Covid vaccine CureVac in turmoil... This Wednesday June 16, the German laboratory announed their solution - developed with Bayer - was only 47% effective according to the intermediary assessment of the ongoing clinical trial. The vaccine "demonstrated an interim vaccine efficacy of 47% against COVID-19 disease of any severity and did not meet prespecified statistical success criteria", the laboratory explained in a release.
But the laboratory tries to stay optimistic: "the overall vaccine efficacy may change", Dr. Franz-Werner Haas - Chief Executive Officer of CureVac - said. What has caused this lower efficacy? The outbreak of variants: "we were hoping for a stronger interim outcome, we recognize that demonstrating high efficacy in this unprecedented broad diversity of variants is challenging", Haas goes on.
As for this new clinical trial phase, it is still going on and involves 40,000 people across Europe and South America. Among them, 134 have caught the virus and among these 134 people, the tests of 124 sick have been sequenced to find out what strain of the virus it was. In 57% of the cases, it was a variant of concern.
And yet, everything started well in late December 2020... The German CureVac laboratory announced this Monday December 14, 2020 they are launching the last phase of the clinical trials for their candidate vaccine, joining the global race of pharmaceutical groups to develop an effective Covid-19 vaccine. “The first participant has been dosed in a Phase 2a clinical trial of its COVID-19 vaccine candidate” CureVac announced this past September in a release when launching the phase 2 of the trials.
“CureVac plans to initiate the global Phase 2b/3 clinical trial” the laboratory explained in the release. As for this new phase, “the first volunteer has been enrolled”. It is expected to be conducted on the larger scale than the previous one, including “over 35,000 participants” CureVac says, mainly from Europe and South America. A vaccine that uses – like Moderna and Pfizer do – the messenger RNA technology said to target elderly people first as they are more likely to get a severe form of the disease.
This Thursday January 7, 2021, pharmaceutical group Bayer stick its oar in saying they signed a partnerhsip with the laboratory to develop the vaccine. Both laboratories concluded - as a release reads - they "enter into a collaboration and services agreement / Bayer to support CureVac in numerous areas" including producing the Covid vaccine. The goal being: "to facilitate the supply of several hundred million doses".
Both companies added in the release that "Bayer will contribute its expertise and established infrastructure in areas such as clinical operations, regulatory affairs, pharmacovigilance, medical information, supply chain performance as well as support in selected countries.".
As for phase 2 of the clinical trials, it included 690 participants coming from Peru and Panama. “The start of the clinical Phase 2a trial in Peru and Panama represents an important step forward in our COVID-19 clinical study program,” Dr. Mariola Fotin-Mleczek, Chief Technology Officer of CureVac, said back in September.
If the vaccine passes all the test phases, it could be issued with delay… Beyond the disappointing preliminary assessments, Bade-Wurtemberg health minister - where the laboratory is found - explained this past June 11 to the AFP they have been told about CureVac vaccine delay because of the extension of the ongoing clinical trial. In early May already, the laboratory said there were encounting supplying issues. The reason? The United States blocking exports of some components necessary to make the vaccine. "We no longer receive the materials we need", CureVac CEO told Spiegel.
A vaccine already secured by the European Commission that ordered 225 million doses. Note that CureVac is also developing another mRNA vaccine in partnership with British laboratory GSK.
