Ebola Virus Disease:
Personal Protective Equipment and
Other Ebola-Related Supplies
UNICEF Supply Division
15 December 2014
Replaces previously posted version dated 26 September 2014
Ebola Virus Disease (EVD):
Personal Protective Equipment and Other Ebola-Related Supplies
1. Summary
•
•
•
•
•
The EVD outbreak in West Africa has reached 17,145 documented cases and 6,070 deaths (as of
30 November) and principally affects three countries with widespread and intense transmission
(Guinea, Liberia and Sierra Leone). No licensed treatment currently exists for EVD. Supportive
care, containment and transmission prevention are the currently broadly available interventions.
UNICEF procures and stocks essential medical and hygiene supplies and personal protective
equipment (PPE) for caregivers and patients in support of EVD outbreak response.
UNICEF is collaborating with WHO, Médecins Sans Frontières (MSF) and other stakeholders to
support the supply of appropriate PPE options to the EVD outbreak. UNICEF has developed
product specifications of essential supplies to assist UNICEF Country Offices (COs) and
Governments in EVD planning, preparedness and response. While some PPE can be used in both
high- and low-risk settings, protective suits (coveralls) which pass the liquid test EN14605:2005
and made of fabric passing viral penetration test (ISO 16604:2004) provide the ultimate protection
against viral infection for medical and non-medical staff in EVD outbreak settings and are sourced
by UNICEF. UNICEF has revised the PPE components list for use in high-risk settings (Table 1),
following feedback from in-country visits and consultation with local government partners and
front-line workers.
Appropriately specified PPE supply remains constrained as demand has outpaced current
production levels, however no stock-outs have been reported at site level. UNICEF provides the
immediate demand for key PPE components in scarce supply over the next 2 months (Figure 2)
and its response supplies to be delivered (Annex 2). UNICEF completed a tender for essential PPE
and is finalising long-term arrangements (LTAs) with awarded suppliers. The tender has expanded
UNICEF’s supplier and geographic supply base, and should improve 2015 supply dynamics.
UNICEF is working with WHO to establish a global overview demand forecast to increase
transparency and provide clarity to industry on the need to increase production capacity. UNICEF
and WHO are planning to launch a portal detailing this demand overview by 31 December.
UNICEF encourages partners to harmonise EVD response and supply content to ensure costeffective and efficient outbreak response management. UNICEF held an industry consultation
meeting early November with partners including WHO, MSF, USAID, DFID, International
Medical Corps (IMC), The International Federation of Red Cross and Red Crescent Societies
(IFRC) and others, to share and discuss supply and demand data, as well as to bring more clarity
and transparency to partners and industry.
2. Background
EVD (previously known as Ebola haemorrhagic fever) is a virulent disease with a case fatality rate
(CFR) that can reach up to 90%. The virus is transmitted through direct contact with infected human
or animal bodily fluids, internal organs and skin tissue.1 It is not transmitted through air, water or
food.2 EVD occurs primarily in remote areas of Central and West Africa, however the current outbreak
includes urban centres. There have been 24 documented outbreaks since 1976, each averaging ~100
cases and a CFR of 66%. The current outbreak has reached 17,145 cases and 6,070 deaths (30
November),3 with a CFR of 36% (Figure 1). But this figure could be materially higher after all cases
have been confirmed. 26 million people, including 10.3 million children live in the areas affected by
Ebola.
1
World Health Organization, Ebola Virus Disease, WHO, Geneva, April 2014.
Centers for Disease Control and Prevention, Ebola, CDC, Atlanta, August 2014.
3
World Health Organization, WHO: Ebola Response Roadmap Situation Report, WHO, Geneva, 3 December 2014.
2
2
Figure 1 EVD Outbreaks, Cases, Deaths and CFR
20,000
120%
80%
10,000
60%
40%
5,000
% of Cases
Number of Cases
100%
15,000
20%
-
0%
1976 1977 1979 1994 1995 1996 2000 2001 2003 2004 2005 2007 2008 2011 2012 2014
Nb of Cases
Nb of Deaths
Case Fatality Rate
Source: WHO.
The incubation period from time of infection to symptoms onset is between 2-21 days. Patients are
only infectious when symptomatic. There is currently no licensed treatment or vaccine for EVD. Only
supportive care and intensive prevention through isolation and containment can be broadly provided.4
UNICEF is working closely with WHO, MSF, IMC and IFRC, as well as other partners and
communities on outbreak response to share information on how to prevent the further spread of EVD
and care for those already affected. The latest updated information and materials critical to assist
countries dealing with EVD and outbreak response management is available here.
UNICEF has prepared a field guide for UNICEF staff to explain EVD epidemiology, describe
UNICEF’s roles and responsibilities, and what can be done to prevent and prepare for an EVD
outbreak. The information and resources are in different languages and put on the UNICEF Ebola
SharePoint for easy access.
UNICEF has also prepared a practical guidance tool to help COs assess and mitigate the risks to health
supply chains in a time of Ebola outbreak and is available here. UNICEF is working on a list of
supplies to be used in planning, preparedness and response.5
3. EVD Personal Protective Equipment and Body Bags
Currently, there is no common selection specification for EVD PPE supplies or burial cadaver bags
(body bags) for response to countries affected by Ebola. The selection of PPE depends on the risk
hazard assessment identified by each treatment centre and the infectious agent transmission in each
facility during medical intervention and care. “High-risk” areas include treatment or isolation facilities
accommodating patients (suspected or confirmed), laboratories and mortuary. “Low-risk” areas
include facilities used for service preparation, stores, laundry and disinfection. In addition to universal
precautions, PPEs include protection for the head, eyes, respiration, body, hands and feet, mucosal
membranes in both high- or low-risk areas. Precautionary measures in high-risk areas should include
patient isolation and full protective clothing. In low-risk areas, minimal PPE is required.
UNICEF participated in WHO’s PPE guideline development meeting in early-October together with
CDC and MSF. UNICEF provided technical support and assistance in developing the rapid guideline
document released by WHO end-October identifying the appropriate EVD PPE technical
specifications, standards and guidance to determine and define the context and end-use function of the
equipment. A harmonised set of standards for supply selection is encouraged, including a defined EVD
PPE kit/set.
4
5
World Health Organization, Frequently Asked Questions on the Ebola Disease, WHO, Geneva, August 2014.
The list is a working document and subject to review.
3
UNICEF has updated the PPE components supply list required for high-risk settings including EVD
treatment units/centres (ETU/Cs), holding centres and for burial teams (Table 1). The quantities of
components in the draft kit will continue to be updated with input from the field and refined through
consultation with stakeholders. The kit includes substitute, or alternate, products for some PPE items
that are currently difficult to source in sufficient quantity to meet the needs without compromising the
safety level of the biological barrier against EVD.
Table 1 PPE Components Supply List for High-Risk Settings
Body Barrier
Area
Body inner layer
Body inner layer
Head inner layer
Head inner layer
Body and head
outer layer
Body and head
outer layer
Body outer layer
Nose and mouth
Hands
Hands
Hands
Face and eyes
Face and eyes
Feet and legs
Feet and legs
PPE Product
Tunic, surgical, woven. Sizes M, L and
XL.
Trousers, surgical, woven. Sizes M, L
and XL.
Cap, surgical, non-woven, disposable.
Hood, protection.
Coverall, protective, Cat. III, liquid /
spray tight, with or without hood, tested
against viral penetration. Sizes M, L, XL
and XXL.
Apron with sleeves (gown), protective,
Cat III, liquid or spray tight, with or
without hood, tested against viral
penetration. Sizes, L, XL.
Aprons, surgical, disposable.
Mask, high filtration/Respirator, (grade
FFP2 or N-95 liquid splash resistant,
without valve, single use.
Gloves, examination nitrile, non-sterile,
single use, sizes S, M and L.
Gloves, surgical, single use, sterile.
Gloves, utility, rubber or nitrile, heavy
duty.
Face shield, fog resistant, full-face
length.
Goggles, protective, wrap around,
panoramic view, plastic, fog resistant,
with indirect side vent.
Boots, lightweight PVC or rubber, heavy
duty (impermeable and puncture proof),
anti-slip, closed, sizes 41, 43 and 45.
Optional: Overboots, with PVC sole and
elasticized top.
Reusable
or Disp.
Reusable
Reusable
Disp.
Disp.
Disp.
Disp.
Disp.
Substitute PPE Product(s) and Notes
Alternative sizes of same item.
Alternative sizes of same item.
Cap, surgical, woven, reusable.
Coverall, protective, Cat. III, limited
splash / spray with or without hood,
tested against viral penetration, sizes M,
L, XL and XXL, worn with apron with
sleeves made of same coverall fabric.
Gown, surgical, standard/ high
performance.
Apron, rubber, heavy duty.
Surgical Mask type IIR, single use.
Disp.
Disp.
Reusable
Reusable
Reusable
Reusabl
e or
Disp.
Reusable
Disp.
Disp.
Reusable
Disp.
Alternative sizes of same item.
Gloves, examination nitrile, long cuff,
non-sterile, single use, sizes S, M, L.
None. Gloves heavy duty, latex.
Face shield, clear with head bank, fog
resistant, full-face length.
Either face shield or goggles depending
on procedure.
-
Disp.
-
Alternative sizes of same item.
Reusable
-
Disp.
Source: UNICEF Supply Division.
In response to the acute outbreak, UNICEF is identifying, sourcing and supplying EVD PPE
components that meet the highest protective standards against viral penetration. EVD PPE for lowrisk settings (a subset of the above list) are generally readily available, but given the surge in demand,
supplier inventories have been depleted and supply has been constrained. As a result, suppliers are
increasing their production. A supply list of available standard and new non-standard medical
equipment, consumables and clinical diagnostics to plan EVD management response according to
preparedness, outbreak and health system strengthening scenarios is provided in the annex to the
previously mentioned UNICEF’s guidance note for UNICEF COs. The note identifies a nonexhaustive list of items that can be used for initial assessment designed to guide supply planning,
budgeting and response in relation to current country EVD situation.
4
Securing EVD PPE supply for high-risk settings is more difficult. The substantial increase in demand
has led to extended production lead-times. A full standard EVD PPE supply selection set has not been
harmonised and industry is not currently able to produce to demand adding to lead-time. As EVD PPE
items for use in high-risk settings are sourced from different suppliers, they typically come as
individual components. Impermeable protective coveralls and leak-proof body bags are especially
difficult to secure. However, UNICEF has recently sourced supplies to respond to the immediate needs
of the affected countries. Body bags for infection control in particular must meet the minimum
specifications to ensure safe disposal of cadavers (Table 2). The material codes and specification
references for the catalogued items are also available.
Table 2 Body Bag Infection Control Specifications
Aspects
Use
Specifications
- Single use, disposable;
- Full-length U or J-shaped zipper with double runner;
- High quality black or white smooth running with teeth made of nylon;
Zipper
- Large plastic or tissue loops on each of the zip-runners to allow for easy manipulation;
- Zipper to be sewed into the body bag fabric with double stitch;
- Stop for the zipper to be reinforced into the body bag;
Impermeability
- Non-porous, body fluid leak-proof during corpse handling and transportation;
- Integrated transparent label pouch for identification tag; Pouch to be 10cm x 15cm (l x w);
Labelling
- Product label to indicate product short description and size in cm and inches;
Material strength - Highly tear-proof and puncture resistant;
Seams
- Entirely heat-sealed seams with minimum 10mm seal-width;
- Non-PVC; Linear enforced PE, EVA or PEVA (Polyethylene, Ethylene, Vinyl Acetate);
Material
- Must not contain chlorides;
Thickness
- 300 to 400um;
Degradability
- Disintegration in soil over a period of 5-8 years;
Volume
- Carry capacity of 120kg (adult) / 50kg (child);
Handle fittings
- Min 6 padded carry handles integrated and reinforced into the body bag using same materials;
Colour
- White;
Dimensions
- Unfolded: 220 x 100 cm (l x w) (adult) / 120 x 80 cm (l x w) (child);
Supply format
- Folded 45cm x 35cm (l x w);
Shelf life
- Shelf life at least 6 years.
Source: UNICEF Supply Division.
UNICEF has been in close communication with manufacturers and wholesalers (DuPont, Indutex,
Kimberly-Clark, Microgard, Honeywell and others) to source additional PPE, particularly to fill the
gaps for garments to be used in high-risk settings. Based on the high volume of demand and lack of
manufacturer inventory and capacity, UNICEF is working with suppliers to identify lead times for
delivery. Countries are asked to split deliveries over time.
UNICEF has recently completed a competitive tender for essential PPE and is engaged with awarded
suppliers to finalise long-term arrangements (LTAs) which will increase the procurement efficiency
for affected EVD countries. It will also support the non-affected countries with supplies related to
emergency preparedness. The tender increased the number of suppliers and brands available through
UNICEF as well as expanded its geographic supplier base. The monthly production capacity of
coveralls available to UNICEF will increase from 80,000 units to 300,000 units by March 2015. The
price range for a full PPE set ranges from $40-$52 and mostly related to quality, standards, place of
production and supply availability. Even though the price for some PPE components were reduced,
some items did not have any price reduction and some even increased.
Table 3 describes the PPE supplies used in low-risk settings procured through UNICEF for Guinea,
Liberia, Mali, Nigeria and Sierra Leone from August to date (30 November).
5
Table 3 UNICEF PPE EVD Response Supplies Procured for Guinea, Liberia, Mali, Nigeria and Sierra
Leone from August to 30 November 2014
PPE
Items
Apron, protection, plastic, disp
Apron, protection, plastic, reusable
Apron, sleeved, Cat III, type 3
Hood, protection, Cat III
Aprons, reusable
Bag, biohazard,50l
Body bag, adult
Body bag, child
Body bag, infection control, adult
Body bag, infection control, child
Boot, adult, pair
Boot cover, anti-skid, elasticated
Boot, rubber/PVC, reusable, pair
Coverall,protection,CatIII,type3/4/5
Coverall,protection,CatIII,type6B
Face mask/surgical/disp
Face shield, fog-resistant, full-face-length
Glasses, safety, regular size, disp
Gloves, heavy duty, non-surgical
Gloves, heavy duty, rubber
Gloves, reusable, pair
Gloves, exam, latex, pwdfree
Gloves, exam, nitrile, non-ster
Gloves, exam, nitrile, non-ster
Source: UNICEF Supply Division.
Units
4,717,800
93,032
201,960
197,160
14,115
467,420
4,410
3,730
11,235
4,495
100
285,000
23,227
376,808
77,920
73,750
27,235
11,720
475
107,800
3,285
32,578,000
21,351,000
4,340,000
Items
Gloves, gyn, pwdfree, ster, s.u., pair
Gloves, heavy-duty, rubber/nitrile, pair
Gloves, rubber, pair
Gloves, surg, pwdfree, ster, s.u., pair
Goggles, protective, indirect-side-ventil
Gown, surgical, nonwoven, disp
Household Protection Kit/KIT-3
Mask, high filtration, regular size, disp
Mask, high-fil,FFP2/N-95,no-valve,non-ster
Mask, surgical, type IIR, disp
Mask, surgical, disp
Nose mask
Overall, hooded
Rain boot
Raincoat
Raincoat w/hood
Rain suit
Safety googles
Spray, anti-fog, goggles/BOT-50ml
Stand, biohazard bag, 50l
Surgical trouser, woven
Surgical tunic, surgical, woven
Surgical cap, non-woven, disp
Units
97,700
97,108
100,000
119,790
19,682
505,605
18,355
238,180
1,001,860
3,862,200
213,200
450
450
4,272
100
110
2,352
450
38,140
1,783
19,820
33,020
1,695,700
See Annex 1 for a full breakdown of other items procured including medicines, medical equipment,
cold chain, vaccines, nutrition, shelter and water and sanitation.
4. EVD PPE Needs
The overall demand for PPEs and related supplies is generally in flux based upon fluid country plans.
UNICEF is working with WHO to establish a global demand forecast to increase transparency and
provide clarity on the needs. UNICEF and WHO are planning on launching a portal by 31 December
communicating the demand forecast and countries’ pipelines.
As part of the UN Mission for Ebola Emergency Response (UNMEER) framework, UNICEF supports
a complementary approach aimed at reducing household transmission through the establishment of
Community Care Centres (CCCs). CCCs complement ETU/Cs. They are simple, temporary structures
that offer suspected EVD patients an isolated area where they can receive supportive care in the
comfort of their community. Each CCC has an eight to ten-bed capacity. Further details are available
here.
UNMEER’s operational plan identifies a need for 329 CCCs under a worst case scenario for the three
principal countries. Table 5 provides an overview the UNMEER’s current actualised, planned and
coverage gaps of key items necessary for ETU/Cs, CCCs, burial teams and other activities. The
delivery and implementation timeline is dependent on each country’s implementation capacity and
operational context.
6
Table 5 Actual, Planned Supply and Coverage Gaps For ETUs, CCCs and PPE Needs
Beds ETU/ETC
Beds CCC
Burial Teams*
PPE needs for
other activities**
Actual
294
52
56
n/a
Sierra Leone
Future
Planned
1,198
1,137
1,296
812
91
60
800,000
-
Gap
61
484
31
Actual
593
420
50
800,000
n/a
Liberia
Future
Planned
2,866
2,860
1,040
1,040
226
120
1,400,000
-
Gap
6
106
Actual
160
34
1,400,000
n/a
Guinea
Future
Planned
670
530
51
35
Gap
140
16
50,000
50,000
-
Note*: 210 PPE sets per team per month.
Note**: Universal protection set (gowns, mask, gloves, face shield).
Source: WHO 11 November 2014 (UNICEF Supply Division Industry meeting).
Figure 2 describes the immediate monthly needs by country for the components in scarce supply over
the next two months (December 2014 - January 2015), to cover needs of ETUs, public health units
(PHUs), CCCs and burial teams. These needs should reach approximately 780,000 PPE sets per
month.6
Figure 2 UNICEF Immediate Monthly Demand for Key PPE Components in Scarce Supply
(December 2014 – January 2015)
600,000
500,000
400,000
300,000
200,000
100,000
Gown,surgical,
nonwoven,disp
Burial Teams qty
Sierra Leone PHU Need qty
Sierra Leone ETU Need qty
Sierra Leone CCC Need qty
Liberia CCC Need qty
Guinea CCC Need qty
138,576
202,500
81,000
81,000
Coverall,protec
tion,CatIII,type
3/5,L
60,480
122,364
-
Hood,protectio
n,CatIII
Apron,sleeved,
CatIII,type3,L
50,625
20,250
20,250
50,625
20,250
20,250
Apron,protecti
on,plastic,reus
able
14,567
-
Source: UNICEF Supply Division.
65 CCCs are currently planned to be set up through UNICEF in West Africa under UNMEER’s first
phase of the roll-out, of which 40 will be in Sierra Leone, 15 in Liberia and 10 in Guinea. UNICEF is
currently planning the supply of equipment and PPE for the 40 CCCs to be set up in Sierra Leone and
the 10 CCCs in Guinea.
Annex 2 describes UNICEF PPE response supply components to be delivered during December 2014
and January 2015 for the 40 CCCs in Sierra Leone. 162,000 PPE sets per month will be delivered
against an immediate demand of 253,125 sets.
Supply plans for additional components as well as for the 10 CCCs in Guinea are being developed and
will be shared in future updates including through the forthcoming demand portal. Upon completion
of the first phase, a review will assess the need for additional CCCs.
5. Pipeline Therapeutic and Medical Interventions
UNICEF has conducted an initial survey of the market to assess pipeline products, which could
eventually be used for EVD prophylaxis and therapeutics (Annex 3a and 3b). Most of the products are
currently in pre-clinical or Phase 1 studies, with limited immediate availability (even if appropriate
6
A PPE set is calculated as per major body protection components in limited supply: gowns, coveralls and sleeved
aprons/hoods.
7
regulatory and ethical clearances were given). These products are usually generously financially
supported, including substantial grants (sometimes greater than $100 million) from various agencies
of the U.S. Government, including the National Institute of Health (NIH).
UNICEF has been contacting individual manufacturers to assess capacity and timing for potential
compassionate use. Initial information has been included from both those communications and other
sources, including manufacturers attending WHO’s recent consultation on potential therapies and
vaccines. UNICEF will update the available information as it materialises. UNICEF’s actions are
intended to be supportive and informed by the normative decisions of WHO and other national
regulatory bodies. UNICEF looks forward to partners’ and governments’ own assessments, and
ongoing interactions with many of the identified manufacturers as it relates to product efficacy and
bioethical and regulatory standards.
6. Next Steps
•
•
•
•
•
•
•
UNICEF has completed a competitive tender for essential PPE. UNICEF is engaging with awarded
suppliers to finalise long-term arrangements (LTAs) which will improve availability for affected
EVD countries, while also supporting the non-affected countries with supplies related to
emergency preparedness.
UNICEF will be preparing procurement strategies for anticipated purchasing of EVD vaccines and
Rapid Diagnostics Tests (RDTs).
UNICEF is collaborating with WHO, DFID, MSF and suppliers to work towards a common and
harmonised set of EVD PPE standards supply selection for use in low- and high-risk settings.
UNICEF will continue to work with the different PPE manufacturers to maintain a diverse supplier
base, balanced response and seek opportunities to ensure increased supply capacity and reduced
lead times for delivery. UNICEF has updated its standards to establish supplier arrangements for
EVD PPE to meet demand for low- and high-risk settings.
UNICEF might need to set-pack EVD PPE kits for high-risk setting until the containment of EVD
or availability of treatment.
UNICEF will continue to survey the EVD prophylaxis and therapeutics markets to assess any
potential for any emerging intervention to be opportunistically used on a compassionate basis,
including manufacturers’ capacity and timing for scale-up. As regulatory authority and other
related normative functions rest with WHO, UNICEF will look to be supportive in our work,
subject to the direction and policies set by WHO.
UNICEF Supply Division staff have been deployed to Ghana, Guinea, Liberia and Sierra Leone
to meet with partners and work on strengthening in-country coordination and the different roles
and responsibilities.
For further questions or additional information, please contact:
Helene Moller
Chief, Health Technology Centre
UNICEF Supply Division
+45 45 33 55 85
[email protected]
Etleva Kadilli
Contracts Manager
UNICEF Supply Division
+45 45 33 55 89
[email protected]
Nagwa Hasanin
Technical Specialist
UNICEF Supply Division
+45 45 33 58 44
[email protected]
Aadrian Sullivan
Information Management
UNICEF Supply Division
+45 45 33 57 68
[email protected]
Other UNICEF information notes can be found at http://www.unicef.org/supply/index_54214.html.
8
Annex 1 EVD Response Supplies Procured for Guinea, Liberia, Mali, Nigeria and Sierra Leone
since August 2014 to 30 November 2014
Items
3TC150mg+AZT300mg tabs/PAC-60
3TC300mg+TDF300mg tabs/PAC-30
3TC30mg+AZT60mg disp tabs/PAC-60
ABC600mg+3TC300mg tabs/PAC-30
ABC60mg+3TC30mg disp tabs/PAC-60
Albendazole 400mg chewable tabs/PAC-100
Amod 135mg+Arte 50mg tab/3/PAC-25
Amod 270mg+Arte100mg tabs/PAC-3
Amod 270mg+Arte100mg tabs/3/PAC-25
Amod 270mg+Arte100mg tabs/6/PAC-25
Amod 67.5mg+Arte 25mg tabs/3/PAC-25
Amodiaquine 135mg+Arte 50mg tabs/PAC-3
Amodiaquine 270mg+Arte100mg tabs/PAC-6
Amodiaquine67.5 mg+Arte25mg tabs/PAC-3
Amox.500mg+Clav.acid125mg tabs/PAC-15
Amoxici.pdr/oral sus 125mg/5ml/BOT-100ml
Amoxicillin 250mg disp tabs
Amoxicillin 250mg tabs
Amoxicillin 500mg tabs
Ampicillin pdr/inj 500mg vial/BOX-50
Artem20mg+Lumef120mg disp tabs/12
Artem20mg+Lumef120mg disp tabs/6
Artemeth20mg+Lumefan120mg tabs/18
Artemeth20mg+Lumefan120mg tabs/24
Artesunate 200mg rectal caps/PAC-6
Artesunate 50mg rectal caps/PAC-6
Artesunate pdr./inj 60mg vial
Ascorbic acid 250mg tabs/PAC-1000
Atenolol 50mg tabs/PAC-1000
Atropine inj 1mg/ml 1ml amp/BOX-10
ATV/r 300mg+100mg tabs/PAC-30
Azithromycin 250mg tablets/PAC-6
Benz acid 6%+salic acid 3% oint/TBE-40g
Benzabenzylpen pdr/inj 2.4MIUvl/BOX-50
Benzyl benzoate 25% lotion /BOT-1000ml
Bottled mineral water, 24x500ml
Calc. glucon. inj 100mg/ml 10ml amp
Cefixime 200mg tabs/PAC-56
Cefixime pdr. sus100mg/5ml,BOT/60ml
Ceftriaxone pdr/inj 1g vial/BOX-10
Ceftriaxone pdr/inj 250mg vial/BOX-50
Chloramphenicol 250mg caps/PAC-1000
Chloramphenicol pdr/inj 1g vial/BOX-5
Chlorhex.diglu.7.1%sol.cord c./BOT-10ml
Chlorhexidine conc sol. 5%/BOT-1000ml
Chlorhexidine conc sol. 5%/BOT-100ml
Chlorphenamine 4mg tabs/PAC-1000
MEDICINES
Units
Items
19,301 Fe(as fum.)+folic 60+0.4mg tabs/PAC-1000
4,675 Furosemide 40mg tabs/PAC-1000
2,692 Furosemide inj 10mg/ml 2ml amp/BOX-10
2,204 Gentamicin inj 40mg/ml 2ml amp/BOX-50
11,329 Gentian violet (Methylros) pdr 25g/PAC-1
2,160 Glucose hyperton. inj 50% 50ml vl/BOX-20
22,317 Glucose inj 5% 500ml w/g.set/BOX-20
121,031 Haloperidol inj.5mg/ml 1ml amp/BOX-10
35,368 Ibuprofen 400mg tabs/PAC-100
37,576 Ketamine inj 50mg/ml 10ml vial/BOX-25
3,600 Lamivudine oral sol.10mg/ml/BOT-100ml
50,000 Lidocaine inj 1% 50ml vial/BOX-5
50,000 LPV/r 100+25mg heat/st tabs/PAC-60
50,000 LPV/r 200+50mg heat/st tabs/PAC-120
5,240 LPV/r oral sol.80+20mg/ml/BOT-5x60ml
40,080 Magn.sulph.inj 500mg/ml 10ml amp
1,281,900 Magn.trisilicate compound tabs/PAC-1000
1,045,000 Mebendazole 500mg chewable tabs
709,000 Methyldopa 250mg tabs/PAC-100
720 Metoclopramide 10mg tabs/PAC-1000
33,450 Metoclopramide inj 5mg/ml 2ml amp
40,470 Metronidazole 250mg tabs
31,950 Metronidazole 500mg tabs
115,320 Metronidazole inj 500mg/100ml vl/BOX-50
4,000 Miconazole nitrate cream 2%/TBE-30g
5,190 Misoprostol 200mcg tabs/PAC-60
99,300 Morphine sulph inj 10mg/ml 1ml
116 Naloxone inj 400mcg/ml 1ml amp/BOX-10
10 Nevirapine 200mg tabs/PAC-60
20 Nevirapine 50mg disp tabs/PAC-30
18,622 Nevirapine oral susp10mg/ml/BOT-100ml
240 Nystatin 100,000IU pess with app/PAC-15
600 ORS low osm. 10.2g/0.5l CAR/1000
770 ORS low osm. 20.5g/1l CAR/100
921 ORS low osm. 20.5g/1l CAR/1000
1,313 Other antibacterials - soap
100 Oxytocin inj 10 IU 1ml amp/BOX-10
239 Paracetamol 100mg disp tabs
1,284 Paracetamol 100mg tabs
26,850 Paracetamol 125mg/5ml or sol/BOT-60ml
1,878 Paracetamol 500mg tabs
90 Phenobarbital 30mg tabs/PAC-100
1,800 Phytomenadi. 10mg/ml inj.1ml amp
100,000 Povidone iodine sol 10%/BOT-500ml
1,220 Promethazine 25mg tabs/PAC-100
1,100 Quinine inj 300mg/ml,2ml amp
52 Quinine sulfate 300mg tabs
Units
1,841
40
90
10,999
100
62
2,917
30
1,644
29
51
115
4,157
8,279
700
400
310
7,500,00
680
1,960
105,120
1,492,000
233,000
2,532
290
5,000
1,800
2
2,250
197
854
490
6,000
20,397
1,090
70
1,611
85,600
781,800
37,740
6,265,800
200
300
935
7,390
5,140
530,000
9
Chlorpromazine inj 25mg/ml 2ml amp
Ciprofloxacin 250mg tabs/PAC-10
Ciprofloxacin 2mg/ml 100ml
Ciprofloxacin 500mg tabs/PAC-10
Clotrimazole 500mg vag tabs/applicator
Cloxacillin 500mg caps/PAC-500
Dexamethasone inj 4mg/ml 1ml amp/BOX-50
Diazepam 5mg tabs/PAC-100
Diazepam inj 5mg/ml 2ml amp/BOX-10
Doxycycline 100mg tabs/PAC-1000
Efavirenz 200mg (scored) tabs/PAC-90
Efavirenz 600mg tabs/PAC-30
Epinephrine inj 1mg/ml 1ml amp/BOX-10
Erythro pdr/oral sus 125mg/5ml/BOT-100ml
Items
Alere Determine/KIT-100
ARI timer, respiration diagnostics device
Bag,urine,collecting,2000ml
Bandage,elastic,7.5cmx5m,roll
Bandage,gauze,8cmx4m,roll
Basin, kidney
Bedpan, polypropylene, adult
Bed screen, hospital
Blood bag, single, 450ml
Blood g.set
Bowl, stainless steel
Cannula,IV short, ster, disp
Catheter, ster, disp
Compress,gauze,10x10cm
Container,sharps,leakproof,5l
Cot, medical, IV-pole, basic
Cotton wool,500g,roll,non-ster
Diarrhoea disease set
Drawsheet,plastic,90x180cm
Drum,sterilizing,165mm diam
Enhanced oversized special needs medical
Feeding tube, ster, disp
First aid kit
Forceps,dressing,standard,250mm
Furniture, medical/surgical
Gauze,roll,90cmx100m,non-ster
IEHK, kit
Infusion g.set, sterile, s.u.
Lancet, safety, 2.0 mm, disp
LLIN,100d,190x180x150cm
LLIN,145d,w/b/g,alt. dimensions LxWxH
Malaria test/KIT-25
Medical cot surgical w/IV pole
Midwifery kit
Needle holder, vacuum tbe
Needle, vacuum tbe
2,700
12,440
28,800
47,584
1,662
184
302
900
7,437
130
5,140
5,887
6,290
80
ReSoMal,42g sachet for 1l/CAR-100
Retinol 100,000IU soft gel caps/PAC-500
Retinol 200,000IU soft gel caps/PAC-500
Salbutamol 4mg tabs/PAC-1000
Salbutamol oral inj 0.1mg/200ds
Sod. lact. comp. inj 1000ml w/g.set/BOX-10
Sod. lact. comp. inj 500ml w/g.set/BOX-20
Sod. chl. inj 0.9% 500ml w/g.set/BOX-20
Sulf.400mg+Trimet.80mg tabs
Sulfadox+Pyrimeth 500+25mg tabs
Tetracycline eye ointment 1%/TBE-5
Water for inj 10ml amp/BOX-50
Zidovudine oral sol.10mg/ml/BOT-100ml
Zinc 20mg tablets/PAC-100
MEDICAL EQUIPMENT
Units
Items
340 Nigeria Kit 2014
2,440 Obstetric, surgical kit,suppl.2-equipment
50 Otoscope, set
5,124 Plastic clamps 18mm
140 Pulse oximeter, spot-check
2,100 Pump, suction, foot-operated
100 Resuscitator, kit
1,700 Sachet,tablet,plastic,10x16cm/PAC-100
6,200 Safety box f.used syrg/ndls 5l
1,500 Scalpel blade, ster, disp
4,000 Scissors,140mm,cvd,s/b
147,749 Sphygmomanometer,(adult),aneroid
310 Sphygmomanometer,(child),aneroid
59,990 Sterilization, kit
1,920 Sterilizer,steam,24l
150 Stethoscope
22,310 Stretcher
25 Suction tube,50cm,ster,disp
816 Surg. inst./SET
14 Sut,abs,DEC2,need 3/8 26mm,tri/BOX-36
330 Syringe,A-D,0.05ml
240 Syringe,A-D,0.5ml
206 Syringe, disp
2,000 Syringe, feeding, ster
1,700 Syringe, RUP, 5ml,w/fixed ndl/BOX-100
11 Table, instrument on castors
1,025 Tape measure,tailor's,fibreglass,1.5m
12,000 Tape umbilical,3mmx50m,non-ster
150,000 Tape,adhesive,Z.O.,2.5cmx5m
250,000 Test strips, urinan. gluc/prot/PAC-100
20,000 Thermometer
720 Thermometer, clinical, IR, handheld, SET
525 Tongue depressor, wooden, disp/BOX-500
1,318 Tourniquet, latex rubber,50cm
20,000 Tray,dressing,ss,480x330x20mm
20,000 Trolley,dressing,ss,2 trays
361
1,485
10,277
12
100
20,516
13,561
2,807
170,000
498,000
75,564
6,727
42
12,235
Units
2,851
5
19
1
70
35
129
342
688,628
3,575
20
1,792
345
272
7
463
2,750
8,000
34
20
15,002,400
54,991,100
1,362,353
60
55,716
30
15
46
360
2,042
1,810
10,409
45
61
30
30
10
Needle, disp, ster
Needle, scalp vein, ster, disp
Needle, spinal, ster, disp
Items
Central temperature monitoring system
Chest freezer
Cold chain temp measuring instruments
Cold room, walk-in type,40 m³
Refrigerator
Items
BCG, vial of 20 doses
DTP-HepB-Hib, vial of 10 doses
IPV, vial of 10 doses
Measles, vial of 10 doses
OPV, vial of 10 doses
OPV, vial of 20 doses
Items
Cooking equip
F-100, therapeutic milk, sachet,114g/CAR-90
F-75, therapeutic milk, sach, 102.5g/CAR-120
Fortified spread, sachet 20g/CAR-546
Lait Nursie
MNP, micronutrient pdr, sachet/PAC-30
MUAC, adult, without colour code/PAC-50
MUAC, child 11.5 Red/PAC-50
Portable baby/child lgt-hgt mea. syst/SET-2
Portable Photometer / Iodine in Salt
Items
Bed cover
Bed mattress
Bed pillow
Bed sheet
Blanket
Cement, 50kg
Chair, folding, steel
Cup, plastic, w/handle
Cup
Cup, disp
Cup, measuring
Electrical cable and fittings
Filing cabinet with 4 cabins
Floor mattress
Generator set
Hospital bed
Jugs, plastic, 1l
Jugs, plastic, 2l
4,077,200
6,100
75
Tube, vacuum
Vacuum extractor, set
Warmer system, newborn, radiant, w/access
COLD CHAIN
Units
Items
29 Refrigerator loggers,30 days
1 SDD Refrigerator 30-60l, hot zone
33 SDD Refrigerator 90-120l, hot zone
2 Vaccine carrier
23
VACCINES
Units
Items
70,700 PCV-10-val, vial of 2 doses
552,550 PCV-13, vial of 1 dose
200,000 TT, vial of 10 doses
166,950 TT, vial of 20 doses
19,100 YF, vial of 10 doses
3,113,600 YF, vial of 5 doses
NUTRITION
Units
Items
6 Reagents for S0000228, PAC-100
4,061 RUIF, ready to use infant formula
802 RUTF, biscuit,packs,510g./CAR-24
2,798 RUTF, spread, sachet 92g/CAR-150
300 Salt test kit, salt fortified w/IODATE
87,022 Scale, electronic, mother/child,150kgx100g
300 Scale,infant,clinic,beamtype,16kgx10g
25,735 Scale,infant,springtype,25kgx100g
283 UHT Milk for Children >6 Months
3 Weighing trousers/PAC-5
SHELTER
Units
Items
200 Mug, plastic
1,158 Paper towel/ROLL
1,000 Plate, disp
3,668 Plate, plastic
5,840 Shovel
34 Sleeping mat
200 Spoon, stainless steel
1,025 Spoon, disp
3,000 Stand for bucket
330,000 Table, plastic
50,000 Tarpaulin, plastic, roll, 4x50m
746 Tarpaulin, plastic, sheet, 4x5m
3 Tarpaulin, roll, black
40 Tent, light weight, rectangular, 24m²
60 Tent, light weight, rectangular, 42m²
558 Tent, light weight, rectangular, 72m²
4,556 Towel
296 Towel, disp/SET-150
44,500
15
15
Units
2,000
64
1
32,904
Units
1,415,400
300,600
1,062,520
28,000
71,980
326,900
Units
25
250,908
15,243
202,308
500
439
510
809
18,200
9
Units
1,000
4,480
390,000
8,400
80
1,600
8,000
330,000
2,362
56
645
3,100
45
15
639
209
2,400
260
11
Kettle, plastic
Kitchenware and utensils
Lighting kit
Mop with handle
Items
Ambulance, 4WD
Bicycle, heavy duty
Hard Top, 4WD
Items
Bag, waste, 90l
Bag, waste, disp, 240l
Basin
Bottle,plastic,1l,w/screw cap
Bowl, plastic, 5l
Bucket incl. w/cover, tap
Calcium hypochlorite (HTH), kg
Chlora, 1l/BOT
Chlorine 0.5% and 0.05% solution
Chlorine, bucket, 45kg
Container, 10l
Container, 120l
Hand pump
Hand sanitizer
Hand washing facility
Jerry can
Latrine slab, plastic mould
Latrine slab, plastic, 120x80cm
Liquid chlorine solution 0.7%, 3.7l
Liquid chlorine solution 250ml
NaDCC, chlorine granules 56%, 500g
NaDCC, water purif.1.67g tabs/PAC-200
Source: UNICEF Supply Division.
3,200
3,805
50
160
Warehouse, prefab., portable, 24x10m
Warning fence
Wood planks, construction, 2x2x1 inch
Zinc nails, boxes
TRANSPORT
Units
39 Motorcycle
140 Pickup, 4WD
153 Truck, 4WD
Items
WASH
Units
Items
6,700 NaDCC, water purif.33mg tabs
15 Pipes and fittings
1,836 Sanitary pad
180 Soap 250-500g
5,600 Soap 90-150g
355,841 Sprayer 10-20l
288,976 Sprayer, 1l
133 Stand, plastic
28 Teflon tape
6 Teflon tape, rolls
50,035 Water bladder, 20l
200 Water distribution kit/KIT-3
4,263 Water filtering, purification equip
2,945 Water floc.,pdr
505 Water hose, 10-20m
108,800 Water pump
30 Water tank, ≤2,000l
1,050 Water tank, ≤6,000l
3,050,340 Water tank, 10,000l
638,760 Water tap
10,995 Water test kit hydrogen sulphide/BOT
4,000 Water test kits
4
100
150
22
Units
796
92
3
Units
1,470,000
3,605
16,200
2,041,765
6,523,883
2,912
10,480
14,846
140
72
2,000
50
4
1,007,280
2
58
43
127
38
260,891
6,000
52,522
12
Annex 2 CCC PPE Response Supplies Forecast to Be Delivered to Sierra Leone during December 2014 and January 2015*
Material
Number
Description
PPE for Delivery by 19 Dec. 2014
Quantity
USD
Volume m³ Weight kg
(40x1mth)
(40x1mth) (40x1mnth) (40x1mth)
6,480
110,030
36
10,122
129,600
335,741
242
24,754
540,000
106,719
49
4,860
10,800
51,937
32
5,562
21,600
103,874
83
12,550
S6780257 Boots,rubber/PVC,reusable,pair,size42
S6780262 Boots,rubber/PVC,reusable,pair,size43
S6780258 Boots,rubber/PVC,reusable,pair,size44
S0305060 Glasses,safety,regular size
S6780265 Faceshield,fog-resistant,fullface-length
S0305020 Apron,protection,plastic,disp/PAC-100
S6780244 Gown,surgical,nonwoven,disp
S6780245 Mask, surgical, typeIIR, disp.
S6780251 Gloves,exam,nitrile,non-ster,S,BOX-100
S6780252 Gloves,exam,nitrile,non-ster,M,BOX-100
S6780253 Gloves,exam,nitrile,non-ster,L,BOX-100
S6780259 Gloves,heavy-duty,rubber/nitrile,pair,M
S6780264 Gloves,heavy-duty,rubber/nitrile,pair,L
3,240
4,342
3
292
S6780261 Spray,anti-fog,goggles,bott/50ml
10,800
120,949
39
972
S6780263 Gloves,heavy-duty,rubber/nitrile,pair,S
S6780266 Goggles,protective,indirect-side-ventil
S6780268 Mask,high-fil,FFP2/N-95,no-valve,nonster
270,000
309,486
69
5,670
S6780276 Cap,surgical,non-woven,disp,box/100
3,240
19,440
S6780279 Trousers,surgical,woven,sizeL
1,440
18,043
5
533
S6780280 Trousers,surgical,woven,sizeM
1,440
18,043
5
533
S6780281 Trousers,surgical,woven,sizeXL
S6780282 Tunic,surgical,woven,sizeL
1,440
18,043
5
533
S6780283 Tunic,surgical,woven,sizeM
1,440
18,043
5
533
S6780284 Tunic,surgical,woven,sizeXL
S6780287 Hood,headcover,protection,CatIII, type3
32,400
70,632
S6780291 Apron,sleeved,CatIII,type3,L
32,400
262,530
102
11,988
S6780292 Apron,sleeved,CatIII,type3,M
S6780294 Apron,sleeved,CatIII,type3,XL
TOTAL
1,567,852
673
78,900
Note*: The use of gowns/aprons with sleeves replace the use of coveralls in CCCs as per WHO recommendations.
Source: UNICEF Supply Division.
PPE for Delivery by 19 Jan. 2015
Quantity
USD
Volume m³ Weight kg
(40x1mth)
(40x1mth) (40x1mnth) (40x1mth)
6,480
129,600
540,000
10,800
21,600
110,030
335,741
106,719
51,937
103,874
36
242
49
32
83
10,122
24,754
4,860
5,562
12,550
3,240
10,800
270,000
3,240
1,440
1,440
1,440
1,440
32,400
32,400
-
4,342
120,949
309,486
19,440
18,043
18,043
18,043
18,043
70,632
262,530
1,567,852
3
39
69
5
5
5
5
102
673
292
972
5,670
533
533
533
533
11,988
78,900
13
Annex 3a Pipeline Prophylaxis & Prevention
Product / Company
ChAd3-ZEBOV
GSK (UK)
Ad26/Ad36/MVA
Crucell
(J&J)+Bavarian
Nordic
Description
- Attenuated strain of recombinant
chimpanzee adenovirus type 3 (ChAd3).
- Chimp Adenovirus 3 that is used as a
carrier, or vector, to deliver benign
genetic material derived from the Ebola
virus Zaire.
- Vaccine based on PER.C6® cells.
- Initially using Adenovirus Serotype 5
(Ad5), additional vectors are expected to
be included in further developments.
- 2 vaccines under development based on
Smallpox and Marburg model.
- Vaccine based on replication-competent
vesicular stomatitis virus (and advanced
vaccine technology developed for Ebola
and Marburg) rVSV-EBOV.
rVSV-ZEBOV
NewLink Genetics
VesiculoVax
Profectus Biosciences
- Profectus VesiculoVax vaccine for both
pre- and post-exposure protection against
haemorrhagic diseases caused by Ebola
and Marburg viruses, based on the use of
vesicular stomatitis virus (rVSV).
Current Status
- Up to 24,000 doses ready to be tested by health workers early next year.
- Consideration being given to supporting parallel production with safety and efficacy trials
currently under way to ensure product production capacity for a million doses during 2015, and
several hundred thousand to be ready before or by June 2015.
- Currently undergoing phase 1 trials analysing safety and immune response in people not at risk
of contracting Ebola. If positive, efficacy trials to start early January in Sierra Leone (8,000) and
Liberia (12,000 people).
- Primary health workers would likely be primary group.
- Cost unknown.
- $200 million investment to accelerate and expand EVD vaccine production targeting more than
one million vaccine doses in 2015.
- 250,000 doses expected to be released for broad based clinical trials by May 2015.
- Targeting the production of more than 1 million doses in 2015 for clinical trials and emergency
use.
- Currently undergoing phase 1 trials.
- Capacity to produce vaccine batches of 100,000 vials and a 28 million production capacity.
- Have just entered phase 1 studies in the US.
- Following August 2014 donation by Public Health Agency of Canada of 800-1,000 doses to
WHO (remaining doses after conclusion of phase 1 trials. Details of the donation are under
discussion, first of 800 vials of the vaccine shipped.
- Further availability will depend on investment into manufacturing.
- Phase 1 trial started USA Oct 2014 / EU Nov 2014 / Africa Nov 2014 for a total of ≤ 250
people.
- Large randomized controlled phase III study planned for early 2015.
- Merck has entered into an exclusive license agreement with NewLink Genetics to research,
develop, manufacture and distribute rVSV-EBOV.
- Animal trials still ongoing and plan to begin human trials by the middle of 2015.
- Studies conducted by a team from US Government Agencies have shown that a single dose of
the VesiculoVax provides 100% protection of non-human primates against 1,000 times the
lethal dose of EVD (and Marburg) viruses.
- A trivalent VesiculoVax vaccine to protect against all filo viruses has entered non-human
primate testing with US financial support.
- VesiculoVax rVSV-vectored vaccine for EVD has completed preclinical studies.
- Funding secured to conduct toxicology studies to evaluate the safety of VesiculoVax and to
manufacture the vaccine for use in Phase 1 clinical studies.
14
Recombinant rabies
EBOV
Thomas Jefferson
University (PA)
DPX-Ebola
Immunovaccine Inc.
Oral Ad5
Vaxart
Recombinant Ebola
Glycoprotein
Protein Sciences
DNA-EBOV with
electroporation
Inovio
EBOV GP Vaccine
Novavax
- Vaccine based upon chemically
inactivated rabies virus (RABV)
containing EBOV glycoprotein in their
envelope.
- Ebola vaccine formulated in DepoVax, a
patented formulation that provides
controlled and prolonged exposure of
antigens plus adjuvant to the immune
system.
- Oral human adenovirus-based Ebola
candidate (tablet vaccine)
- Based FluBlok influenza vaccine.
Baculovirus-expressed recombinant
protein.
- DNA Ebola vaccine candidate.
- Recombinant nanoparticle with
proprietary adjuvant Matrix-M.
- The vaccine to be further developed through partnership with IDT Biologika.
- Vaccine has been licensed to Exxell BIO to advance the product through clinical testing and to
commercialization.
- Within the next few weeks, production will begin on 2,000 doses for clinical trials in humans to
begin by mid-2015.
- Vaccine production component of clinical trial is estimated at ~$2m.
- Positive challenge study results reported for DPX-Ebola performed by NIAID/NIH using
primates sensitive to the Ebola virus.
- Planning additional studies expected in 2015.
- Trials to start during first quarter of 2015.
- Clinical trials in first trimester of 2015.
- Clinical trials during 2015.
- Clinical trials to start during December, 2014.
15
Annex 3b Pipeline Treatments
Product / Company
Convalescent plasma /
Blood Transfusion
Services
Polyclonal
Immunoglobulins /
Fab’Entech -France
ZMapp /
Mapp
Biopharmaceutical;
LeafBio
Description
- Blood transfusions derived from EVD
survivors.
- Considered safe if well-managed.
- Risks are those associated with any blood,
blood products and blood borne
pathogens.
- Theoretical concern about antibody
dependent enhancement of EVD
infection, which may increase infectivity
in cells.
- Hyper immune globin of purified
concentrated plasma of immunised
animals and previous infected humans
with high titres of neutralising antibodies
to be used.
- Antibodies that can neutralize the
different EVD strains shown offer
protection in monkeys 48 hours after
EVD exposure.
- Combination of 3 monoclonal antibodies.
- Plant-system based production.
Current Status
- WHO recently published an interim guide for national health authorities and blood transfusion
services outlining how to collect convalescent whole blood (CWB) or plasma (CP) from EVD
recovered patients for transfusion. See: “Use of Convalescent Whole Blood or Plasma Collected
From Patients Recovered from Ebola Virus Disease - Empirical Treatment During Outbreaks”.
- Whole blood from patients in convalescent phase of infection is used as an empirical treatment
with promising results in some EVD cases. CFR rate was significantly lower (12.5%) than
overall CFR (80%) (Kikwit 1995), though reasons for this low fatality rate remains to be
explained. It is not known if antibodies from survivors’ plasma is sufficient to treat or prevent
disease.
- More research is ongoing and options to conduct studies are being explored.
- Logistics and blood management, transport and shipping from source to point of use may be a
challenge.
- First batches of convalescent plasma might be available by end-2014.
- Generally considered safe. Extensive experience with the use of hyper immune globulin against
other infectious diseases. Inactivation and purification procedures eliminate blood-borne
pathogens.
- Not currently available.
- Several months needed to immunize animals, collect plasma and purify product. Work has
started on producing immune globulin in horses, and human immune globulin in cattle.
- Studies in horses could take place in 6 months, but large scale batches for human use not
expected before mid-2015.
- Federal health officials and Bill & Melinda Gates Foundation working to increase production of
ZMapp as it is viewed as the most promising experimental treatment to date.
- Planning Phase I clinical trials for which it needs to still produce sufficient quantities.
- Current supply has been exhausted (originally intended for just animal safety and efficacy
testing); working with U.S. Gov’t to “accelerate scale-up” of production which might yield a
few hundred doses by end-2014 / 6 months.
- Active pharmaceutical ingredient appears to be able to be produced on the order of several
weeks. Subsequently, distillation and purification processes are required to isolate the API (time
unknown).
16
- Small interfering RNA molecular
(encapsulated in lipid nanoparticles)
against Ebola virus RNA polymerase L
protein.
TKM-Ebola /
Tekmira
Pharmaceuticals
- An experimental antiviral drug for the
treatment of cytomegalovirus, adenovirus,
smallpox, and Ebola virus infections
CMX001 /
Brincidofovir
Chimerix
BCX4430 /
BioCryst
Pharmaceuticals
- Broad-spectrum RNA dependent-RNA
polymerase inhibitor.
- Phosphorordiamidate oligonucleotide.
- RNA-based therapeutics.
AVI-7537 /
Sarepta Therapeutics
- 83% effective in primates if administered 48 hours after infection and 67% survival 72 hours
after infection.
- Single dose study found adverse effects of headaches, dizziness, and chest tightness and raised
heart rate at high doses. Lower dosage thought to be better tolerated and inform proposed
treatment.
- US FDA has authorised emergency use in EVD infected patients. A limited number of
treatment courses are potentially available.
- A potential 900 courses could be produced by early 2015.
- Phase 1 clinical trials begun in January 2014. Previous hold on clinical trials was removed
allowing for treatment with currently Ebola-infected patients (subject to all other clearances).
- Company has inventory to cover Phase I trials. Requires “months” to produce new quantities.
- Tekmira has started limited manufacture of a new Ebola therapy targeting Guinea EVD variant,
to be available early December, 2014.
- Tekmira completed design of a modified RNA therapeutic specifically targeting Guinea variant
EVD.
- A conjugated lipid compound designed for cidofovir intracellular release to increase activity
against DNA viruses.
- Preliminary in vitro tests show potential for EVD treatment, despite EVD not being a DNA
virus.
- Chimerix received FDA authorization on 6th October for emergency investigational new drug
applications for EVD treatment.
- Chimerix received FDA approval on 16th October to start Phase 2 trials in patients infected with
EVD for safety, tolerability and efficacy.
- Brincidofovir tablets are available for immediate use in clinical trials.
- 83-100% survival in rodents with EVD and effective in animals 48 hours after infection with
Marburg virus (same family as Ebola). Study is still in preclinical trials with safety studies
planned.
- Awaiting clarification of potential capacity and timing. Need animal treatment and protection
data for EVD prior to consideration for availability and feasibility.
- No material is currently available for field use.
- Compounds found to protect up to 80-100% non-human primates to EVD challenge infections.
Human tolerability has been demonstrated in early studies.
- Active ingredient is available for 20-25 courses by mid-October. Potential production of approx.
100 treatment courses could available by early 2015.
- Previous clinical trials has been cancelled (supposedly due to U.S. Federal government budget)
- Company has publicly stated that it has active pharmaceutical ingredient which can, given
appropriate waivers, be available in a week. Quantities prospectively available is currently
unknown, however.
17
Favipivavir / T-705 /
Toyama Chemical/Fuji
Film
- IV infusion of lyophilised siRNA
prevents replication within cell (0.3mg/kg
infusion once for 7 days).
Interferons (IFN) many - IFNs demonstrate clinically to have a role
non-exhaustive list:
in treating viral diseases, as they enhance
Alpharona /
innate and adaptive immune and antibody
Pharmaclon; IntronA
responses.
(Intron-A) / Schering- They have widespread potential
Plough;
(generally for HepB and C infections). It
IFN-ß / Realderon /
is not yet known if this product could be
Teva;
efficacious in EVD, and no tests have yet
Reaferon EC / GNC
been done.
Vector;
- IFNs could be used where clinicians have
Reaferon EC-Lipint /
experience in IFN use for other
Vector-Medica;
conditions.
Infagel / Recolin /
Vector-Medica;
Altevir / Bioprocess;
Viferon / Feron;
Kipferon / Alfarm;
Giaferon / A/S
Vitafarma; Genferon /
Biocad; Grippferon /
Opthalamoferon /
Gerpferon / Firn-M
Source: UNICEF Supply Division / WHO.
-
Effective in mice, but limited in NHP (1 in 6 survived).
A study using a different dose regimens underway.
Approved in Japan for flu treatment and under study in other countries.
Tested in 1,000 people with no adverse effects.
EVD doses are to be 2-5 times higher than currently tested, and treatment duration to be longer
than for flu.
Use for field post-exposure prophylaxis under discussion.
10,000 treatment courses may be available, pending dosage volume to be used for EVD.
Use of IFN-ß in NHP prolonged time to death from Ebola (Zaire) at 18 hours post infection. ⅓
of NHP survived infection from Marburg infection.
IFN-α2b daily therapy starting 18 hours after infection reduced viremia without significant
delay time to death.
Availability of US-FDA and other approved stocks unlimited, though cost, and absence of an
approved product for use with EVD will be a barrier.
18