EMA Launches Rolling Review of CureVac’s COVID-19 Vaccine

The European Medicines Agency (EMA) said it has launched a rolling review of CureVac’s messenger-RNA-based COVID-19 vaccine, CVnCoV.

The agency said the decision was supported by nonclinical data and early-study results in adults that suggested the mRNA vaccine induced antibodies against the SARS-CoV-2 virus.

The EMA’s human medicines committee will evaluate safety and efficacy data from CureVac’s ongoing phase 2b/3 trial, initiated in December, which aims to enroll more than 35,000 participants across Europe and Latin America (DID, Dec. 15, 2020). But it will be months before the company will have data to support an application for conditional marketing authorization, as the study’s primary completion date isn’t until June 30, according to ClinicalTrials.gov.

CureVac will also need that data to support a filing for Emergency Use Authorization from the FDA.

In January, the company teamed up with fellow German drugmaker Bayer to assist with global regulatory approvals and large-scale distribution (DID, Jan. 8).

CureVac has also forged separate pacts with the UK and GlaxoSmithKline (GSK) to speed development of messenger-RNA-based vaccines to combat coronavirus variants (DID, Feb. 4). The companies expect to market the co-developed vaccine in 2022.

Under the UK deal, the British government would be entitled to 50 million doses of variant vaccine. And GSK will also help manufacture up to 100 million doses of CVnCoV this year.

CureVac previously negotiated an advance purchase agreement with the EU to supply up to 405 million doses of CVnCoV, contingent upon regulatory approval. ― Jason Scott