The Ebola virus disease outbreak, which began in Western Africa in 2013 was unpa

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.

QUESTION: Your company, EbVac, has developed a novel engineered humanized trispecific antibody targeting the Ebolic 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.

Explanation / Answer

Ans. 1 a The regulatory agencies which are widely responsible for the approval of the vaccine are the USFDA, European EMEA OR Health Canada. As these regulatory agencies have a strong hold over the world. As the outbreak of ebola resulted in an emergency like situation the regulatory body WORLD HEALTH ORGANISATION (WHO) also plays a pivotal role. As WHO controls the emergency like situation.

Ans. 1 b The WHO has laid down strict guidelines concerning the quality safety and efficacy for the vaccines developed for EBOLA. The regulatory requirements are laid down below:

1) Requirements concerning the development, manufacturing and control. Laying down manufacturing guidelines for developing a product. Controlling of the source materials. Sorting out the contamination during filling the containers. Controlling the products for the final lot. Ensuring proper labelling, storage and tranport. Carrying out the stability studies.

2) Performing Non clinical Evaluation such as pharmacodynamic studies, nonclinical safety studies, pharmacokinetic studies and environmental risk.

3) Developing the clinical data for the ebola vaccine which ensures the safety of the vaccine. Due emphasis on statistical evaluation and studying the post marketing survelliance after the release of the product in market.

Ans 2. The potential risk associated before going to an agency are answering the key ethical issues which may be needed prior approval. The data should be shared when the product would be developed and to the best possible extent the harmonisation of data should be done. The provision of harmonised data and sharing the information would result in the fast approval of the product. Post marketing survelliance should be done when the product would be in the market. Reporting of adverse events should be carried out simultaneously in order to avoid any product recall after finalisation.

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