THE European Medicines Agency (EMA) started the evaluation of the application for its conditional marketing authorization Novavax vaccine for coronavirus, Nuvaxovid.
The evaluation will proceed to quick schedule and a marketing authorization opinion could be issued within weeks, if the data submitted are sufficiently strong and complete in terms of efficacy, safety and quality of the vaccine, transmits the RES EIA.
Such a short time frame is only possible because the EMA has already reviewed a significant portion of the vaccine data during rolling evaluation.
The preliminary evaluations of competent Committees have been completed
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 studies in adults.
At the same time, the EMA Security Committee (PRAC) has completed its preliminary assessment 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 on Medicinal Products for Children (PDCO) issued its opinion on the draft pediatric research of the company, which describes how to develop and study the drug for use in children, according to the accelerated schedules for drugs related to COVID-19.
If the EMA concludes that the benefits of Nuvaxovid prevail of the risks associated with protection against COVID-19, will recommend the marketing authorization under conditions.
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