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



 
 
. In relation to the second question, CureVac explained that they have just started 
a pilot study to test the model itself and also looking into a mouse model that they could use with 
a view to obtaining more confidence/ support on efficacy data for Phase III CT data.  
 commended CureVac on the considerable improvement for the higher dose 
regimen and all the immune assays and reactogenicity profiles. Questions were asked on new 
data: for reactogenicity, Spike-specific multifunctional CD4+ T-cells were measured, but is 
CureVac also measuring the type 2 cytokines for a balanced response and whether they would 
expand those data for the 12μg group. A second question on the upfront prescription of 
paracetamol was asked in view of addressing more prolonged severe effects after the second 
dose in the 12μg reactogenicity group. CureVac concurred with the suggestions of the speaker 
for both questions and confirmed that T-cell analysis is underway in the cytokine panel; 
expansion to 12μg is ongoing. Based on previous rabies data, no signs of biased Th2 responses 
were observed. On the prophylactic use of paracetamol, CureVac explained that whilst 
recommended (posology 500 mg), the company do not wish to impose it.
 
 
 
 
A question was asked on the chosen locations for the roll-out of the Phase III study. CureVac 
replied that the latter would take place in
 
 

Another question was asked about the reactogenicity profile in seropositives as the latter appears 
to be lower with a response even after the first dose. CureVac explained that the recent data gives 
a lot of hope with respect to the induction of memory cells in patients. 
 
.  
A further question was asked regarding the increase in IgG titers. CureVac replied that 
 for 
the 
 dose, an increase 
for all subjects 
was observed. 
 provides further data on NAbs, also for IgG (binding antibodies), for 
which a similar increase is observed. The increase is more pronounced for subjects that have low 
antibody titers. The reactogenicity also seems to be lower compared to the naïve persons. In the 
Phase III trial, proportion of seropositive subjects may well be higher. For IgG, the picture is 
very similar.  
 asked whether testing of 16μg and 20μg in humans was planned. CureVac 
explained that these assays are ongoing. Safety of those higher dosages is being monitored. 
Whilst there are not many vaccinees in the 16μg and 20μg group (under 20 vaccinees) amounting 
to a relatively small sample, the observation that reactogenicity increases with the dose is of 
note. Consensus around the 12μg dose exists in view of a balanced human response 
reactogenicity.  
 enquired about regulatory approvals for a Phase III start in 

CureVac was asked whether they have considered how their plans can be modified just in case 

 

 
other vaccines obtain regulatory approval before them and how their Phase III trials could be 
adjusted in this light. A question was also asked about the use of more than two doses. CureVac 
replied that Phase IIb/ III trials are indeed planned in 
 
 
 
 
 CureVac further explained 
that it is predictable that other vaccines would be on the market. Some vaccines might obtain 
approval whilst CureVac Phase III study is ongoing – in this case CureVac has an obligation to 
inform the vaccinees, as these developments might impact their willingness to continue the 
study. Subjects eligible to participate might indeed leave the study as information from 
competitors comes in, hence adjustments in the study planning may well be needed. With respect 
to the prospect of having three doses, CureVac informed that 
 
 
 The company further explained that the
 
 
 
 
A question on publication timelines was raised. CureVac informed that in the coming week the 
work would be presented at an mRNA Conference and a publication would be prepared in 
parallel. Regarding the NHP data, the partnership with PHE for the manuscript is expected to 
result in a publication in 
.  
 requested the final version of the presented slides and referred to the 
reactogenicity in the older group and whether expectations for immunogenicity and 
reactogenicity in this group would not be for lower read-outs. CureVac replied that the point was 
well taken and in view of the few subjects 
, more data would be needed for an 
assessment. CureVac also clarified that these were a subset of adults and not 60+ adults. As the 
studies are in Europe and Latin America, the perception of side effects can be different from 
country to country. Whilst fever is objectively measured, all other symptoms (myalgia, fatigue, 
etc) are subjective and can change with age and country. 
 
 
 
 
The Chair thanked once again the representatives of CureVac and the company signed off, 
allowing for more discussion amongst the experts. 
 
 
 

 

 
 
 
 
 
 
 expressed a minor reservation regarding reactogenicity which 
might jeopardise the acceptance of the second dose. He added that the role of prophylactic 
paracetamol was also not very clear. The key aspect compared to other mRNA vaccines is the 
storage conservation, i.e. the stability of the CureVac candidate vaccine. 
 remarked that the company was making good progress on many aspects that 
were previously not clear 
 
 
. Overall, the 
development is positive for CureVac and data on paracetamol can still be used in relation to 
reactogenicity. The profile chosen by their Data monitoring board is appropriate.  
 explained that reactogenicity in the case of mRNA vaccines is to be 
expected. Low fever is a characteristic of these types of vaccines, with a recent paper by 
BioNTech/ Pfizer pointing to high to moderate fever and chills. This is a question of risk/ 
benefit. AstraZeneca also used Paracetamol, hence not uncommon. 
In reply to a question from the Chair, 
 explained
 

The Chair remarked that the situation may improve with the second wave of vaccines. 
 agreed that  % efficacy is needed for vaccines to render them appropriate for 
deployment. 
 
 
 
 
 
 
 enquired about views on a possible third dose and reactogenicity. As data on 16 
and 20μg is still being collected (for the elderly the 12μg dosage may not be enough), a third 
dose may be of interest.  
 confirmed that logistics can be very complicated with three doses.  


 

 
 expanded that in nursing homes this can be done. In Latin America, a dose 
reduction is being tested for improved immunity. If there is a marked improvement, this is 
doable – however, if the improvement is marginal, then such a reduction and dosage may not be 
worth the effort. 
The Chair thanked all experts for their independent views and expertise and concluded that 
logistics will likely be key in the choice of vaccines by Member States. The Chair thanked all for 
their active engagement and closed the meeting. 
 
 
Participants 
CureVac: 
 Managing 
 
 Technology Officer 
 
 Infectious Diseases 
 COVID-19 Programme Lead 
 Area Head Infectious Diseases 
 Supervisory Board  
 
Member States: 
 (AT) 
 (DE) 
 (DE) 
 (ES) 
 (ES) 
 (FR) 
 (FR) 
 (FR) 
 (IT) 
 (IT) 
 (NL) 
 (NL) 

 

 
 (PL) 
 (SE) 
 
European Commission: 
Sandra Gallina (EC, Chair) 
 (EC) 
 (EC) 
 (EC) 
 (EC) 
 (EC) 
 (EC) 
 (EC) 
 (EC) 
 (EC, Minutes)