Regulatory agencies are often seen by industry as gatekeepers, preventing products from reaching market until after they pass rigorous trials. But in the UK, the Medicines and Healthcare Products Regulatory Agency (MHRA) is trying to position itself as something else, in part: a facilitator.
An example is a new case study issued by MHRA in which the agency describes how it was able to help bring a novel vaccine delivery mechanism developed by the University of Oxford closer to market.
A new Vector
Part of what makes these vaccines innovative is the approach used to deliver genetic material to the patient. The vaccines use a viral vector—an altered form of another virus that is unable to replicate. Scientists use viral vectors to deliver genetic information from the disease they wish to treat to the patient, which elicits an immune response.
Vaccines using viral vectors derived from human viruses are made less effective due to the potential for patients to already have been exposed to the virus used for the vector. Thus, the researchers hypothesized that a viral vector derived from a chimpanzee virus would make a more effective vaccine, as patients would not have prior exposure to the viral vector. This, the researchers hoped, would cause patients “to develop an immune response from scratch.”
Collaborating With MHRA
One of the development challenges the researchers faced was determining how regulatory authorities would treat a product derived from a chimpanzee virus. The researchers also needed to determine how to design appropriate tests to demonstrate the safety of such vaccines in humans.
To answer these questions, MHRA recalls, the researchers began dialogue with MHRA early on “to receive feedback, guidance and support” in designing their studies. Eleanor Berrie, qualified person at the Clinical BioManufacturing Facility at Oxford, was quoted saying MHRA was “quick to recognize [the researchers’] innovative approach” and helped advance a major breakthrough in vaccine development.
In part, they said MHRA assisted them by:
- “Connecting the researchers to the relevant MHRA teams at the right time, depending on their queries, including:
- clinical trials teams
- good manufacturing practice inspectorate
- pharmaceutical assessors
- initiating discussions and meetings with academic groups and their representatives
- reviewing information packages and risk assessments
- providing invaluable feedback that helped the researchers progress their project.”
MHRA says the outcome of this research has the potential to hugely impact public health worldwide, and said the agency is keen to provide its expertise “at every step of the clinical product development lifecycle.”
Early Clinical Trials
In December, the researchers published the results of an early phase study of a malaria vaccine developed using the new viral vector. The Phase 1a study found the vaccine candidate to be “safe and highly immunogenic,” warranting further research toward its efficacy.
The study was registered with the European Medicines Agency (EMA), MHRA and the Irish Medicines Board, and was reviewed by the relevant national ethics committees in the UK and Ireland.
The university is currently working to develop other vaccines based on the new viral vector, and has plans for early phase studies for vaccines using this new approach to treat HIV, tuberculosis and Ebola.
MHRA Press Release