CureVac's shots use messenger RNA technology similar to that of the highly effective Moderna and Pfizer/BioNTech vaccines
Shares of CureVac (CVAC) are under pressure on Thursday following the company's release of Phase 2b/3 study data, with overall vaccine efficacy reported at about 48%. While "significant protection was demonstrated among participants in the age group of 18 to 60," in participants above 60 years, who represented 9% of the analyzed cases, the available data "did not enable a statistically significant determination of efficacy." Commenting on the results, Berenberg analyst Zhiqiang Shu believes CureVac's COVID vaccine data may be enough for EU approval.
COVID VACCINE STUDY: CureVac has announced results from the final analysis of its 40,000 subject international pivotal Phase 2b/3 study, the HERALD study, of the first-generation COVID-19 vaccine candidate, CVnCoV. In the "unprecedented context of 15 strains circulating within the study population at the time of final analysis," CVnCoV demonstrated an overall vaccine efficacy of 48% against COVID-19 disease of any severity, including single non-respiratory mild symptoms. Significant protection was demonstrated among participants in the age group of 18 to 60, with an efficacy of 53% against disease of any severity and across all 15 identified strains; protection against moderate to severe disease was calculated to be 77%. In the same age group, CVnCoV provided 100% protection against hospitalization or death. In participants above 60 years, who represented 9% of the analyzed cases, the available data "did not enable a statistically significant determination of efficacy," the company said. The data confirm the favorable safety profile of CVnCoV in all age groups. The study will continue to complete follow-up analyses for trial participants. Available data have been communicated to the European Medicines Agency.
CureVac plans to continue work on its COVID-19 vaccine despite disappointing clinical trial results that showed the shot is just 48% effective, CNBC's Holly Ellyatt reported. "We need now to speak to the EMA and want to make sure we have an open dialogue and share all the data we have to assess the path forward," CureVac CEO Pierre Kemula told CNBC's Squawk Box Europe. The executive added that, "We have a contract with the European Commission to supply 225 million doses of the drug so I think, with that in mind, we need to plow forward."
DATA MAY BE ENOUGH FOR EU APPROVAL: Commenting on the final results from CureVac's Phase 3 trial evaluating its COVID-19 vaccine CVnCoV, which showed 48% efficacy in the overall population and 53% efficacy in participants younger than 60, Berenberg analyst Zhiqiang Shu acknowledged that the data "appears inferior to other mRNA vaccines." However, the analyst argued that the study was conducted in a variant-rich environment and is "probably sufficient to support a potential regulatory approval by the EMA." Safety of the vaccine was favorable, he added. Shu, who said the agency review timeline is unclear and noted that a potential label may be restricted to certain age groups, has a Buy rating and $123 price target on CureVac shares.
PRICE ACTION: In Thursday morning trading, shares of CureVac have dropped about 7% to $68.52.