FDAnews
www.fdanews.com/articles/198664-eu-curevac-near-advanced-purchase-agreement-for-covid-19-vaccine

EU, CureVac Near Advanced Purchase Agreement for COVID-19 Vaccine

August 21, 2020

German vaccine maker CureVac and the European Union (EU) are close to finalizing a supply deal for the company’s COVID-19 vaccine candidate that will stock the EU with hundreds of millions of doses.

CureVac said that it is now in “advanced discussions” with the European Commission and anticipates signing a contract for 225 million doses of the mRNA-based vaccine for European member states.

The planned contract, which will be paid for from the EU’s $2.7 billion COVID-19 vaccine fund, includes an option to buy an additional 180 million doses.

European Commission President Ursula von der Leyen said the EU “will soon have an agreement with CureVac,” adding that “negotiations continue with other companies to find the technology that would protect us all.”

The doses purchased in advance from CureVac will be distributed after the vaccine candidate has been shown to be safe and effective in trials, the company said.

The drugmaker received regulatory approval for a German and Belgian phase 1 trial of the vaccine candidate in June, along with $338 million from the German government (DID, June 18). The study is aimed at finding the optimal dose for the vaccine and assessing its safety and immunological profile. Initial results from the trial are slated to come out early in the fourth quarter, and the company expects to launch a phase 2b/3 trial around that time.

Earlier this week, the EU confirmed its first COVID-19 vaccine supply deal, an agreement that reserves up to 400 million doses of AstraZeneca’s vaccine candidate. The EU is also expected to enter into a deal with Johnson & Johnson for up to 400 million doses of the drugmaker’s vaccine candidate (DID, Aug. 17). — James Miessler