Dies ist eine HTML Version eines Anhanges der Informationsfreiheitsanfrage 'The Vaccines Procurement Steering Committee & the Joint Negotiation Team'.



location. It should be borne in mind that the results originate in a Phase I study, where the 
requirement to report events in a stringent manner prevails. 
 enquired about the start of the trial with prophylactic 
paracetamol. CureVac replied that they

 asked whether the elderly would be divided into groups based 
on the threshold of 60 or 70 years of age. CureVac replied that they are running presently two 
groups: 18-60 years of age and 61+. In the HERALD Phase IIb/III study (six countries in 
Latin America, Germany, France, Netherlands, Spain and Belgium) also older participants are 
enrolled. 
A further question concerned data in vulnerable, immune-suppressed individuals. CureVac 
explained that subjects with comorbidities are indeed included. 
 enquired whether the trials are overlapping with the 
administration of the flu vaccines (i.e. whether roll-out is concomitant). CureVac replied that 
this data would come later. 
 asked about specific requirements for syringes and whether polycarbonate 
syringes could be used. CureVac explained that polycarbonate is a very rough material, which 
does not slip so easily. Manufacturers often include silicon oil, which might interfere with the 
lipid. Therefore, such syringes would need to be avoided.
.  
 enquired about paediatric studies. CureVac replied that the protocol is under 
validation and the start date 

 asked about the underlying reasons for the cold chain management 
being different in the case of CureVac compared to the other mRNA vaccine candidates. 
CureVac replied that this is indeed a striking difference compared to the other vaccines. 

 enquired what percentage of participants with comorbidities would be enrolled in 
Phase III trials. CureVac replied that the latter are included and a specific study is also 
targeted for patients with diabetes, for obese patients and for subjects with severe cardiac 
disease who might not be recruited so easily. 


 asked whether anything is known on the “stability” or persistence of vaccine 
mRNA in vivo and whether this has been studied in animals. 
further enquired for how 
long the antigen is being produced, and by which cell types. CureVac replied that they have 
been studying the stability very carefully.
 
 
  
 enquired whether CureVac plan studies concerning the booster effects for 
subjects that already received another vaccine dose, since other vaccines entered Phase III 
clinical trials by now. The company replied that it is hard to have such data but that they could 
make the vaccine work on boosters as well. 
 asked whether CureVac plan to test for antibodies before administering the 
vaccine in some or in all the subjects in the trial. 
 asked whether there was any 
relationship to be found between seropositive vaccinees and reactogenicity. CureVac 
explained that they proactively included subjects known to be seropositives to ensure that the 
reactogenicity profile would be similar. These showed lower reactogenicity than other 
vaccinees; a boost effect was observed. A further question was asked regarding the duration 
of the cellular or humoral immunity,
 
 
 
 
 enquired whether CureVac already had the regulatory approvals to start 
Phase III CTs and whether they could be more specific in terms of potential approval for the 
vaccine, 
. CureVac replied that they would be applying in 
 for conditional marketing authorisation. 
 asked whether CureVac could comment on the interpretation of the 
findings that a tendency to a reduction in Upper Respiratory tract Infections (URI) was found 
after the viral challenge. 
 enquired whether the implication was that transmission would not 
be blocked after vaccination. In terms of prevention of viral transmission, 
 
 asked whether the viral load in nose and throat is being 
evaluated during follow-up in a subgroup of participants in the Phase III study. 
 
remarked that it seems that the preclinical study did not prevent virus in nose and 
throat. CureVac replied that PCR tests are being performed and that the impact of 
transmission cannot be predicted. If a level of vaccination of 
% is reached, there is 
widespread agreement amongst epidemiologists that this coverage should be sufficient for the 
vaccination campaign. 
 
 
 
 enquired about studies in pregnant women and vaccination in 
CoV2 positive individuals. CureVac replied affirmatively – it is envisaged. 

 

 asked how advanced CureVac was regarding the 16ȝg and 20ȝg groups. These 
studies were still ongoing but the selected dose for Phase III was 12ȝg. 
 thanked CureVac for explaining the in vivo mRNA fate and protein expression. 
Upon request, CureVac provided the reference1. The full study published in the peer-reviewed 
journal Nature Partner Journals Vaccines can be found here.
The Chair thanked CureVac and all experts for their independent views and expertise and 
highlighted the usefulness of this informative meeting as a platform for exchange. The Chair 
thanked all for their participation and active involvement and closed the meeting. 
 
Participants 
CureVac: 
 Managing 
 
 Technology Officer 
 Infectious Diseases 
COVID-19 Programme Lead 
 Area Head Infectious Diseases 
 Supervisory Board  
Member States: 
 (AT) 
 (AT) 
 (AT) 
 (AT) 
 (AT) 
 (BE) 
 (BG) 
 (CZ) 
                                                           
1 https://www.biospace.com/article/releases/publication-in-npj-vaccines-demonstrates-curevac-s-rnactive-
vaccine-is-superior-to-licensed-vaccines/ 
 

 

 (CZ) 
 (CY) 
 (CY) 
 (DE) 
 (DE) 
 (DK) 
 (DK) 
 (DK) 
 (EL) 
 (EL) 
 (ES) 
 (ES) 
 (FR) 
 (HR) 
 (HR) 
 (HU) 
 (HU) 
 (HU) 
 (IE) 
 (IE) 
 (IE) 
 (IE) 
 (IE) 
 (IT) 
 (IC) 
 (LT) 
 (LT) 
 (LU) 
 (LU) 

 

 (LV) 
 (NL) 
 (NL) 
 (PT) 
 (PT) 
 (PT) 
 (NO) 
 (NO) 
 (RO) 
 (SE) 
 (SK) 
 (SI) 
 (SI) 
 (SI) 
European Commission: 
 (EC, Chair) 
 (EC) 
 (EC) 
 (EC) 
 (EC) 
 (EC) 
 (EC) 
 (EC) 
 (EC, Minutes)