构建目标产品概况（TPP）以帮助疫苗克服批准后障碍。
Constructing target product profiles (TPPs) to help vaccines overcome post-approval obstacles.
机构信息
School of Medicine, University of Pittsburgh, Pittsburgh, PA 15213, USA.
出版信息
Vaccine. 2010 Apr 1;28(16):2806-9. doi: 10.1016/j.vaccine.2009.09.047. Epub 2009 Sep 25.
Abstract
As history has demonstrated, post-approval obstacles can impede a vaccine's use and potentially lead to its withdrawal. Addressing these potential obstacles when changes in a vaccine's technology can still be easily made may improve a vaccine's chances of success. Augmented vaccine target product profiles (TPPs) can help vaccine scientists better understand and anticipate these obstacles and galvanize conversations among various vaccine stakeholders (e.g., scientists, marketers, business development managers, policy makers, public health officials, health care workers, third party payors, etc.) earlier in a vaccine's development.
摘要
正如历史所证明的那样，批准后障碍可能会阻碍疫苗的使用，并可能导致其被撤回。在疫苗技术发生变化时解决这些潜在障碍，可能会提高疫苗成功的机会。增强的疫苗目标产品概况（TPP）可以帮助疫苗科学家更好地理解和预测这些障碍，并在疫苗开发的早期就激发各种疫苗利益相关者（例如科学家、营销人员、业务发展经理、政策制定者、公共卫生官员、卫生保健工作者、第三方支付者等）之间的对话。
相似文献
1
Constructing target product profiles (TPPs) to help vaccines overcome post-approval obstacles.
Vaccine. 2010 Apr 1;28(16):2806-9. doi: 10.1016/j.vaccine.2009.09.047. Epub 2009 Sep 25.
2
Post-marketing safety monitoring of a new group B meningococcal vaccine in New Zealand, 2004-2006.
Hum Vaccin. 2007 Sep-Oct;3(5):196-204. doi: 10.4161/hv.3.5.4458. Epub 2007 May 18.
3
Assessment of Communication Strategies for Mitigating COVID-19 Vaccine-Specific Hesitancy in Canada.
JAMA Netw Open. 2021 Sep 1;4(9):e2126635. doi: 10.1001/jamanetworkopen.2021.26635.
4
How vaccine safety is monitored before and after licensure.
Pediatr Ann. 2001 Jul;30(7):392-9. doi: 10.3928/0090-4481-20010701-06.
5
Vaccine Safety.
Prim Care. 2020 Sep;47(3):431-441. doi: 10.1016/j.pop.2020.04.001. Epub 2020 Apr 22.
6
Pricing of new vaccines.
Hum Vaccin. 2010 Aug;6(8):619-26. doi: 10.4161/hv.6.8.11563.
7
Postmarketing Safety of Vaccines Approved by the U.S. Food and Drug Administration : A Cohort Study.
Ann Intern Med. 2020 Sep 15;173(6):445-449. doi: 10.7326/M20-2726. Epub 2020 Jul 28.
8
Synopsis of a workshop on post-marketing surveillance of vaccine-associated adverse events.
Can Dis Wkly Rep. 1991 May 11;17(19):97-8.
9
An introduction to analytical methods for the postmarketing surveillance of veterinary vaccines.
Adv Vet Med. 1999;41:749-74. doi: 10.1016/s0065-3519(99)80057-3.
10
Vaccine safety.
N Z Med J. 2020 Feb 21;133(1510):83-87.
引用本文的文献
1
Pre-clinical studies of Schistosoma mansoni vaccines: A scoping review.
PLoS Negl Trop Dis. 2025 Jun 2;19(6):e0012956. doi: 10.1371/journal.pntd.0012956. eCollection 2025 Jun.
2
Vaccine value profile for schistosomiasis.
Vaccine. 2024 Jul 23:126020. doi: 10.1016/j.vaccine.2024.05.068.
3
The potential epidemiologic, clinical, and economic value of a universal coronavirus vaccine: a modelling study.
EClinicalMedicine. 2024 Jan 11;68:102369. doi: 10.1016/j.eclinm.2023.102369. eCollection 2024 Feb.
4
Neglected tropical disease vaccines: hookworm, leishmaniasis, and schistosomiasis.
Vaccine. 2023 Nov 3;41 Suppl 2(Suppl 2):S176-S179. doi: 10.1016/j.vaccine.2023.04.025. Epub 2023 Oct 6.
5
Novel Influenza Vaccines: From Research and Development (R&D) Challenges to Regulatory Responses.
Vaccines (Basel). 2023 Oct 9;11(10):1573. doi: 10.3390/vaccines11101573.
6
Should countries switch to using five- or ten-dose rotavirus vaccines now that they are available?
Vaccine. 2021 Jul 13;39(31):4335-4342. doi: 10.1016/j.vaccine.2021.06.021. Epub 2021 Jun 19.
7
Potential Clinical and Economic Value of Norovirus Vaccination in the Community Setting.
Am J Prev Med. 2021 Mar;60(3):360-368. doi: 10.1016/j.amepre.2020.10.022. Epub 2021 Jan 27.
8
Future perspectives on swine viral vaccines: where are we headed?
Porcine Health Manag. 2021 Jan 4;7(1):1. doi: 10.1186/s40813-020-00179-7.
9
Vaccine Efficacy Needed for a COVID-19 Coronavirus Vaccine to Prevent or Stop an Epidemic as the Sole Intervention.
Am J Prev Med. 2020 Oct;59(4):493-503. doi: 10.1016/j.amepre.2020.06.011. Epub 2020 Jul 15.
10
The potential economic value of a therapeutic Chagas disease vaccine for pregnant women to prevent congenital transmission.
Vaccine. 2020 Apr 3;38(16):3261-3270. doi: 10.1016/j.vaccine.2020.02.078. Epub 2020 Mar 12.
本文引用的文献
1
Currents in contemporary ethics: HPV vaccines, privacy, and public health.
J Law Med Ethics. 2009 Spring;37(1):134-8. doi: 10.1111/j.1748-720X.2009.00357.x.
2
Lack of association between measles virus vaccine and autism with enteropathy: a case-control study.
PLoS One. 2008 Sep 4;3(9):e3140. doi: 10.1371/journal.pone.0003140.
3
Assessing mandatory HPV vaccination: who should call the shots?
J Law Med Ethics. 2008 Summer;36(2):384-95, 214. doi: 10.1111/j.1748-720X.2008.00282.x.
4
Mandating a human papillomavirus vaccine: an investigation into whether such legislation is constitutional and prudent.
Am J Law Med. 2008;34(1):65-84. doi: 10.1177/009885880803400103.
5
Latin America. Price is the main barrier to wider use of papillomavirus vaccine.
Science. 2008 May 16;320(5878):860. doi: 10.1126/science.320.5878.860.
6
Wakefield admits fabricating events when he took children's blood samples.
BMJ. 2008 Apr 19;336(7649):850. doi: 10.1136/bmj.39553.506597.DB. Epub 2008 Apr 17.
7
Rotavirus vaccine introduction in the Americas: progress and lessons learned.
Expert Rev Vaccines. 2008 Apr;7(3):345-53. doi: 10.1586/14760584.7.3.345.
8
Wakefield tells GMC he was motivated by concern for autistic children.
BMJ. 2008 Apr 5;336(7647):738. doi: 10.1136/bmj.39539.438056.DB.
9
The HPV vaccine mandate controversy.
J Pediatr Adolesc Gynecol. 2007 Dec;20(6):325-31. doi: 10.1016/j.jpag.2007.03.101.
10
Andrew Wakefield is accused of paying children for blood samples.
BMJ. 2007 Jul 21;335(7611):118-9. doi: 10.1136/bmj.39280.513310.4E.
Zotero 插件