Regulatory Aspects of Biotech Vaccines

An overview of the regulation of vaccines produced by biotechnology by Dr Jean de Foucauld of Ceva Hungary, speaking at the Vector Vaccines Symposium organised by Ceva Santé Animale in San Diego in October.
calendar icon 15 November 2010
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Vector vaccines are becoming in the recent years, an essential tool to prevent diseases. As it will be shown this week, they can bring unique features, not found in conventional vaccines.

Dr Jean de Foucauld

Regulatory authorities around the world are particularly interested to understand well this aspect: the 'Why did we do it?' first, before the 'How did we do it?' is discussed. This will be always the first task of any company to explain clearly to the regulatory authorities these unique features that should of course be demonstrated in the submitted registration dossier.

Although our world is very much attracted by the novelty for itself, the use of the new vaccine technology for its own sake would not be appealing to regulatory authorities – and most probably to our customers.

Novelty of vector vaccines must first reside in their 'quality', 'safety' and 'efficacy' features or claims. This is how authorities will first start looking at the vaccine and its registration dossier.

The specific advantages brought by vector vaccines can be for some authorities around the world a strong driver for the establishment of relevant new legislation and regulatory processes to handle vector vaccines.

Besides judging the interest of candidate vector vaccines, their registration process follows the principles that are used for any other live conventional vaccine: it is first a scientific approach.

The basic information on quality (vaccine production and control processes), safety and efficacy must be provided. Naturally, additional details are requested, covering the vector and its parent strain, the gene(s) and their insertion into the vector and finally the behaviour of the vaccine in different in vitro and in vivo models.

One of the key aspects of vector vaccine scientific evaluation is that the different tests must converge to the same conclusions and should also be in line with parallel available information (on vector structure and replication mechanisms, on experimental data from same vector family etc.). Each test has a given value but the global picture is what counts.

Although different in some technical and non-scientific (administrative) aspects, the way pioneer authorities handle registration of vector vaccines is similar. This helps obviously to have harmonised action on development and registration processes.

Some authorities that have handled vector vaccines recently have set up specific procedures ensuring that adequate experts review the dossier.

Also, recognition of well established European or US regulatory systems by authorities around the world helps in the registration process. In all cases, close relation between the applicant and the authorities is essential to a smooth and successful process.

The local focus, in parallel with the global approach, is essential. A live vaccine, vector or conventional is always considered very specifically by authorities, for their own market, e.g. epidemiology. The benefit/risk assessment and conclusion might differ because of a specific situation and this has to be discussed with authorities and expert of each target country.

In conclusion, regulatory handling of vector vaccines requires first to present clear evidence of the specific interests brought by the vaccine over conventional vaccine for the same disease. It should also give the relevant information allowing seeing the global picture on the vaccine's quality, safety and efficacy aspects. Finally, the local specifics must always been taken into account.

Further Reading

- You can view other papers presented at the Vector Vaccines Symposium by clicking here.

November 2010
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