United States of America
South Africa
Poland
Morocco
Jamaica
India
Ghana
Cuba
China
Brazil
Bangladesh
Angola
Tetanus
TB
Smallpox
Polio
Pertussis
Mumps
Measles
Hepatitis B
Campaign
Post00375 VAX INTRO + QUALITY DRAFT + SOLAR + NEWS 18 September 2001
CONTENTS
1. RE: A "THINK PIECE" ON INTRODUCTION OF COMBO VACCINES
2. ENSURING QUALITY OF VACCINES AT COUNTRY LEVEL: DRAFT FOR COMMENT
3. SOLAR POWER IS REACHING WHERE WIRES CAN'T
4. MENINGOCOCCAL DISEASE IN ANGOLA - UPDATE
5. NEWS
Visit the TechNet 21 Delhi meeting web pages at:
http://www.who.int/vaccines-access/index.html
Get the latest Technet21 documents at:
http://www.who.int/vaccines-
access/Vaccines/Vaccine_Cold_Chain/Technet/2001_Delhi_Technet.htm
____________________________________*______________________________________
1. RE: A "THINK PIECE" ON INTRODUCTION OF COMBO VACCINES
In Post00373, 10 September 2001, Robert Steinglass, BASICS, contributed a
thought provoking paper: "How to introduce new combination vaccines
(tetravalent and pentavalent): some practical and ethical questions"
In todays posting, Alan Schnur, WHO/CHN, adds to the discussion
" I realize there are cost, training and logistics implications for
this policy to provide full hepatitis B immunization to the "first" cohort,
but I would submit that the ethical and programmatic considerations of
sending children away from our immunization sessions only partially
immunized must also be considered."
Replies, comments and additions to: [[email protected]][email protected][/email]
* or use your reply button!
___________________________________________________________________________
From: "Schnur, Mr A (CHN)"
To: Robert Steinglass , [[email protected]][email protected][/email]
Subject: RE: a "think piece" on introduction of combo vaccines
Date: Tue, 11 Sep 2001
Hi Robert,
Robert and I talked about this interesting issue during Technet. I
remember the fights we had in the early days of EPI about focusing on
infants so as not to endanger the most important age group (infants) to do
"catch-up" on older, and less vulnerable, children. I strongly supported
this strategy. However, the current situation is somewhat different.
Previously we were talking about going out to look for children to immunize.
The situation that Robert discusses is one where an eligible child who
already received one or two doses of DPT is coming to an immunization
session expecting to be protected. We are not talking about searching for
children, but children still within our system. I would propose that we have
an obligation to fully immunize those partially immunized children who
present to us. As a parallel, in the early days of EPI we said that we
should not look for older children, but any child who had started the series
had the right to finish, no matter at what age he/she came back to an
immunization session. I would have problems justifying giving an infant
attending an immunization session only DPT2 and DPT3 when I had DPT-HB in my
vaccine carrier, or of giving him/her only one or two doses of hepatitis B
vaccine which would leave the child partially protected. Certainly, if we
had monovalent Hepatitis B vaccine this would not be an issue and we would
fully immunize the child. At this point, I am not proposing to reimmunize
infants who have completed three DPT doses and are returning for measles
vaccine (although I propose that this should also be considered), only those
children who have already started the DPT series.
However, this policy of fully protecting all children already within
the system would have technical implications, already raised by Robert, such
as how safe would it be to give a child up to 5 DPT doses in the first year
of life. Would using acellular pertussis vaccine affect this? What will
happen to the remaining stocks of DPT? Training and logistics implications
are apparent.
Perhaps another way to deal with this issue would be to initially
provide sufficient monovalent hepatitis B vaccine to immunize all infants
already within the system who received 1 or 2 doses of DPT to fully protect
them against hepatitis B as well. I would also support providing sufficient
monovalent hepatitis B vaccine so that we can fully immunize those infants
still in the system who have completed their DPT series, but not yet
received their measles vaccine (although I would propose this as a separate
issue). I realize there are cost, training and logistics implications for
this policy to provide full hepatitis B immunization to the "first" cohort,
but I would submit that the ethical and programmatic considerations of
sending children away from our immunization sessions only partially
immunized must also be considered.
Best regards.
Alan Schnur
____________________________________*______________________________________
2. ENSURING QUALITY OF VACCINES AT COUNTRY LEVEL: DRAFT FOR COMMENT
Gordon Larsen, WHO/V&B/ATT, kindly posts this draft document "Ensuring
Quality of Vaccines at Country Level - a Guideline for Health Staff" for
Technet Forum comment.
Replies, comments and suggestions to Gordon at: [[email protected]][email protected][/email]
* or use your reply button!
___________________________________________________________________________
Get the File!
QualityGuideline7.pdf 134 kb 35 pages
on the web at:
ftp://ftp.acithn.uq.edu.au/Technet/1-ClickHereForTECHNETfiles/Quality
or send an email to: [[email protected]][email protected][/email]
with the message: get technet QualityGuideline7.pdf
___________________________________________________________________________
From: [[email protected]][email protected][/email]
To: [[email protected]][email protected][/email]
Subject: RE: Vaccine Quality Document?
Date: Mon, 17 Sep 2001
Dear Allan,
Please find draft 7 attached for posting, which incorporates all comments
received to date from Technet and Sign members, & etc. As before, comments
and suggestions are welcome and can be sent to me at the usual address.
Best regards and go well,
Gordon
___________________________________________________________________________
DRAFT FOR COMMENT DRAFT FOR COMMENT DRAFT FOR COMMENT DRAFT FOR COMMENT
___________________________________________________________________________
DRAFT 7 30 Aug 01/G.L
Ensuring Quality of Vaccines at Country Level
- a Guideline for Health Staff
Access to Technologies
Department of Vaccines & Biologicals
WHO, Geneva
Supplies Division
UNICEF
Copenhagen
2001
__________________________________________________________________________
CONTENTS
INTRODUCTION 4
PART 1
1. ENSURING THE QUALITY OF VACCINES SUPPLIED THROUGH UN AGENCIES 5
2. CONTINUED MONITORING OF THE QUALITY OF PRE-QUALIFIED VACCINES 7
3. LIST OF WHO-PREQUALIFIED VACCINES 7
PART 2
1.TENDER REQUIREMENTS FOR SHIPPING VACCINES 8
PART 3
1. CHECKING VACCINE SHIPMENTS ON ARRIVAL 11
2. PROCEDURE FOR RELEASE OF VACCINE LOTS FOR USE 13
3. STORAGE AND DISTRIBUTION OF VACCINES AND DILUENTS 13
4. STOCK CONTROL SYSTEM 17
5. HANDLING OF INJECTION EQUIPMENT AND SAFETY BOXES 21
6. VACCINE RECONSTITUTION AND ADMINISTRATION 22
7. PACKAGE INSERTS 25
8. REPORTING OF ADVERSE EVENTS FOLLOWING IMMUNIZATION 26
SUMMARY 28
REFERENCES 29
ANNEXES 30
ABBREVIATIONS
__________________________________________________________________________
INTRODUCTION
In order to better understand typical procedures for receipt, storage,
distribution, handling and administration of vaccines in countries where UN-
procured vaccines are used, WHO carried out three field surveys in three
different regions of the world. These surveys attempted to identify factors
that might adversely affect vaccine quality at country level, and to suggest
changes in user and/or UNICEF Supply/ WHO-HQ procedures which might correct
or avoid these problems. The most common problems observed are listed in
Table 1. The surveys clearly indicated a need for guidance on all procedures
for managing vaccines, diluents and injection equipment, including shipping,
receiving, quality control, release, storage, distribution and
administration.
___________________________________________________________________________
Table 1.- Problems commonly observed that can damage the quality of
vaccines
* Shipments: Inadequate advance notice, route deviations, hold ups on
route, breaks in the cold chain
* Receipt/Acceptance : quantity received is checked, but quality
aspects are not always and systematically checked.
* Storage: cold chain failures, inadequate recording and/or stock
control system
* Release for use: Release certificates from NRAs of the producing
country are not always checked, often no formal release system is in place
* Distribution: Freeze-dried vaccines are frequently not distributed
with diluents in matching quantities, cold chain failures or interruptions
* Point of use: problems with storage, reconstitution, administration
and disposal
___________________________________________________________________________
This guideline has been prepared for use of all programme staff at country
level to assist in ensuring that vaccine quality is maintained throughout
the storage and distribution chain, and down to the point of use, and
describes the procedures necessary to ensure vaccine quality from the
moment when production starts until the time of administration. The
guideline is divided into 3 parts:
- Part 1 describes the procedures to ensure that vaccine production in
maintained at a high standard. This is mainly the role of WHO, working
closely with manufacturers and regulatory authorities.
- Part 2 describes the procedures to ensure safe and efficient shipping to
the country of destination. This in mainly the role of UNICEF, working with
airline agencies and transport forwarders.
- Part 3 describes the control mechanisms needed by receiving countries to
ensure that only high quality shipments are accepted, and the correct
storage, handling, reconstitution and administration systems needed to
ensure that vaccines maintain their quality thereafter up until the moment
of use. This in mainly the role of Ministries of Health and immunization
programme staff.
____________________________________*______________________________________
3. SOLAR POWER IS REACHING WHERE WIRES CAN'T
___________________________________________________________________________
http://www.nytimes.com/2001/09/09/business/09SOLA.html?todaysheadlines
September 9, 2001
Solar Power Is Reaching Where Wires Can't
By DAVID LIPSCHULTZ
Two hours outside Durban, South Africa, deep in the Valley of a Thousand
Hills, Myeka High School had no electricity. Students struggled to read by
candlelight, and few textbooks and newspapers were available. The school was
clearly having a hard time doing its job: only 30 percent of the students
graduated, and even those had little hope of going beyond their isolated
village.
Then, in the spring of last year, solar energy came to town. Photovoltaic
solar panels, firing up 2.4 kilowatts of power, were brought into the school
by the Solar Electric Light Fund, a nonprofit group based in Washington.
SELF also persuaded Dell Computer (news/quote) and Infosat
Telecommunications to donate computers and a satellite uplink so that the
students could have Internet access.
Now that the students can download materials from the Internet and have
access to the Learning Channel, the graduation rate has shot up to 70
percent. Some students have won science awards, and many are applying for
college. "I never thought the sun could do all this," said Melusi Zwane, the
school's principal.
Myeka is a vivid example of the impact of computers on society. But what
makes this tale stand out is the arrival of solar power. "It's the reason
for all that we have now," Mr. Zwane said. "Everything comes from power."
Business has long been keenly aware of the potential of providing energy to
deprived areas. And interest in narrowing the world's much-discussed digital
divide, between the connected and the unconnected, has only made the
opportunity more inviting.
That is why energy projects like the one at Myeka High School are not solely
philanthropic. Though many financing hurdles remain, there is money to be
made, especially for solar energy companies, when markets like these go
online.
In fact, according to Strategies Unlimited, a market research firm in
Mountain View, Calif., for the solar industry, roughly 40 percent, or $1.2
billion, of the $3 billion worldwide solar business last year came from
rural markets like the Valley of a Thousand Hills. In the United States, for
example, solar has had decent sales as an environmentally friendly
complement to the existing power grid, but there is a more immediate need
for it in rural areas. Strategies Unlimited predicts that the leading
companies in the industry, like the Royal Dutch/Shell Group, Siemens, BP,
Sanyo Electric, Sharp (news/quote), Kyocera and AstroPower, will continue to
have revenue growth of about 20 percent a year from these markets. That will
make the remote rural market alone worth roughly $2.5 billion by 2005.
Two billion people, roughly 30 percent of the world population, are off the
energy grid, living in areas without utility services. And a billion of them
have the means to pay for power, said Prof. Daniel M. Kammen, director of
the Renewable and Appropriate Energy Laboratory at the University of
California at Berkeley.
According to solar industry vendors and analysts, many of these billion
people spend $5 to $10 a month on kerosene, almost exclusively for lights.
Solar power, of course, has many more uses, and by amortizing the start-up
costs over perhaps five years, the total cash outlay is about the same.
"There's a lot of money to be made in converting those people to solar,"
said Dr. Allen M. Barnett, chief executive of AstroPower, a publicly traded
company based in Newark.
In July, for example, Shell Solar signed an agreement with the Sun Oasis
Company, a distributor in Beijing, to supply systems for up to 78,000
households in rural western China.
Aside from selling directly to remote areas, solar energy companies are
expected to achieve much of their growth in powering telecommunications
companies that want to extend their services, including the Internet.
"In some cases the economics involving off-grid power, such as power
generators, don't allow telecom carriers to go further out," said David
Dunsworth, director for power systems of Hutton Communications, a Dallas-
based distributor of telecommunications equipment. "Solar allows them to do
it."
Robert A. Freling, executive director of SELF, said, "There's no question
that telecommunications and computer availability are major issues when
trying to get communities online, but without energy you can't even talk
about those."
Solar power has become the energy of choice in many rural markets, in large
part because the price has dropped considerably in the last few years.
Prorating over roughly 10 years, the upfront cost of solar panels and
accompanying batteries gives the energy a cost of roughly 18 cents a
kilowatt-hour, competitive with any off-grid power.
Moreover, solar energy has no moving parts, unlike other renewable sources,
including wind and hydro, which makes it easy to maintain in areas where
technicians are hard to find.
Solar power's attractiveness off the grid, and an overall interest among
governments, corporations and international organizations in bridging the
digital divide, have put it in a sweet spot.
"I think getting people online in rural areas will be a huge growth driver
going forward for local solar companies," said Steve Cunningham, an
investment officer for the Energy House Capital Corporation of Bloomfield,
N.J., one of several private American equity firms that have millions of
dollars to invest in energy companies in rural markets in the developing
world.
But big challenges remain. Though they can last for 20 years, solar panels
and batteries cost a minimum of $500 for a small house. That would be a huge
upfront payment for many people, said Charles Gay, a director of Greenstar,
a nonprofit group based in Los Angeles that promotes the use of solar energy
in bringing remote areas online.
"Coming up with a viable financing arrangement is definitely one of the
biggest challenges," Mr. Barnett of AstroPower said.
International organizations like the World Bank and the United Nations
Development Program have started to put money into projects, and businesses,
to help solve the financing problem.
Two years ago, the International Finance Corporation, the private investment
arm of the World Bank, began investing $30 million through its Photovoltaic
Market Transformation Initiative for solar projects in developing countries
like India and Morocco.
But some people contend that even though these projects provide power for
remote areas, many people in those areas have more pressing priorities than
spending their scarce dollars on computers and Internet access.
"Clearly, for those numerous people in the developing world that are hungry
or sick, food and health must take priority over everything, even
education," said Lester Brown, chairman of the Worldwatch Institute in
Washington.
But many people who are involved in solar projects say the access to power
can help deal with those issues, too.
In some remote villages, the economy is "a barter system where they exchange
crops for kerosene, kerosene for medicine and things like that," Mr. Gay
said. "You have to give them the resources to transform themselves into a
real currency-earning society."
In Parvathapur, a remote village in south- central India that is off the
power grid, Greenstar is starting to find evidence of that. Last year,
Greenstar invested about $75,000 in solar panels, computers and Internet
access to provide the village with money-generating tools.
The village now sells its music, art and calendars online to customers who
include expatriate Indians in the United States. Fifty-five percent of the
revenue now goes to Greenstar to pay back the initial solar and
infrastructure expenditure. "Within four years, we expect to have recovered
our investment," Mr. Gay said.
Once the money is paid back, Greenstar's share will fall to 10 percent,
which will go toward financing other projects in places like Jamaica, Ghana
and the West Bank or future ones in Brazil and Tibet. "It's a self-
replicating finance mechanism," he said.
In return, villages like Parvathapur receive not only a way to build a
micro- economy for their music and arts products, but also a tool to better
support their principal source of income, agriculture.
Mr. Gay said the village is using the Internet to learn the most efficient
times to plant and harvest crops and the best markets in which to sell them.
"The village is making more money than before," he said.
Over the last two years, with a similar goal in mind, the Grameen Bank has
financed more than 30 rural communities in Bangladesh for energy projects.
It gives interest-bearing loans to people in those areas to buy Internet
connectivity products like solar panels and phone equipment. Enough
entrepreneurial activity has emerged to achieve a 90 percent payback rate on
the loans.
SELF has provided revolving-credit loans to various areas for home lighting.
When it comes to projects with fully integrated Internet access, SELF relies
on grants and does not have a specific repayment plan. It says it hopes that
some type of commerce arises from the efforts.
Building such commerce appears crucial. Many vendors and project managers
agree that if a village cannot set up a business model and generate enough
income from the new energy and the Internet access, it will eventually be in
the dark again.
"I've seen it many times," Mr. Gay said. "If the community isn't self-
sustaining after a while, none of this will work."
____________________________________*______________________________________
4. MENINGOCOCCAL DISEASE IN ANGOLA - UPDATE
___________________________________________________________________________
Date: Mon, 17 Sep 2001
To: [[email protected]][email protected][/email]
From: [[email protected]][email protected][/email]
WHO WER and Epidemiological Bulletin
Item(s)published on World Wide Web20
(http://www.who.int/disease-outbreak-news/)
Disease Outbreaks Reported 17 September 2001
Meningococcal disease in Angola - Update
An outbreak of meningococcal disease in May this year was reported to WHO
from the Balombo district in Benguela Province (see earlier report).
Neisseria meningitidis serogroup A was laboratory confirmed for this
outbreak and a mass vaccination campaign was launched in the affected
district. To date, the Benguela Province has reported 94 cases and 14
deaths. Recently other provinces in Angola (Cunene: 44 cases, 7 deaths);
Cuando Cubango: (25 cases, 0 deaths) have reported meningococcal disease to
WHO. However, the data from the newly affected provinces does not allow the
determination of whether any districts in these provinces have exceeded the
epidemic threshold. Angola has reported a total of 193 cases and 24 deaths
of meningococcal disease so far this year. For more information about
meningococcal disease, visit the WHO/CSR web site .
NOTES CONCERNING THIS SERVICE:
The Weekly Epidemiological Record (WER) serves as an essential instrument
for the rapid and accurate dissemination of epidemiological information on
cases and outbreaks of diseases under the International Health Regulations,
other communicable diseases of public health importance, including the newly
emerging or re-emerging infections, non-communicable diseases and other
health problems.20 The WER is distributed every Friday in a bilingual
English/French edition.
Any queries on subscription to the printed edition should be addressed to:
World Health Organization, Distribution and Sales, 20 Avenue Appia, CH-1211
Geneva 27, Fax: (+4122) 791 48 5720 Issues of the WER are in AdobeTM
AcrobatTM version 4.0 portable document format (.pdf). To view the WER, the
programme Acrobat Reader version 4.0 is required.20 Additionally, when
disease news is published on the World Wide Web, at
http://www.who.int/disease-outbreak-news/
____________________________________*______________________________________
5. NEWS
Selected news items reprinted under the fair use doctrine of international
copyright law: http://www4.law.cornell.edu/uscode/17/107.html
___________________________________________________________________________
"Vaccine Verity"
Science News (www.sciencenews.org) (08/18/01) Vol. 160, No. 7, P. 110;
Christensen, Damaris
Vaccines have helped to eradicate, or nearly eliminate, diseases like
smallpox, measles, mumps, and polio, but the shots' very success has raised
other issues. As immunization rates soar to all-time highs and fewer people
see just how devastating these diseases can be, questions about vaccine side
effects have increased. Gregory A. Poland of the Mayo Clinic and Foundation
notes that while nothing is 100 percent effective and 100 percent safe and
safety questions are fair to ask, vaccines are among the safest and most
effective medical interventions there are, and "we can't throw these
unparalleled advances away." Some parents are concerned that too many
immunizations could actually weaken the child's immune system, says
Vanderbilt University's Bruce Gellin, the executive director of the National
Network for Immunization Information. Still, a survey he conducted of 1,600
parents with young children found that even with their concerns, 87 percent
of the parents believe that vaccinations are essential to their children's
health. In some cases, vaccine side effects have been documented and
manufacturers have altered their products to eliminate or reduce the
problem. But in other cases, scientists have been hard pressed to find
legitimate evidence to link vaccines to certain diseases or conditions.
According to Poland, one important step for health officials to take is to
develop better ways of identifying the children most likely to suffer an
adverse reaction to a vaccine, while the Centers for Disease Control and
Prevention's Robert T. Chen also points out that disease elimination needs
to occur on a global scale, as increased worldwide travel can help diseases
spread quickly.
---
"UNICEF Reports on State of the World's Children"
Reuters Health Information Services (www.reutershealth.com) (09/13/01)
According UNICEF head Carol Bellamy, the U.N. group's "State of the World's
Children" report for 2001 focuses on leadership and promises that have not
been kept since the 1990 World Summit for Children. Bellamy notes, however,
that while collectively the organization failed to meet its goals and follow
through on the promises made, there were some small strides. For instance,
the infant mortality rate dropped 14 percent overall and child malnutrition
dropped 17 percent, although both fell short of their respective 33 percent
and 50 percent targeted goals. Charles MacCormack, president of Save the
Children, highlighted the advances made over the past decade, noting, for
example, that despite what appears to be a lack of progress in many ways
regarding the health and well-being of children, the global rate of deaths
from diarrheal illnesses and measles dropped significantly.
---
"Simple Measures Could Save World's Newborns, Group Says"
USA Today (www.usatoday.com) (09/10/01) P. 6D; Manning, Anita
A recent report from Save the Children, titled "State of the World's
Newborns 2001," says that the tiniest and most vulnerable of the world's
children are being left behind in the worldwide effort to improve child
health. According to the report, the death rate among children below the
age of five has gone down by 14 percent since a little over a decade ago,
thanks to treatments for the dehydration caused by diarrheal disease and
higher vaccination rates. The death rate for infants in the first month of
life has remained steady, however, at 34 out of every 1,000 newborn babies
in developing countries. The most common causes of newborn deaths are
prematurity, complications during delivery, and infections. Nevertheless,
Anne Tinker, director of Saving Newborn Lives, an initiative sponsored by
the Bill & Melinda Gates foundation and by Save the Children, says the
solution to this problem is not that difficult or expensive. Low-cost
solutions include tetanus shots for mothers, a blanket and warm hat, and
safe delivery kits.
---
"Trials to Start on Nicotine Vaccine"
Financial Times (www.ft.com) (09/10/01) P. 9; Firn, David
Sixty Belgian volunteers, including 10 non-smokers, will participate in
Xenova's clinical trial of TA-NIC, a vaccine against nicotine that works by
making the body's immune system attach antibodies to nicotine that make it
too large to enter the brain. Xenova Medical Director John St. Clair
Roberts believes the vaccine could become a safety-net for ex-smokers,
noting that "if you've been a smoker, you are primed so that the high from
just one cigarette can push you back across the addiction path."
____________________________________*________________________
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