Module 9 2021

23/03/2021

Features of a Fast-Track Development and Review

Fast-track vaccine development in a public health emergency (based on information from European Medicines Agency)

Reduce development timelines , e.g. - incr. resources to analyse results + execute regulatory strategy; - combining CT phases or conducting in parallel where safe Guidance on study designs to generate robust data (so embedded early and not compromised by fast-track) – done via ICMRA ICMRA = International Coalition of Medicines Regulatory Authorities Early scientific advice helps accelerate development

Expanded manufacturing capacity and large-scale production Facilitate vaccine deployment without delay once approved.

Compressed development time

Manufacturing before obtaining an EU marketing authorisation Ready to distribute doses rapidly to meet demand once authorised.

Regulators play a key role providing support to facilitate vaccine development and deployment as quickly as possible.

Developers must still uphold the same good manufacturing practice (GMP) standards All pharmaceutical manufacturers need a manufacturing licence

Use of established production systems already used for safe + effective vaccines (can use existing production)

Applying extensive knowledge on vaccine production gained with existing vaccines

OR Novel approaches to producing and developing vaccines (incr production, enhance stability, strong immune response

Source: EMA website -https://www.ema.europa.eu/en/human- regulatory/overview/public-health-threats/coronavirus-disease- covid-19/guidance-medicine-developers-other-stakeholders- covid-19#regulatory-expectations-and-flexibility-(human- medicines)-section

59

Many PACs Expected for COVID 19 Vaccines

CHANGE is inevitable

Covid Vx – rapid development Need for scale up, new sites, process improvements, challenge for comparability and PACMPs

Need Innovative Regulatory Solutions for a Global Problem

BUT we cannot take 4+ years to get global approvals…..

60

30