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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 (http://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 (http://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 (http://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 (http://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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