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.
2
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.
3
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/
4
(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)
5
(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)
6