The EMA has begun evaluating the conditional marketing authorization application for the Novavax vaccine for COVID-19, Nuvaxovid.
The evaluation will proceed quickly and a marketing authorization opinion could be issued within weeks if the data submitted is strong and complete enough to show the efficacy, safety and quality of the vaccine.
Such a short time frame is only possible because the EMA has already reviewed a significant portion of the vaccine data during a rolling evaluation. At this stage, the EMA Committee for Medicinal Products for Human Use (CHMP) evaluated data from laboratory studies, some information on the quality of the vaccine and how it is produced, and data on its safety, immunogenicity (how well it triggers a response). antiviral) and efficacy against COVID-19 from clinical trials in adults.
At the same time, the EMA safety committee (PRAC) completed the preliminary evaluation of the risk management plan (RMP) proposed by the company, which describes measures to identify, characterize and minimize the risks of the drug.
In addition, the EMA Committee for Pediatric Medicines (PDCO) issued its opinion on the company’s pediatric research plan, which describes how to develop and study the medicinal product for use in children, according to the accelerated timetables for medicines related to in COVID-19.
If the EMA concludes that the benefits of Nuvaxovid outweigh the risks associated with COVID-19 protection, it will recommend a conditional marketing authorization.
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