Delnaval
12/03/21 22:09
Ha respondido al tema Novavax (NVAX): Un Nuevo Comienzo
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Según esta respuesta de la EMA a un tal Pierre, lo que Novavax ha solicitado no es una autorización de emergencia (EUA) sino una CMA o autorización comercial de la vacuna. A lo mejor al final nos llevamos una grata sorpresa “Dear Mr Zgheib,Thank you for your query of 3 March about the COVID-19 candidate vaccine by Novavax.We are sorry to hear of your perception that the Agency is late in the authorisation of this vaccine.EMA can only recommend approval of a vaccine if its scientific committee concludes that the vaccine’s benefits outweigh its risks. It must therefore evaluate the data submitted by Novavax against the high standards of pharmaceutical quality, safety and efficacy that are found in the EU pharmaceutical law. EMA’s thorough evaluation means that, when a vaccine is approved, we can confidently assure EU citizens of the safety and efficacy of this vaccine and that it meets necessary quality standards.As announced on 3 February ([https://www.ema.europa.eu/en/news/ema-starts-rolling-review-novavaxs-covid-19-vaccine-nvx-cov2373]), the rolling review procedure was initiated for the Novavax vaccine, before a formal application for conditional marketing authorisation (CMA) is submitted. This ad-hoc procedure allows EMA to assess data on a vaccine or a medicine as they become available, while the development is still ongoing. Such procedure is one of the fast-tracking measures introduced by EMA to speed up approval.Please note that the rolling review and the subsequent CMA is not an emergency use authorisation. CMA is a marketing authorisation which allows for marketing the medicine, while emergency use authorisation is not. Emergency use authorisation is a mechanism to facilitate the temporary use of a medicine in emergency situations, but the medicine remains unlicensed. EMA is expediting its scientific assessment however this takes longer than a temporary provision for supply and use.More detailed information about the development, evaluation, approval and monitoring of COVID-19 vaccines can be found here: [https://www.ema.europa.eu/en/human-regulatory/overview/public-health-threats/coronavirus-disease-covid-19/treatments-vaccines/vaccines-covid-19/covid-19-vaccines-development-evaluation-approval-monitoring]We can assure you that across EMA and the national authorities, there are hundreds of experts who work very hard to support a rapid evaluation of evidence generated for COVID-19 vaccines to make recommendations on their use in EU citizens while ensuring that the EU standards are met.