Module 9 2021

23/03/2021

And this can be seen with Covid vaccines…

57

Covid Vaccine Registration Pathways

Europe EMA e.g. Pfizer/BionTech, Moderna mRNA vaccines and Astra Zeneca/Oxford vaccine

USA FDA e.g. Pfizer/BionTech and Moderna mRNA vaccines

UK MHRA e.g. Pfizer/BionTech, Moderna mRNA vaccines and Astra Zeneca/Oxford vaccine

Data requirement (FDA example): Final analysis of Ph3 efficacy or interim analysis (incl. safety data from Ph1-2 with follow up Ph3 data) Ph3 safety database well above 3,000 vaccine recipients (with efficacy much higher)

Regulatory Review Mechanism: Fast track and rolling review e.g. EMA Review time in practice 1-2m plus rolling review of 3m

Conditional Approval** (renewed yearly and may be converted to full licence)

Emergency Use Authorisation*

Temporary Authorisation*

Post-licencing safety e.g. EMA - under additional monitoring - monitored even more intensively than other medicines (as for all Vx)

* Temporary licence or emergency use authorisation permits the temporary use of an unauthorised medicine in an emergency situation. An emergency use authorisation is not a marketing authorisation

**Type of approval for medicines addressing unmet medical needs, and in particular those to be used in emergency situations in response to public health threats recognised by the WHO or the EU

Source: EMA website - https://www.ema.europa.eu/en/medicines/human/EPAR/comirnaty; MHRA website: https://www.gov.uk/government/publications/regulatory- approval-of-covid-19-vaccine-astrazeneca/conditions-of-authorisation-for-covid-19-vaccine-astrazeneca; FDA website: https://www.fda.gov/vaccines-blood- biologics/vaccines/emergency-use-authorization-vaccines-explained

18 March 2021

Vx accelerated development

58

58

29