Danish firm expects to sell smallpox vaccine to US

first_imgApr 18, 2007 (CIDRAP News) – Bavarian Nordic, a Danish company, announced this week that the US government plans to buy 20 million doses of the company’s Imvamune smallpox vaccine, but a US official said no decision has been made yet.Imvamune is Bavarian’s version of modified vaccinia Ankara (MVA), which is considered safer than the conventional smallpox vaccine, particularly for people with weakened immune systems, pregnant women, and children.”Following a competitive RFP process, Bavarian Nordic has received notification from the US Department of Health and Human Services that it intends to procure 20 million doses of the company’s third-generation IMVAMUNE smallpox vaccine for the strategic national stockpile,” the company said in an Apr 16 statement.But Holly Babin, an HHS spokeswoman in Washington, DC, said no decision has been made on the vaccine. “We can’t comment on it now,” she told CIDRAP News, but added that an announcement is expected within the next few weeks.Bavarian Nordic and the British drug company Acambis each received an HHS contract in early 2003 to develop and test a vaccine based on MVA. In September 2004 HHS awarded each company a further contract calling for production of 500,000 doses of the vaccine and clinical trials. But Acambis announced in November 2006 that HHS had notified it that the company’s vaccine was too expensive.Bavarian said the expected HHS contract would require the company to win US Food and Drug Administration approval for use of the vaccine in healthy people and those with limited immunity.Peter Wulff, Bavarian’s chief executive officer, said the company plans to begin phase 3 clinical trials early in 2008 and expects to win a US license for the vaccine in 2010, according to an Apr 16 Bloomberg News story.”While the principal terms of the agreement [with HHS] have been reached, the contract is currently being finalized,” the company statement said. “It is expected to be the first procurement contract under the BioShield program since enactment of the Pandemic and All-Hazards Preparedness Act in December 2006.”Bavarian said it has built a facility that can produce at least 40 million doses of Imvamune annually.The BioShield program was established in 2004 to promote the development of medical treatments for the effects of chemical, biological, and other unconventional weapons. But major drug companies showed little interest in the program. In passing the All-Hazards Preparedness Act in December, Congress tried to revitalize the program by authorizing partial payments to companies working under BioShield contracts before final delivery of their products.Existing smallpox vaccines are made with live vaccinia virus—a cousin of the smallpox virus—which in rare cases can cause serious or life-threatening side effects such as a severe rash or encephalitis. MVA is a strain of vaccinia that cannot replicate inside human cells and therefore cannot cause a severe or spreading infection, HHS has said.An MVA-based vaccine was found to be safe when it was given to 120,000 Germans in the 1970s, according to HHS. But research on MVA ended when smallpox was declared eradicated in 1980.Although smallpox was eradicated, disease experts fear that terrorists may have supplies of the virus, which the Soviet Union made in large quantities during the Cold War. Since 2001, HHS has stockpiled enough doses of the conventional smallpox vaccine to immunize the entire US population. The United States and Russia still hold samples of the smallpox virus for research purposes.See also:Oct 4, 2004, CIDRAP News story “Further contracts awarded for weakened smallpox vaccine”Feb 25, 2003, CIDRAP News story “HHS awards contracts to develop safer smallpox vaccine”Dec 15, 2006, CIDRAP News story “Congress passes public health preparedness bill”last_img read more

Inside Conditions…Nature Boy

first_imgChicago Cubs shortstop Starlin Castro tags out Pittsburgh Pirates Andrew McCutchen during the second inning of a baseball game on Tuesday, April 8, 2014, in Chicago. (AP Photo/Andrew A. Nelles/File)“There was a boy, a very strange enchanted boy. They say he wandered very far, very far, over land and sea. A little shy and sad of eye, but very wise was he. And then one day, a magic day he passed my way.  And while we spoke Of many things, fools and kings, this he said to me.”The greatest thing you’ll ever learn is just to love and be loved in return.” “The greatest thing you’ll ever learn is just to love and be loved in return.” (Recorded by the great Nat King Cole, written by Eden Ahbez)I have observed Pirates centerfielder Andrew McCutchen from his time working his way up to play in the big leagues to the present.Aubrey BruceThe first time we met was at a Pirates media function at the Lexus Club, (It was named something else back then) at the moment I am having a senior memory episode.  Anyway, he politely introduced himself to me and to be quite honest, I had a terrible migraine headache that day, and if all I had to do to get into heaven was to remember that conversation in its entirety; let’s just say that I’d better be stocking up on bottled water.He was joined at the table by ex-Pirates pitcher Ian Snell who I remember being very excited about an upcoming MMA event that was scheduled to air that night.  However, the thing that I remember the most about the encounter was that these were just young men, interested in other things happening in their lives and not just throwing and catching a ball. McCutchen was at ease, peaceful and very down to earth.Please push the fast forward button for me.The other night during when McCutchen suffered a “minor” ankle injury during a Pirates’ loss to the Milwaukee Brewers, I heard one of the post game radio so called “pundits” speculating and discussing the injury saying in a very sly, slick  and “wicked, wicked, yeah” way that; “the injury didn’t appear to be serious.”O’kay Dr.Vinnie Boom-Boom.  I have observed the shingle outside of your office door and the walls within, and I swear, I really do swear that for the life of me, I cannot find a medical degree hanging anywhere in your vicinity.The next game when McCutchen hit a double and “glided” into second base the “nurse practitioner” disguised as a journalist gloated, “I had a feeling that the injury was not that serious.”See boys and girls that bugs me, that really really bugs me.Tell you why; A few years ago, I experienced severe muscle cramps as a result of my long battle with spinal scoliosis.  Into my ER cubicle marched a “teaching phlebotomist” with 3 or 4 “ducklings in tow” hanging on every word that the “expert” had to say.  He attempted several times to extract blood but was unsuccessful.“Have you ever used drugs?”  He asked in a very arrogant and irritated way expressing anger at me because of his shortcomings. “I fired back, “read the chart, furthermore you are not a doctor and I am not about to publicly share my medical history with you and a bunch of students; schools out.”He turned as red as a beet, turned to his students and said to them as if I wasn’t there; “sometimes patients can be uncooperative but you can’t lose your cool.” Seems to me that he had already lost his cool and I was about to lose mine.See, I wasn’t that sick. If he had said one more word; I would have leaped out of that bed and lit his behind up, “junior doctor” or not.My anger was not just at him. I was reflecting on a book that I had read that was written by Dr. Harriet Washington titled; “Medical Apartheid.”  The book profiled some of the most insidious and inhumane human experimentation ever chronicled after the medieval period.  In the book Dr. Washington writes that; “Researchers who exploit African-Americans were the norm for much of our nation’s history, when Black patients were commonly regarded as fit subjects for nonconsensual, non therapeutic research.”The book also points out that slaves were also “rented out” for experimentation during the winter months when there were seeds to be planted or crops to be harvested.Even today Blacks mythically have a higher pain tolerance, thus powerful Schedule II medications are often grudgingly and sparingly prescribed for African Americans.  Even the injuries of the great Roberto Clemente were often questioned when his performance was subpar as a result of an injury.Will the “Pirates nation” really love young their young MLB superstar Andrew McCutchen through thick and thin, healthy or injured? Only time will tell.Aubrey Bruce can be reached at: abruce@newpittsburghcourier.com or 412.583.6741last_img read more