Jan 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.
Related Stories Tyson-Thomas steadily leads Syracuse with 22 points in loss to Villanova Kayla Alexander buried her face in a towel and sat in disbelief on the sideline.It was a shot she’s made countless times.But she didn’t knock it down with five seconds left in double overtime. No. 22 Syracuse (22-6, 20-5 Big East) missed out on multiple chances to win the game, falling to Villanova (19-9, 8-7) 77-75 at the Carrier Dome on Saturday afternoon in an exhilarating game that featured 19 lead changes. The Orange pulverized the Wildcats in the paint, outscoring VU 50-30, but failed to convert when it mattered the most.“I haven’t been in a game that went back-and-forth as much as this,” SU head coach Quentin Hillsman said. “It was a tough one. I thought that when we went down the stretch we had some opportunities to win the basketball game and we just didn’t close it.”SU turned the ball over with 11 seconds remaining in regulation, paving the way for a clutch layup with 1.8 seconds left by Devon Kane. Kane knifed her way through the SU defense and converted on a left-handed layup that knotted the game at 52.AdvertisementThis is placeholder textIn the first overtime, Carmen Tyson-Thomas snagged a rebound with seven seconds to go and blazed down the court with a chance to win the game for the Orange. But she lost control of the ball and it grazed the backboard as time expired and she hunched over in agony.“In both overtimes to win the game I thought we got some easy shots that we just missed,” Hillsman said.In the second overtime, Alexander’s two-footer was the best look imaginable for Syracuse. Elashier Hall blew by Villanova’s Laura Sweeney with seven seconds remaining, feeding the senior in perfect position.SU’s center – who finished with 22 points and 11 rebounds and kept her team in the game – clanked the ball off the backboard, as the shot barely grazed the rim. The usually calm and unaffected Alexander let out a scream and flung her right leg in the air in frustration, dejectedly walking over to the sideline after time expired. She was stunned.“That could have been the game right there,” Alexander said, still visibly rattled and disappointed with herself after the game. “It was frustrating.”The aggravation mounted for Alexander and the Orange heading into the third and final overtime. After the game Hall admitted fatigue started to kick in as the game progressed.Hall said she’s played for 40-plus minutes in practice with periodic breaks, but she’s never been part of a game with so many twists and turns.“Third overtime? That was the last one, right?” Hall said. “I think for a lot of us we hadn’t played that long, so it was just a matter of focusing and collecting energy from somewhere – anywhere – and just getting it done.”But Syracuse couldn’t do so. The Orange and Wildcats each flirted with a win multiple times, but neither team was able to capitalize until the third overtime when the Wildcats finally seized the momentum.Two possessions into the third overtime, Alexander missed another easy one right around the basket – a shot that would have given the Orange the lead.Instead, Villanova embarked on an 8-2 spurt to start the final frame, finally distancing itself from the Orange in a game in which the lead never ballooned to more than five for either team in the second half or first or second overtime periods.After Sweeney – who punished the Orange with a career-high 29 points – nailed a jumper, Tyson-Thomas threw up a prayer and converted. Syracuse was only down two.Two possessions later, Villanova’s Devon Kane was fouled after Rachel Coffey missed a 3-pointer from the top of the key. Kane’s free throw danced around the rim, the Orange’s hopes seesawing with every bounce. Following the third bounce, the ball plopped out. Tyson-Thomas snatched the rebound and rifled an outlet pass to Coffey with four seconds to go.Syracuse had one last chance. Despite its late-game struggles and missed opportunities, the Orange still had to a shot to earn a massive win and remain perfect at the Carrier Dome.Coffey heaved it up toward the rim with just her right hand from two feet beyond the arc. The shot was perfectly aimed, but came up just a tad short, clanging off the rim. Bending over to the ground, Coffey looked physically wounded by the miss for a few seconds.“I was just thinking like man, if that had went in that could have been the game,” Tyson-Thomas said. “Sometimes it falls, sometimes it doesn’t. Unfortunately this was one of the times that it didn’t.” Comments Published on March 2, 2013 at 8:46 pm Contact Trevor: email@example.com | @TrevorHass Facebook Twitter Google+
A unique tribute to first responders is coming to Florida. The Blue Angels announced yesterday they will fly over hospitals in Jacksonville and Miami tomorrow. The Navy’s flight demonstration team will take off from Jacksonville’s NAS Mayport at 11:40 a.m. They’ll then fly over South Florida, starting at one, from Boca Raton to Fort Lauderdale and Miami.