Professional Documents
Culture Documents
Vaccine shortage
Editorial Board
Datuk Dr Zulkifli Ismail
Dr Selva Kumar Sivapunniam
Dr Yong Junina Fadzil
The MPA is aware of, and affected only the private market of
MPA 2013 – 2015 has received feedback from Paediatricians and GPs.
EXECUTIVE COMMITTEE Paediatricians nationwide regarding,
President the shortage of the primary vaccines. The reasons
Dr Kok Chin Leong We have also received emails
Immediate Past President asking about what steps MPA is The problem is with the production
Dr Noor Khatijah Nurani taking to help solve this problem. of these vaccines by the
Private General Practitioners who manufacturers. There was a problem
Vice-President
Dr Thiyagar Nadarajaw give vaccinations are also affected. with production of the primary
In fact, at the Asia Pacific level, pentavalent vaccine by a major
Secretary manufacturer resulting in a shortfall
Assoc Prof Dr Tang Swee Fong
other private practitioners in other
countries especially the South Asian in supply. Priority had to be given to
Asst Secretary countries have also complained the National Immunisation Program
Dr Hung Liang Choo (NIP) and those already committed.
of vaccine shortages. So it is not a
Treasurer local problem! Hence, all the vaccine supply went
Dato’ Dr Musa Mohd Nordin to our Ministry of Health for the
Committee Members pentavalent DTaP/IPV/Hib vaccines.
Datuk Dr Zulkifli Ismail
The vaccines involved The MMR vaccine has ramped up
Dr Koh Chong Tuan The shortage first started with the its production so it is available but
Datuk Dr Soo Thian Lian optional varicella vaccine because there is still a shortage of varicella
Dr Selva Kumar Sivapunniam
a company producing this vaccine vaccine with only one supplier at
Dr Ariffin Nasir
Dr Muhammad Yazid Jalaludin decided it was not viable to the moment. Competition for the
continue. Then the quadrivalent vaccines within the region added to
Co-opted Committee Members
measles, mumps, rubella, varicella the shortfall. These vaccines naturally
Prof Datuk Dr Mohd Sham Kasim
Dato’ Dr Hussain Imam Haji (MMRV) vaccine disappeared from ended up in countries where they
Mohd Ismail the market resulting in a temporary cost more. As Malaysia was getting
Professor Dr Zabidi Azhar Hussin shortage of MMR vaccines too. the vaccines at rates lower than our
Honorary Auditors The varicella vaccine is currently neighbours, the priority was obvious.
Dr Lim Wei Leng available in limited supply by one
Dr Khoo Teik Beng company (MSD) while MMR vaccines Short-term solution
Affiliated to:
returned.
• Malaysian Council For Child Welfare There have been requests by
• ASEAN Pediatric Federation
As if that was not enough, the Paediatricians for MPA to take
• A
sia Pacific Pediatric Association
– APPA (Previously Association of primary DTaP vaccine started proactive measures to prevent
Pediatric Societies of the South East disappearing from the market. vaccine shortages from happening.
Asian Region – APSSEAR) The hexavalent DTaP/IPV/Hib/HB As this is an issue of production, the
• International Pediatric Association produced by GSK (Infanrix Hexa) and solution lies with the manufacturers,
(IPA)
Sanofi Pasteur (Hexaxim) were not not with MPA. Short of stockpiling in
The Berita MPA is published for members to accessible in the beginning and has anticipation of another shortage,
keep them informed of the activities of the
Association and to keep up with developments remained unavailable. The primary there is nothing much that MPA
in paediatrics and child health. pentavalent DTaP/Hib/IPV by both could do. Stockpiling would be an
The views and opinions in all the articles
companies then became scarce. expensive and counter-productive
are entirely those of the authors unless
otherwise specified. The shortage of these vaccines response by MPA. We have had
We invite articles and feedback from
readers – Editor <editor.bmpa@gmail.com>
continued on page 3…
3rd Floor (Annexe Block), National Cancer Society Building, 66, Jalan Raja Muda Abdul Aziz, 50300 Kuala Lumpur.
Tel: 2691 5379 / 2698 9966 Fax: 2691 3446 E-mail: mpaeds@gmail.com Web page: www.mpaweb.org.my
Lessons Learnt as
President
Dear friends and colleagues, Nurses group who are associate
members to strengthen and
What a relief, I survived the 2-year organize themselves as a
term as President. Allow me to recognizable profession. I consider
share some lessons learned and the Paediatric Nurses as our
some wishes for MPA. partners in child health and the Better governance
In the beginning, there were pillar of good quality care and an
extension of our management. My greater wish is to see
enthuasiam, ideas and plans.
You must rise to be recognized, better governance, and
One would want to make things
noticed and be one of our complete implementation of
different. However I realised that
advocates for quality care. government policies for a more
it took more than enthuasiam and
comprehensive child education,
drive to make things different.
inclusive healthcare reforms
Certain issues may take more than More interaction and strengthening values and
2 years to change. I also realised needed culture in positive parenting and
that there were many things that
I hope there will be more frequent childcare for all.
I did not know. I learned a lot
from the Exco members and at and greater interaction between
Lastly I wish to thank all my Exco
least at all times we decide as public, private and university
members for giving me all the
a team after a good exchange members in current issues and
support and the harmony we
and discussion. I learn more about in their respective specialties or
kept in the meetings and most
organizing conferences, relations common interests. We should
of all the ever hardworking and
with the Ministry and authorities, not just interact during annual
efficient Secretary, Prof Tang
with the pharmaceutical & congresses only but in all avenues
Swee Fong. My thanks also goes
nutritional industries, ethical and be it in cyberspace, chats or in
to Datin Saadiah Ahmad, and
public issues, the media and the lecture halls.
her team for keeping us “filled
press. However, unfortunately I In future I can foresee greater up” during our Sunday morning
am not in the “movers or shakers” difficulty in sponsorship and meetings.
group. less funding from the private
I welcome the President Elect,
industries. As demand for more
Dr Thiyagar to the President’s
More pending issues transparency in educational
chair for the next 2 years and
grants, and funding from the
There are still many issues continue to lead us for the better
pharmaceutical industries, big
that need our attention. We and into the future.
players are shying away or
need more of our members are reluctant to participate. It I again extend our invitation
to be directly involved in is already happening in some to all to attend our 37th Annual
subcommittees, in expert groups countries. It is good governance Congress organized with the
and in advocacy. It is always the to be transparent but not at Asia Pacific Vaccinology update
same voices that make their noise the expense of stifling CME focusing on Pneumonia and
heard or dare to speak. I am sure programmes and furthering Diarrhoea at the Shangri La
there are talents out there. There knowledge and research. A better Hotel KL. 2
are people with burning desires way is to formulate a guide for the
to make a difference in our sponsors and reduced loopholes Kok Chin Leong
children’s well being. Please make and abuse of funds. We need President 2013-2015
yourselves heard to us. self-governing rather than be kokcl1@gmail.com
I would encourage the Paediatric governed by laws and legislation.
discussions with the different companies and we give What’s left for private sector?
their feedback in the ensuing pages.
The vaccines that are still available to private
What we can do as Paediatricians in private practice practitioners will be MMR, varicella, pneumococcal,
is to refer or divert our patients who require the primary rotavirus, influenza, hepatitis A and meningococcal
pentavalent vaccines to the Klinik Kesihatan (KK) or ACWY vaccines.
Health Clinic nearest their homes. The KK staff should
not refuse these patients even though they are not We have to make the best of the current situation and
delivered at MOH facilities (this was clarified after a ensure that our patients get their primary vaccinations
meeting with MOH). Some privileged private practices as in the NIP from the nearest KK. They can be told to
have managed to get the pentavalent vaccine with get the other recommended vaccines from the private
short expiry dates. The hexavalent vaccine looks like it sector.
is not likely to make a comeback until the end of the
year, and possibly beyond. As MMR is still available in Zulkifli Ismail
limited quantities, these can still be given by private drzulkifli.ismail@gmail.com
practitioners. With regard to varicella vaccines, MSD For the Executive Committee
is able to bring limited volumes of the monovalent
varicella vaccines (Varivax) for our use.
GlaxoSmithKline Pharm
aceutical Sdn. Bhd.
Level 6, Quill 9
No. 112, Jalan Semangat
46300 Petaling Jaya,
Selangor
Tel: 603-7495 2600
15th October 2014 Fax: 603-7954 2190
www.gsk.com
Supply Constraint of
GSK Vaccines
As one of our valued
customers, we deeply
global challenges in regret to inform you that
our production capacity GSK is experiencing
affect supply throughout for the vaccines belo
2015. w which will significa
ntly
However, for Infanrix
Hexa and Priorix, supp
expected to resume by ly constraints are tem
the first quarter of 201 porary with supply
5.
No Product Name
1 Infanrix®-IPV+HIB Estimated out-of-stock
date
Combined diphtheria
-tetanus-acellular pertu October 2014
inactivated polio and Haemophil ssis,
vaccine us influenzae type b
2 Infanrix Hexa®
Combined diphtheria
-tetanus-acellular pertu November 2014 (tempora
hepatitis B, enhanced ssis, rily out-
Haemophilus influenzae
inactivated polio vacci
ne and of-stock)
type b vaccine
3 Priorix ®
†
Measles, mumps, rubel
la (live, attenuated) November 2014 (tempora
rily
4 Havrix® 720 Junior out-of-stock)
Inactivated hepatitis
A vaccine January 2015
5 Havrix® 1440 Adult
Inactivated hepatitis
A vaccine January 2015
6 Hiberix ®
Haemophilus influenzae
type b (Hib) vaccine †June 2015
7 Infanrix®-IPV
Combined diphtheria
-tetanus-acellular pertu June 2015
inactivated polio ssis and
8 Varilrix®
varicella vaccine (live,
attenuated) Currently out of stock
9 Priorix-Tetra®
Measles, mumps, rubel
la and varicella vacci Currently out of stock
attenuated) ne (live,
10 Typherix®
Vi polysaccha
† this out-of-stock situati ride typhoid vaccine Currently out of stock
on is only applicable to
the private sector
Registered in Malaysia
Company No. : 3277-U
Q1 – Why is supply for those well engaged in their SP: It is important to note that all
last manufacturing steps (filling, pediatric acellular-pertussis (aP)
constrained? packaging and labelling). It containing combination vaccine
has to be known that each doses currently on the market meet
SP: The manufacturing operations manufacturing step and each QC all approved safety and quality
performed to produce and test might experience technical standards requirements.
distribute the AcXim products difficulties making the decision to
are among the most complex proceed to the next step delayed
of the vaccine industry as (or even cancelled if a decision to Q3 – What is the
they encompass multiple and not use the intermediate product impact?
successive operations to be under analysis is taken).
executed in order to manufacture
SP: The current supply plan that
ten different Drug Substances (the In addition, and as expected for
vaccine manufacturers has
antigens or their components) and this kind of products, a multitude
estimated / projected is not
the aluminium adjuvant gels and of Chemistry, Manufacturing
sufficient to fully satisfy the global
then to manufacture 3 different and Control modifications
market needs that have been
Drug Products (the vaccines). are constantly ongoing to
requested of it. The long lead times
introduce improvements to the
to produce these combination
These 3 Drug Products are in turn manufacturing (equipment and /
vaccines will prevent vaccine
filled, labelled and packaged in or processes) and quality control
manufactures from significantly
a multitude of final presentations (assays, equipment, reagents,
increasing supply in the short term.
(single-dose vials or syringes, standards) steps of these raw
single- or multi-container box with materials (the Drug Substances
In countries where there will be
a multitude of country-specific and the adjuvant), Drug Products,
a shortfall / shortage, vaccine
labelling documents). and finished products.
manufacturers are working to
meet public health needs as best
Each raw material (dozens), each It can therefore be understood
as possible to ensure continuation
Drug Substance (and all of their the extreme complexities for
of public vaccination programs in
intermediates), and each Drug vaccine manufacturers to manage
those countries.
Product are tested by a battery delivery of products aligned with
of in vitro and in vivo assays to their regulatory status in all the
allow the next manufacturing step countries where these products are Q4 – When will you be
to proceed, resulting in a total of marketed.
hundreds of tests done over the able to come back
entire set of manufacturing steps As the global demand for aP- to a normal supply
for every batch of final product to backboned products is surging in
be shipped to customers. 2015 and in the subsequent years,
situation?
depending on countries, either the
These quality control tests are often quantities of finished products that SP: The long lead times to produce
initiated at risk (next manufacturing will be delivered will be decreased these combination vaccines will
step already engaged) and many and / or the supply dates will be prevent vaccine manufacturers
of them (the in vivo assays) are delayed for variable periods. This from significantly increasing supply
suffering from high sensitivity to will create in some countries (or in in the short term. However SP is
execution variations inducing high some regions within countries or at doing its best to ensure supply
rates of invalid assay runs. some point of vaccination within resumes to normal in the near
regions) out-of-stock (OOS) events future.
As a result, the total cycle time for that will last for variable periods.
all these products are roughly 18
to 24 months, and the customer
Q5 – How long does it
and regulatory constraint Q2 – Are these take to produce these
attached to all product batches production issues vaccines?
are making extremely difficult
any decision to re-allocate one
linked to a vaccine
batch of a given product from safety issue? SP: Production cycle of the
one market to another, particularly pertussis containing combination
vaccines takes 18 to 24 months.
Q6 – What is the Policy Committees and WHO, in all pre- and post-licensure
infants should receive time- clinical trials, but one might easily
recommendation in appropriate vaccinations with understand that starting regimen
the situation where any available DTP, Hib and IPV later will always be better than not
containing combination vaccines vaccinating at all.
a child who has to complete the series.
received a birth and
Vaccination should not be Q10 – What is the
1st month dose of Hep deferred and should be performed recommendation if
B monovalent vaccine within the licensed time intervals
there is no supply
be given a hexavalent because the brand used for
previous doses is not available. available to ensure
combination vaccine
timely completion of
in primary series Q8 – Interchangeability the series according
and/or booster between pediatric to the recommended
immunisation? acellular-pertussis immunization
SP: It is always preferable to (aP) containing schedule?
follow recommended schedule combination vaccines
for Hepatitis B vaccination. In this SP: Prescribers should refer to their
regard, both WHO and CDC say
in primary series? national official recommendations.
that for programmatic reasons,
it is acceptable to use 4 doses of SP: In general, we encourage As a principal, all efforts should
Hepatitis B in the primary series- the vaccine users who have started be made to ensure that a child
1st dose as Hepatitis B at birth and with a particular brand to receives the appropriate primary
then the next 3 doses as part of a complete the series with the and booster vaccination in a
combination regimen. same brand for the primary series. timely manner.
Nevertheless, if the previously
Nevertheless, based on principles administered vaccine is not In a situation where it is impossible
of vaccination, extra doses of known or not available, then any to complete the vaccination
Hepatitis B are not necessarily licensed DTaP containing vaccine regimen within time-appropriate
seen as detrimental, rather they may be used to complete the vaccination windows, infants
can even boost the response to primary series according to the should receive vaccination
Hepatitis B, in fact, for Hepatitis recommended schedule. as close as possible to time-
B non-responders or for those appropriate vaccinations with
who are immunocompromised,
regimens using double doses or
Q9 – What is the any available DTP, Hib and IPV
containing combination vaccines
repeated series are often used. recommendation when to complete the series. An
Thus, the schedule of Hepatitis B at
0 and 1, followed by 3 hexavalent
primary or booster interruption in the vaccination
schedule does not require
doses for primary series, would dose cannot be given restarting the entire series of a
not be a practice that we would at the recommended vaccine or addition of extra doses.
advocate routinely, but would still
be accepted as valid. time according to the
schedule and need to Q11 – How long can
Q7 – What is the be postponed? a vaccination be
recommendation in delayed?
SP: Prescribers should refer to their
the situation where national official recommendations. SP: Vaccination should not be
primary immunisation deferred because the brand used
In infants who have not yet
is not able to be received their doses of the 3-dose
for previous doses is not available
and should be performed within
completed with the infant series, the objective would the licensed time intervals. Longer
same product? be to start the infant series as soon intervals (>2 month) have not
as possible and at an age as close been pro-actively documented
as possible to the recommended in pre- and post-licensure clinical
SP: In a situation where it is age. trials. but one might easily
impossible to complete the
understand that giving the dose
vaccination regimen with the Starting infant primary series at an later will always be better than not
same product, as recommended age older than 3 months has not vaccinating at all. 2
by several National Immunization been pro-actively documented
(L-R) Presiden
ts of APPA, PI
DST and APF
/MPA
entertainment backed by
Soprano singer opening ceremony
talented cham ber orche stra Indonesia, Ph
ilippines, Thai
land & Malay
sia after open
ceremony ing
Condolences
Dr Lam Pan Nam From another friend, Dr Goh Teck Leong: “The first
(18 July 1959 – 23 June 2015) private paediatrician in BP. Main person behind the
graduated from UM with MBBS setting up of a learning facility for handicapped and
1985 and obtained his MRCP disabled children. A devoted Christian.” As the fund-
(UK) in 1990. He started his raising chairman, he raised RM330,000 for the centre
Paediatric GP practice in 1990 in Batu Pahat, Johor (The Star-on-line, Friday Sept 26, 2008).
becoming the first private paediatrician in that town.
He will not only be missed by his family members, but
From Dr SP Chuah, Paediatrician “I know he was also by the Batu Pahat community especially the
very active in the early intervention centre for the Down syndrome and disabled children, for whom he
handicapped in BP and helped raise much fund and devoted so much of his time and energy. The MPA
was a chairman of the centre run by the Grace BP sends our condolences to his wife and 3 daughters,
Church, his church.” and granddaughter.
We had recently concluded our diabetes camp, A total of 35 young diabetics participated. To
which was held in “Lost World of Tambun” Ipoh, on facilitate teaching activities, the diabetic children
1st to 3rd June 2015. Diabetes camp has always were grouped according to their ages ie 6-8,
been a much-awaited event for children and 9-12, 13-14 and 15-18 years. We had an exciting
adolescents with diabetes. It is not just a time of fun educational program as prepared by the Young
and outing, most importantly it is a time of learning, Diabetics Support Group of UKMMC. The children
sharing and building friendship. For the doctors, learned and re-learned about hypos, hypers, carb
nurses and the rest of the medical team, diabetes counting, calculation of meal and correction doses
camp is an opportunity for us to share the lives of of insulin, reading nutritional labels on food etc. We
these young diabetics, empowering them with the even had a practical session when the children
knowledge and skills to self-manage their diabetes learned to prepare healthy sandwiches. While the
in their daily living. To many of us, it is also a humbling young children were having their lessons, the older
experience as we learned a lot from our young group (15-18 years) had private discussions with
diabetics who have far greater practical experience our psychologists who helped them to gain deeper
in diabetes management than us. insight of themselves, uncover their hidden feelings
and empower them to work out strategies to cope to live an active life just like any other normal kids,
with their struggles and barriers to diabetes control. despite their diabetes. With incessant education
and guidance, we believe the diabetic children
Among the outdoor activities, the children most “BOLEH”. This is evident by the high standard of
enjoyed the Water Park where they spent almost four blood glucose control in many of them during the
hours under the adults’ supervision. Hypo kits were camp despite unceasing activities. The winner of
at hand, but none of our children had significant the “best glucose control” in each of the age-group
hypoglycaemia. Throughout the camp, each child had scored an average blood glucose value of 10.6
had about 8-10 finger-pricks per day to monitor mml/L, 10.00 mmol/L, 8.2 mmol/L and 6.6 mmol/L
their blood glucose to ensure the levels are within in the 6-9, 10-12, 13-14 and 15-18 years age-group
acceptable limits. The children learned through respectively. We are convinced that the camp has
camp experiences the effects of prolonged/ definitely helped the children in their knowledge,
strenuous physical activities on their blood glucose self-confidence, and emotions etc towards better
and appropriate measures to prevent or treat self-management of their diabetes. We hope this will
hypoglycaemia during and for many hours after have a lasting impact.
such physical activities.
The camp would not have been possible without
The highlight of the camp was on the last day when our sponsors. We are very grateful for their continual
there was prize giving for all the competitions and support and contributions. Thank you. 2
activities followed with the grand finale of a talent-
time when each group of children would perform
a skid. The youngest group (6-8 years old) emerged Wu Loo Ling
champion for their spontaneity and creativity. It is llwu@ppukm.ukm.edu.my
so encouraging to see these children being able
Local Venues
37th MPA Congress & Asia Pacific Neonatal Update 2015 “The Science of
Vaccinology Update Newborn Care”
“Focus on Pneumonia & Diarrhoea” Date : 30 Nov – 4 Dec, 2015
Theme : “Paediatric Infections and Vaccinology” Venue : BMA House, London, England
Date : 16-19 September 2015 Website : http://symposia.org.uk/neonatal/main.asp
Venue : Shangri-La Hotel, Kuala Lumpur Email : sympreg@imperial.ac.uk
Tel : 603-2698 9966, 603-2691 5379 Tel : +44 (0) 20 7594 2150
Fax : 603-2691 3446 Fax : +44 (0) 20 7594 2155
Email : mpaeds@gmail.com
Website : www.mpaweb.org.my 15th APCP and Pedicon 2016
Date : 21-24 Jan 2016
Klang Valley Paediatric Cardiology Venue : Hyderabad, India
Grand Rounds Email : secretariat@apcppedicon2016.in
Date : 11 September 2015 Website : www.apcppedicon2016.in
Venue : Auditorium, IJN
Tel : 03-2617 8317 (Ms Nisak)/ 03-2617 8470 2nd International Neonatology Association
(Ms Haslina) Conference (INAC 2016)
Email : pchcevent@ijn.com.my Date : 5-17 July 2016
Venue : Vienna, Austria from 15-17 July, 2016
Paediatric Diabetes Education Day Tel : +41 22 5330 948
Date : 19-20 September 2015 Fax : +41 22 5802 953
Venue : Auditorium TJ Danaraj, 3rd Floor, Faculty Website : www.worldneonatology.com
of Medicine University Malaya
Tel : 03-7949 2065 New Life Members
Email : nushadia81@gmail.com (Dr Nurshadia) Dr Hasaruddin Ridzal Hanafi Dr Shalini Shanmugam
Department of Paediatrics B2-29-05, Sri Putramas 2
Hospital Kemaman Jalan Putramas
Jalan Da Omar 51200 Kuala Lumpur
International Venues 24000 Chukai
Terengganu Dr Vindhu S. Venugopal
14th Scientific Meeting Commonwealth No. 10, Jalan 4/33
Dr Florence Wong 46050 Petaling Jaya
Assocaition of Pediatric Gastroenterology 1, Jalan SS 25/39A Selangor
and Nutrition in association with ISPHAN Taman Mayang
Date : 2-4 October 2015, New Delhi, India 47301 Petaling Jaya Dr Phang Yuk Jean
Selangor 100, Persiaran Permata
Venue : The Grand New Delhi, India
Taman Permata
Tel : 011 4766 1234 Dr Cheah Wen Nee 35500 Bidor
71, Lorong 2, Taman Desa Perak
Update in Paediatric Respiratory Diseases Indah
08000 Sungai Petani Dr Sim Hui Ling
2015 & Paediatric Respiratory and Kedah 201, Lorong 5F
Critical Care Workshop Jalan Lapangan Terbang
Conference Venue: Dr Marina Md Sham 93350 Kuching
79, Jalan Ibu Kota Kiri Sarawak
Shaw Auditorium, Postgraduate Education Taman Ibu Kota
Centre, Prince of Wales Hospital, China 53100 Kuala Lumpur
Workshop Venue:
Li Ka Shing Medical Sciences Building, New Ordinary Member
Prince of Wales Hospital, China Dr Farhana Syazwani Abdul Rahman
2A, Lorong Wangsa 6A1, Damaisari, Wangsa Melawati
Date : 13-15 November 2015
53300 Kuala Lumpur
Tel : 852 – 2632 2829
Email : pae_conferences@cuhk.edu.hk
Website : www.pae.cuhk.edu.hk/PRD2015