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.
Saddam was executed Dec. 30 for his role in the killings. Two of his co-defendants in the Dujail case – Ibrahim, Saddam’s former intelligence chief, and Awad Hamed al-Bandar, former head of Iraq’s Revolutionary Court – were executed in January. Around Iraq, meanwhile, bombs tore through a Shiite mosque during prayers in Baghdad and struck several targets in the oil-rich city of Kirkuk on Monday, killing at least 26 people. In Kirkuk, 180 miles north of Baghdad, at least 18 people were killed and more than 50 wounded in a series of bombings, the most devastating when two parked car bombs exploded within 10 minutes in a southern part of the city. The latest attacks highlighted the challenges facing U.S. and Iraqi forces in their bid to curb sectarian bloodshed with the month-old security crackdown. Execution-style killings usually blamed on Shiite militias have fallen dramatically but bombings have not matched the downward trend. Late Monday, U.S. and Iraqi troops engaged in a major operation as part of the crackdown in the volatile Hurriyah neighborhood in northern Baghdad, state television said. BAGHDAD – A former deputy in Saddam Hussein’s government was hanged before dawn today for the killings of 148 Shiites, an official with the prime minister’s office said. Taha Yassin Ramadan, who was Saddam’s vice president when the regime was ousted four years ago, was the fourth man to be executed in the killings of 148 Shiites following a 1982 assassination attempt against the former leader in the city of Dujail. The official, who witnessed the hanging but spoke on condition of anonymity because an official announcement had not been made, said precautions had been taken to prevent a repeat of what happened to Saddam’s half brother Barzan Ibrahim, who was decapitated on the gallows. Ramadan was weighed before the hanging and the length of the rope was chosen accordingly, the official said. Ramadan was convicted in November of murder, forced deportation and torture and sentenced to life in prison. A month later, an appeals court said the sentence was too lenient and returned his case to the High Tribunal, demanding that he be sentenced to death. The court turned it into a death sentence. 160Want local news?Sign up for the Localist and stay informed Something went wrong. Please try again.subscribeCongratulations! You’re all set!