from 8μg assays is forthcoming).
oreover, CureVac highlighted that results look for induction of T-cell
responses, not just neutralising antibodies (NAbs).
The T-cell data is expected in
, with the second dose study
starting in
. The data in non-human primates (NHP) will be available in
.
asked whether primate data would be part of the EMA submission. CureVac
explained that the data would not be ready for the advice meeting in September but that the
Protocol would be shared.
enquired whether CureVac had any data on mucosal immunity (i.e.
efficacy for infection prevention versus disease severity reduction). CureVac answered that
they expect data
–
.
asked how long the follow-up of subjects is planned for in what concerns the
persistence of the immune response. CureVac answered that
the follow-up is envisaged for
after vaccination. Based on the rabies study,
the stable response was monitored
after vaccination. The duration of the immune
response is expected to be
.
The Chair asked CureVac to elaborate on when they expect the drug substance dosage to be
final. CureVac replied that they would select the dose in
. Initial
indications point to an 8μg formulation, as safety data seems in order.
CureVac informed that the 12μg formulation is considered a back-
up for which the capacity needs to be in place. The 8μg dosage shows initial good results.
The 12μg is a conservative
fallback but so far significant differences between the elderly and the younger vaccinees have not
been observed.
The Chair asked how likely the 8μg single dose would be. CureVac answered that the study in
Latin America to select the appropriate dose has started
.
asked whether challenge trials in NHP were performed and whether disease
enhancement was investigated. CureVac answered that
2
studies are
ongoing to shed more light on these elements.
The Chair thanked CureVac for their insightful presentation and all experts for their interest and
active participation and closed the meeting.
Participants
CureVac:
Managing
,
Supervisory Board
,
Technology Officer
,
Pre-Clinical
,
Infectious Diseases
Vice-President
Member States:
(AT)
(AT)
(AT)
(BE)
(BE)
(BG)
(CZ)
(CZ)
(CZ)
(DE)
(DK)
(DK)
(DK)
(EE)
3
(EL)
(EL)
(ES)
(FI)
(FI)
(HU)
(HU)
(HU)
(IE)
(IE)
(IT)
(LT)
(LT)
(LV)
(LU)
(MT)
(MT)
(NL)
(NL)
(NO)
(NO)
(PL)
(PT)
(PT)
(PT)
(PT)
(RO)
(SI)
(SK)
4
European Commission:
(EC, Chair)
(EC)
(EC)
(EC)
(EC)
(EC, Minutes)
5