• EMA’s expert committee meets 6 January to decide on Moderna’s COVID-19 vaccine

    | 22 December 2020 |

    The expert committee of the European Medicines Agency, EMA, which is presently assessing Moderna’s application for conditional marketing authorisation of their COVID-19 vaccine in the EU has scheduled a meeting on 6 January at which it may recommend authorisation to the European Commission. If so, the European Commission may formally authorise the vaccine within a few days.

  • EMA starts rolling review of corona vaccine from Janssen

    | 02 December 2020 |

    The European Medicines Agency, EMA, has started a rolling review of data from the clinical trials of a potential COVID-19 vaccine from the manufacturer Janssen. The EMA has previously started the same process for other potential vaccines from AstraZeneca, BioNTech/Pfizer and Moderna.

  • EMA receives the first applications for conditional marketing authorisation of COVID-19 vaccines

    | 02 December 2020 |

    The EMA has received the first two applications from companies for conditional marketing authorisation of COVID-19 vaccines. The authorisations could be granted in only a few weeks’ time if the agency’s independent pharmaceutical experts assess the documentation on efficacy and safety to be sufficient.