists who analyzed mortality records from the 1918 influenza pandemic estimate that a similarly severe pandemic today would kill about 62 million people worldwide, the vast majority of them in the developing world. Read article...

 

[gsgs]

Re: CIDRAP News Headlines - Aug. 2007

Re: CIDRAP News Headlines - Aug. 2007

http://www.cidrap.umn.edu/cidrap/content/influenza/panflu/news/aug1607glaxo-jw.html

Glaxo sells more H5N1 vaccine to US, launches trial
Robert Roos News Editor

Aug 16, 2007 (CIDRAP News) ? The British pharmaceutical company GlaxoSmithKline (GSK) recently announced another major order of prepandemic H5N1 influenza vaccine from the US Department of Health and Human Services (HHS), along with plans to launch a North American clinical trial of the vaccine.
HHS ordered enough vaccine in bulk form to provide 22.5 million 15-microgram (mcg) doses, the company announced on Aug 3. The order is in addition to the bulk equivalent of 5 million 15-mcg doses that HHS ordered in November 2006, officials said.
The cost of the new vaccine order is $97 million, according to Marc Wolfson, a spokesman for the HHS Office of the Assistant Secretary for Preparedness and Response in Washington, DC.
The new order includes 9 million doses produced in the 2006 "manufacturing campaign" and 13.5 million doses to be produced in the 2007 campaign, GSK reported. The vaccine is based on clade 2 strain of the H5N1 virus.
GSK will make the bulk vaccine at its facility in Ste. Foy, Quebec, and store it in Marietta, Pa.
When HHS announced the plan to buy H5N1 vaccine from GSK in November 2006, the agency said it was ordering 800,000 doses, not the 5 million doses cited in the company's Aug 3 announcement. Wolfson of HHS and Ken Inchausti, a GSK spokesman in Philadelphia, explained that the two announcements involve the same amount of bulk vaccine, but the HHS statement was based on a dose of 90 mcg, whereas the company announcement assumed a dose of 15 mcg.
"The confusion between the 5 million doses that GSK talks about and what we have is that we're still ordering it at the bulk rate of 90 [mcg] per dose," Wolfson told CIDRAP News. "They're doing tests that could possibly take it down to 15 [mcg] per dose, and if you do the math, that's where the difference comes."
Based on 90 mcg per dose, HHS currently has 2.3 million doses of GSK vaccine in its H5N1 vaccine stockpile, Wolfson reported.
The vaccine contract provides that HHS may direct the company to formulate the bulk vaccine into doses in the future, GSK said. In addition, HHS has an option to buy the vaccine in combination with one of the company's proprietary adjuvants, or immune-boosting chemicals, which could reduce the amount of vaccine antigen needed to induce a protective immune response, the company reported.
Funds for the vaccine contract will come through the Biomedical Advanced Research and Development Authority (BARDA) in the HHS Office of the Assistant Secretary for Preparedness and Response, according to GSK.
Clinical trial starting
GSK also announced the start of the first North American clinical trial of its prepandemic H5N1 vaccine. The trial is described as a phase1/2 study that will compare the safety and immunogenicity of the H5N1 antigen alone and in combination with one of GSK's adjuvant systems in 675 adult volunteers. Inchausti said the trial will be conducted at sites in Montana, California, Florida, Georgia, Alabama, Kansas, and Nevada and in Halifax and Quebec, Canada.
The company said it plans to follow up later this year with a phase 3 trial that will involve about 4,400 volunteers. Results of the phase 1/2 trial are expected in early 2008.
Last March, GSK reported that in a clinical trial, one of its adjuvanted H5N1 vaccines triggered a strong immune response with two 3.8-mcg doses, or about half of the 15-mcg dose typically used for each viral strain in seasonal flu vaccines. The company also said tests showed that the vaccine, based on a Vietnam strain of H5N1, generated cross-reactive immunity against an Indonesian strain.
GSK, Baxter sign vaccine deals with UK
In other developments, both GSK and US-based Baxter International today announced agreements to sell vaccine to the United Kingdom in the event of a flu pandemic.
Under the GSK agreement, the company will make preparations to provide a "tailored" vaccine as soon as possible after a pandemic is declared by the World Health Organization, according to a company news release. GSK said it also has agreements to sell pandemic vaccines to Switzerland, Denmark, and Iceland.
Baxter, based in Deerfield, Ill., said its European subsidiary in the UK signed an agreement giving the UK an option to buy Baxter's vaccine in the event of a pandemic. The company's candidate pandemic vaccine is produced in vero cell culture rather than in eggs, the conventional medium for flu vaccine production. Baxter said it recently enrolled volunteers for a phase 3 clinical study of its cell-based H5N1 vaccine in Europe.
See also:
Mar 6 CIDRAP News story "Glaxo H5N1 vaccine may work against multiple strains"
Nov 20, 2006, CIDRAP News story "HHS awards 3 contracts for more H5N1 vaccine"
Aug 16 GSK news release about agreement to sell vaccine to the UK
Aug 16 Baxter International news release about agreement to sell vaccine to the UK