Editor’s note: The title and first two paragraphs of this story were revised Dec 16 to correct a statement in the original that gave a more positive reflection of the trial results described below than may be warranted. The original version said that Sanofi Pasteur had described the trial results as “promising,” but the company actually said only that the results were “a sign of progress.”Dec 15, 2005 (CIDRAP News) – Sanofi Pasteur today announced preliminary trial results suggesting that using an additive to boost the immune response may help to stretch the supply of a vaccine for H5N1 avian influenza by a modest amount.Previous results had indicated that an H5N1 vaccine without an immune-boosting adjuvant would have to contain 12 times as much antigen (active ingredient) as seasonal flu vaccines do. In the results announced today, it took four times as much antigen as in a seasonal flu vaccine to induce an adequate immune response—an improvement, but far from what is needed to remedy the global shortage of vaccine production capacity.Sanofi tested an H5N1 vaccine it is making for the French government on 300 volunteers, using three different doses: 7.5, 15, and 30 micrograms. The volunteers were divided into six groups, and each group received two doses of vaccine with or without alum, an adjuvant used in many vaccines, according to Len Lavenda, US spokesman for Sanofi. The shots were given 3 weeks apart.”A 30-microgram dose with an adjuvant in a two-dose regimen demonstrated an immune response at levels consistent with requirements of regulatory agencies for licensure of seasonal influenza vaccine,” the company said in a news release.The two 30-microgram doses of vaccine containing alum induced an immune response in line with what the European Agency for Evaluation of Medicinal Products (EMEA) requires for flu vaccines, Lavenda told CIDRAP News.”We saw responses in all six groups, but the two-30-microgram-dose adjuvant group was the only one within the range of EMEA approval,” he said.”The 7.5- and 15-microgram studies provided results that were not as high as the 30, but we are continuing to study that data and we expect to publish the full set within a few months,” Lavenda said.Seasonal flu vaccines typically contain 15 micrograms of antigen, the active ingredient, for each viral strain covered. The amount that proved adequate in the Sanofi trial was 60 micrograms (two 30-microgram doses), four times as much.However, 60 micrograms is a much smaller amount than what was found to be adequate in a trial of an H5N1 vaccine that Sanofi is producing for the US government, according to results announced in August. In that trial, which didn’t involve an adjuvant, the regimen that looked most promising was two 90-microgram doses, a total of 180 micrograms.H5N1 vaccines are being developed in the hope that they will be protective if the H5N1 virus evolves into a pandemic strain. But even if the current experimental vaccines turn out be effective, the world’s current production capacity is far too small to provide enough vaccine for more than a small fraction of the population, according to disease experts. Researchers hope that dose-sparing tools such as adjuvants will help stretch the supply.Sanofi called the new trial results “a sign of progress” that will help guide further development of a pandemic flu vaccine. “Subsequent trials will explore different dosages, which may be helpful in answering questions about dose-sparing strategies,” the company said.The vaccine used in the latest trial is being developed to provide a stockpile for the French government, the company said. It comes from a different human isolate of H5N1 virus than the one used in the vaccine Sanofi is making for the United States, according to Lavenda.See also:Aug 8, 2005, CIDRAP News story “Hopeful news on human H5N1 vaccine, but production concerns considerable”
Vera Zhao, a sophomore majoring in communication and law, history and culture, attended the event for her “Law, Atrocity Crimes, and Transitional Justice” class and said she appreciated the discussion’s global perspective. Dicker, who served as an international attorney and worked with numerous governments, discussed the experiences he had while working with governments to increase legal accountability for war crimes. Richard Dicker, director of the International Justice Program at Human Rights Watch, spoke about the current state of the International Criminal Court Wednesday at a discussion hosted by the Gould School of Law and the International Law and Relations Organization. Though Dicker began his career in international law, he said he wasn’t expecting to experience many events that he later became involved in. Dicker responded that the court helps hold nations accountable for major crimes. He concluded the discussion with a call to action, encouraging students in the audience to work toward justice and hold leaders accountable. “I thought [the talk] was a really comprehensive and concise overview of international criminal justice and where we’re at today,” Garry said. “I think that Mr. Dicker really provided rich insight into the evolution of international criminal justice with his personal experience … behind the movement pushing for accountability, and has provided a somewhat hopeful perspective for the future.” “I feel for these communities most affected by [crimes against humanity] that have no other recourse of justice,” Dicker said. “Fair trials matter … I believe fervently in the importance of a fair trial and what it guarantees.” During the event, one student asked, “What impact has [the International Criminal Court] had on international relations overall?” “If you had told me, ‘Well, the president of Serbia will be tried by international courts [and] the president of Liberia will be tried by another international court,’ I would have asked you if a science fiction magazine had merged with a law book because it was totally, totally unforeseeable,” Dicker said. Garry said she appreciated Dicker’s message of optimism about the future of the international courts system. Nearly 50 students and faculty attended the event. The discussion, titled “The Future of International Criminal Justice: Challenges & Opportunities,” was moderated by Hannah Garry, a clinical professor of law and director at the International Human Rights Clinic at Gould. Human Rights Watch program director Richard Dicker said that international law will grow more complex in the future as it requires citizens to hold leaders accountable. (Photo by Krystal Gallegos) “There will be plenty of individuals like yourselves that are committed, involved and active in trying to apply legal norms in situations where crimes occur,” Dicker said. “It’s going to be tough; it’s not 1998 anymore. Yet, there’s a demand for accountability that neither President Putin, President Erdoan or President Trump will be able to upend.” The conversation revolved around the establishment of the International Criminal Court, a judicial body independent of the United Nations. Dicker said he believes that the United Nations has too much power, and thus the International Criminal Court is important for holding it accountable. Dicker said he wanted to go into international human rights law because he was inspired by a personal search for justice and altruism. “It’s important to encourage more international corporations and not just focus on certain countries,” Zhao said.