Human medicines committee at European Medicines Agency has recommended granting an extension of indication for Spikevax to include use in children aged 12 to 17 years.


Human medicines committee at European Medicines Agency has recommended granting an extension of indication for Spikevax to include use in children aged 12 to 17 years.

The 9th revision of the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance – ENCePP Guide on Methodological Standards in Pharmacoepidemiology has just been published.

CHMP at EMA has recommended granting an extension of indication for the COVID-19 vaccine Comirnaty® to include use in children aged 12 to 15.

The European Commission granted a conditional marketing authorisation for the fourth COVID-19 vaccine, developed by Janssen Pharmaceutica NV.

The human medicines committee (CHMP) at the European Medicines Agency (EMA) has issued a reflection paper outlining the requirements for manufacturers planning to modify their COVID-19 vaccines in order to address SARS-CoV-2 variants.

In occasion of the Rare Disease Day 2021, Fondazione Gianni Benzi developed an informative material focused on rare diseases and COVID-19.

The company completed enrolling children aged 12 to 15 in the first study (NCT04368728) that aims to evaluate the safety, tolerability, immunogenicity, and efficacy of BNT162b2 vaccine.

The European Medicines Agency recommended granting a conditional marketing authorisation for COVID-19 Vaccine AstraZeneca to prevent COVID-19 disease in people from 18 years of age.

The European Medicines Agency (EMA) has recommended the conditional marketing authorisation for COVID-19 Vaccine Moderna (mRNA-1273) that the European Commission granted. EMA’s human medicines committee has thoroughly assessed the data on the quality, safety...

European Medicines Agency has recommended granting a conditional marketing authorisation in the European Union for the vaccine Comirnaty, developed by BioNTech and Pfizer, to prevent COVID-19 in people from 16 years of age.
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