Feb 27, 2007 (CIDRAP News) – A US Food and Drug Administration (FDA) panel today recommended that the agency approve the nation’s first H5N1 influenza vaccine, despite new evidence that the vaccine is less protective than reported in a clinical trial last year.The panel of health advisors, convened to weigh the risks and benefits of the “prepandemic” vaccine made by Sanofi Pasteur, voted today to call the vaccine safe and effective, according to an Associated Press (AP) report. The FDA is not bound by the advisory panel recommendations but usually follows them.The vaccine is based on an H5N1 virus isolated from a Vietnamese patient in 2004. Two companies, Sanofi and Chiron Corp., have been producing clade 1 H5N1 vaccines for the national stockpile under US Department of Health and Human Services (HHS) contracts worth more than $200 million.At least 3 million courses of the vaccine are already in the national stockpile. The government’s most recent pandemic planning update, released in November 2006, said up to 5 million more courses could be added in 2007 if vaccine seed stock supply and production yield are adequate. The stockpile goal is 20 million courses.Sanofi, in a report submitted to the FDA panel, revealed that two 90-microgram (mcg) doses, administered 28 days apart, generated a protective immune response in 45% of patients. That level is less than the 54% rate reported almost a year ago in the New England Journal of Medicine. The higher rate was based on interim findings, the AP reported yesterday. The researchers used a neutralizing antibody titer of 1:40, a fourfold or more increase in antibody titer, to define adequate immune response.The clinical trial, led by John J. Treanor, MD, was funded by the National Institute of Allergy and Infectious Diseases (NIAID) and conducted at NIAID centers at the University of Rochester in New York, the University of Maryland School of Medicine in Baltimore, and Harbor–University of California, Los Angeles, Medical Center in Los Angeles.During discussion yesterday, panel member Monica Farley, MD, an infectious disease specialist at Emory University School of Medicine in Atlanta, said she was struggling to balance the urgency for an H5N1 vaccine with “how low to set the bar on immunogenicity,” according to a Canadian Press report.The two-dose course used in the study is 12 times the standard (15-mcg) dose used in the seasonal flu vaccine and lags behind its 75% to 90% protection rate. However, the vaccine is still better than nothing in the event of a pandemic, Norman Baylor, director of the FDA’s vaccine office, told the panel, according the AP report yesterday.In its final analysis presented to the FDA panel, Sanofi echoed interim findings that there were almost no serious side effects, even at the highest dosages. The company said no clinically significant adverse reactions were identified after a two-dose, 7-month controlled follow-up study in adults aged 18 to 64.”The benefit of having a licensed vaccine against a potential pandemic influenza virus strain must be weighed against the risk of having no vaccine at the time of an inevitable pandemic,” Baylor said, as quoted by the AP today.Last November, the World Health Organization (WHO) cautioned governments against rushing to stockpile prepandemic flu vaccines, because too many scientific questions about them remained. The WHO said vaccines that seemed to work well against one H5N1 clade didn’t work well against others. Also, the agency said no one knew what level of measured immune response indicated an adequate level of protection.However, on Feb 16 the WHO issued a statement saying that a number of new vaccines against various strains of H5N1 look promising.When HHS issued its most recent pandemic preparedness update, it acknowledged that a prepandemic vaccine would provide only partial protection against new viral strains. “It is, for now, the best vaccine defense we have, and so we are stockpiling it,” the HHS said in the update.The HHS has said that it is moving forward with the development of a clade 2 H5N1 vaccine based on viruses that circulated in birds in China and Indonesia in 2003-04 and spread to the Middle East, Europe, and Africa in 2005 and 2006. Also, the HHS has supported the development of cell-based vaccine production methods that would streamline and modernize vaccine production and is exploring new adjuvants that would stretch the vaccine supply.See also:Sanofi’s FDA panel briefingMar 30, 2006 CIDRAP News article “H5N1 vaccine trial shows limited benefit”http://www.cidrap.umn.edu/cidrap/content/influenza/panflu/news/mar3006vaccine.htmlTreanor JJ, Campbell JD, Zangwill KM. Safety and immunogenicity of an inactivated subvirion influenza A (H5N1) vaccine. N Engl J Med 2006 Mar 30;354(13):1343-51 [Full text]November 2006 HHS pandemic planning updatehttp://www.flu.gov/professional/pdf/panflureport3.pdf
“For the time being, we have not focused on investigating the location of the source, where it came from, why it was there, who brought it. At the moment the joint team is still focusing on clearing the scene,” Qohhar told The Jakarta Post on Saturday.He added, however, that the team’s initial findings indicated that the radiation did not come from a nuclear reactor leak. The Puspiptek building, which is located about five kilometers away from the Batan Indah complex, houses several small reactors used for experimental purposes. “The source of radiation that we found [in the complex] is Caesium-137, which is frequently used for industrial purposes,” he said. “Caesium-137 is also one of the substances that will contaminate the environment when there is a reactor accident, such as at Chernobyl or Fukushima. But in addition to Caesium-137 there would also be other substances [in a reactor accident]. In this case, the only radiation source is Caesium-137, so the hypothesis that this incident is due to a reactor leak is baseless.”Qohhar added that when radiation exposure rate went above a certain threshold, the effects would be felt by humans, with symptoms such as changes in skin color, dizziness, nausea or even death.“The exposure rate in Batan Indah is far below this threshold,” he said.A resident of Batan Indah complex, who asked to remain anonymous, said that she received a letter from the neighborhood unit (RT) earlier this week informing her about the radiation. She felt everything was under control. “I think there is no need to panic. I believe that the authorities are doing their best to solve the problem. And if they thought it was dangerous, they would have warned us. But so far there is still no warning, so we’re safe,” she said.She said that she passed the volleyball field every day during her morning walk and that besides the yellow barrier tape around the vacant lot, everything looked normal.Heru said that Batan was currently in the process of cleaning up the exposed area and had collected 52 drums of soil and vegetation from the locations.“The results of the cleanup showed that the material causing the radiation had mixed with the soil. The findings are currently being analyzed in the Batan laboratory,” he said.He added that after the cleanup, the radiation levels fell by 30 percent, from 149 microSieverts per hour to 98.9 microSieverts per hour. The normal exposure rate from background radiation is around 0.03 microSieverts per hour.The clean-up process, Heru said, started on Feb. 12 and would continue until early March.He added that the team would soon conduct a radiation test known as “whole-body counting” on residents who lived in the exposed area to measure their bodies’ radioactivity levels.”We will keep doing the cleanup until the area is thoroughly clean and there is no longer any danger to the people and the environment,” Heru said.Topics : The Nuclear Energy Regulatory Agency (Bapeten) first detected the radiation during a routine check meant to ensure that the agency’s mobile radiation detection unit was working properly.“From Jan. 30 to 31, Bapeten conducted a function test with target areas of Pamulang, the Puspiptek [Center for Science and Technology Research] housing complex, the Muncul area, the ITI [Indonesia Institute of Technology] campus, the Batan Indah housing complex and the Serpong train station,” Bapeten spokesperson Indra Gunawan said in a statement on Friday. He said that all of the areas showed normal radiation levels except for a vacant lot next to the volleyball court at Block J of the Batan Indah complex.“A joint Bapeten and Batan team conducted a search to find the source of the high radiation on Feb. 7 to 8 and found several radioactive fragments,” he said, adding that after the fragments were removed, tests showed that the radiation levels in the area had decreased but were still above normal levels. “Based on those results, we concluded that the contamination had spread in the area and decontamination efforts had to be conducted by removing or dredging contaminated soil and removing contaminated trees and other vegetation.” Bapeten spokesperson Abdul Qohhar Teguh said that the agency was not yet able to confirm the source of the radioactive fragments found in the area. The National Nuclear Energy Agency (Batan) has asked residents of the Batan Indah housing complex in South Tangerang, Banten, to remain calm after finding high levels of radiation within the complex.Agency spokesperson Heru Umbara said locals should not panic because the case was being handled by the relevant authorities.”Residents can carry out activities as usual, as long as they do not enter the area that has been marked as contaminated. If managed properly, exposure to this radiation will not endanger the residents,” Heru said in a statement on Saturday.
MILWAUKEE >> A day that began with the Brewers hiring a new manager and Clayton Kershaw attempting to win the 100th game of his career ended with a stunning loss that Dodgers manager Don Mattingly was forced to watch from inside Miller Park.Milwaukee scored three runs in the eighth inning against Kershaw and reliever Chris Hatcher to erase a 3-1 deficit in a 4-3 victory Monday.The Dodgers saw their four-game winning streak come to an end.Joc Pederson led off the game with a home run, and the Dodgers added two runs in the fourth inning in support of Kershaw. But the Brewers got back-to-back triples in the sixth inning to end Kershaw’s shutout bid. In the eighth inning, Hector Gomez homered off Kershaw and Carlos Gomez added an RBI double off reliever Chris Hatcher (0-3) to tie the game.Gomez scored on an infield single by Ryan Braun for the game-winning run. The Dodgers challenged the play, but the initial call was upheld.Mattingly could do nothing; he was ejected for arguing a balk call against Kershaw early in the game.The Brewers made a winner of new manager Craig Counsell, who took over after Ron Roenicke was fired Sunday.Kershaw was charged with three runs in 7 1/3 innings. He allowed five hits, walked none and struck out eight. Newsroom GuidelinesNews TipsContact UsReport an Error