The evaluation will proceed quickly and an opinion on the marketing authorization could be issued shortly
EMA has begun evaluating a conditional marketing authorization application for Novavax’s Covid-19 vaccine, Nuvaxovid. The evaluation will proceed quickly and an opinion on the marketing authorization could be issued within a few weeks if the data presented is robust and complete enough to demonstrate the efficacy, safety and quality of the vaccine. This was announced by the European Medicines Agency in a note. «Such a short period of time – explains the Agency – is possible only because the EMA has already examined a substantial part of the data on the vaccine during a continuous review. During this phase, EMA’s Committee for Medicinal Products (CHMP) evaluated data from laboratory studies (non-clinical data), some information on the quality of the vaccine and how it will be produced and data on its safety, immunogenicity (how well it triggers a response against the virus) and efficacy against Covid-19 from clinical trials in adults “.
“In parallel – continues the note – the safety committee of Ema (Prac) has completed the preliminary assessment of the risk management plan proposed by the company, which outlines the measures to identify, characterize and minimize the risks of the drug . In addition, EMA’s Committee for Medicinal Products for Children has issued its opinion on the company’s pediatric investigation plan, which describes how the medicine should be developed and designed for use in children, in accordance with the accelerated timeframe for Covid-19 medicines. If the EMA concludes that Nuvaxovid’s benefits outweigh its risks in protecting against Covid-19, it will recommend granting a conditional marketing authorization. The European Commission will therefore speed up the decision-making process in order to grant a conditional marketing authorization valid in all EU and SEA member states within a few days ”.
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