EMA starts rolling review of Novavax COVID vaccine
The vaccine against COVID-19 being developed and tested by Novavax has been accepted for rolling review by the European Medicines Agency (EMA). The vaccine, NVX-CoV2372, is in Phase 3 clinical trials in the United Kingdom and the United States.Early results from the UK Phase 3 trial showed vaccine efficacy of over 89% in a setting where more than 50% of cases were caused by the more contagious – and potentially more virulent – strain of SARS-CoV-2 that now predominates in the UK.
In a 28 January press release announcing these interim results, Novavax also reported Phase 2b results from South Africa showing 60% efficacy. Here, according to the press release, approximately 90% of COVID-19 infections were caused by a variant strain that, because of its potential for reinfection and vaccine escape, is causing concern for some infectious disease researchers and epidemiologists. Among HIV-infected individuals in the South African study, the Novavax vaccine was less than 50% effective against COVID-19.
In the US, the PREVENT-19 clinical trial has randomized more than 16,000 participants; this trial is funded with support through the initiative formerly known as Operation Warp Speed and is overseen by the unified data and safety monitoring board established when Operation Warp Speed was launched. (RELATED: Novavax COVID vaccine takes first step toward Australian approval, Regulatory Focus 20 January 2021)
EMA’s rolling review process allows for ongoing review of clinical trial data as they are made available, continuing until data regarding both safety and effectiveness, as well as quality considerations, are sufficient to make a determination as to whether a marketing authorization should be granted. “While EMA cannot predict the overall timeliness, it should take less time than normal to evaluate an eventual application because of the work done during the rolling review,” according to EMA.
Once EMA’s human medicines committee (CHMP) determines the data are sufficient, Novavax can submit a formal marketing authorization application to the committee. EMA has already granted conditional marketing authorization to the COVID-19 vaccines developed by Pfizer and BioNTech, by Moderna and the US National Institutes of Health, and by AstraZeneca in conjunction with the University of Oxford. (RELATED: EU authorizes Pfizer-BioNTech COVID vaccine, Regulatory Focus 21 December 2020; EMA okays Europe's second COVID vaccine, Regulatory Focus 07 January 2021; EMA authorizes AstraZeneca COVID-19 vaccine, Regulatory Focus 29 January 2021)
EMA