In terms of stability data for storage conditions, CureVac representatives
at 4°C instead of the previously announced 3 months, whilst long-term storage is in cold
chain at -80°C. Full stability data should become available by November 2020.
Vaccine production is fully managed by CureVac, partnerships envisaged
inter alia for
Fill/Finish.
With regards to timelines,
. Phase
IIa/b is planned for autumn
. Phase IIb/III trials should start by
.
Phase II trials were starting in Panama and in Peru.
For further details, the reader is referred to the
presentation.
Q&A:
The Chair thanked for the presentation and opened the Q&A session. Certain questions were
asked during the presentation but they are recorded for the purposes of these Draft Minutes as
being a part of the Q&A session.
The Chair asked whether assays with 16 and 20μg mRNA would continue as planned. CureVac
confirmed that the intention behind these assays
.
expressed a
CureVac further explained they have plans to expand their panel of convalescent subjects.
queried the usefulness of the hamster model and asked whether there were any
plans to set up a transmission model since protection is much stronger if transmission is
prevented.
further enquired on the state of play of NHP data. CureVac replied that the
transmission model would be built
and that first draft NHP data
(imaging read-outs for the lung pathology) is expected in the first half of October, thanks to the
cooperation with Public Health England.
congratulated CureVac for the considerable progress made in the last few weeks.
enquired how CureVac interprets the data
2
. CureVac replied that
With regards to the age
grouping, CureVac explained that
.
enquired whether T-cell immunogenicity data would feed into selection
criteria for the dose, especially if a higher dose is to be considered. CureVac replied that they
indeed aim to complete the full analysis
in the next
weeks and to compare
with
to have a good picture. The dose selection will be based on the entire dataset,
but also on the reanalysis.
The Chair supported the drive for an optimised dataset and enquired whether there is any
threshold for which the
dose would not be sufficient. CureVac explained that the dose
selection would depend entirely on the data,
. The 12μg group is of a key interest and as compared to other vaccine candidates, even
16μg mRNA is a low dosage.
enquired whether Phase I data would be published soon. CureVac
replied that also pre-clinical results would be seeing the public domain soon.
asked whether CureVac would be prepared to use paracetamol when going up in
doses. CureVac replied affirmatively that participants are not prohibited from using anti-
inflammatories. This dimension can be built into the analysis ex-post.
enquired what would be the T-cell assay for the clinical samples – peptide pools
or Th1 versus Th2. CureVac replied that they can discriminate between CD4 and CD8 induction
in blood.
asked whether CureVac can concentrate on specific antibodies and
differentiate RBD specific antibodies. CureVac explained that
.
enquired about sterilising immunities and whether the vaccine aims
at achieving high risk group efficacy or herd immunity (i.e. where younger subjects can be
vaccinated as well). CureVac replied that the primary endpoint is stopping the disease, followed
by prevention of infection. Symptom-based swabbing will be applied.
asked whether a one-dose regimen is still an option or whether a boost is needed.
CureVac elaborated that a two-dose regimen is the best solution, with a strong observed
expansion after the first dose. The T-cell response specifically benefits from a vaccination boost.
In the low dose cohort, a third cohort will be included to show the boost effect of the response –
in the seropositive group, a good primed response can be observed.
3
(ES)
(ES)
(FR)
(FR)
(FR)
(IT)
(IT)
(NL)
(NL)
(PL)
(SE)
European Commission:
(EC, Chair)
(EC)
(EC)
(EC)
(EC)
(EC)
(EC)
(EC)
(EC, Minutes)
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