COVID-19 Vaccines Under Review at European Medicines Agency

first published: 18.12.2020
text updated continously as new data becomes available.

This is a short summary of the status of the COVID-19 candidate vaccines currently under review at the European Medicines Agency (EMA) and few characteristics of the vaccines.

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1. Clinical Current status at EMA

Vaccine1Developer/ Manufacturer/ ApplicantRolling review2CMA Approval3
AZD1222AstraZeneca & University of Oxford01.10.202029.01.2021
BNT162b2BioNTech & Pfizer06.10.202021.12.2020
mRNA-1273Moderna Biotech Spain, S.L.16.11.202006.01.2021
Ad26.COV2-SJanssen-Cilag International N.V.01.12.202011.03.2021
NVX-CoV2373Novavax CZ AS03.02.2021
CVnCoVCureVac AG12.02.2021
Sputnik VGamaleya National Centre of Epidemiology and Microbiology (Russia)04.03.2021
Vero CellSinovac Life Sciences Co., Ltd (China)04.05.2021
1 name of vaccine as reported at EMA,
2 start of rolling review,
3 ‘conditional marketing authorisation’ (CMA) approval date

2. Clinical status

VaccineClinical Phase4Participants5Status6
AZD1222Phase III20,000 vaccine +
10,000 placebo
NCT04516746↗
BNT162b2Phase III~44,000NCT04368728↗
mRNA-1273Phase III20,000 vaccine +
10,000 placebo
NCT04470427↗
Ad26.COV2-SPhase III44,000 totalNCT04505722↗
NVX-CoV2373Phase III30,000 totalNCT04611802↗
CVnCoVPhase IIb / III36,500 totalNCT04652102↗
4 ongoing,
5 estimated total number of participants, currently recruiting,
6 opens a new window at https://clinicaltrials.gov

3. Dosage, Efficacy and Logistics

VaccineMain ComponentDosage7EfficacyStorage
AZD1222Non-replicating
DNA vector
2x62.1% 82 to 8 °C
BNT162b2mRNA2x~90% 9−80 to −60 °C
mRNA-1273mRNA2x94.1% 10−20 °C
Ad26.COV2-SNon-replicating
DNA vector
1x67 % 11a−20 °C
NVX-CoV2373laboratory-grown protein-based 2x 11b−20 °C
CVnCoVmRNA2x
7 intramuscular (IM) injections,
8 research publication (08.12.2020),
9 research publication (17.12.2020)
10 company website (17.12.2020)
11a information on EMA website (11.03.2021)
11b no information on company website (11.02.2021)

HOW MANY DOSES?
Initial data shows that Luxembourg would have 0.138% pro-rata share of the vaccine procured and distributed through EU, which effectively means that of the first 300 Million doses of the Pfizer/BioNTech COVID-19 vaccine Comirnaty® available, Luxembourg would have a share of 414,000 doses. Similarly, out of 80 Million doses of the Moderna COVID-19 vaccine, Luxembourg’s share would be 110,400 doses. Below are additional details of packaging and some delivery/vaccination updates.

11.01.2021 It was mentioned today that Luxembourg has secured 414,210 doses of BioNTech/Pfizer and 110,462 doses of Moderna vacine, in line with the above expectations. With a total of 524,672 doses secured so far, Luxembourg is expected to vaccinate 262,336 residents and non-resident (cross-border) workers before the end of 2021.

PACKAGING
The Pfizer / BioNTech COVID-19 vaccine Comirnaty® has a standard pakaging of 195 vials in one box, and each vial contain 5 doses*. This effectively means each box contains (195×5=) 975 doses. The vaccination (for 16 years or older) would need 2 intramuscular injections of 0.3ml each, injected at 21 days apart.
The Moderna COVID-19 vaccine has a standard pakaging of 10 vials in one box, and each vial contain 5 doses. This effectively means each box contains (10×5=) 50 doses. The vaccination (for 18 years or older) would need 2 intramuscular injections of 0.5ml each, injected at 28 days apart.

* European Medicines Agency clarified that a 6th dose is possible to be extrated from each Pfizer/BioNTech vaccine vial if a ‘low dead-volume syringe and/or needle’ is used! So, technically more people could be vaccinated if right syringes are used to get a 6th dose out of each vial! Luxembourg is expected to procure the right needles in near future.

WHEN?
The above vaccine doses are expected to be delivered before the end of 2021, as per the agreement with the EMA / EU.

By the end of March 2021, Luxembourg is expected to recieve 80 boxes of the Pfizer / BioNTech COVID-19 vaccine Comirnaty®, total (80x195x5=) 78,000 doses, meaning 39,000 Luxembourg residents and cross-border workers of age 16 years or older can be vaccinated.

The ‘Priority List’ for vaccination currently comprises:
• health professionals and hospital staff,
• liberal health professionals,
• staff of the old people’s homes and help-staff, and
• residents from the retirement homes.


TIMELINE
21.12.2020
European Medicines Agency (EMA) recommends for ‘conditional marketing authorisation’ in EU27 for Pfizer/BioNTech COVID-19 vaccine Comirnaty®, making it the first vaccine to get approval.

26.12.2020
Luxembourg has recieved the first batch of 10 boxes of Pfizer/ BioNTech COVID-19 vaccine (equivalent to 9,750 doses).

28.12.2020
1,200 healthcare professionals and hospital staff are the first to recieve the first doses of Pfizer/ BioNTech COVID-19 vaccine.

06.01.2021
European Medicines Agency (EMA) recommends for ‘conditional marketing authorisation’ in EU27 for Moderna COVID-19 vaccine, making it the second vaccine to get approval.

07.01.2021
Up to 6,200 residents from 11 old age homes and care centers are expected to be vaccinated by 14th Jan 2021

11.01.2021
A second trache of 5 boxes of Pfizer/ BioNTech COVID-19 vaccine (equivalent to 4,875 doses) and 24 boxes of Moderna COVID-19 vaccine (equivalent to 1,200 doses) were recieved today.

13.01.2021
Luxembourg has received a total of 15,825 Doses of COVID-19 Vaccine so far, suitable to vaccinate 7,912 People. Of the 15,825 doses, 2,871 doses has been administered as of 13.01.2021.

Of the total 24,000 invitations sent for serological tests, 3,416 tests were done (16.11.2020 – 05.01.2021), of which 235 came positive, indicating a natural antibody prevalence against SARS-CoV-2 of 6.88% in the people sampled. This percentage is quite similar to the 7.26% of the resident population deemed recovered after being tested SARS-CoV-2 positive by PCR since the beginning of pandemic, 45,449 residents as of 14.01.2021.

17.01.2021
Luxembourg currently has a single COVID-19 vaccination centre (Hall Victor Hugo) with a theoretical capacity to make 7,600 injections per week.

21.01.2021
1,637 people has set up an appointment for COVID-19 vaccination against 5,226 invitations sent (01–20 Jan 2021), indicating a preliminary participation rate of only 31.3% amongst the priority group in Luxembourg!

29.01.2021
European Medicines Agency (EMA) recommends Astrazeneca / Oxford COVID-19 vaccine for ‘conditional marketing authorisation’ in EU27, making it the third vaccine to get approval.
Additionaly, quite remarkably – the EMA has noted – the AstraZeneca/ Oxford vaccine demonstrated around a 60% efficacy in the clinical trials, in comparison, the other two CMA approved vaccines have over 95% efficacy!
Also, quite strikingly, the second dose should be given between 4 and 12 weeks after the first, making a long in-between time possible between the two intramuscular injections.

02.02.2021
The Ministry of Health, Luxembourg, has shared a priority list for the invitation for COVID-19 vaccination in Phases, from Phase 1 to 6 (high to low) on 01.02.2021 and below is a ‘best estimation‘ in terms of the total number of recipients / invitations based on the list. The numbers are subject to change when more accurate information is available in future:

PhaseCategoryEstimated Max. Participants*
1Hospital and medical professionals (a) + old-age and care-home residents (b) + hadicap(a) 16,500 +
(b) 6,000
2>=75y residents + highly vulnerable**40,000
374-70y residents + significantly vulnerable**22,000
465-69y residents + moderately vulnerable**27,500
564-55y residents and non-residents + increased risk due to certain medical conditions**77,000
654-16y residents and non-residents + at-risk due to their activity and vulnerable communities358,000
Total547,000
* Luxembourg residents
** medical level of vulnerability defined by Le Conseil Supérieur des Maladies Infectieuses (CSMI)

24.03.2021
The AstraZeneca COVID-19 vaccine efficacy data recently got into question and here we compile vaccine efficacy data from three manufactureres currently either approved or under rolloing review at EMA, which showed different efficacies in their study / analysis.

ManufacturerPublicationEfficacy Reported (Region)
AstraZeneca
(AZ1222)
08.12.20 13a70.4%
(UK and Brazil)
12.02.21 13b21.9%
(South Africa)
NovaVax
(NVX-CoV2373)
28.02.21 14a89.3%
(UK)
28.02.21 14a49.4%
(South Africa)
Janssen
(Ad26.COV2-S)
29.01.21 15a72%
(U.S.A)
29.01.21 15a66%
(Latin America)
29.01.21 15a57%
(South Africa)
13a LANCET
13b MedXxiv
14a Novavax Press Release
15a Johnson & Johnson Press Release

Together, the table above gives a first impression that the vaccine efficacy changes with the regions where the clinical trials were conducted, which in turn is probably due to different SARS-CoV-2 varaints in these regions. Also, recent studies found different antibody reponse post-vaccination against different variants, in support of the differential efficacies reported.

From the above delivery schedule, in next 5 weeks (29 Mar – 26 Apr, 2021), a total of 127,569 COVID-19 doses are expected to be delivered to Luxembourg, more than the total doses delivered in last 12 weeks (up until 22.03.2021). So Luxembourg is expected to immensely increase the number of vaccine invitations as well as vaccine administration in coming weeks. Also, the single-dose Janssen COVID-19 vaccine is expected to be delivered in late April 2021, but dates and doses are still not known.

So with 247,779 doses available till end of April 2021, Luxembourg is theoretically able to vaccinate every resident of age 65y or older and vulnerable in Phase 1 – Phase 4 (estimated 112,000 individuals, see table above dated 02.02.2021), at least the first dose administered by mid-May 2021 and start invitations for Phase 5 by the end of April 2021 or start of May 2021.

28.03.2021
Luxembourg has received a total of 113,010 doses of COVID-19 vaccine as of 25.03.2021. Of these doses, 82,653 doses were used as of 25.03.2021 (73.14% usage).
The high usage is partly due to (a) the time between AZ doses were increased to 10 weeks and (b) this week, 22-28 March 2021, only 9,360 doses of Comirnaty (Pfizer-BioNTech) vaccine doses were received. The other planned Moderna (4,800 doses, this week) and AstraZeneca (2,400 doses, previous week) were not received yet.
Below is the vaccine uptaje data up until Wed, 24 Mar 2021.

Pfizer-BioNTechModernaAstraZeneca
received*74,6109,60028,880
first dose usage*43,465
(58.26%)
3,793
(39.51%)
13,776
(47.83%)
second dose usage*17,476
(23.42%)
1,817
(18.93%)
8
(0.03%)
total usage81.68%58.44%47.86%
* data as of 24.03.2021

16.04.2021
The Luxembourg share (quantities ordered by Luxembourg) of the European Medicines Agency’s conditional marketing authorization approved COVID-19 vaccines from Pfizer-BioNTech, Moderna, AstraZeneca and Janssen, and a ‘contract’ with CureVac (following a CMA) are as follows (without a delivery date):

ManufacturerEU totalLuxembourg Share
Pfizer-BioNTech500M
+ (100M12)
675,290**
Moderna230M
+ (230M12)
210,462**
AstraZeneca300M
+ (100M12)
415,048**
Janssen200M
+ (200M12)
276,156*
CureVac225M
+ (180M12)
310,649**
Total1,887,605
M = Million doses,
12 doses are OPTIONAL (not an obligation)
** 2x doses needed per person for full vaccination
* 1x dose needed per person for full vaccination

28.05.2021
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has today, 28 May 2021, approved an application to extend the use of the Pfizer-BioNTech COVID-19 vaccine Comirnaty to children aged 12 to 15 years old. Until now Comirnaty is recommended by EMA for 16 years or older individuals.

Also, an article in the New England Journal of Medicine (NEJM), a leading medical journal, reported favorable safety and side-effect profile for Pfizer-BioNTech COVID-19 vaccine in clinical trials in 12 – 15 year olds (Published: 27 May 2021, PDF file 563kb)

22.07.2021
The actual and planned delivery of number of COVID-19 vaccine doses to Luxembourg from four EMA approved vaccine manufacturers is as follows:

Weekly Pfizer- BioNTech Moderna AstraZeneca Janssen
28.12.2020 9,750
11.01.2021 4,875 1,200
18.01.2021 4,875
25.01.2021 2,340 1,200
01.02.2021 4,680 1,200 2,400
08.02.2021 4,680 4,800
15.02.2021 5,850 4,800
22.02.2021 7,020 2,400
01.03.2021 7,140 2,400
08.03.2021 7,020 3,600 12,000
15.03.2021 7,020 2,400
22.03.2021 9,360 4,800 2,400
29.03.2021 10,530 12,000
05.04.2021 16,380 4,800
12.04.2021 16,380 4,800 2,400
19.04.2021 17,550 2,400 2,400
26.04.2021 24,570 2,400 6,000
03.05.2021 22,230 3,600 21,600
10.05.2021 22,230 3,600 2,400 4,600
17.05.2021 22,230 3,600 4,800
24.05.2021 22,230 3,600 4,800
31.05.2021 35,100 3,600 19,200
07.06.2021 30,420 3,600 4,800
14.06.2021 30,420 4,800 12,000
21.06.2021 39,780 6,000 7,200
28.06.2021 40,950 6,000 38,300
05.07.2021 24,750 3,600 4,800 9,600
12.07.2021 24,750 3,600 4,800
19.07.2021 24,750 3,600 7,500
26.07.2021 25,740 3,600 1,764
02.08.2021 25,740 7,200
09.08.2021 26,910 7,200
16.08.2021 7,200
23.08.2021 7,200
30.08.2021 8,400
Total 577,710 144,000 165,800 41,164
Actual delivery / Planned delivery (data of 22.07.2021)

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