癌症疫苗計劃暫停 在4名女孩死亡後
Cancer vaccine programme suspended after 4 girls dieVineeta Pandey / DNA
Thursday, April 8, 2010 0:39 IST
New Delhi: The Indian Council of Medical Research (ICMR) has told Andhra Pradesh and Gujarat to immediately suspend the cervical cancer control vaccination programme for girls. The programme is part of a two-year study to look into the utility of a vaccine in public health programmes and acceptability of Gardasil, the human papillomavirus (HPV) vaccine made by Merck. Gardasil, available in medical stores across the country, is marketed in India by MSD Pharmaceuticals Pvt Ltd.
新德里：印度醫學研究理事會（ICMR）已告訴安得拉邦和古吉拉特邦，立即暫停給女孩的子宮頸癌控制疫苗接種項目。該項目是一個為期兩年的研究的一部分，探討在公共保健方案和接受Gardasil的疫苗效用，人類乳頭狀病毒（HPV）疫苗由Gardasil的默克公司製造 ，提供於全國各地的醫療物品士多，並由印度的默沙東製藥有限公司銷售。
The programme was marred by controversy after four deaths and complications among 120 girls were reported after vaccination. The girls complained of stomach disorders, epilepsy, headaches and early menarche. Women activists fear the vaccine may impact the mental health of girls who have shown no signs of distress so far.
計劃被爭議破壞，4人在接種疫苗後死亡和在120名女生中有併發症。女孩們投訴有關胃疾病、癲癇、頭痛和月經初潮早。婦女活躍份子害怕，疫苗可能會影響女孩的心理健康，他們至今沒有表現出憂傷的跡象。
Health ministry sources said the vaccination programme is being conducted by Gardasil, jointly with PATH, a Seattle-based NGO, ICMR and the two state governments. About 32,000 girls, aged 10-14, were to be tested in the study.
ICMR chief Dr VM Katoch clarified ICMR was only a technical partner, with an advisory role, in the project. But Katoch said they were checking out who was at fault.
Questioning the study, CPM leader Brinda Karat said: “How has the government embarked on the study of giving three injections to the girls when it is also planning a massive multi-centric dose determination study to see if two doses will suffice?”
For a drug to be administered to children, Karat said, it has to go through stages of clinical trial, including phase 3 adult clinical trials. With Gardasil, only one trial has been carried out with a small sample of 110 girls, which has followed up with them for a month after completion of vaccination and that too only to look at the immune response post-vaccination, Karat said. The vaccine has also been approved for adult women aged 27, Karat said, without any trials on them.
Karat also alleged scientific logic and ethical guidelines have been violated at each step during drug and vaccine trials.
http://www.dnaindia.com/india/report_cancer-vaccine-programme-suspended-after-4-girls-die_1368681
子宮頸癌疫苗受害者就流產、致命反應針對默克公司採取訴訟行動
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