Drug Regulators, EMA (EMEA), Publish a Standard Paediatric Investigation Plan for Non-adjuvanted or adjuvanted pandemic influenza vaccines during a pandemic.
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Novel strains of influenza virus, which are highly contagious and harmful to humans, can emerge suddenly. Their potential to cause a pandemic is monitored by the World Health Organization, and the phases of the pandemic are declared following well established rules, in a stepwise approach:
Phase 4 is characterised by verified human-to-human transmission of an animal or human-animal influenza reassortant virus able to cause “community-level outbreaks.” The ability to cause sustained disease outbreaks in a community marks a significant upwards shift in the risk for a pandemic. Any country that suspects or has verified such an event should urgently consult with WHO so that the situation can be jointly assessed and a decision made by the affected country if implementation of a rapid pandemic containment operation is warranted. Phase 4 indicates a significant increase in risk of a pandemic but does not necessarily mean that a pandemic is a forgone conclusion.
Phase 5 is characterised by human-to-human spread of the virus into at least two countries in one WHO region. While most countries will not be affected at this stage, the declaration of Phase 5 is a strong signal that a pandemic is imminent and that the time to finalise the organisation, communication, and implementation of the planned mitigation measures is short.
Phase 6, the pandemic phase, is characterised by community level outbreaks in at least one other country in a different WHO region in addition to the criteria defined in Phase 5. Designation of this phase will indicate that a global pandemic is under way. According to the degree of pathogenicity and the transmission speed in an outbreak, Regulatory Authorities will adapt their level of requirements before giving access to vaccines to different target groups of different ages within the general population.
The EU Regulation foresees that any marketing authorisation (MA) application for a new medicinal product should include either the results of studies conducted in compliance with an agreed paediatric investigation plan (PIP), or an Agency decision on a waiver or on a deferred PIP. This also applies to authorised medicinal products which are protected by a Supplementary Protection Certificate (or a patent that qualifies for it), when a new indication is requested. While the PIP should not delay the granting of the MA for any age group, it still needs to be agreed with the PDCO before validation of the MAA.
In order to facilitate such a procedure, this document defines a standard set of data that applicants should include in their application for a PIP for a pandemic influenza vaccine, when submitted during an emergency situation (WHO phase 5 or 6). Manufacturers and Marketing Authorisation Holders are encouraged to anticipate and submit a request for a PIP and a Waiver, or a request of modification of an existing agreed PIP, as early as possible.
The standard PIP is not a guideline, nor a complete protocol; it contains only the so-called “key binding elements”, which are the measures and timelines on which compliance check will be performed prior to validation of the MAA or the variation application. Consequently, elements that are not cited in the study tables (e.g., the exclusion criteria), may remain at the discretion of the applicant.
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