Judge OKs optional anthrax shots for troops

first_img DoD subsequently asked Sullivan to modify his injunction to allow for anthrax vaccinations under the emergency authority. Sullivan granted that motion yesterday, stipulating that the shots have to be voluntary. Sullivan’s ruling came in a suit filed by six military members and DoD civilian contractor employees. In an initial ruling in December 2003, the judge ordered DoD to stop requiring the shots on the ground that the FDA had never specifically approved the vaccine for inhalational anthrax. (The vaccine was originally licensed in 1970.) The FDA responded a week later with a declaration that the vaccine was safe and effective for all forms of anthrax. Sullivan then lifted his injunction in January 2004, little more than 2 weeks after he had issued it. Feb 2 CIDRAP News story “FDA issues emergency order on military anthrax shots” Then-HHS Secretary Tommy Thompson granted the Department of Defense (DoD) request on Jan 14. But the “Emergency Use Authorization” (EUA) said DoD had to make the vaccinations optional. Sullivan had ruled last October that the mandatory vaccination program was illegal because the Food and Drug Administration (FDA), in his opinion, did not follow proper procedures in approving the vaccine for inhalational anthrax, as opposed to cutaneous anthrax. He said troops could not be required to take the vaccine, called Anthrax Vaccine Adsorbed (AVA), without their informed consent or a special presidential waiver. Apr 7, 2005 (CIDRAP News) – A federal judge who stopped the US military’s compulsory anthrax vaccination program last October has ruled that the Pentagon can resume giving anthrax shots, but only on a voluntary basis. In his ruling, Sullivan left the door open to challenges to the legality of the emergency authorization granted by HHS. He said his ruling signaled no “prejudice to a future challenge to the validity of any such EUA,” adding, “The court expressly makes no finding as to the lawfulness of any specific EUA that has been or may be approved by the Department of Health and Human Services.” The Department of Defense (DoD) said it was pleased with the ruling but did not predict when vaccinations will resume. In a brief statement provided by e-mail, DoD officials said, “No vaccinations will be offered until the Defense Department issues detailed implementing instructions in the near future.” District Judge Emmet G. Sullivan in Washington, DC, said yesterday the Pentagon can administer the shots to volunteers under the terms of an emergency authorization granted in January by the Department of Health and Human Services (HHS). Military officials had asked for the emergency authority on grounds that troops in some regions face a risk of anthrax attack. AVA requires six shots over a period of 18 months, followed by annual boosters. Last November HHS awarded an $877 million contract for a new anthrax vaccine that officials hope will require fewer doses and have fewer side effects. The contract went to VaxGen Inc., Brisbane, Calif., for 75 million doses, which are destined for the Strategic National Stockpile of drugs and medical supplies to protect the public. AVA is derived from whole anthrax microbes, whereas the new vaccine contains a purified form of just one anthrax component, called protective antigen. See also: More than 1.3 million people have received anthrax shots in the DoD program since 1998, according to the Pentagon. Hundreds of troops have refused the shots out of concern about side effects, and some have been punished or forced out of the military as a result. Last December, the FDA quietly published a Federal Register notice inviting the public to comment on a proposal to confirm the vaccine’s approval for all forms of anthrax. The deadline for comments was Mar 29. But in his subsequent ruling in October 2004, Sullivan said the FDA had failed to follow its own rules in declaring the vaccine safe for all forms of the disease. Those rules, set up after the FDA took over drug licensing from another federal agency in 1972, included gathering public comments. Sullivan said that the FDA’s declaration relied partly on evidence on which the public never had a chance to comment. In December, military officials responded to the ruling by asking the Department of Health and Human Services (HHS) for emergency authority to resume the vaccination program. Under the Project Bioshield Act of 2004, the FDA, in a declared emergency, can authorize the use of a medical product that has not gained ordinary FDA approval. Nov 4, 2004, CIDRAP News story “HHS to spend $877 million on new anthrax vaccine”last_img read more

Liverpool boys swimmers go 5-0 in dominant week

first_imgA pair of undefeated boys swim teams were ready to battle for first place in the Salt City Athletic Conference as Liverpool made the short trip to Baldwinsville on Wednesday night.They did so after an astonishing eight-day stretch where the Warriors competed in an elite tournament and then beat five opponents head-to-head, capped by last Saturday’s sweep of host Jamesville-DeWitt/CBA and Watertown.During that meet, Liverpool handled the Red Rams 101-77 and the Cyclones 102.5-60.5, and the starting point was having Brandon Nguyen, Curtis Merrick, Griffin Merkling and Julien Brownlow win the 200-yard medley relay in a state meet-qualifying time of 1:40.67. Liverpool and B’ville saw each other compete on Jan. 4 in the Yeti Invitational at Webster Schroeder, near Rochester. Here, the Warriors finished third in the 13-team field as the Bees settled for sixth place.The big highlight for the Warriors was seeing its 400 freestyle relay team of Merkling, Merrick, Brownlow and Nguyen win in 3:17.70 and, by doing so, qualify for March’s state championship meet.Earlier in the meet, Merkling had improved his 200 individual medley time to 1:57.58, just behind the 1:57.16 from McQuaid’s Max Murray.Brownlow went 22.66 seconds to finish third in the 50 freestyle, with Nguyen third in the 100 freestyle in 50.08 seconds. In the 500 freestyle, Merkling got fifth place in 4:56.86. Andrejko was eighth in the 100 backstroke in 59.23 seconds.As a follow-up, Liverpool ventured to West Genesee last Tuesday night and improved to 4-0, handling the Wildcats 101-82.Merkling would swim the 500 freestyle in 4:59.64 and Merrick won the 100 butterfly in 56.46 seconds, while Brownlow took the 50 freestyle in exactly 23 seconds. Merrick, in 2:17.47, edged Andrejko (2:17.54) in the 200 IM.Elsewhere, Will Allen was victorious in the 200 freestyle in 1:59.01, with Jack Hyde going 1:02.90 to beat the field in the 100 backstroke. Nguyen helped Merkling, Merrick and Brownlow go 1:42.35 in the 200 medley relay as Ryan Wilhelm joined Nguyen, Merrick and Brownlow to wint he 200 freestyle relay in 1:33.52.The day before it beat J-D/CBA and Watertown, Liverpool swept another three-team meet at Oswego, handling the host Buccaneers 101-63 and also topping Mexico 94-83.Merkling was first in the 200 freetstyle in 1:48.44 and took the 100 butterfly in 54.63 seconds as Merrick was first in the 100 backstroke in 55.28 seconds.Nguyen beat the field in the 50 freestyle in 22.91 seconds as Andrejko, in 51.79 seconds, claimed the 100 freestyle and Jack Hyde took the 200 IM in 2:19.30. Uriy Grabovyy earned 227.65 points in diving, just behind Mexico’s Kian Long, who had 231.45 points.While all this was going on, Cicero-North Syracuse found its own success last Tuesday night when it earned a 98-72 victory over Syracuse City.Logan Petralia, John Harbaugh, Dom Bagozzi and Seaver Schultz would tear to a time of 1:36.23 in the 200 freestyle relay, with that same quartet winning the 400 freestyle relay in 3:43.36.Petralia was first in the 200 IM in 2:20.77 as Harbaugh won the 100 butterfly in 1:02.24. Bagozzi got to first in the 50 freestyle in 24.69 seconds as Sawyer Powell added a 100 backstroke title in 1:05.31.Schultz would finish second twice to Syracuase’s Lelal Hamad, his 1:57.05 in the 200 freestyle behind Amad’s 1:51.54 and his 51.03 seconds in the 100 freestyle trailing Amad’s 48.999.Against Pulaski/Sandy Creek on Friday, C-NS won 51-28, with Harbaugh (500 freestyle), Bagozzi (100 backstroke), Josh Kubala (200 freestyle), Anthony Bouziden (50 freestyle), Joe Gucciardi (100 butterfly) and Crispin Coombs (100 freestyle) each winning individual races.Share this:FacebookTwitterLinkedInRedditComment on this Story Merkling, Nguyen, Brownlow and Merrick teamed up again in the 200 freestyle relay and finished in 1:29.06 to edge Watertown’s 1:29.30, both of them state qualifying times.Individually, Merkling swam the 200 individual medley in 2:01.49 and the 100 breaststroke in 1:01.66, with Merrick going 54.78 seconds in the 100 butterfly and 22.96 seconds in the 50 freestyle.But it was Brownlow winning the 50 freestyle in 22.36 seconds and the 100 freestyle in 49.94 seconds as Jack Andrejko went 1:00.43 in the 100 backstroke and Will Allen swam the 500 freestyle in 5:22.30.center_img Tags: C-NSliverpoolswimminglast_img read more