The State of Eritrea

Ministry of Agriculture Newsletter

A Monthly Newsletter Prepared by the Public Relations Division, Issue No 60, June 2023

A Glance at the Historical Journey and Recent
Achievements of Vaccine production: 1903-2023
Recently, the Ministry of Agriculture (MoA)
announced the commencement of production oftwo animal disease vaccines for Peste des Petitis
Ruminants (PPR) and Newcastle Disease (NCD). The
Public Relations Division of the MoA presents, Mr.
Efrem Ghebremeskel, Director of the National Animaland Plant Health Laboratory (NAPHL), Mr. AmanuelMebrahtom, Head of Vaccine Production Unit andMs. Ghirmawit Habtom, Head of Quality Control
Unit, to provide our readers with the necessary
details on this significant accomplishment, precededwith substantial information regarding the process ofthe two vaccines in a question-and-answer (Q and A)
form.
Question: Mr. Efrem Gebremeskel, could you give us
brief information on the historical background of theNAPHL?

Mr. Efrem Gebremeskel

soldiers with meat. However, the purchased animals
were severely affected by Rinderpest and, therefore,
the Italian government set up a study team in a bid toassess the situation and to find solution to control theoutbreak. To this end, a team was setup; conducted
its study; and came up with an idea that the army
can rely on meat supply from Eritrea. Subsequently,

Mr. Efrem: This laboratory was one of the few
pioneering laboratories in Africa. The active periodof this laboratory’s history extends from 1903 to1972. At the beginning of this period, the Italian
government used to purchase livestock, including
cattle, sheep and goats from India to supply its1

findings that reflected status of various diseases
among diverse animal species. Considerable types oflaboratory animal species were also raised within its
premises and used for vaccine production, diagnosis
and research purposes.

a new vaccine production laboratory with the name
‘Istituto Siero-Vaccinogenito’ was established in 1903,
in Villagio, Asmara. The laboratory started active
work like performing various laboratory activities andrendering services: Vaccine production, veterinary
diagnosis, food safety and quality testing for productsof animal origin, as well as diagnostic supporting
research works and others.

The period 1972 to 1991 constituted a status of total
regression and shutdown of vaccine production
operation due to the destructive war with the Derg
regime of Ethiopia. Especially with the intensificationof the war in 1975, vaccine production came to an end
and eventually the laboratory was totally abandoned.
Part of the entire premises and the laboratory houses
were even used as military camp by the Ethiopianregime.

Since its establishment to this date, the laboratory
assumed different names: Istituto SieroVaccinogenito, Veterinary Research Institute, Central
Veterinary Laboratory, and NAPHL, among others.
This laboratory work was not a smooth sail. Its
operational history was punctuated by events ofprogression, regression and shut down.

After independence, a new dawn ushered andthe laboratory operations showed a sign of comeback with a good momentum. The Government ofEritrea, through the MoA made all possible efforts
to rehabilitate the laboratory through constructing
various new laboratory infrastructures, equipping itwith the required facilities and training laboratory
personnel. Vaccine Production and Quality Control
Laboratory Establishment Project was launched in2005 with a fund from African Development Bank(ADB) under the National Livestock Development(NLDP) Project. Major infrastructures of thelaboratory including the fence of the premises,
laboratory building, laboratory animal housingsand other subordinating houses were constructed
through this project. Besides, various laboratory
equipment and supplies were procured. In 2010, theMoA in collaboration with the International Fundfor Agricultural Development (IFAD), focused on theQuestion: Can you give us more details regarding
the subsequent fates of the laboratory, with moreemphasis on history of vaccine production?
Mr. Efrem: Documents reveal that, at the beginning,
more than ten different types of veterinary vaccines
and anti-venom sera were produced by this laboratory
and utilized locally. It even satisfied vaccine demands
from Ethiopia and other neighboring countries.
Some of the then-prominently produced vaccine
types include against diseases like Rinderpest, Fowl
Fox, Fowl Pox Septicemia, Rabies, African Horse
Sickness, Contagious Caprine Pleuro Pneumonia(CCPP), Black Leg and Anthrax. Apart from vaccine
production, the institution was actively involved inanimal disease treatment, field service activities andresearch studies. As a result, many scientific journals
and documents were published on the basis of theThe 1903 built labaratory

2The newly built laboratorycompletion of the civil works, construction of waterand drainage systems, procurement of the remaining
essential equipment and supplies, recruitmentof vaccine production and quality control experts(Sudanese and Cubans), training of laboratory
personnel, as well as conducting trial activities. Apartfrom this, certain laboratory construction works werefunded by the government and the civil work was
mainly done by government parastatal construction
companies namely Debwin and Segen construction
companies. Some of the construction works havebeen active until 2019. However, as of 2017, thevaccine production training and trial paces were
progressing well side by side.
In 2019, professional communication was establishedbetween the NAPHL and the African-Union-Pan African
Veterinary Vaccine Center (AU-PAN-VAC) laboratory,
which is based in Ethiopia. The two leading directorsof the AU-PANVAC visited the NAPHL in 2019 andexpressed positive promises to technically support
the vaccine production laboratory with the required
vaccine seeds, cell line and some reagents. Lack ofvaccine seeds and cell lines was a critical bottleneckin the previous years. Then they sent us Peste desPetitis Ruminants (PPR) and Newcastle Disease (NCD)
vaccine seeds in 2020. They further sent one expert
to train our laboratory staff on PPR and NCD vaccine
production and quality control techniques for twoweeks. This was in 2022 and the laboratory has been
carrying out several scientific internal trial activities.

international standard requirements, representative
samples were sent to the AU-PAN-VAC laboratory
pursuant to the procedure given. Ultimately, the AUPAN-VAC laboratory tested the vaccine and confirmed
their good quality and granted certificates to thisend. The certificates for PPR and NCD vaccines wereissued on the 3rd of April and 13th of May this year
respectively.
The progress so far indicates that the NAPHL has
developed and is equipped with the required capacity
in terms of laboratory setup and human resource(knowledge and skill) to produce these. Moreover, it
implies that we can embark upon production of otherrelated vaccines with the help of some technicaladjustment and adoptions mechanisms.
Question: Why were the PPR and NCD vaccines givena priority?
Mr. Efrem: PPR and NCD are very infectious diseases
with a long period of prevalence in Eritrea. Dependingon the situation and degree of infection, PPR and NCD
can cause mortality rate up to 100% in small ruminants(mainly in kids) and poultry flocks respectively. For
this very reason, the Ministry of Agriculture, almostyearly, has been importing vaccines for these diseases
and others in big quantities. On the other hand, thesevaccines relatively do not require a complicatedtechnology, unlike some of the very expensive
vaccines. These two vaccines were selected for
production in the first phase, taking these facts intoaccount. It is also worth mentioning that the NCD isfurther linked with the strategic plan of the MoA for
small-holder farmers where every household in thevillage is encouraged to keep at least a small poultry
flock. This gives NCD vaccine production a priority as
chicken need to be immunized four times with NCD
vaccine to maintain a good immunity level.

Finally, it was in a position to produce the actuallyrequired two vaccines with full confidence. As aresult, three batches of NCD vaccine (327,000 dosesin total) and one batch of PPR vaccine (30,000 dosesin total) were produced in 2023. Samples fromthe vaccines were tested through internal quality
measures and well-passed the recommended test
parameters. Then, for more confirmation and to meet3

Question: What kind of advantage can Eritrea securefrom PPR and NCD vaccine production?
Mr. Efrem: Comparatively, notable advantages andbenefits can be obtained from these vaccines when
they are produced locally. Based on the ministry’s
report in the last 10 years’ vaccine imports, it wasroughly estimated that, every year, about 3.9 million
doses of PPR vaccine and 3.3 million doses of NCD
vaccines were imported at costs of about 383,000 and30,000 dollars respectively. The cost of production
for the same amounts of dose, i.e. considering theexpenses used for processing the two vaccines locally(excluding the lab facilities and other assets) stands
at around 31,000 and 20,000 dollars for PPR and NCDcorrespondingly. This implies that we can save up to353,000 and 10,000 dollars respectively.

facilities, i.e. with some modification, adoption andtraining, depending on the future required products.
The laboratory also provides groundwork for furthering
disease diagnostic techniques and research works.
Question: Mr. Amanuel Mebrahtom, let’s come to you,will you shed light on the critical process and journey
the NAPHL went through with a view of justifying
standard production capacity?

Mr. Amanuel: A good-quality vaccine always comes
as a result of integrating trained capacity with allfeatures of the installed system. To attain such agood result, the laboratory building, rooms and allmaterials within need to be designed in such a waythat it ensures safety and quality of the vaccine. The
entire process should not be compromised at any
cost. All the procedures, guidance, personnel training
Procurement and import of vaccines require hard manual etc. should be aimed at and designed withcurrency. Moreover, vaccines are not ready for sale major consideration to safety and quality of theat the shelf. Most of the time, veterinary vaccines are vaccine. All the stated undertakings are performed in
produced on demand basis. Procurement process also a proper way, then vaccine quality can be on the safe
has its own complications. Consequently, such delays side. Therefore, the same and satisfactory procedureand complications can cause further/ extensive spread was followed in our case.
of a disease to susceptible population.
Once the vaccine processing environment and facilities
However, the well-equipped laboratory that has been were ready for the production of standardized vaccine,
established and the nurturing of knowledgeable, with the process proceeded and recommended tests werewell-trained and highly motivated young laboratory done at every stage, from the beginning to the end.
staff constitute a great asset for our country. The The Vaccine Quality Control unit took the required
laboratory facility and its staff are versatile and can samples from the finished products and carried out all
serve in many laboratory settings. Other vaccines the recommended tests. Meanwhile, the Regulatory
can be produced through the knowledge and skills Services Department (RSD) of the MoA conductedthat have been acquired and the available laboratory inspection activities on all steps and areas of the4Mr. Amanuel Mebrahtom

laboratory and ensured compliance of the entire
process, in addition to issuing the permit thereof.
Then, representative samples from each batch of
newly produced vaccines were collected and sent
to the African Union – Pan-Africa Veterinary Center(AU-PAN-VAC) to be further tested and validated
for quality in the recommended international
laboratory. Eventually, all the samples perfectly met
the requirements for standard qualification and wereceived certificates confirming good result for eachsample.
Question: Please explain to us the major steps in NCD
vaccine production process.
Mr. Amanuel: In the first place, it is important to notethat the eggs used for NCD vaccine production mustcome from specific pathogen-free (SPF) flocks or fromhealthy flocks that are free from vertically transmitted

agents such as Salmonella Pullorum, Mycoplasma
Gallisepticum, Mycoplasma Synovae, etc. The eggs
and embryos are checked using candling techniquefor viability and fertility. The external part of theegg shell is properly cleaned and disinfected before
inoculation and incubation to avoid contamination.
Fertile eggs are incubated from 9-11 days in ahumidified incubator for the growth of the embryoand eggs with enlarged blood vessels are inoculatedwith vaccine seed through the allantoic route. After
96 hours of incubation, the allantoic fluid is harvested
and samples are sent to Quality Control Laboratory forsterility, while it is kept under bulk titration process.
Hence, through titration, concentration of the virus
present in the solution, as well as the amount ofvirus that can trigger antibody production on thetarget animals can be measured. Once titration is
successfully accomplished, Lactalbumin Hydrolysate
and Sucrose – on free dry medium– are added to thevaccine solution to maintain its stability and increase
shelf life.
Question: How about the major steps in PPR vaccine
production process.
Mr. Amanuel: In the virus seed used for PPR vaccine
it is inoculated into Vero cells that are prepared fromAfrican monkey kidney. The Vero cells are inoculatedwith passaged working seed. The Vero cells arecultured and made to grow on different growth media
such as GMEM, MEM while frequently being checked
for sterility and level of cytopathic effect (CPE) i.e.
shown in the media. Normally, first harvest starts
when it shows 40-50% CPE on the 6th day, and wecontinue harvesting and passaging until it reaches
70-80% CPE. Titration is carried out in 96 well microplates with 10-fold serial dilution and result reading,5

from day-7 to day-14, using inverted microscope. The
solution of the vaccine in vials is placed in free driermachine at least for 48 hours to remove its moisture
content through sublimation.

of the virus. In-vivo testing was further conducted
through challenging target animals (chicks) todetermine the immune response of their bodies, andthus gauging the titer using serological tests suchas Haem-Agglutination (HA), Haem-Agglutination
Inhibition (HI) and Enzyme-Linked-Immunosorbent
assay (ELISA). Afterwards, identity test is done using
Polymerase Chain Reaction (PCR) technique to ensurethat the product contains only the required vaccine
strain. Safety test was also done on immune responseof the target animals, making sure that there is noadverse effect due to the vaccine on them. Safety test
can be done both on target animals and lab animals.
Likewise, Stability test was executed using vacuum
and moisture test approaches on the vaccine todetermine the product’s stability rate during storage
period.

Finally, the vaccine vials are packed, labeled andstored in cold room until quality control certificate areobtained from the Quality Control Unit. In our earlier
case, representative samples from each batch of
production were sent to the AU-PAN-VAC laboratoryfor quality control test and certification at this stage.
Question: Ms. Ghirmawit Habtom, please tell us how
the Quality Control Unit dealt with the process of PPR
and NCD vaccine development?
Ms. Ghirmawit: Any vaccine produced should be tested
and pass the minimum requirement of quality control
test parameters including purity, safety, stability,potency and identity before it is released for use.
Consistent with this precondition, the Quality Control
Unit performed tests on starting raw materials, inprocess quality factors and the final product quality.
Before the start of vaccine production process, therequired raw materials; including eggs, media andPhosphate Buffer Solution (PBS); equipment andmaster seed were collectively assessed to ensuresterility avoiding further contamination. In-vivo(in embryonated eggs) and in vitro (in cell-culture)potency test was performed during the process aswell as the final vaccine products to gauge the titer

Moreover, the Regulatory Services Departmentof the MoA, worked side by side with us, startingfrom controlling the quality of buildings, ways andstandards of the vaccine production.
Question: What can we expect from NAPHL’s futureplans vis-à-vis vaccine production?
Mr. Efrem: I feel that there are three short-term goals
worth-mentioning now. First, the case of these two
vaccines is just a beginning. Only limited amounts
are being produced. So, we are looking forward toproducing the required amount of vaccines pursuingthe demand and request from the Agricultural
Extension Department (AED) of the MoA. Secondly,
based on the list of prioritized diseases, two more
vaccines mainly Infectious Bronchitis (IB) among
poultry and Sheep/ Goat Pox among ruminants will
be produced within same laboratory facility. Lastly,depending on circumstances, further developmentof the laboratory and roadmap of the MoA etc, thelaboratory will put up efforts to accommodate theserecommended tasks accordingly.
Mr. Efrem Gebremeskel, Director of NAPHL, Ms.
Ghirmawit Habtom, Head of Quality Control Unit,
and Mr. Amanuel Mebrahtom, Head of Vaccine
Production Unit, thank you for being willing to takethis interview.
***Ms. Ghirmawit Habtom

Editor-In-Chief: Ermias Solomon, Director of Public Relations Division: Email:- ersohab@gmail.com, Tel: 182225/ 002917143877
Assisstant-Editor-In-Chief: Filmawit Measho; Copy Editor: Medhanie Tsegai
Photo Credit: Aradom Bereket, Habteab Andemariam, Tomas Mehari, MoA Archives

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