[NVAX] EMA Review Process & Current Status

NOV 17, European Medicines Agency (EMA) has begun its evaluation of an application for conditional marketing authorization (CMA) for Novavax' COVID-19 vaccine. Here is a summary of NVAX EMA review process and current status.

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[Process]

1. Rolling reveiw (Several rolling review cycles can be done)

- NVAX : data submission to EMA

- EMA : evaluate data for promising medicine as soon as possible (to enable fast approval)

 

2. Application for CMA* (by vaccine developers)

* CMA - Conditional Marketing Authorization)

 

3. Evaluation

- CHMP* : all aspects of medicines evaluation

- PRAC** : safety and risk minimization

- ETF*** : all aspects of medicines evaluation

 

* CHMP (Committee for Medical Products for Human Use)

** PRAC (Pharmacovigilance Risk Assessment Committee)

*** ETF (COVID-19 Task Force)

 

4. Provide EMA's opinion to EC*

* EC : European Commission

 

5. Conditional marketing authorization (by EC)

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[Current Status]

1. Rolling review : Done

=> NOV 01, 21 : Novavax Completes Submission for Rolling Review to European Medicines Agency

https://ir.novavax.com/2021-11-01-Novavax-Files-for-COVID-19-Vaccine-Authorization-with-Health-Canada-and-Completes-Submission-for-Rolling-Review-to-European-Medicines-Agency

Novavax Files for COVID-19 Vaccine Authorization with Health Canada and Completes Submission for Rolling Review to European Medi

 

2. Application for CMA : Done

 

3. Evaluation : On-going

- CHMP : assessed non-clinical data, data on safety and quality and efficacy

- PRAC : completed the preliminary assessment of the risk management plan

=> EMA will communicate at the time of CHMP's opinion

 

Evaluation Status (Extracted from EMA)

 

https://www.ema.europa.eu/en/news/ema-receives-application-conditional-marketing-authorisation-novavaxs-covid-19-vaccine-nuvaxovid

EMA receives application for conditional marketing authorisation of Novavax’s COVID-19 vaccine, Nuvaxovid - European Medicines

4. Provide EMA's opinion to EC : TBD

 

5. Conditional marketing authorization : TBD

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[Additional Info.]

1. Rolling review?

Rolling review (Extracted from EMA)

 

• To evaluate data for promising medicine as soon as available
• Several rolling reveiw cycles can be done as data continue to emerge
• Once all quality, safety and efficacy data are ready, company can apply for CMA

 

2. Conditional Marketing Authorization?

CMA (Extracted from EMA)

• CMA can be used in public health emergencies
• It can be approved if benefits outweigh the risks
• After approval, vaccine can be provided to European population

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