CureVac says well on track to request vaccine approval as planned

FRANKFURT: Germany's CureVac is on track to file for European approval of its COVID-19 vaccine as early as this month because high infection rates among trial participants are bringing a read-out on efficacy within closer reach.

"The cases are coming in fast," Chief Executive Franz-Werner Haas told Reuters.

Since starting out in 2000, the biotech firm has focused on so-called messenger RNA (mRNA), a drug and vaccine technology that has also become the recent focus of the European union's procurement negotiations.

The mRNA approach has been validated by the wide use of coronavirus vaccines developed by pioneers BioNTech and its partner Pfizer, as well as by Moderna, in Europe and North America.

But more volumes will be needed to boost lagging immunisation coverage in Europe and potentially for repeated booster shots.

The group's late stage trial involves more than 37,000 volunteers in Europe and Latin America, half of whom are receiving a placebo.

An interim analysis is due when 56 and then 111 volunteers across both groups have fallen ill with COVID-19.

CureVac has not publicly determined at which checkpoint it would publish first results but has said it expects to file for European authorization in late May or early June.

Current infection rates in participating country Peru, in particular, have put CureVac well on track to meet its timetable, Haas said.

As CureVac's only major supply deal, the European Union in November last year secured up to 405 million doses of the shot, of which 180 million are optional.

The Nasdaq-listed firm, which is backed by investor Dietmar Hopp, GlaxoSmithKline as well as the German government, has said it aims to produce up to 300 million doses of the vaccine in 2021 and up to 1 billion in 2022.

The CEO, which has flagged equipment and material supply issues due to the US Defense Production Act, confirmed the production target, but said that some volumes may not be cleared for delivery before the first quarter of 2022.

This is due to "validation by regulators" that is needed for the release of the produced volumes to customers, which may require additional time, he said.

For the trial read-out expected later this month, CureVac will publish details on its primary goal of preventing COVID-19 across all virus variants.

It also aims to disclose efficacy data specifically on the variant known as B117 that was first detected in Britain, as well as on the initial variant that emerged in Chinese city of Wuhan.

All infections in the trial will undergo genetic sequencing of any variant, offering a unique picture of the variations of the pathogen in Europe and Latin America.

"We'll have the only study that will offer real-world data on the current distribution of variants," said Sarah Fakih, the firm's head of investor relations.