Bayer joins the COVID-19 vaccine push, backing CureVac shot

Shortly after launching large-scale trials of its COVID-19 vaccine candidate, CureVac has the partner it will need to roll the shot out at scale if it works as hoped.

Bayer has joined forces with the German biotech to support the development and supply of CVnCoV, an mRNA candidate using a similar technology to the Pfizer/BioNTech and Moderna jabs, with the drugmaker saying it will help CureVac produce “several hundred million doses".

CureVac has been working steadily on CVnCoV over the last few months as the spotlight was trained on candidates originated by BioNTech, Moderna and AstraZeneca, which were a little further ahead in development, but began its own phase 2b/3 study in mid-December.

It’s hoping for interim results from that in the first quarter of this year, which if positive could be followed by rolling regulatory submissions and – potentially at least – emergency approvals sometime towards the late spring/early summer.

The trial is assessing the safety and efficacy of CVnCoV in adults of various ages and once fully enrolled will include more than 35,000 participants in Europe and Latin America.

It aims to demonstrate the efficacy of CVnCoV in preventing first cases of confirmed COVID-19 of any severity, as well as preventing moderate to severe disease, in participants who have never been infected with the SARS-CoV-2 virus.

The European Commission – which has just approved the Moderna vaccine and previously gave a green light to the Pfizer/BioNTech shot – already has an order in for 405 million doses of the CureVac vaccine. It gave CureVac €75 million in funding to develop CVnCoV last July, adding to around €100 million provided by the German government in 2020.

The biotech would likely struggle to supply without the help of its new big pharma partner, although it has been expanding its production capacity in the last few weeks with the help of contract manufacturers like Wacker and Fareva.

Bayer said it will contribute in areas like clinical operations, regulatory affairs, pharmacovigilance, medical information, and supply chain performance to help get the vaccine to the public as quickly as possible.

“We are highly committed to making our capabilities and networks available to help end this pandemic,” said Stefan Oelrich, president of the German group’s pharma division.

Bayer is providing assistance to CureVac primarily in the EU and some other markets, where the German biotech will be the marketing authorisation holder, but has an option to seek approval of CVnCoV on its own account in countries outside Europe.

CureVac has previously said however that it does not intend to introduce its vaccine in the US – at least while the pandemic is ongoing – because the government there has already ordered enough supplies of rival jabs to immunise the entire population.

At last count, there are more than 60 coronavirus vaccines at in clinical development around the world, with another 170 in preclinical testing, according to the World Health Organization (WHO).