EMA begins rolling review of Sinovac's COVID vaccine

Regulatory NewsRegulatory News | 04 May 2021 |  By 

The European Medicines Agency (EMA) has added Sinovac’s COVID-19 vaccine to its portfolio of vaccines under rolling review.
The inactivated, adjuvanted Vero cell vaccine, known as Coronavac, joins three others that are in EMA’s rolling review process, which allows sponsors to add to the candidate vaccine’s portfolio as data accrues.
EMA’s human medicines committee (CHMP) then meets periodically to assess reports in support of the submission, notifying the sponsor when enough data are available to support the submission of a formal application for marketing authorization. In this way, the rolling review speeds the path to a regulatory decision.
CureVac’s CVnCoV COVID-19 vaccine and NVX-CoV2372, the Novavax candidate, have been under review since February 2021. Sputnik V, the vaccine being developed by Russia’s Gamaleya National Centre of Epidemiology and Microbiology, was accepted for rolling review in early March.
EMA currently does not have any formal applications for conditional marketing authorization before its human medicines committee (CHMP). Conditional marketing authorizations have already been granted to the Pfizer/BioNTech messenger RNA (mRNA) COVID-19 vaccine marketed as Comirnaty in the EU; to Moderna’s mRNA vaccine; to the single-dose adenovirus vector vaccine developed by Janssen, Johnson & Johnson’s vaccine unit; and to Vaxzevra, AstraZeneca’s two-dose adenovirus vector vaccine.
In clinical trials occurring in regions such as Brazil with high prevalence of SARS-CoV-2 variants, Sinovac’s two-dose regimen has been reported to have efficacy of about 80% in preventing severe disease; in Brazil, that figure fell to about 50% when patients with mild disease were included in the data analysis.  The vaccine is currently in use in Brazil, China, Indonesia, the Philippines, Turkey, and elsewhere.
Coronavac was developed by Sinovac Life Sciences Co. and is being brought before EMA by Lif’On S.r.l. “While EMA cannot predict the overall timelines, it should take less time than normal to evaluate an eventual application because of the work done during the rolling review,” noted the agency in announcing Coronavac’s inclusion in the rolling review process.


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Tags: coronavirus, EMA, EU

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