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.

10/11/2023: Further clinical data for COVID-19 medicine published.

The clinical data for Veklury address the safety of this COVID-19 treatment in patients with hepatic impairment. More information is available on the EMA corporate website.

19/09/2023: Further clinical data for COVID-19 medicine published.

The clinical data for Comirnaty support an extension of indication to include a new strength of this COVID-19 vaccine for use in children aged 6 months to 4 years. They also support the use of its adapted BA.4-5 version as a primary vaccination course in people aged 5 years and over. More information is available on the EMA corporate website.

14/09/2023: 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.4-5 version as a two-dose primary vaccination course in children aged 6 months to 5 years and as a single-dose primary vaccination course, irrespective of vaccination history, in children aged 6 years and over. More information is available on the EMA corporate website.

28/08/2023: Further clinical data for COVID-19 medicine published

The clinical data for Vaxzevria support updates to its summary of product characteristics to reflect updated long-term efficacy data. More information is available on the EMA corporate website.

10/08/2023: Further clinical data for COVID-19 medicine published

The clinical data for Veklury support the update of its risk management plan with information on safety in pregnant persons. More information on this medicine is available on the EMA corporate website.

09/08/2023: 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.4-5 version as a booster in children aged 6 to 11. They also refer to updates to the immunogenicity and safety data for its adapted BA.1 and BA.4-5 versions. More information is available on the EMA corporate website.

02/08/2023: Further clinical data for COVID-19 medicine published.

The clinical data for Spikevax support updates to its pharmacovigilance plan, including the addition of its Original/Omicron BA.4-5 version, changes to several studies and an update to its INN. More information is available on the EMA corporate website.

07/07/2023: Further clinical data for COVID-19 medicine published.

The clinical data for Veklury support updates to the information in its summary of product characteristics on its use for patients with reduced kidney function. More information is available on the EMA corporate website.

22/06/2023: Further clinical data for COVID-19 medicine published.

The clinical data for Ronapreve support its use to treat COVID-19 in hospitalised adults and adolescents aged 12 and older who weigh at least 40 kg. More information is available on the EMA corporate website.

16/06/2023: Further clinical data for COVID-19 medicine published.

The clinical data for Ronapreve refer to a withdrawn variation that included introducing a dose for Omicron subvariants and updating information on this treatment's efficacy. More information is available on the EMA corporate website.

06/06/2023: Further clinical data for COVID-19 medicine published.

The clinical data for Paxlovid support several updates to its summary of product characteristics based on data from different studies. More information is available on the EMA corporate website.

26/05/2023: Further clinical data for COVID-19 medicine published.

The clinical data for Spikevax refer to a final report from a study on its safety and immunogenicity in healthy adults. More information is available on the EMA corporate website.

25/05/2023: Further clinical data for COVID-19 medicine published.

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

17/05/2023: Further clinical data for COVID-19 medicine published.

The clinical data for Evusheld support its use to treat COVID-19 in adults and adolescents aged and over who weigh at least 40 kilograms and who do not require oxygen. More information is available on the EMA corporate website.

17/05/2023: Further clinical data for COVID-19 medicine published.

The clinical data for Olumiant refer to an application from the company to extend the indication of this since withdrawn COVID-19 treatment. More information is available on the EMA corporate website.

17/05/2023: Further clinical data for COVID-19 medicine published.

The clinical data for Comirnaty refer to a study on its efficacy and confirm its known safety profile in children aged 5 to 11. More information is available on the EMA corporate website.

17/05/2023: Further clinical data for COVID-19 medicine published.

The clinical data for Comirnaty support updates to the immunogenicity data after a booster dose in its summary of product characteristics. More information is available on the EMA corporate website.

03/05/2023: Further clinical data for COVID-19 medicine published.

The clinical data for Evusheld support its use to prevent COVID-19 in adults and adolescents aged 12 and older who weigh over 40 kilograms. More information is available on the EMA corporate website.

02/05/2023: Further clinical data for COVID-19 medicine published.

The clinical data for VidPrevtyn Beta support its use as a vaccine in adults. More information is available on the EMA corporate website.

25/04/2023: EMA to resume publication of non-COVID-19 clinical data

EMA intends to gradually resume clinical data publication from September 2023, having temporarily suspended this activity for all products except treatments and vaccines for COVID-19. More information is available on the EMA corporate website.

20/04/2023: Further clinical data for COVID-19 medicine published.

The clinical data for Jcovden refer to a final clinical study report on its safety, side effects and immunogenicity in adults and adolescents. More information is available on the EMA corporate website.

18/04/2023: Further clinical data for COVID-19 medicine published.

The clinical data for Veklury support an update to the clinical virology information in its summary of product characteristics. More information is available on the EMA corporate website.

18/04/2023: Further clinical data for COVID-19 medicine published.

The clinical data for Spikevax refer to a final report from a study on the safety and immunogenicity of its booster dose and flu vaccine in adults aged 65 and older. More information is available on the EMA corporate website.

11/04/2023: Further clinical data for COVID-19 medicine published.

The clinical data for Nuvaxovid refer to a final clinical report from a study on its safety and immunogenicity. More information is available on the EMA corporate website.

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.