EU concludes discussions with Moderna for COVID-19 vaccine

The European Commission (EC) has finished exploratory discussions with Moderna for a supply deal for the company’s investigational mRNA-based COVID-19 vaccine candidate.

The initial deal would include the purchase of 80 million doses of the vaccine, and would also provide a further option for EU member states to purchase an additional 80 million doses once the vaccine has proven to be safe and effective against COVID-19.

The potential contract would allow all EU member states to purchase the vaccine, as well as donate to lower- and middle-income countries or redirect to European countries.

Moderna is the fifth company with which the EC has concluded such talks, which includes Sanofi/GlaxoSmithKline, Johnson & Johnson, CureVac and AstraZeneca.

Last week, AstraZeneca finalised an agreement with the EC to provide 400 million doses of its potential COVID-19 vaccine once it completes clinical testing and wins regulatory approval

The EC added that while the regulatory processes for potential coronavirus vaccines will be flexible, they will still remain robust. It will use existing flexibilities in the EU’s regulatory framework to expedite the authorisation and availability of successful vaccines for COVID-19.

“After intense negotiations, the European Commission has now concluded talks with a fifth pharmaceutical company, to enable rapid access to a vaccine against coronavirus for Europeans,” said Ursula von der Leyen, president of the EC.

“We continue talks with other companies – as we want to make sure that vaccines are rapidly available on the market. European investments in coronavirus vaccines will benefit the whole world and will help us beat this virus,” she added.

Earlier this month, Moderna reached an agreement with the US government for an initial 100 million doses of its vaccine candidate mRNA-1273 in a deal worth up to $1.525bn.

The US, under it’s Operation Warp Speed initiative, will also have the option to purchase up to an additional 400 million doses of the vaccine from Moderna.

An interim analysis of a phase 1 study of mRNA-1273 showed that the vaccine produced rapid and strong immune responses against SARS-CoV-2, the virus which causes COVID-19.

Following two doses of the vaccine, neutralising antibody levels among participants were similar to those seen in individual who had tested positive and recovered from COVID-19.

“We are advancing the clinical development of mRNA-1273 with the ongoing phase 3 study being conducted in collaboration with NIAID and BARDA. In parallel, we are scaling up our manufacturing capability with our strategic partners, Lonza, Catalent and Rovi, to address this global health emergency with a safe and effective vaccine,” said Stéphane Bancel, Moderna's chief executive officer.