The success of the Belgian vaccination campaign creates difficulties in ongoing vaccine studies. At the Ghent Vaccine Center (CEVAC), nearly 400 of the 620 German CureVac study participants withdrew from the study because they were eligible for a vaccine approved by the European Medicines Agency.
In the future, producers will have to look for other ways to verify the effectiveness of their vaccines.
In Belgium, more than 2,000 people participated in the studies to ensure the efficacy and safety of the German vaccine. Some receive the vaccine, while others receive a placebo. But the manufacturer must be able to identify a certain number of infections in order to compare the two groups and draw conclusions about the effectiveness of the vaccine.
The CureVac study has already been delayed several times and that’s bad news for a growing group of participants. They don’t know if they’ve been vaccinated with an effective vaccine and are asking for clarification now because they qualify for an already approved vaccine and want to make plans for the holidays. Subjects may not be vaccinated with a second vaccine during the study, but can therefore opt out of the study. This “non-blinding” is happening more and more often. When participants are told that they have received an effective vaccine, the question often arises as to whether a second vaccination is necessary or safe.
Another approach
CureVac is likely the last manufacturer to investigate the efficacy of its vaccine through placebo-controlled Phase III studies. “The new phase III studies should look different, that’s for sure,” says CEVAC Professor Isabelle Leroux-Royles. “For example, we can look at antibody concentrations and compare them to registered vaccines.”
About 36,000 people worldwide took part in the phase 3 study for CureVac, a German manufacturer that says it will be able to demonstrate results by mid-June.
Leroux-Roels expects “the approval by the EMA to proceed very smoothly.” CureVac’s candidate vaccine, CVnCoV, is an mRNA vaccine and therefore works in a similar way to vaccines from pharmaceutical companies Pfizer-BioNTech and Moderna. Belgium has already signed 2.9 million doses of the vaccine. After Pfizer-BioNTech, Moderna, AstraZeneca and Johnson & Johnson, it should be the fifth vaccine to receive marketing authorization from the European Medicines Agency (EMA).
In the future, producers will have to look for other ways to verify the effectiveness of their vaccines. In Belgium, more than 2,000 people are involved in studies to ensure the effectiveness and safety of the German vaccine. Some receive the vaccine, while others receive a placebo. But the manufacturer must be able to identify a certain number of infections in order to compare the two groups and draw conclusions about the effectiveness of the vaccine. The CureVac study has already been delayed several times and that’s bad news for a growing group of participants. They don’t know if they’ve been vaccinated with an effective vaccine and are asking for clarification now that they are eligible for an already approved vaccine and want to make plans for the holidays. Subjects may not be vaccinated with a second vaccine during the study, but can therefore opt out of the study. This “non-blinding” is happening more and more often. When participants are told that they have received an effective vaccine, the question often arises as to whether a second vaccination is necessary or safe. So CureVac is likely to be the last manufacturer looking at its vaccine’s efficacy through placebo-controlled Phase III studies. “The new phase III studies should look different, that’s for sure,” says CEVAC Professor Isabelle Leroux-Royles. “For example, we can look at antibody concentrations and compare them to registered vaccines.” June. Leroux-Roels expects “the approval by the EMA to proceed very smoothly.” CureVac’s candidate vaccine, CVnCoV, is an mRNA vaccine and therefore works in a similar way to vaccines from pharmaceutical companies Pfizer-BioNTech and Moderna. Belgium has already signed 2.9 million doses of the vaccine. After Pfizer-BioNTech, Moderna, AstraZeneca and Johnson & Johnson, it should be the fifth vaccine to receive marketing authorization from the European Medicines Agency (EMA).
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