![]() “In parallel, EMA’s safety committee (PRAC) completed the preliminary assessment of the risk management plan (RMP) proposed by the company, which outlines measures to identify, characterise and minimise the medicine’s risks.” During this phase, EMA’s human medicines committee (CHMP) assessed data from laboratory studies (non-clinical data), some information on the quality of the vaccine and the way 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 studies in adults. “Such a short timeframe is only possible because EMA has already reviewed a substantial portion of the data on the vaccine during a rolling review. In an update yesterday, the EMA said: “ The assessment will proceed under an accelerated timeline, and an opinion on the marketing authorisation could be issued within weeks if the data submitted are sufficiently robust and complete to show the efficacy, safety and quality of the vaccine. ![]() This will later be supplemented with data from additional manufacturing sites in Novavax' global supply chain. (SII), the world's largest vaccine manufacturer by volume. The chemistry, manufacturing and controls (CMC) data package submitted to EMA (as well as other global regulatory agencies) is based on Novavax' manufacturing partnership with the Serum Institute of India Pvt. Erck, President and Chief Executive Officer, Novavax. "Novavax looks forward to providing an additional vaccine option in Europe, built on a proven, well-understood technology platform, and thanks the European Commission for its ongoing partnership and confidence in our COVID-19 program,” said Stanley C. Phase 3 trials of Novavax' candidate have demonstrated 89.7% efficacy (96.4% efficacy against the original virus strain and 86.3% against the Alpha B.1.1.7 variant). A UK Phase 3 trial reported efficacy of 96.4% against the original virus strain, 86.3% against Alpha (B.1.1.7) and 89.7% efficacy overall.Ī Phase 3 trial in the US & Mexico showed 100% protection against moderate/severe disease and 90.4% efficacy overall.
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