The international vaccine rollout encountered a new obstacle Thursday when Curevac released a set of disappointing late stage trial results that sent its shares tumbling while analysts slashed their price targets.
CureVac said on Wednesday its COVID-19 vaccine was only 47% effective in a late-stage Phase 2b/3 3 trial, missing the study's target and casting doubt upon the potential delivery of hundreds of millions of doses to the EU.
The disappointing efficacy of the shot, known as CVnCoV, emerged from an interim analysis based on 134 COVID-19 cases in the study with about 40,000 volunteers in Europe and Latin America. The importance of CureVac has increased in Europe after several EU governments i mposed age limits on the use of the J&J and AstraZeneca vaccines due to a link to extremely rare but potentially fatal clotting disorders, Reuters reports.
The company's shares dropped more than 50% on the news.
The shot was also supposed to help in low and middle-income countries that have lagged far behind richer nations in the global immunisation drive.
On Wall Street, analysts cut their price targets, with Kempen analysts Suzanne van Voorthuizen, lowering their target to $50 from $80. They expect the shares will remain under pressure until the final readout of trial results, which is expected in 2-3 weeks. According to her, the inclusion of least 80 more cases to a total of almost 200 cases was a large enough number to swing the 47% efficacy preliminary outcome. Analysts told BBG that they briefly spoke to the company yesterday, and management said that it had hoped to see higher efficacy at this stage.
To be sure, the data released on Thursday isn't the final word. As we've seen already, efficacy numbers for various vaccines have shifted, sometimes dramatically, from trial to trial (who could forget how the Pfizer jab's efficacy was magically revised higher after Moderna topped it?)
Minutes after the results were released, German public health officials released a statement saying that the failure of the German biotech firm to meet its efficacy goal wouldn't impact the speed of Germany's vaccination rollout.
Unfortunately, the same cannot be said for other countries with fewer resources.
The European vaccine rollout has accelerated over the past month, pushing the 27-member bloc's vaccination rate higher; now, more than 40% of adults have received at least one jab.
The EU has even gained on the US, where state governors are rolling back restrictions to normal or near-normal.
Read the press release below:
CureVac N.V. (Nasdaq: CVAC), a clinical-stage biopharmaceutical company developing a new class of transformative medicines based on messenger ribonucleic acid (“mRNA”), today announced results of the second interim analysis of its international pivotal Phase 2b/3 study in approximatively 40,000 subjects (the HERALD study) of CureVac’s first-generation COVID-19 vaccine candidate, CVnCoV. In the unprecedented context of at least 13 variants circulating within the study population subset assessed at this interim analysis, CVnCoV demonstrated an interim vaccine efficacy of 47% against COVID-19 disease of any severity and did not meet prespecified statistical success criteria. Initial analyses suggest age and strain dependent efficacy. Available data were communicated with the European Medicines Agency (EMA). The Data Safety Monitoring Board (DSMB) confirmed a favorable safety profile for CVnCoV. The study is continuing to the final analysis and the totality of the data will be assessed for the most appropriate regulatory pathway.
In total, 134 Covid-19 cases were assessed in this interim analysis. Out of these cases, 124 were sequenced to identify the variant causing the infection. The outcome confirms that only one single case was attributable to the original SARS-CoV-2 virus. More than half of the cases (57%) were caused by Variants of Concern. Most of the remaining cases were caused by other less characterised variants such as Lambda or C.37, first identified in Peru (21%) and B.1.621, first identified in Colombia (7%). In this context, the interim results suggest efficacy in younger participants but did not allow to conclude on efficacy in the age group above 60.
"While we were hoping for a stronger interim outcome, we recognize that demonstrating high efficacy in this unprecedented broad diversity of variants is challenging. As we are continuing toward the final analysis with a minimum of 80 additional cases, the overall vaccine efficacy may change,” said Dr. Franz-Werner Haas, Chief Executive Officer of CureVac. “In addition, the variant-rich environment underlines the importance of developing next-generation vaccines as new virus variants continue to emerge."
The HERALD study, conducted by Curevac in conjunction with Bayer, enrolled approximately 40,000 participants in ten countries in Latin America and Europe. The second interim analysis included 134 cases, occurring at least two weeks after administration of the second dose. To identify strains causing COVID-19 infections within the trial, sequencing of virus variants has so far been performed on 424 COVID-19 cases, of which 124 fulfilled adjudication criteria and were included in the present efficacy analysis.
CureVac remains committed to COVID-19 vaccine development. Beyond CVnCoV, the company develops in partnership with GSK second-generation COVID-19 vaccine candidates. These candidates are based on new mRNA backbones and include potential variants in multivalent vaccine formats as well as combination vaccines for potential protection against multiple infectious diseases in one vaccine. Preclinical data from the first vaccine candidate, CV2CoV, has recently been accepted for publication in Nature Communications. CureVac and GSK expect to progress the second-generation vaccine candidate into clinical testing in the third quarter of 2021, with the goal of introducing the vaccine in 2022, subject to regulatory approval.