In 2004 Acambis temporarily halted one of its phase 3 trials comparing ACAM2000 with Dryvax, the currently licensed smallpox vaccine that is no longer produced, after myopericarditis developed in at least three of the research subjects. The HHS, in an Apr 20 release of its plan for developing and buying medical countermeasures against a range of biological, chemical, and other threats, said it was planning to stockpile a weaker version of the smallpox vaccinemodified vaccinia Ankara (MVA)for certain groups, such as pregnant women and immuncompromised people, who can’t receive the conventional smallpox vaccine. The agency “is well advanced in the pre-award stage” of a program to buy an MVA vaccine. Two companies have developed MVA vaccines: Acambis and Copenhagen-based Bavarian Nordic. Acambis has a contract with the US Department of Health and Human Services (HHS) to make 209 million doses of smallpox vaccine for the Strategic National Stockpile (SNS) to use in the event of a terrorist release of smallpox virus. Marc Wolfson, a spokesman for the HHS Office of Public Health Emergency Preparedness in Washington, told CIDRAP News in an e-mail that the company has delivered 192.5 million doses of ACAM2000 so far and has been paid $573,650,000. May 18, 2007 (CIDRAP News) A US Food and Drug Administration (FDA) panel yesterday recommended that the agency approve a smallpox vaccine made by British biotechnology company Acambis plc that is currently being stockpiled for the US government. “This vaccine should not be used lightly,” said Pamela McInnes, a panelist who directs the Center for Integrative Biology and Infectious Diseases at the National Institutes of Health. See also: Panel members said if the FDA approves the vaccine it should require the company to continue clinical trials and other measures, Reuters reported. The US Centers for Disease Control and Prevention (CDC) and Acambis are discussing an arrangement for Acambis to provide long-term production of the vaccine using a US-based supply chain and production (ie, warm-base manufacturing), Acambis said in its press release. Having an FDA-licensed product is a prerequisite to finalizing a warm-base manufacturing contract with the CDC, Garland said. HHS countermeasures implementation planhttp://www.hhs.gov/aspr/ophemc/enterprise/strategy/strategy.html Panelists said they had to weigh the risks of heart inflammation, which would be unacceptable for routine vaccination, against the threat that US military personnel and others in high-risk settings face regarding smallpox exposure, Reuters reported. Ian Garland, Acambis’ chief executive officer, said in a company press release that the FDA panel’s recommendation reinforces the company’s confidence that ACAM2000 will be licensed. The FDA told Acambis its target date for an approval decision is Aug 31, 2007. The panel unanimously voted 11 to 0 that ACAM2000 is both safe and effective, Karen Reilly, an FDA spokesperson, told CIDRAP News in an e-mail after the meeting. The FDA is not bound by the advisory panel recommendations but usually follows them. The positive recommendation came despite some concerns panel members raised about the side effects of the vaccine. Some outside experts who spoke at the meeting said the risk of heart inflammation in people who had been vaccinated warranted further review, according to a Reuters report yesterday. May 17 Acambis news releasehttp://www.acambis.com/default.asp?id=1893 ACAM2000 uses vaccinia virus, a close relative of smallpox, and is grown in cell culture. It is derived from Dryvax, a first-generation vaccine that was used in global smallpox eradication programs. The newer vaccine is grown in cell culture rather than on the skin of calves, which is thought to produce a purer and safer vaccine that has less risk of rare but serious complications.
Published on June 13, 2015 at 5:33 pm Contact Paul: [email protected] | @pschweds Facebook Twitter Google+ Related Stories Syracuse football recruiting: safety Will Harper commits to Class of 2016Syracuse football recruiting: 3-star quarterback Rex Culpepper chooses Syracuse over national powerhouses Plant (Florida) High School safety Scoop Bradshaw verbally committed to Syracuse on Saturday afternoon, per Syracuse.com. He is the sixth member of the Orange’s Class of 2016.Bradshaw’s commitment is SU’s third in the past five days, following Plant teammate and quarterback Rex Culpepper on Tuesday and Georgia safety Will Harper on Friday.Bradshaw and Harper are the only defensive players in the class thus far. Bradshaw, who is listed at 5 feet, 11 inches and 170 pounds, chose Syracuse over offers from Indiana, Iowa State and Utah, according to Scout.com.The Orange’s roster currently has five safeties — redshirt freshman Rodney Williams, sophomore Chauncey Scissum, sophomore Antwan Cordy, junior Eric Anthony and junior Joe Stanard. Comments AdvertisementThis is placeholder text
Newsroom GuidelinesNews TipsContact UsReport an Error HOUSTON >> Kiké Hernandez got the start in center field over Joc Pederson against a left-handed starting pitcher, Scott Kazmir. That’s more a trend than a fluke.Pederson has struggled to hit for average against all pitchers this season (.215). Against left-handers, the struggles have extended to his on-base percentage (.305) and power (.349 slugging average). Mattingly all but conceded that Hernandez will start against left-handers for now. “I think you have to look at (Hernandez), the way he’s swinging, and the decisions we’ll make will be based on trying to put the best lineup out there,” Mattingly said. “This is the time of year with everyone you’re going to try to put the best club on the field. You make a little different decisions now than you would in May or June, as far as trying to build your team over the course of the season, keeping everyone involved in the decisions you make.” Mattingly doesn’t believe that benching Pederson against lefties might hinder the 23-year-old rookie’s development. “If it is, then it’s not who you think he is,” Mattingly said. “It’s like anything else — you hate sending guys down. You know it breaks their spirit a little bit to go down, but everybody’s had to do it. If you can’t overcome that, you’re not going to be able to make the adjustments you need to be here anyway.”