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FDA seeks comments on controversial anthrax vaccine

first_imgJan 13, 2005 (CIDRAP News) – As a result of a federal court ruling that stopped the US military’s anthrax vaccination program last October, the Food and Drug Administration (FDA) is asking for public comments on its finding that the anthrax vaccine is safe and effective. A week after the ruling, the FDA responded with a statement, based on the findings of an expert panel in 1985 and subsequent research, that the vaccine is safe and effective for all forms of anthrax. In response, Sullivan lifted his injunction against the DoD vaccination program. But in October 2004, Sullivan said that the FDA had failed to follow its own rules in not soliciting public comments before confirming (in December 2003) that the vaccine is approved for all forms of anthrax. Citing a 1998 law that bars DoD from forcing military members to take drugs not approved for their intended use, Sullivan said military personnel could not be forced to receive anthrax shots without a special presidential order. DoD then suspended the vaccination program. In the notice, the FDA concedes that the 1950s clinical trial data on which its licensing decisions were largely based included too few cases of inhalational anthrax to show clearly that the vaccine prevents that disease. But the notice says the trial data show that the vaccine’s efficacy against all types of anthrax combined was 92.5%. In 1985, an FDA expert panel recommended confirming the approval of the anthrax vaccine, along with various other bacterial vaccines and toxoids. In December 1985, FDA proposed to confirm the approvals and gave the public 90 days to comment on them. The agency received no specific comments on AVA at the time. AVA, also called BioThrax, is made by BioPort Corp. of Lansing, Mich. HHS announced last November that it planned to buy 5 million doses of the vaccine for potential civilian use. HHS also has contracted with VaxGen, Inc., to produce 75 million doses of a new, not-yet-licensed anthrax vaccine that officials hope will require fewer doses and have fewer side effects than the existing vaccine. The existing vaccine requires six doses over 18 months, followed by annual boosters. Last month, DoD officials asked the Department of Health and Human Services (HHS) for emergency authority to resume the vaccination program because of what they said was an increased risk of anthrax attacks on US forces. HHS officials were still reviewing that request as of yesterday, Marc Wolfson of the HHS Office of Public Health Emergency Preparedness told CIDRAP News. A federal judge in Washington, DC, ruled in December 2003 and again in October 2004 that the FDA acted improperly in authorizing the use of the anthrax vaccine to prevent inhalational anthrax, as distinguished from cutaneous anthrax. The military vaccination program has been on hold since the October ruling. The FDA rules that Sullivan said the agency ignored went back to 1972, when the FDA took over the licensing of drugs and vaccines from the National Institutes of Health (NIH). The FDA then set up a procedure for reviewing products that had been licensed by the NIH. The procedure included reviews by independent expert panels and inviting public comments before confirming the product approvals. The FDA notice is the latest chapter in a dispute between the government and military personnel who are fighting the anthrax vaccination program because of concern about side effects. Since 1998, about 1.25 million Department of Defense (DoD) personnel, mostly those serving in the Middle East and Korea, have received the vaccine. But some have resisted the shots and been disciplined or forced out of the military as a result. The two court rulings came in a lawsuit filed by six military members and civilian contractor personnel. In the first ruling, in December 2003, US District Judge Emmet G. Sullivan concluded that AVA had never been specifically approved or labeled for use against inhalational anthrax, which is the form the military is most concerned about. In the controlled trial, called the Brachman study, 1,249 workers at four textile mills that processed goat hair received either AVA, a placebo, or no treatment. Five cases of inhalation anthrax occurred in the trial, all in unvaccinated workers. There also were 21 cases of cutaneous anthrax, all but three of them in unvaccinated workers. The agency concludes that the vaccine label doesn’t need to state what route of anthrax exposure the vaccine is intended for. “We propose the indication section of the labeling for AVA [Anthrax Vaccine Adsorbed] not specify the route of exposure, and the vaccine be indicated for active immunization against Bacillus anthracis, independent of the route of exposure,” the notice states. In the Federal Register notice, the FDA describes the 1950s clinical trial of AVA and later epidemiologic data on the vaccine’s efficacy and safety. In an effort to overcome the court’s objections, the FDA on Dec 29 quietly published a Federal Register notice explaining its proposal to reaffirm the vaccine’s approval and also inviting the public to comment on the matter. The deadline for comments is Mar 29. The notice also cites some epidemiologic data in support of the FDA proposal to reconfirm the AVA approval. The Centers for Disease Control and Prevention collected data on anthrax cases in industrial settings from 1962 to 1974 and also monitored adverse reactions to the vaccine in about 7,000 at-risk workers from 1967 to 1971. From the latter study, the expert panel concluded that the vaccine was “fairly well tolerated” and that severe local reactions and systemic reactions were “relatively rare.” Also in support of the vaccine, the FDA notice cites a small clinical study conducted by DoD after 1985 and data collected by the Vaccine Adverse Event Reporting System. In addition, the report cites the 2002 analysis by the Institute of Medicine, which found that the vaccine was “acceptably safe” and effective against inhalational and other forms of anthrax. The 1985 expert panel said that ethical concerns and the low incidence of anthrax make it impossible to conduct further controlled clinical trials of the vaccine, according to the notice. The expert panel concluded that the vaccine provided 93% protection overall but that cases of inhalational anthrax were too few to assess the vaccine’s effect against that form of anthrax, the Federal Register notice says. According to Sullivan’s October 2004 ruling, the FDA never followed up with specific confirmation of the AVA licensing until after his December 2003 ruling. When the FDA then said the vaccine was effective for all forms of anthrax, it relied partly on post-1986 research findings, on which the public never had a chance to comment, according to the judge. “FDA agrees that the five cases of inhalation anthrax reported in the course of the Brachman study are too few to support an independent statistical analysis,” the notice states. But it adds that the study included all types of anthrax, the overall efficacy of the vaccine was 92.5%, and no inhalational cases occurred in vaccinated workers. Therefore, the FDA proposes to label the vaccine for anthrax immunization without specifying the route of exposure.last_img read more

Governor Wolf Approves 106 Local Water Clean Up Projects Statewide

first_imgMultiple Counties·         Armstrong Conservation District, Excitation emission matrix analysis water quality testing in Armstrong and Indiana Counties, $7,839·         Cooks Creek Watershed Association, Watershed Implementation Plan, $39,080·         Headwaters Resource Conservation and Development Council, Agricultural best management practices on nine farms, $181,352·         Pennsylvania Association of Conservation Districts, CREP Outreach Program Office, $382,355·         Pennsylvania Lake Management Society, Lake best management practices phase 3, $103,068·         Stroud Water Research Center, Healthy Soils, Healthy Streams training and technical assistance, $336,630·         Trout Unlimited, Nonpoint Source Technical Assistance Program, $191,300·         Villanova University, Impact of nutrient and fine sediment accumulation and distribution on stormwater rain garden performance study, $244,937·         Western Pennsylvania Coalition for Abandoned Mine Reclamation, Quick Response 8: Timely repair projects to prevent environmental degradation or costly repairs, $100,000·         Wildlands Conservancy, Implementing high priority stream restoration in the Lehigh Watershed, $138,039 Environment,  Press Release Harrisburg, PA – Governor Tom Wolf announced today that 106 projects to clean up local waters statewide, benefiting hundreds of communities, have been selected to receive funding through the Department of Environmental Protection’s (DEP) Growing Greener program.“These grant projects represent important opportunities for citizen and community engagement in local water cleanup around the commonwealth. The vitally important roster of local governments and nonprofit organizations who willingly tackle them is a great representation of our spirit of partnership,” said Governor Wolf. “Their efforts are invaluable investments in our public health, the vitality of our communities, and the quality of our environment in Pennsylvania.”Growing Greener grants will go to 106 projects. Fifty-one are in Pennsylvania’s part (43 counties) of the Chesapeake Bay Watershed, reflecting part of the ramped-up state and federal funding commitment to Pennsylvania’s federal mandate to reduce nitrogen, phosphorous, and sediment pollution in the watershed.Fifty-five Growing Greener projects are in the 24 counties beyond the watershed. Together, all projects will receive just over $20.7 million.“There’s no magic wand to wave to clean up all of Pennsylvania’s streams and rivers at once. Reducing acid mine drainage, nutrients, sediment, and other pollutants requires countless strategic, collaborative community efforts at the creek, river, lake, and watershed levels. Achieving a collective impact is the essential role Growing Greener projects play,” said DEP Secretary Patrick McDonnell.The Growing Greener grant program–the largest single investment of state funds to address Pennsylvania’s environmental challenges–is supported by the Environmental Stewardship Fund, which receives its funding from landfill tipping fees. Since it was launched in 1999, the Growing Greener program has provided more than $296 million to environmental projects statewide.GRANT AWARDS BY COUNTY:Allegheny·         Allegheny County Parks Foundation, Pinkertons Run acid mine drainage treatment and streambank stabilization, $318,672·         Urban Redevelopment Authority of Pittsburgh, Larimer/East Liberty Park green infrastructure, $60,000·         Western Pennsylvania Conservancy, Deer Creek stream restoration, $38,642Armstrong·         Armstrong County Conservation District, Pine Run stream restoration, $59,889; Agricultural best management practices to reduce sediment and nutrient loads to Spra Run, $110,096·         Western Pennsylvania Conservancy, Buffalo Creek stream restoration, $73,995Berks ·         Berks County Conservation District, County agricultural best management practices implementation, $231,486Bucks·         Bucks County Conservation District, Dimple Creek Watershed water chestnut management project, $95,385·         Carversville Farm Foundation, Carversville farm stream restoration, $60,904·         Middletown Township, Sediment reduction initiative to retrofit five stormwater basins, $175,000·         Warrington Township, Naturalizing the detention basin at Folly and Pickertown Roads, $16,515Butler·         Stream Restoration Incorporated, Slippery Rock Stream bioengineering, $125,450Carbon·         Carbon County Conservation District, Nesquehoning Creek stabilization phase 3, $215,000Chester·         Brandywine Red Clay Alliance, Plum Run Watershed Renaissance Initiative, $150,000·         Kennett Area Park Authority, Red Clay/Nixon Park stream restoration, $77,500·         New Garden Township, Bucktoe Creek stream restoration, $36,000·         Open Land Conservancy of Chester County, Design and installation of stormwater best management practice in Airdrie Preserve, $52,360·         Uwchlan Township, Ludwig’s Run stormwater basins retrofit, $90,775·         Valley Forge Chapter of Trout Unlimited, Wilson Run stream restoration, $130,812Crawford·         Crawford County Conservation District, Agricultural Best Management Practice Cost Share Program, $263,343; Little Sugar Creek streambank stabilization, $79,368Delaware ·         Borough of Media, Bioretention and infiltration best management practices, $163,050Erie ·         Environment Erie, Begin ANEW stormwater education and management, $55,556; Service Learning Projects, $36,650Greene ·         Greene County Conservation District, Browns Creek stabilization/best management practice implementation, $207,484Indiana ·         Indiana County Conservation District, McKee Run streambank stabilization, $20,494·         Western Pennsylvania Conservancy, Ross Run restoration phase 2, $52,193Jefferson ·         Jefferson County Conservation District, Pine Run agricultural best management practices implementation, $486,580Mercer·         Mercer County Conservation District, Elder Run streambank stabilization, $40,247; Sandy Creek Watershed conservation project, $209,000Montgomery ·         Borough of Ambler, Growing Ambler Greener 2017-2020, $206,100·         Upper Dublin Township, Rose Valley Creek Willowmere Study, $18,991·         Wissahickon Valley Watershed Association, Thompson Dam alternatives analysis, $44,000·         Worcester Township, Defford/Clyston Roads retrofit basin, $42,804Northampton·         Northampton County, Monocacy Creek restoration at Archibald Johnston Conservation Area, $80,000Philadelphia·         City of Philadelphia, Philly Tree Canopy (Renew Philly Trees), $250,000Venango·         Scrubgrass Creek Watershed Association, Restoration of Upper Scrubgrass Creek phase 2, $147,418Warren·         Western Pennsylvania Conservancy, Brokenstraw Watershed improvement phase 2, $96,072Washington·         Washington County Conservation District, Covered Bridge Meadow agricultural best management practices, $36,683Wayne·         Equinunk Watershed Alliance, Equinunk Area Watershed Management Plan, $50,000·         Lake Wallenpaupack Watershed Management District, Stormwater structure installation at Deerfield Lake, $123,910Westmoreland ·         Jacobs Creek Watershed Association, Route 31 green infrastructure urban stormwater best management practices, $350,000·         Sewickley Creek Watershed Association, Lowber treatment system iron sludge management, $171,725·         Westmoreland County Conservation District, Murrysville stormwater basin retrofits, $64,620; Vandergrift CBD stormwater management phase 2, $5,000 Governor Wolf Approves 106 Local Water Clean Up Projects Statewide Multiple Counties or Regions·         Chesapeake Bay Foundation, Prioritizing forested buffer investments, $629,557·         Columbia County Conservation District, Multicounty soil health project, $409,465·         Endless Mountains Resource Conservation and Development Council, Applied agroforestry education, $46,200·         National Fish and Wildlife Foundation, Pennsylvania-NFWF Agricultural Conservation Collaborative, $550,000·         Northcentral Pennsylvania Conservancy, Focused sediment reduction in Chesapeake Bay, $425,000·         Pennsylvania Horticultural Society, TreeVitalize XIII, $100,000Western Pennsylvania Conservancy, Chesapeake Bay Conservation Easement Incentive Project, $379,000; Juniata best management practices implementation/technical assistance, $194,770For more information on DEP or the Growing Greener Program, visit www.dep.pa.gov. December 07, 2017 Pennsylvania Counties in the Chesapeake Bay WatershedBedford·         Western Pennsylvania Conservancy, Bobs Creek erosion/sediment reduction, $46,572Berks ·         Berks County Conservation District, Creekside Stables erosion best management practices, $50,033; Dennis Bross Farm best management practices, $306,551Blair·         The Trust for Tomorrow, Freedom Township stream restoration project, $57,801Bradford ·         Bradford County Commissioners, Bradford County sediment and nutrient reduction initiative, $220,000·         Sugar Creek Watershed Association, Browns Creek stream corridor restoration, $68,000Cambria·         Cambria County Conservation District, Glendale Lake shoreline stabilization project phase 5, $167,618; Northern Cambria flood control restoration project phase 2, $29,838Centre·         Centre County Conservation District, Reducing pollution loads from Centre County farms, $702,147·         Penns Valley Conservation Association, Upper Penns Valley streambank best management practices, $65,911Cumberland·         Cumberland County Conservation District, Agricultural best management practices, $289,813Dauphin·         Capital Area Greenbelt Association, Paxtang Parkway Watershed restoration and management, $421,200Huntingdon·         The Trust for Tomorrow, Brown Farm Stream Restoration Phase 2, $182,866; Peachy and Brown Farms Stream Restoration, $249,194Indiana ·         Cambria County Conservation District, Cherry Tree flood control restoration phase 2, $70,701Juniata·         Juniata County Conservation District, Lost Creek restoration phase 2, $116,028Lackawanna·         Throop Borough, Sulphur Creek restoration, $280,000Lancaster·         Borough of Ephrata, Ephrata Wastewater Treatment Plant stormwater management improvements, $85,033·         City of Lancaster, Long’s Park stormwater mitigation, $500,000Luzerne·         Dallas Township, Toby Creek streambank stabilization and stormwater enhancement design, $36,550·         Harvey’s Lake Borough, Eradication/control program for Hydrilla in Harvey’s Lake, $208,870·         Luzerne County Conservation District, 2016 Agricultural best management practice projects, $318,000; Nescopeck Creek Watershed restoration efforts, $140,000Lycoming·         Lycoming County Conservation District, Agricultural and streambank best management practices, $214,984Montour·         Montour County Conservation District, Chillisquaque Creek/Limestone Run restoration, $746,713Potter·         Potter County Conservation District, Potter County streambank stabilization, $20,050·         Trout Unlimited, Kettle Creek nonpoint source sediment reduction, $32,100Schuylkill County·         Schuylkill Conservation District, Good Spring Creek floodplain restoration phase 1, $230,000; Swatara Creek floodplain restoration phase 1, $2,991,000Snyder·         Snyder County Conservation District, Snook barnyard improvement – lower lot, $163,840Susquehanna·         Susquehanna County Conservation District, Countywide spring developments, $71,808; Priority watershed spring developments, $32,651; Meshoppen Watershed barnyards, $38,328; Tunkhannock Creek Watershed barnyards, $170,000; Wyalusing Watershed barnyards, $180,000Tioga·         Tioga County Conservation District, Marsh Creek Watershed improvement, $60,389Wyoming ·         Lake Carey Welfare Association, Nutrient inactivation of phosphorous in Lake Carey, $69,210·         Wyoming County Conservation District, Freeman Farm manure and wastewater handling and storage, $134,650York·         American Rivers, Inc., Removal of Kehm Dam and wetland and riparian buffer development, $219,632·         Hallam Borough, Unnamed tributary to Kreutz Creek stream restoration, $80,000·         Jackson Township, Jackson Township Community Park stream restoration, $190,000·         Wrightsville Borough, Wrightsville green infrastructure plan, $356,350 SHARE Email Facebook Twitterlast_img read more

I want the Black Stars head coach job not as an assistant- Tanko

first_imgFormer Black Stars forward and now assistant coach of the Indomitable Lions of Cameroon, Ibrahim Tanko has declared his intention of joining the technical team of the Black Stars only as head coach not as an assistant.This revelation comes as the Ghana FA made an official statement last Friday that its outfit and the Black Stars coach James Kwesi Appiah had agreed to mutually part ways therefore making the position vacant.Reports in the media are that apart from the assistant coach Maxwell Konadu the   rest of the technical staff will follow suit and it is believed Konadu will be named as substantive coach anytime soon.Tanko has  been linked to the Black Stars assistant coach job due to his commitment exhibited  since he joined the four times African champions, Cameroon.But in an exclusive interview with Asempa Sports, the former Borussia Dortmund player says he will only accept an offer from the Ghana FA as head coach of the Black Stars.“I will not join the Black Stars coaching staff as assistant but head coach rather because if I look at those who are applying for the job at the moment then nothing prevents me from applying for the top most one”. “Anyway, am very happy with where the Cameroonian national team has gotten me into. Although is in my plan that as a coach I will come back home one day to serve my motherland”“The coach am working with is one of the best so am not sure that if any country approach me to assist now, I don’t think I will be able to do so just because I know what am getting from Volker Finke”. He addedTanko joined the Cameroon national team in June 2013 following the appointment of the German tactician, Volker Finke and was also appointed as a scout for Ghana at the 2012 Africa Cup of Nationslast_img read more