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EU drugs regulator says it won’t impose 50% efficacy threshold for Covid-19 vaccines after disappointing result in CureVac trial EU drugs regulator says it won’t impose 50% efficacy threshold for Covid-19 vaccines after disappointing result in CureVac trial
(2 months later)
The European Medicines Agency (EMA) has said it will not bring in a minimum efficacy threshold for Covid-19 vaccines. The comment comes after clinical trials showed Germany’s CureVac jab to be only 47% effective against the virus.The European Medicines Agency (EMA) has said it will not bring in a minimum efficacy threshold for Covid-19 vaccines. The comment comes after clinical trials showed Germany’s CureVac jab to be only 47% effective against the virus.
CureVac announced data on the efficacy of its jab on Wednesday after it was tested in second- and third-phase trials involving 40,000 people across ten countries.CureVac announced data on the efficacy of its jab on Wednesday after it was tested in second- and third-phase trials involving 40,000 people across ten countries.
The company suggested variants of the virus may be behind the poor result.The company suggested variants of the virus may be behind the poor result.
On Thursday, the EMA’s vaccine chief Marco Cavaleri said it was “a bit early to say” after being asked by a journalist about the CureVac results and the threat variants may pose to vaccine efficacy.On Thursday, the EMA’s vaccine chief Marco Cavaleri said it was “a bit early to say” after being asked by a journalist about the CureVac results and the threat variants may pose to vaccine efficacy.
“We will need to collect all the final data from this clinical trial, and have a good analysis of the outcome throughout different regions, age groups and according to different variants,” he told an EMA briefing.“We will need to collect all the final data from this clinical trial, and have a good analysis of the outcome throughout different regions, age groups and according to different variants,” he told an EMA briefing.
Asked specifically about a 50% efficacy minimum level for vaccines, he added that the EMA had “always felt it was difficult to define upfront a threshold.”Asked specifically about a 50% efficacy minimum level for vaccines, he added that the EMA had “always felt it was difficult to define upfront a threshold.”
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