Approval of COVID-19 vaccines
COVID-19 vaccines are being developed following the same legal requirements for pharmaceutical quality, safety and effectiveness as other medicines. To gain approval (authorisation) for a vaccine, the vaccine developer must submit the results of all testing and trials to the relevant regulatory authority. Regulators carry out a scientific evaluation of the vaccine’s safety, effectiveness and quality, before concluding whether there is sufficient scientific evidence supporting approval.
For COVID-19, it is expected the applications for vaccines will be made centrally to the European Medicines Agency (EMA). If the EMA concludes that the benefits of the vaccine outweigh its risks in protecting against COVID 19, it will make a recommendation to the European Commission to grant a conditional marketing authorisation. Once the European Commission grants a marketing authorisation for a medicine, this is valid and legally binding across all EU Member States, including Ireland.
Ireland, through the HPRA, is an active participant in all European reviews. The HPRA contributes directly to the assessment of all new medicines and the monitoring of their safety once in use. This is also the case for COVID-19 vaccines and treatments.
Further information on the development, evaluation, approval and monitoring of COVID-19 vaccines can be found on the EMA website.
Expedited process – the rolling review
For COVID-19 medicines, the EMA is applying an expedited procedure, called a rolling review.
A rolling review is one of the regulatory tools that the EMA uses to speed up the assessment of a promising medicine or vaccine during a public health emergency.
Normally, all data on a medicine’s effectiveness, safety and quality and all required documents must be submitted at the start of the evaluation in a formal application for marketing authorisation. In the case of a rolling review, the EMA reviews data as they become available from ongoing studies.
During this phase, the EMA assesses data on the vaccine’s quality (such as information about its ingredients and the way it is produced) as well as results from laboratory studies. The EMA also looks at results on the vaccine’s effectiveness and initial safety data emerging from large-scale clinical trials as they become available.
Visit the EMA website for more information about accelerated procedures for COVID-19 treatments and vaccines.
Conditional marketing authorisation
Once the EMA decides that sufficient data are available, the formal application should be submitted by the vaccine developer.
According to the EMA, an opinion on a conditional marketing authorisation can be issued within weeks, depending on whether the data submitted are sufficiently robust and complete to show the quality, safety and effectiveness of the vaccine. Such a short timeframe is only possible because the EMA has already reviewed certain data on the vaccine during the rolling review process.
If the EMA concludes that the benefits of the vaccine outweigh its risks in protecting against COVID‑19, it will recommend granting a conditional marketing authorisation. The European Commission will then fast-track its decision-making process with a view to granting a conditional marketing authorisation valid in all EU and EEA Member States within days.
Conditional marketing authorisation is a 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. Conditional marketing authorisation can help speed up patient access to new medicines.
See below details of COVID-19 vaccine candidates as they move through the European regulatory approval process. This begins with the rolling review stage, moving to an application for a conditional marketing authorisation before potential authorisation is confirmed by the European Commission based on a positive assessment and recommendation for approval from the EMA.
Conditional marketing authorisation
The European Commission has granted a conditional marketing authorisation for the vaccines listed below.
Product information, including the Summary of Product Characteristics and the Package Leaflet are available on our COVID-19 Vaccines: Product Information page.
Conditional marketing authorisation applications under evaluation
Start of evaluation
of conditional marketing authorisation
COVID-19 Vaccine Janssen
Janssen-Cilag International N.V.
16 February 2021
EMA press release (1/12/2020)
EMA press release (16/2/2021)
Ongoing rolling reviews
The EMA has begun a rolling review process for two vaccines, listed in the table below. The rolling review will continue until enough evidence is available to support a formal marketing authorisation application.
Start of rolling review
|Novavax CZ AS ||3 February 2021 ||EMA press release |
|CureVac AG |
|12 February 2021 ||EMA press release |
|Sputnik V (Gam-COVID-Vac) |
|Russia’s Gamaleya National Centre of Epidemiology and Microbiology |
| 4 March 2021 || EMA press release |