The anthrax vaccine currently in the national stockpile, Anthrax Vaccine Adsorbed (AVA), was developed in the 1950s and is produced by Emergent BioSolutions under the brand name BioThrax. The product, required for US military personnel serving in high-risk areas such as the Middle East, is given in six doses over 18 months, followed by an annual booster. Both companies—Emergent BioSolutions, based in Rockville, and PharmAthene, based in Annapolis—announced in Jul 31 statements that they submitted responses to a request for proposal (RFP) from the US Department of Health and Human Services (HHS). The RFP was issued in February and seeks 25 million doses of recombinant protective antigen (rPA) anthrax vaccine, based on a key anthrax protein, with a shelf life of at least 2 years. Feds spell out vaccine requestThe contract would require companies to secure Food and Drug Administration approval for the rPA anthrax vaccine. Initially, the vaccine would be used for pre-exposure prophylaxis in adults, with a future label extension to allow postexposure prophylaxis alongside antibiotics. David P. Wright, PharmAthene’s president and CEO, said the competition for the HHS contract is stiff, according to the Sun report. “This will not be a cakewalk for us. We have very strong competitors, but I believe, with the caliber of staff we have, that we will be successful at the end of the day in producing for this country the vaccine we need,” he told the Sun. Oct 31, 2007, CIDRAP News story “GAO critiques anthrax vaccine procurement, management” HHS request for proposal listing Aug 12, 2008 (CIDRAP News) – Two Maryland pharmaceutical companies recently announced that they have submitted proposals to produce and deliver at least 25 million doses of a next-generation anthrax vaccine to the nation’s Strategic National Stockpile. Jul 29 CIDRAP News story “Anthrax vaccine maker wins NIAID grants” Federal officials said they expect to award the contract to one or more companies, based on available funding, by late September. Federal officials didn’t say if any other companies submitted proposals to produce an rPA anthrax vaccine for HHS. Robin Robinson, director of the HHS Biomedical Advanced Research and Development Authority (BARDA), said the agency received multiple offers and that they appear promising, according to a report yesterday in the Baltimore Sun. It said phase 1 and 2 studies involving 700 human subjects suggest that its rPA anthrax vaccine is safe and well tolerated and produces a protective immune response. Jul 31 PharmAthene press release In May, VaxGen sold its experimental anthrax vaccine to its competitor, Emergent BioSolutions, according to previous reports. One month earlier, PharmAthene acquired an rPA anthrax vaccine candidate that was developed by Avecia, a biotechnology company based in the United Kingdom. The National Institute for Allergy and Infectious Diseases (NIAID) has supported both candidates with research grants. Phase 2 studies completeEmergent BioSolutions said its vaccine candidate is a reformulated and more stable version of the rPA 102 vaccine that was originally developed at the US Army Medical Research Institute of Infectious Diseases. In its statement, the company said phase 2 studies of rPA have been completed. The company said it would produce the vaccine at its new manufacturing facility in Lansing, Mich. PharmAthene said its new anthrax vaccine consists of rPA adsorbed into alhydrogel and packaged as a filled syringe for intramuscular injection. In its statement, the company said preclinical studies suggest that two or three doses administered several weeks produce an immune response that requires annual boosters. Federal officials have been seeking a new vaccine formulation that can provide immunity in three doses, rather than the six doses required for the licensed vaccine, and that will cause fewer side effects. Robinson told the Sun that BARDA expects to allocate $1.5 billion toward adding anthrax vaccines to the national stockpile. The government has said it wants to boost the national anthrax vaccine stockpile from 18.2 million doses to enough to protect 300 million, the report said. In 2007, HHS withdrew an $877.5 million contract to VaxGen, a South San Francisco, Calif., biotechnology company, after it missed some of its development milestones. The contract required VaxGen to produce 75 million doses of the rPA anthrax vaccine, enough to immunize 25 million people. A number of service members have reported serious side effects from the vaccine, and some sued to shelve the program. However, in late February a US district court judge dismissed the suit. Jul 31 Emergent BioSolutions press release The latest federal call for a new version of the anthrax vaccine came 4 months after the Government Accountability Office (GAO), the investigative arm of Congress, criticized previous attempts to secure a second-generation anthrax vaccine as premature, unrealistic, and vague regarding its intended use. See also: James Jackson, senior vice president and chief executive officer (CEO) of Emergent BioSolutions, said in the statement its analytical and nonclinical data support the vaccine’s stability improvements: “We believe that the current formulation will meet the US government’s stability requirements for an rPA vaccine,” he said.
Florida Senators Rick Scott and Marco Rubio, together with Representatives Brian Mast and Francis Rooney, have released the following joint statement after President Trump’s Fiscal Year 2020 budget request to Congress failed to include sufficient funding for Everglades restoration efforts. “For the third year in a row, the administration’s budget request underfunds critical projects in South Florida. It is incredibly short-sighted to continue to underfund a series of projects that are absolutely necessary to ensure the environmental sustainability and economic vitality of one of the most dynamic regions of our nation,” the officials stated.“Everglades restoration is critically important to the State of Florida and enjoys broad bipartisan support in Congress. Failing to meet the basic federal funding commitments to restore the Everglades is contrary to the administration’s goal of improving project partnerships and cost-sharing with states. “Successive Florida Governors have remained committed to this goal, pushing state funding of this 50/50 federal-state partnership to historic highs.“Congress and the Army Corps of Engineers envisioned a $200 million per year federal commitment when the Comprehensive Everglades Restoration Plan was first authorized nearly 20 years ago, and it is time for the administration to meet that commitment.”Last month, Senator Scott, Senator Rubio, and Florida Governor DeSantis urged President Trump to include a commitment of $200 million in construction funding for South Florida Ecosystem Restoration (SFER). read more
Tottenham head coach Mauricio Pochettino is hopeful Ryan Mason will be fit. The 23-year-old midfielder has established himself in Pochettino’s side in recent weeks but was forced off during Saturday’s 2-1 win over Burnley with a twisted ankle. But Pochettino revealed the issue is not as bad as first feared and is now in contention for the game at the King Power Stadium, as is striker Emmanuel Adebayor, who has not featured since early November. After a shaky start to the campaign, Pochettino now has his side playing some good football and, with a Capital One Cup semi-final against Sheffield United and a Europa League tie against Fiorentina on the horizon, Spurs sit just four points outside the Barclays Premier League’s top four. United States international DeAndre Yedlin will link up with the squad in the new year after a deal was originally struck with his current club Seattle Sounders in August. But the 21-year-old is likely to be one for the future and, although Pochettino has been linked with a string of central defenders, he insists he would be happy if he is left with his current crop come February 1. “We have a lot of chats and have I told him all my thoughts,” Pochettino said of transfer window discussions with chairman Daniel Levy. “We have common sense, when the window opens in January we will start to decide but so far we are very happy with our squad. “I am happy, it’s not about if you sign or not. I’m happy here and I’m happy with our squad. I never put pressure (on the chairman). “We need to understand in football, when you are a head coach you need to try to explain to the chairman, sporting director, my thoughts and advice and then decide the best for the team.” Nigel Pearson knows how to pull off a great escape but the Leicester boss insists there are no quick fixes to save the Foxes. And Pearson was Bryan Robson’s assistant when the Baggies became the first team in Premier League history to survive the traditional relegation. They stayed up on the final day of the 2004-05 season with the lowest ever points total to beat the drop, 34. Now, Leicester are winless in 12 games and five points from safety and Pearson insisted they must match the Baggies’ ethic and strength to survive. He said: “You’re looking at strength of character and we made additions and key players came in then: Kieran Richardson and Kevin Campbell added to what was a really good group of people who had a common goal and worked exceptionally hard. “That’s always going to be the base line. “To win things you need those qualities, to avoid relegation you need those qualities. Ability gets you so far, strength of character too, but it’s trying to get a balance of the two. “There is a desire and a willingness to look for the answers. There are no quick fixes in life, well there might be but they don’t have enough longevity. It’s about winning the next game, as it always has been for us.” Chris Wood is a doubt, Matt Upson is expected to make his return from a foot injury in the new year while Kasper Schmeichel remains out with a broken metatarsal he suffered in training. They are bottom of the Barclays Premier League at Christmas ahead of the Boxing Day visit of Tottenham. Only two sides have ever survived being bottom on December 25 – Sunderland last season and West Brom in 2005. Press Association read more