Ceci est une version HTML d'une pièce jointe de la demande d'accès à l'information 'The Vaccines Procurement Steering Committee & the Joint Negotiation Team'.



 
The Co-Chair of the Steering Board (European Commission) welcomed participants and 
introduced the independent experts. 
 
 
  
By way of introduction
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Regarding the adenoviral vaccines, 
 informed that there are 
 teams 
world-wide working on these vaccines. 
 
 
 
 
 
 
 
                                                           
1 Platforms are technologies used to express the viral antigens. 

 

 
With respect to AZ, and the recent publication of their latest clinical trial results in The 
Lancet medical journal, 
 acknowledged that the vaccine can induce protection 
in rhesus macaques, however the animals continue to secrete the virus via the nasal tract and 
hence the vaccine would not effectively block transmission of the disease. The data in 
humans show neutralising antibodies of moderate titers, good T-cell immunity as AZ is 
relatively advanced 
 in their Phase III clinical 
trial. Whilst the advantage of this platform is the ease with which the vaccine could be 
produced, the immunogenicity in older adults is yet to be demonstrated/ observed. 
 
 issued the recommendation to continue monitoring this candidate’s evolution 
 

With regards to Johnson & Johnson (J&J), a vaccine based on human Adenovirus 26 was 
expected to enter Phase I clinical trials on 
July in Belgium and in US in people older than 
55 years of age. The booster would follow the first administration at day 56. 
 
 
 
 Immunogenicity evidence was scarce to 
date 
 
 
 
 
 complemented the analysis of 
 highlighting that the AZ approach is 
relatively good. Since the Phase II clinical trial participants were 18-50 years of age, further 
trials should include the 65+ contingent as the latter is more susceptible to contracting the 
disease. The recent publication includes some data on prophylactic use of paracetamol. The 
most effective schedule appears to be based on two doses, a first administration followed by a 
booster.  Emerging data on duration of protection or sterilising immunity is an outstanding 
issue. 
 
On the J&J candidate, 
 stated that the Phase II CT is starting this July, hence no 
solid opinion of this vaccine as yet. However, it may well be as promising as the AZ 
candidate. In conclusion, both the AZ and the J&J candidates may prove to be good options, 
based on currently available information. 

 

 
 started by introducing 
 
 
 
 
 
 
 agreed 
 
 AZ product is 
more advanced in development but the J&J product is from a company that is well aware of 
the adenoviral platform and has a lot of expertise. Whilst both parties draw on their solid 
background, 1:1 comparability of their products may well be hindered by the fact that assays 
are likely different
 
. For the AZ candidate, immunogenicity 
looked good, although painkillers may be needed for mitigating side-effects. She mentioned 
NOVAVAX having a potentially serious candidate as well in the long run. 
 thanked for the contributions and moved on to the mRNA platform category
 explained that the assessments 
 pertained to 
the candidates put forward by Moderna, BioNTech and CureVac, 
 
 
.  
With regards to Moderna’s and BioNTech’s candidates, the mRNA used has a modification 
which enhances the odds of inducing an immune response. 
 
 
. Moderna is starting their Phase III clinical trials. In animal studies, Moderna’s 
candidate has shown partial protection against the disease, yet not against infection; in human 
studies, it has triggered a relatively high reactogenic reaction 
 
. A dose of 100 microgram is the highest tolerated by vaccinneesThe 
recruitment is completed for Phase II CT 
, with Phase III planned covering 
30 000 vaccinees in the US. Moderna decided to cancel their European CT planned 
 

 highlighted that 
 
 

 



 
 agreed that rather big differences in the data currently available exist with 
hardly any results for CureVac, rendering ranking difficult. Moderna recently published a 
study in the New England Journal of Medicine for their mRNA-1273 candidate with similar 
results in the older group as in other studied groups. Moderna also shared some confidential 
 data for which a publication is forthcoming.  
Regarding the BioNTech product, 
 did not completely agree with 
 
 counterpart. 
 
 
 
 
  
On CureVac’s product, the 
 may well have more information and 
theoretically, it could be a good candidate but lagging behind currently. The only official data 
seen by 
 was limited 

In conclusion, Moderna and BioNTech are promising candidates for 
, with good 
immunogenicity profile and good tolerability also in the older age group. 
 
 
 

 then proceeded to the Sanofi-Pasteur and NOVAVAX category (the subunit 
vaccines). 
 explained that Sanofi-Pasteur are a large producer and have 
 vaccines in 
their portfolio as well as the expertise of producing vaccines as their core business. In terms 
of timing, 
 acknowledged that they 
 planning to start their Phase I 
CT in 
. The technology is adapted from that developed for one of their seasonal 
influenza vaccines (technology acquired from Protein Sciences). The antigen is administered 
with a squalene-containing adjuvant 
 

 
 In terms of production capacity, purification of antigens from insect cells 
infected with a recombinant baculovirus encoding the SARS-CoV-2 S protein (a well-
controlled procedure adapted from that developed for seasonal influenza vaccine). Sanofi-
Pasteur has the necessary infrastructure to ensure very large-scale production.  

 

 
With respect to the candidate put forward by NOVAVAX, 
 informed that 
 
certainly one to be followed very 
closely. The antigen is a complete recombinant Spike protein of SARS-CoV-2, stabilised in a 
pre-fusion conformation. The antigen is presented as trimers on lipid nanoparticles, normally 
more immunogenic than those on lipid form. The candidate is capable of producing high 
titers 
 even at the 
lowest dosage tested. Matrix-M™ adjuvant (saponin, cholesterol and phospholipid-based). 
Preclinical studies in mice and challenge experiments in non-human primates. Results of an 
infectious challenge study in macaque monkeys show a reduction in viral load in the upper 
respiratory track and lungs of vaccinated animals, suggesting a protective effect of the 
vaccine candidate. It is of note that the dose of virus used for the infectious challenge 
corresponds to the dose used by Moderna, but is lower than the dose used by AstraZeneca. 
Phase I CT commenced in May in Australia, Phase II ongoing currently in US and Australia. 
Production capacity is very high, with recently acquired capacity in CZ. NOVAVAX clearly 
capable of producing large amounts of vaccine. Plan to produce 
 doses in 

 
  
On Sanofi, 
 issued a note of caution regarding its AS03 adjuvant. GSK used this 
adjuvant in their pandemic vaccine and it induced narcolepsy in adolescents in 2009-2010. 
Many studies published since then and it seems that narcolepsy was not caused by the 
adjuvant itself, but by an antigen (one produced in BE, one in Canada) and only one of these 
seems to have caused narcolepsy. 
 
 
 
 
 
 quoted a study published in 2018 in the journal “Vaccine” which did not find 
an association between Sanofi’s pandemic flu vaccine and narcolepsy in children and adults. 
No data in humans yet from Sanofi’s candidate. As regards NOVAVAX, it seems that the 
vaccine can induce an immune response in vaccinees. 
  

 

 
found NOVAVAX’s Matrix-M™  formulation of interest. Perhaps a plus for the 
NOVAVAX product is the T-cell response
 
  
In 
concluding remarks, 
 highlighted the importance of spreading the vaccine portfolio 
over different platforms. The mRNA candidates are 
 for authorisations, 
. Manufacturers in this category draw on 
their experience with this platform, known for its effectiveness in respiratory infectious 
diseases.  
 thanked all speakers and opened the Q&A session. 
 Expert pointed out that direct comparisons of vaccine candidates should be 
avoided. Having read all published papers,
 wondered whether the limited number of 
participants in the BioNTech study data would be an issue and if the multivalent display in 
their mRNA design engendered any reactions. 
also invited comments on their lipid 
envelope. 
 acknowledged the intrinsic difficulty in drawing comparisons, generally speaking 
but a platform by platform comparison is feasible. There were a lot of data in animal studies. 
 Difficult to have a definitive 
conclusion but it seems reasonable to take different elements into account. 
 
 
 Expert enquired about storage temperatures. 
 explained that Moderna’s candidate consists in a powder to be reconstituted. It 
should be stored at -20 to -40° C 
 
. The BioNTech candidate indicated -80°C for long-term storage. 
Whilst CureVac’s candidate has two-dose vials stored frozen at -80°C for long-term storage, 
stability at 4°C can be preserved for several months. NOVAVAX has ten-dose vials 
(reconstituted for use), storage at -80° for several years but also at higher temperatures for 
administration. AZ has ten-dose vials, stable at 4°C for 6 months. J&J has ten-dose vials, 
stable for several months at 4°C to 10°C. 
 enquired how these temperatures might impact a vaccine’s workability in 
primary care centres in LMI countries. 

 

 
 responded that for Ebola vaccines in Africa, storage was in liquid nitrogen (in a 
cold chain container), keeping the temperature quite well. 
 
 
 (SE) suggested that 
 a more traditional adjuvanted 
protein vaccine would be needed for the elderly. 
 enquired whether adjuvants could be 
avoided at all. 
 replied that the jury is still out on that aspect. 
 
 Similar uncertainties remain for 
the other categories.  
 shared that current plans involve seeking to organise small immunogenic studies for 
the very old – over 75 years of age. Some manufacturers want to work with 
on this. 
 
wondered whether informing manufacturers of this forum’s endorsement may bring value 
added.  
 suggested that an independent organisation might compare samples from 
different CTs.  
The Chair (EC) highlighted that 
 Nobody 
knows what the future will hold. The Steering Board, along with the EC, can make informed, 
educated guesses and this is what we are seeking to do via the portfolio. A demand we are 
making recurrently is Phase III CT data. 
 
 We note the suggestion to contact NOVAVAX but 
doubts remain over their ability to deliver to the EU 
. A 
more traditional candidate such as the one put forward by Sanofi (or NOVAVAX), AZ or 
J&J is of interest. In the mRNA category, we will need to rely on other elements, not just 
scientific ones. Moderna is having a very commercial proposition, BioNTech/ Pfizer 
guarantees scalability whilst on CureVac, seemingly a good product but having difficulties to 
understand if they can produce at scale. The panel could have been clearer on the mRNA 
category. 
 clarified that 
 was referring to getting biological samples in this 
unprecedented vaccine development race with everyone wanting to be able to make a good 
judgment on products. 
 deemed it fair to ask the companies to collaborate in a 
standardised assay to measure the data, 
  

 

 
 Expert shared 
concerns that the companies may well be apprehensive in this 
regard. 
 
 

 Expert expressed concerns over the respect of purely scientific criteria in the 
ongoing negotiations.  
The Chair (EC) explained that the matter is rather more complex in that the Steering Board 
decides which companies to open negotiations with. For NOVAVAX, for example, no 
contact has been established 
  
 continued that the panel is not fully clear in their comparative assessment also 
because the information is not equally available. 
 
 
The Chair (EC) concluded discussions thanking all for their participation 
 

 also pointed out no objections from the 
Steering Board to the AZ candidate; good comments for J&J but a duplication of the AZ 
platform. For the innovative mRNA group, any of them would do for different reasons: 
scientific reasons for some or other reasons for others. The EC heard the panel’s views on the 
scientific data for CureVac’s candidate. 
 
 
 The JNT has not 
declined any of the candidates discussed today so this discussion will feed productively into 
future ones.  
The co-Chair (AT) thanked 
 (NL) and the Commission for putting this session 
together. 
 closed off the debate 
 
. Much too early to make a decision on turning down a 
candidate, although we are closing in on a portfolio. 
 
 
 
 
 
 
10 
 

 
 
Participants 
(AT, Co-Chair) 
 (NL)  
 
 (BE) 
 (BE) 
 (BG) 
 (CZ) 
 (CZ) 
 (DE) 
 (DK) 
 (EE) 
 (EL) 
 (ES) 
 (FI) 
 (FR) 
 (FR) 
 (HU) 
 (IE) 
 (IE) 
 (IT) 
 (LT) 
 (LV) 
 (PL) 
 (PL) 
 (PL) 
 (PT) 
 (PT) 
 (PT) 
 (PT) 
11 
 

 
 
 (SE) 
 (SI) 
 (SI) 
 (SK) 
 
Sandra Gallina (EC, Chair) 
 (EC) 
 (EC) 
 (EC) 
 (EC) 
 (EC) 
 (EC) 
 (EC, Minutes) 
 
12