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.
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AddThis Sharing ButtonsShare to FacebookFacebookShare to TwitterTwitterShare to MoreAddThisPersevering Michigan farm land a magazine unveiling called: ‘Taste the Local Difference’ was recently presented to bring attention to residents of Northeast Michigan to buy local year round, to keep the economy where they live growing.“If every single Michigan household spent $10 on local food a week from a grower or producer in Michigan, that’s 1.6 billion dollars that would back into the Michigan economy a year,” Northeast Michigan Local Coordinator, Molly Stepanski said.Stepanski said thanks to farmers, and the support of the community her own farm along with others is growing.“We have more access to food in this region. I’m pretty passionate about this, and so the reason we were able to do as well as we’ve done is because farmers have helped us,” she added.When it comes to creating more access to local foods throughout the community, one example is the new salad bar Posen Schools now has. Stepanski said having local food throughout the community of Northeast Michigan has been amazing thanks to everyone pulling together to keep families having healthier menu options at their tables.“The community has been so supportive, they’re so behind what we’re doing. They’re incredibly supportive of fresh food and local food. It’s been a world wind of support and love from our community, it’s amazing,” she said.AddThis Sharing ButtonsShare to FacebookFacebookShare to TwitterTwitterShare to MoreAddThis Tags: Farming, Magazines, Taste the Local DifferenceContinue ReadingPrevious “Field Trip Friday”: Shipwreck ToursNext Alpena’s 911 Director Gurisko Resigns