The Ebola virus disease outbreak, which began in Western Africa in 2013 was unpa
ID: 214659 • Letter: T
Question
The Ebola virus disease outbreak, which began in Western Africa in 2013 was unparalleled in scope and spread, and the global response was far slower and less coherent than was optimal given the scale and pace of the epidemic. Past experience with limited localized outbreaks, lack of licensed medical countermeasures, reluctance by first responders to direct scarce resources to clinical research, community resistance to outside interventions, and lack of local infrastructure were among the factors delaying clinical research during the outbreak. Despite these hurdles, the global health community succeeded in accelerating Ebola virus vaccine development, in a 5-month interval initiating phase I trials in humans in September 2014 and initiating phase II/III trails in February 2015. Each of the three Ebola virus disease-affected countries conducted phase II/III Ebola virus vaccine trials. Only one of these trials evaluating recombinant vesicular stomatitis virus expressing Ebola virus glycoprotein demonstrated vaccine efficacy using an innovative mobile ring vaccination trial design based on a ring vaccination strategy responsible for eradicating smallpox that reached areas of new outbreaks. Thoughtful and intensive community engagement in each country enabled the critical community partnership and acceptance of the phase II/III in each country. Due to the delayed clinical trial initiation, relative to the epidemiologic peak of the outbreak in the three countries, vaccine interventions may or may not have played a major role in bringing the epidemic under control. Having demonstrated that clinical trials can be performed during a large outbreak, the global research community can now build on the experience to implement trials more rapidly and efficiently in future outbreaks. Incorporating clinical research needs into planning for future health emergencies and understanding what kind of trial designs is needed for reliable results in an epidemic of limited duration should improve global response to future infectious disease outbreaks.
Your company, EbVac, has developed a novel engineered humanized trispecific antibody targeting the Ebolia virus and you need conduct a phase II/III trial. You are leading the regulatory strategy team and have been asked to describe the path to approval.
Please discuss the following:
(1) Which agency or agencies will be responsible for approving/reviewing your EbVac Trispecific: (a) before commercial introduction, and (b) after approval for commercialization/sale. Specifically cite any relevant Federal Statutes and standards that must be met (HINT: I would consult and cite the Coordinated Framework to start!), and
(2) Provide an analysis of the potential risks you see with going before a particular agency (agency expertise, complexity of rules, history etc.) under the particular regulations identified.
Two typed pages, 12pt font, and proper citations.
Explanation / Answer
1. a. Arcian Vaccine Regulatory Forum (AVAREF) is responsible for the approval of the EbVac trispecific antibody for Ebola virus before commecrial introduction.
It will see the potential vaccines , clinical trial design for vaccines and the ways of their expedited approval, regulatory pathways fpor the approval of vaccines and the use of blood therapies.
The approval committee will bring together public health officials, regulatory and industrial experts in an attempt to facilitate and expedite the development, regualtory review and use of new vaccine against EVD- Ebola Virus Disease.
The approval depends on mecahnism and clear pathway for expedited regulatory review of clinical trials and approval of products that are being developed tpo address EVD emergency, agrement on timelines and joint review by regulators and ethics committees of clinical trial application by AVAREF countries. WHO assistance to facilitate these processes and endorsement of a panel of safety experts to review safety data of new vaccine and relevent contries with National Regulatory Authorities.
It is a multi-step process
i. An investigational New Drug application.
ii. Pre-license vaccine clinical trials
iii. A bilogics licence application
iv. Inspection of the manufacturing facility
v. Presentation of findings
vi. Usability testing of product lebeling.
1. b. After commercialization of the vaccine, WHO aids countries to strengthen regulation, including post-marketing survellience and to eliminate substandard and falsified vaccines. It also develops international norms and standards , so that countries world wide can regulate health products and technologies consistently.
WHO facilitates access to quality assured, safe and effective health products by assessing vaccines for priority diseases.
2. The potential risks may be
i. At pre-clinical stage: Pre-clinical studies use tissue culture or cell culture system and animal testing to assess the safety of the vaccine and its immunogenecity.
Many baccines never progress beyond this stage because they fail to produce desired response anf it lasts 1-2 years.
ii. The vaccine production has to go through investigational New Drug application process.
iii. The vaccine is subjected to three phases of testing.
Phase I testing includes a small group of adults of 20-80 years age are involved to assess the vaccine.
Phase II testing includes a large group of hundreds to study the safety, immunogenecity , proposed doses , schedule of immunization and method of delivery.
Phase III testing is subjected to thousands of individuals to see the safety and side -effects.
iv. Post licence monitoring of vaccine : to monitor the vaccine after thay have been approved.
v. Phase iv trials are optional studies that drug company may conduct after a vaccine is released.
vi. Vaccine Adverse Event reporting of system is to detect any adverse events after the administration of the vaccine in long run.
Related Questions
drjack9650@gmail.com
Navigate
Integrity-first tutoring: explanations and feedback only — we do not complete graded work. Learn more.