EMA is publishing clinical data for COVID-19 medicines in line with its exceptional transparency measures for COVID-19. Clinical data publication for all other centrally authorised products remains suspended until further notice.

21/03/2023: Further clinical data for COVID-19 medicine published.

The clinical data for Paxlovid support updating information on side effects and drug interactions in its summary of product characteristics. More information is available on the EMA corporate website. 

14/03/2023: Further clinical data for COVID-19 medicine published.

The clinical data for Spikevax support the extension of indication to include use of its adapted BA.1 version as a booster in children aged 6 to 11. More information is available on the EMA corporate website. 

23/02/2023: Further clinical data for COVID-19 medicine published.

The clinical data for Vaxzevria support its use as a booster. More information is available on the EMA corporate website.

22/02/2023: Further clinical data for COVID-19 medicine published.

The clinical data for Regkirona support updates to information on clinical resistance in its summary of product characteristics. More information is available on the EMA corporate website.

20/02/2023: Further clinical data for COVID-19 medicine published.

EMA published clinical data supporting the use of Jcovden as a booster dose following initial vaccination with an adenoviral vector-based vaccine. More information is available on the EMA corporate website.

15/02/2023: Further clinical data for COVID-19 medicine published.

The clinical data for Xevudy support updates to its summary of product characteristics based on final results from a study on its safety and efficacy in non-hospitalised patients. More information is available on the EMA corporate website.

03/02/2023: Further clinical data for COVID-19 medicine published.

The clinical data for Regkirona submitted in a clinical study report confirm its known safety profile when used in adults who do not require supplemental oxygen and who are at risk of severe COVID-19. More information is available on the EMA corporate website.

03/02/2023: Further clinical data for COVID-19 medicine published. 

The clinical data for Comirnaty support the addition of a new strength of this COVID-19 vaccine for use in children aged 6 months to 4 years. More information is available on the EMA corporate website.

26/01/2023: Further clinical data for COVID-19 medicine published.

The clinical data for Veklury support a study report on the efficacy and safety of this COVID-19 treatment. More information is available on the EMA corporate website. 

26/01/2023: Clinical data for COVID-19 medicine published.

The clinical data for COVID-19 Vaccine Valneva support its use in adults aged 18 to 50. More information is available on the EMA corporate website. 

23/01/2023: Further clinical data for COVID-19 medicine published.

The clinical data for Comirnaty support a new strength for its Original/Omicron BA.4-5 version for vaccination in children aged 5 to 11 who have previously received at least a primary vaccination course against COVID-19. More information is available on the EMA corporate website.

21/12/2022: Further clinical data for COVID-19 medicine published

The clinical data for Spikevax support the authorisation of its adapted BA.1 version. More information is available on the EMA corporate website.

21/12/2022: Further clinical data for COVID-19 medicine published

The clinical data for Jcovden support updating the list of side effects in its summary of product characteristics. More information is available on the EMA corporate website.

29/11/2022: Further clinical data for COVID-19 medicine published

The clinical data for Veklury support updating prescribing information in the summary of product characteristics for this COVID-19 treatment. More information is available on the EMA corporate website.

29/11/2022: Further clinical data for COVID-19 medicine published

The clinical data for Vaxzevria support the final study report on the link between vaccination with this COVID-19 vaccine and thrombocytopenia syndrome (TTS). More information is available on the EMA corporate website.

14/11/2022: Further clinical data for COVID-19 medicine published

The clinical data for Spikevax support its extension of indication to include use in children aged 6 months to 5 years. More information is available on the EMA corporate website.

10/11/2022: Further clinical data for COVID-19 medicine published

The clinical data for Nuvaxovid support its extension of indication to include use in adolescents aged 12 to 17. More information is available on the EMA corporate website.

09/11/2022: Further clinical data for COVID-19 medicine published

The clinical data refer to the occurrence of myocarditis in children aged 5 to 11, and to the risk of myocarditis after a third dose of Comirnaty. More information is available on the EMA corporate website.

09/11/2022: Further clinical data for COVID-19 medicine published

EMA published clinical data supporting the use of Nuvaxovid as a booster dose for adults who have received the same or another COVID-19 vaccine for their initial vaccination. More information is available on the EMA corporate website.

07/11/2022: Further clinical data for COVID-19 medicine published

The clinical data for Spikevax support the possibility of administering this vaccine together with a dose of the QIV-HD flu vaccine. More information is available on the EMA corporate website.

28/10/2022: Further clinical data for COVID-19 medicine published

The clinical data for Comirnaty support the authorisation of its adapted bivalent version Original/Omicron BA.1 sub-variant. More information is available on the EMA corporate website.

25/10/2022: Further clinical data for COVID-19 medicine published

EMA published clinical data supporting the use of Comirnaty as a booster dose for children aged 5 to 11. More information is available on the EMA corporate website.

16/09/2022: Further clinical data published for medicine used for COVID-19

The clinical data for Kineret (anakinra) includes final study results on efficacy and safety data. Further information about this medicine is available on the EMA corporate website.

29/08/2022: Further clinical data for COVID-19 medicine published

EMA published clinical data supporting the use of a booster dose of COVID-19 vaccine Spikevax in adolescents aged 12 to 18. More information is available on the EMA corporate website.

26/08/2022: Further clinical data for COVID-19 medicine published 

EMA published clinical data supporting the marketing authorisation of COVID-19 treatment Veklury. More information is available on the EMA corporate website.

01/08/2022: Further clinical data for COVID-19 medicine published

EMA published six-month follow-up data on the efficacy, safety and tolerability of two doses of Comirnaty in adolescents aged 12 to 15. More information is available on the EMA corporate website.

21/07/2022: Further clinical data for COVID-19 medicine published

EMA published the clinical data supporting a booster dose of Comirnaty in adults who received a different COVID-19 vaccine during their initial course of vaccination. More information is available on the EMA corporate website.

11/07/2022: Further clinical data for COVID-19 medicine published

The clinical data for Veklury support its December 2021 extension of indication to include treating adults who do not require supplemental oxygen and who are at increased risk of severe COVID-19. More information is available on the EMA corporate website.

06/07/2022: Further clinical data for COVID-19 medicine published

The clinical data for Comirnaty include efficacy and safety updates on the use of its booster dose in participants aged 16 and older. More information is available on the EMA corporate website.

06/07/2022: Clinical data for COVID-19 medicine published

EMA published clinical data supporting the marketing authorisation of COVID-19 treatment Paxlovid (PF-07321332 / ritonavir). More information is available on the EMA corporate website.

22/06/2022: Further clinical data for COVID-19 medicine published

The clinical data for Spikevax support its use in children aged 6 to 11. More information is available on the EMA corporate website.

17/06/2022: Further clinical data for COVID-19 medicine published

The clinical data refer to interim safety and efficacy results for Spikevax. More information is available on the EMA corporate website.

16/06/2022: Clinical data for COVID-19 medicine published

The clinical data for Nuvaxovid support its marketing authorisation. More information is available on the EMA corporate website.

15/06/2022: Further clinical data for COVID-19 medicine published

The clinical data for Spikevax support the use of a booster dose in adults who received a different COVID-19 vaccine during their initial course of vaccination. More information is available on the EMA corporate website.

10/06/2022: Further clinical data for COVID-19 medicine published

EMA published clinical data on the immunogenicity of Spikevax against the SARS-CoV-2 Delta virus variant. More information is available on the EMA corporate website.

02/06/2022: Further clinical data for COVID-19 medicine published

EMA published clinical data for Comirnaty supporting the use of a booster dose of this COVID-19 vaccine in adolescents aged 12 to 15. More information is available on the EMA corporate website. 

12/05/2022: Clinical data for COVID-19 medicine published

The clinical data for Xevudy (sotrovimab) support its initial marketing authorisation. More information on this medicine is available on the EMA corporate website.