Esta es la versión HTML de un fichero adjunto a una solicitud de acceso a la información 'The Vaccines Procurement Steering Committee & the Joint Negotiation Team'.



 
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
 
 

 

 
 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) 

 

 
 (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) 

 

 
 
European Commission: 
 (EC, Chair) 
 (EC) 
 (EC) 
 (EC) 
 (EC) 
 (EC, Minutes)