Meeting highlights from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) in relation to COVID-19, 20 – 23 February 2023
The committee recommended authorising the use of COVID-19 Vaccine Valneva (inactivated, adjuvanted) as a booster dose for adults 18 to 50 years of age.
An overview of all the COVID-19 vaccines authorised in the EU is available on EMA’s website.
The committee recommended the refusal of a marketing authorisation for Lagevrio (molnupiravir) for the treatment of COVID-19 in adults.
The review of the marketing authorisation application for Lagevrio had started on 23 November 2021, following advice intended to support decisions at Member State level to enable possible early use of the medicine prior to marketing authorisation. Having evaluated the interim data available at the time of the advice, and all additional data provided by the company since then, the CHMP concluded that the clinical benefit of Lagevrio in the treatment of adults with COVID-19 who are not receiving supplemental oxygen and who are at increased risk of developing severe COVID-19 could not be demonstrated. Based on the totality of data, it was not possible to conclude that Lagevrio can reduce the risk of hospitalisation or death or shorten the duration of illness or time to recovery in adults at risk of severe disease. Furthermore, it was not possible to identify a specific group of patients in whom a clinically relevant benefit of Lagevrio could be demonstrated. For more information on this negative opinion, see the question-and-answer document here.
Merck and Ridgeback announced that they will appeal the decision and request a re-examination of the CHMP’s opinion. The full press release can be accessed here.
Source : European Medicines Agency
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