CureVac Seals Vaccine Supply Deal with EU

19.11.2020 - German biotech CureVac has signed a supply agreement with the European Commission to provide an initial 225 million doses of its mRNA-based Covid-19 vaccine, with an option for another 180 million doses.

As with many other supply deals, a price per dose was not disclosed. Likewise, the agreement carries a provision that the vaccine must be approved by the relevant national medical authorities after successful completion of Phase 3 trials. The candidate CureVac has chosen to advance, CVnCoV, is currently in Phase 2 trials in Peru and Panama.

In a recent statement, the company shared initial data from the trial, saying its 12-µg dose of CVnCoV raised levels of binding and neutralizing antibodies to levels seen in the plasma of a set of 67 seriously ill Covid-19 patients, including some 16 people who were hospitalized.

The relative proportion of neutralizing to binding antibody levels was similar in the vaccinated and convalescent individuals, CureVac said, adding that it saw “indications of functional T cells confirming activation of cellular immune response.” What’s more, the 12-µg dose was “well tolerated, with no related serious adverse events.”

CureVac aims to produce 300 million doses of the candidate in 2021 and up to 600 million doses in 2022. Over the coming weeks, it plans to sign manufacturing deals with CDMOs in Germany, as well as France, the Netherlands, Belgium, Spain and Austria. The company is also weighing options for supplying Sweden, Poland, Italy and Ireland.

To meet its ambitious supply target, the biotech, owned 23% by the German government, said it is boosting its manufacturing network to produce "pandemic-scale volumes.”

Development work on a new large-scale production facility is in progress at CureVac’s Tübingen headquarters, financed in part by a €75 million loan granted in July by the European Investment Bank. This three- tranche credit facility will also cover expansion of existing production suites.

As regards distribution, the German company claims its vaccine has better logistics prerequisites, compared with the Pfizer-BioNTech candidate, as it can be stored at higher temperatures.

Pfizer-BioNTech now reporting 95% efficacy

After winding up their Phase 3 trial, Pfizer and BioNTech said on Nov. 18 that their BNT162 Covid-19 vaccine candidate had shown a 95% success rate. With the two months of safety data required, this paves the way for Pfizer to apply for an emergency use authorization (EUA), as planned, within the next several days.

In a preliminary report released two weeks ago, the companies pointed to an efficacy rate of “more than 90%.”

The FDA’s vaccine advisory committee is expected to review and discuss the developers’ data in a public meeting, probably in December. Pfizer and BioNTech said they also plan to submit the data from the study to other regulatory agencies and publish it in a peer-reviewed scientific journal.

Data for Moderna’s rival mRNA vaccine candidate released Nov. 15 showed a comparable efficacy rate of 94.5%. The US biotech also plans to apply to the FDA for an EUA toward the end of the month after accumulating more safety data.

Author: Dede Williams, Freelance Journalist