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EMA begins rolling review of CureVac’s COVID-19 vaccine

Investigational vaccine is currently being evaluated in a phase 2/3b clinical trial

The European Medicines Agency (EMA) has announced today that its Committee for Medicinal Products for Human Use (CHMP) has started a rolling review of CureVac’s COVID-19 vaccine.

In November 2020, CureVac revealed early data for its investigational COVID-19 vaccine – the jab was found to trigger an immune response in participants in a phase 1 study.

The mRNA-based vaccine candidate, CVnCoV, also induced strong binding and neutralising antibody responses in the early study, according to CureVac.

In addition, the vaccine demonstrated early indications of functional T cells, confirming activation of a cellular immune response.

CureVac also announced last year that CVnCoV has up to 24 hours of stability when stored at room temperature.

The German biotech company said that data for the potential COVID-19 vaccine suggests the jab remains stable and within defined specifications for at least three months when stored at a standard refrigerator temperature - +5 °C (+41°F).

Currently, CVnCoV is being investigated in a phase 2/3b clinical trial in healthy adults at sites in Europe and Latin America.

“We are confident in the potential of our mRNA technology to contribute to the fight against the global public health emergency that is COVID-19,” said Lidia Oostvogels, vice president, area head infectious diseases at CureVac.

“Working together with the EMA to initiate a rolling regulatory process is a critical step in enabling potential access to our vaccine by the many people who still need protection from this deadly disease,” she added.

The European Commission (EC) has signed a supply agreement with CureVac for 405 million doses of CVnCoV.

According to Reuters, the deal includes access to an initial 225 million doses of CureVac's vaccine, with the EC eligible to purchase a further 180 million.

German pharma company Bayer is supporting the development, supply and key territory operations for CureVac’s potential vaccine.

This includes contributing its expertise and established infrastructure in areas such as clinical operations, regulatory affairs, pharmacovigilance, medical information and supply chain performance.

Bayer and CureVac also have a manufacturing agreement in place to bolster production of CVnCoV.

Stefan Oelrich, head of Bayer’s pharmaceutical division, said that the company expects to produce 161 million doses of CureVac’s vaccine in 2022.

EMA clarification on Russia’s Sputnik V vaccine

The EMA also announced earlier this week that it has not received an application for a rolling review or marketing authorisation for a vaccine developed by Russia’s Gamaleya National Centre of Epidemiology and Microbiology – known as Sputnik V.

‘The [Sputnik V] developers have expressed their interest that the vaccine be considered for a rolling review,’ the EMA said in a statement.

The EMA clarification comes on the heels of reports that an application for Sputnik V had been received by the regulatory agency for review.

Article by
Lucy Parsons

12th February 2021

From: Regulatory



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