Added on 30 June 2025:
'Exceptional transparency measures for Comirnaty and Spikevax' section
EMA introduced exceptional transparency measures during the public health emergency of international concern brought on by the COVID-19 pandemic. These measures included:
The World Health Organization (WHO) declared an end to the COVID-19 public health emergency in May 2023.
EMA continues to monitor the safety of approved COVID-19 medicines and to make related information available.
To find out more about EMA's role and responsibilities on COVID-19 medicines, see:
EMA is making data from the marketing authorisation applications for COVID-19 mRNA vaccines Comirnaty and Spikevax publicly available.
It includes information on residual DNA measurements, as well as some quality and non-clinical aspects of the dossiers for these COVID-19 vaccines. The data are as presented in the dossiers on 12 June 2025.
It also includes data released prior to 12 June 2025, under the EU regulation governing access to documents (Regulation (EC) 1049/2001).
This release of data is in line with the exceptional transparency measures that EMA introduced during the COVID-19 pandemic, an unprecedented global crisis. These measures allowed EMA to support public-health efforts, foster trust and enable informed decision-making.
EMA is publishing these data gradually, in document format, in consultation with marketing authorisation holders.
To access these documents, and to subscribe to related updates, see:
EMA is grouping the quality and non-clinical documents according to the structure laid out in the ICH guideline on common technical documents (CTD) for the registration of pharmaceuticals for human use.
This structure divides the documents into modules. EMA publishes some of these modules on this website, while others are available on the Clinical Data website.
Refer to the table below to see where you can find each module.
| Module | Type of data | Where to find data |
| 2.3 | Quality overall summary | This website |
| 2.4 | Non-clinical overview | This website |
| 2.5 | Clinical overview | Clinical Data website |
| 2.6 | Non-clinical written and tabulated summaries | This website |
| 2.7 | Clinical summary | Clinical Data website |
| 3.2 | Body of quality data | This website |
| 4.2 | Non-clinical study reports | This website |
| 5.3 | Clinical study reports | Clinical Data website |
For more information, see:
The table below features information on the exceptional transparency measures for COVID-19 medicines that EMA introduced during the COVID-19 public health emergency, between 2020 and 2023.
These measures were considered exceptional by comparison to pre-COVID-19 standard practice, also outlined in the table:
| Standard practice | COVID-19 medicines | |
|---|---|---|
Scientific advice | No information published | List of medicines that have received scientific advice or guidance from COVID-ETF published |
Compassionate use opinion | Published in compassionate use after CHMP opinion | News announcement published within 1 day of CHMP opinion |
Start of rolling review | Not applicable | News announcement published within 1 day of start of review |
Marketing authorisation application | Active substance and therapeutic area listed in medicines for human use under evaluation | COVID-19 medicine page updated; news announcements published on case-by-case basis |
Product information | Published and updated in all EU languages with the European public assessment report (EPAR) | Published (in English) within 1 day of positive CHMP opinion; published in other EU languages with EPAR. Updates to be expedited for major post-authorisation changes |
Publication of European public assessment report (EPAR) | Published at least 2 weeks after marketing authorisation and updated following changes to the authorisation. | Published as soon as possible and ideally within 7 days of marketing authorisation. Updates to be expedited for major post-authorisation changes. EPARs can only be published once all necessary steps are completed, which is not always possible within 7 days |
Risk management plan (RMP) | Summary of RMP published | Full body of the RMP (plus Annex 4) published. Updated RMPs also published after major post-authorisation changes |
Clinical trial data | Publication suspended until further notice | Trial data published on Clinical data website after marketing authorisation; additional trial data also published after major changes to authorisation |
Application for extension of indication | Not announced | COVID-19 medicine page updated; news announcements published on case-by-case basis |
Monthly safety updates for vaccines | No information published | Published monthly for approved COVID-19 vaccines (and ad-hoc as needed) between January 2021 and December 2022. Periodic Safety Update Reports (PSURs) and their EMA assessments made available from August 2023. |
Assessment of safety signals | Information published with PRAC meeting highlights as necessary | Information on start and finalisation of procedure published with PRAC meeting highlights routinely |
Table last updated 11 March 2022
These measures aimed to address the high interest for information and to support global research on COVID-19 medicines.
They were added to the information that EMA normally publishes on human medicines.
EMA may increase transparency of other regulatory procedures.
For more information, see: