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”
Yashaswini ended the final a massive 1.9 points ahead of the event’s next best performer.Manu Bhaker and Esha Singh finished 1-2 in the women’s 10m Air Pistol.The 22-year-old is a former junior world champion. highlights Rio de Janeiro: An authoritative Yashaswini Singh Deswal secured India’s ninth Olympic quota in style, upstaging the women’s 10m air pistol’s numero uno shooter Olena Kostevych of Ukraine for a gold in the ISSF World Cup in Rio de Janeiro. The 22-year-old former junior world champion on Saturday recorded 236.7 in the eight-woman final of the season’s fourth ISSF World Cup for pistol and rifle shooters. Ukraine’s world number one Kostevych, also a former Olympic and world champion, claimed the silver with 234.8, while Serbia’s Jasmina Milavonovic bagged the beonze with 215.7. Such was the dominance of Yashaswini that she ended the final a massive 1.9 points ahead of the event’s next best performer, Kostevych. Yashaswini, a student of Economics, had also the topped the qualifications by a mile, aggregating a score of 582. Starting the finals with 10.1, 10.5 and 10.1, the Indian was third after the first five-shot series of stage 1. A 10.6 pushed her to number two and a 10.1 to the top, eventually ending the stage as number one. She started the elimination rounds with a bumper 10.4, which was followed by 10.0. The standing was not disturbed despite a 9 as her lead was pretty big by that time. She beiefly slipped to second with a 9.1, but a humongous 10.8, soon after, firmly established Yashaswini’s place at the top. After confirming the quota, Yashaswini shot a perfect 10.9, extending her dominance and securing the top prize with an effortless performance. Also Read | Despite India boycott threat, shooting excluded from 2022 Commonwealth GamesHer two final shots where in the 9s, but importantly, both were higher than those of the Ukranian champion. The brilliant performance saw Yashaswini join Sanjeev Rajput, Anjum Moudgil, Apurvi Chandela, Saurabh Chaudhary, Abhishek Verma, Divyansh Singh Panwar, Rahi Sarnobat and Manu Bhaker as India’s other quota holders for the 2020 Olympic Games in Tokyo. Also Read | Abhinav Bindra not in favour of India boycotting 2022 Commonwealth Games This is also India’s third gold in Rio, after Abhishek Verma and Elavenil Valarivan won the yellow metal in the men’s 10m Air Pistol and women’s 10m Air Rifle respectively. Earlier in the day Kajal Saini of India delivered a hugely improved performance in the women’s 50m Rifle 3 Positions (3P) by finishing 22nd with a qualifying round score of 1167. Former world champion in prone, Tejaswini Sawant finished 47th with a score of 1156. In the men’s 25m Rapid Fire Pistol, Adarsh Singh and Anish Bhanwala shot 291 out of 300 in the first precision round to be in 13th and 14th spots respectively.Anhad Jawanda, the third Indian in the fray, shot 281 to be in 48th spot. The trio will comeback for the final Rapid Fire round on Sunday to try and make it among the top six finalists. The Indians also continued to do well in the non-competition Minimum Qualification Score (MQS) section. Manu Bhaker and Esha Singh finished 1-2 in the women’s 10m Air Pistol, shooting scores of 580 and 577 respectively. For all the Latest Sports News News, Other Sports News, Download News Nation Android and iOS Mobile Apps.