CureVac's COVID vaccine enters EMA's rolling review
The European Medicines Agency (EMA) has begun a rolling review of another vaccine against COVID-19, the agency announced Friday.EMA’s human medicines committee (CHMP) will review available data on CureVac’s messenger RNA (mRNA) vaccine CVnCoV. The vaccine is currently being tested in a Phase 2b/3 clinical trial of about 36,000 participants in Germany, as well as in a German Phase 3 trial involving healthcare workers. (RELATED: COVID-19 vaccine tracker, Regulatory Focus 11 February 2021)
The rolling review should speed the time to a marketing authorization decision, said EMA in its announcement of CHMP’s decision. “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.”
EMA’s fast-track procedures for COVID-19 vaccines and therapeutics shorten the return time for scientific advice to less than 20 days, less than the 40 to 70 days of the standard timeline. The rolling review speeds the process further by breaking reviews out into shorter cycles of about 14 days each, completed as new data are made available.
“When the medicine’s development is progressed enough for a marketing authorization application (MAA), the formal assessment procedure can take place in a very short timeframe, because the data have already been scrutinized during rolling review,” explained EMA in outlining the accelerated regulatory pathways it is using during the pandemic.
Preclinical studies showed that the vaccine produced high neutralizing titers and robust T-cell responses in vitro, as well as humoral and cellular immune responses in rodents. These findings along with promising early clinical results were the basis for CHMP’s decision to undertake the rolling review.
EMA is also conducting a rolling review of the single-dose vaccine being developed by Johnson & Johnson’s Janssen group, as well as a vaccine being developed by Novavax. An antibody combination of casirivimab and imdevimab produced by Regeneron and Roche is the only therapeutic against COVID-19 currently under rolling review by EMA.
Previously, EMA authorized the mRNA vaccine co-developed by Pfizer and BioNTech, marketed in the EU as Comirnaty, under the rolling review scheme. Two other vaccines, Moderna’s mRNA vaccine co-developed with the US National Institutes of Health and the chimpanzee adenovirus vector vaccine co-developed by AstraZeneca and the University of Oxford, have also been granted conditional marketing authorization in the EU after rolling reviews. (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)
Holders of conditional marketing authorizations are required to submit monthly safety reports to EMA for all COVID-19 vaccines authorized under the rolling review scheme.
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