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Vaccines and VaccinationUpdated: December 2012 The positive impact of vaccines on public health is well-documented—in the past century, vaccines have helped eradicate smallpox and significantly reduced the burden of communicable childhood diseases such as diphtheria and measles. Each year, immunization with eight standard antigens is estimated to avert 2.5 million future deaths. According to the Global Alliance for Vaccines and Immunization (GAVI Alliance), the introduction of new vaccines against pneumococcal disease and rotavirus is expected to increase that number significantly. But twenty percent of all the babies born in the world each year—the equivalent of nearly five times the children born yearly in the United States—are not getting the basic vaccines they need to protect them from killer diseases. In 2010, a total of 19 million children went unvaccinated. That number rose to 22.4 million in 2011. Specific data was as alarming as the overall picture—for example, in India’s Bihar state, 60 percent of babies are not fully vaccinated—and current working strategies on vaccines leave key questions and challenges unanswered or unaddressed. MSF vaccinates more than ten million children every year around the world against diseases like measles and meningitis, and more recently against pneumococcal disease. MSF vaccinates in response to disease outbreaks as well and also leads proactive and preventive immunization campaigns. At the same time, MSF, and in particular MSF’s Access Campaign, conducts extensive research and advocacy campaigns designed to increase access to routine vaccination in the countries that need it most. While MSF welcomes the increase in attention paid to vaccines, and the effort to put real money behind research and development efforts articulated in the “Decade of the Vaccines” plan and elsewhere, the organization remains extremely concerned that the products resulting for this push will leave behind many of the children who today go unvaccinated. The strategy as it stands does not adequately emphasize the need to strengthen basic immunization or to developing vaccines that are better adapted to reach children in remote or unstable locations—i.e. vaccines that do not require refrigeration, do not require needles, and that can be given in fewer doses. Better products are needed to alleviate the growing number of un-immunized children. “There’s no reason children should still be dying of vaccine-preventable diseases,” said Dr. Manica Balasegaram, Executive Director of the Access Campaign. “The global vaccines community could be doing a lot better to make sure all babies in developing countries are fully vaccinated against killer diseases. We need vaccines that are easier to use in hard-to-reach places.” How Vaccines Work, and Don’t Work Traditionally, routine immunization consisted of vaccines recommended by the World Health Organization’s Expanded Program on Immunization (EPI). EPI aimed for global vaccination of children against six diseases—diphtheria, pertussis (whooping cough), tetanus, tuberculosis, measles, and polio. However, the past decade has seen new vaccines against hepatitis B, hemophilus influenza type B, pneumonia, meningitis, and diarrhea come to market that are also recommended globally. MSF supports traditional routine immunization, as well as the introduction of newer vaccines such as pneumococcal. However, in many countries, the systems to deliver routine immunization are weak, and products are not always well-suited for easy delivery to low-resource areas. Inflexible vaccination schedules and strategies, as well as competing political vaccination priorities, mean many children still don’t receive traditional routine immunizations. Organizations like the GAVI Alliance focus vaccination support on children aged 12 months or younger, as many best-practice immunization schedules are administered by that age. Given that infants are highly susceptible to vaccine-preventable diseases, it is recommended to complete vaccinations on time. But the reality in developing countries is that many children without access to health services or in countries where health system outreach is weak will not be fully immunized by the age of one, if they are vaccinated at all. In areas of ongoing conflict, entire generations of children can miss out on vaccinations. Countries such as Chad, Somalia and Central African Republic, as well as countries with sizeable populations like India and Nigeria, have persistent low levels of routine immunization coverage of children under twelve months of age. In fact,70 percent of the world’s unimmunized children live in ten countries: Afghanistan, Chad, DRC, Ethiopia, India, Indonesia, Nigeria, Pakistan, Philippines and South Africa. New Policies Needed There is a clear need to reach more children, be it through greater flexibility in vaccine schedules, studies to determine whether age ranges might be increased in some cases, policy changes that can encourage expanded access to vaccines, or other measures. Some of this will require a different mindset. GAVI estimates demand based on countries’ annual birth rates and only finances enough vaccines to immunize children up to 12 months of age. If low-income countries do not have enough money to fund expensive new vaccines for “catch-up” campaigns that attend to children outside the designated age window, older children who miss out once may continue to go without. Even for traditional, affordable vaccines that can be administered at older ages, additional immunization activities are not occurring. Recent and widespread outbreaks of measles in low-coverage countries are evidence of the failure to immunize young children. The measles vaccine is inexpensive and easy to administer, yet support to eliminate the disease has waned in recent years with donor finances being directed toward newer vaccines and initiatives like eradicating polio. Also, outbreak response is often substandard because not enough data is available to design a timely response, effectively direct resources, and ensure an adequate supply of vaccines. While there are many important global vaccination priorities, none should occur to the detriment or exclusion of another. Introducing new vaccines in developing countries should not result in neglecting routine immunization and the provision of adequate resources for catch-up campaigns and outbreak response. Rather, vaccine interventions should be integrated where possible, so when children are immunized, they receive protection against multiple diseases. Better coordination is also needed to incorporate vaccination with other crucial health priorities; many children who fail to receive vaccinations may also not be obtaining adequate nutrition, or be vulnerable to other diseases such as malaria. MSF and Vaccination In countries where vaccination coverage is generally low, MSF strives to offer routine vaccinations for all children under five as part of the basic health care program. This includes the vaccines recommended by the WHO: DTP (diphtheria, tetanus, pertussis), hepatitis B, Hemophilius influenzae type b (Hib), BCG (against tuberculosis), human papillomavirus, measles, polio and rotavirus. What’s more, immunization forms a key part of MSF’s response to outbreaks of measles, yellow fever, and meningitis. Teams often take part in large-scale vaccination campaigns, working to raise awareness in the community about the benefits of immunization and setting up vaccination posts in places where the community is likely to gather. A typical campaign lasts between two and three weeks and can reach hundreds of thousands of people. What follows are specific examples of MSF’s vaccination work on certain diseases (measles, meningitis, and cholera): Vaccination Before, and After, Measles Outbreaks: A safe and cost-effective vaccine against measles exists, and large-scale vaccination campaigns have drastically decreased the number of cases and deaths from measles. However, coverage remains low in countries with weak health structures, or among people with limited access to health services, and large outbreaks still occur. In addition to preventative vaccination, MSF began conducting mass vaccination campaigns for measles after outbreaks had already occurred, something that had previously been though ineffective or implausible. But data collected during these campaigns should that it was indeed an effective tactic, one that likely saved many lives in the process. The WHO, after seeing the data, changed its guidelines for responding to measles outbreaks. Overall, in 2010 MSF treated 188,704 people for measles and vaccinated more than 4,500,000 people. In 2011, MSF treated some 126,500 people during measles outbreaks and vaccinated more than 5 million. From September 2010 to May 2011, MSF vaccinated over 2.5 million children against measles in the Democratic Republic of Congo alone. Supporting New Meningitis Vaccine: In late 2010, MSF participated in the campaign to introduce a new meningitis vaccine in Mali and Niger that provided protection against the strain of the disease prevalent in Africa’s “meningitis belt," an east–west geographical strip from Ethiopia to Senegal where the disease is rife. The new vaccine was designed to protect people for 10 years—far longer than past iterations—and to prevents healthy carriers from transmitting the infection. Such long-term protection means that preventive vaccination campaigns are now a possibility, potentially changing the lives of millions of people living in the meningitis belt. The vaccine, which is called MenAfriVac and targets meningococcal conjugate A, was developed by the Serum Institute of India and prequalified for use by the WHO. Developed specifically for Africa, the new vaccine protects against serogroup A meningitis. In addition to lasting longer and provided better protection, the new vaccine helps stop meningitis transmission by eliminating healthy carriers—people who are infected but do not manifest the disease, yet can still pass it on to others—thus conferring “herd immunity,” where immunization of part of the population provides protection for the whole. MSF ordered 3 million doses of the new meningitis A vaccine as part of larger vaccination campaigns led by the Ministries of Health in Niger, Mali, and Burkina Faso, and the WHO. MSF aimed to support the vaccination of 800,000 people in Mali and 600,000 people in Niger. Before this, MSF teams carried out reactive vaccination campaigns against meningitis outbreaks, but because the existing vaccine is not highly effective, vaccination teams had to return every year in anticipation of new epidemics. Stocks of the older vaccine were also often limited. The new vaccine meant that campaigns can be planned ahead of time in an attempt to prevent meningitis outbreaks before they occur. With this more effective and longer-lasting vaccine, MSF and other health actors now have the opportunity to stop “chasing” meningitis A epidemics and can instead prevent them from occurring in the first place. However, the rollout of the new vaccine will take several years. In the meantime, existing vaccines will still need to be used. In 2010, MSF treated 5,911 cases and vaccinated more than 1,330,000 people against meningitis. And in 2011, MSF treated 5,900 people with meningitis and vaccinated some 952,600 people. Cholera in West Africa: In April 2012, after a cholera epidemic broke out in Guinea, MSF began a mass vaccination campaign, vaccinating more than 170,000 people in the Boffa region, near the capital of Conakry. They used an oral vaccine designed to protect those who take it from contracting the disease. MSF had used the vaccine as a preventative measure in cholera endemic countries in the past, but this was the first time the organization has done so in Africa. Traditionally, the fight against cholera has involved treating patients, promoting hygiene activities, and providing access to drinking water. Although these measures are crucial, they do not necessarily limit the spread of the disease. The use of an oral vaccine—two doses, taken six weeks apart—during an epidemic represents a real opportunity to limit the transmission. Efficacy is over 60 percent for at least two years. Teams require only basic training and the vaccine is easy to administer, causes few side effects, and is well accepted by the population. Vaccination cannot be used alone, however, it should be noted. Awareness-raising activities, improved hygiene practices, and treatment are still important components of the cholera response. The provision of safe water and sanitation remain essential during all outbreaks. "We were faced with an outbreak and we wanted first to protect people by vaccinating them, and to limit the spread of cholera," said Dr. Dominique Legros, MSF’s innovation initiative manager in Geneva. "MSF is regularly involved in responding to cholera outbreaks and it is always difficult to control the disease. Because cholera evolves quickly, oral vaccination provides us with a new tool to try to contain [it]. If we can control the most active spots, we can reduce the spread of cholera.” Vaccine R&D As some of the earlier examples show, new and improved vaccines can have profound impacts. Two fundamental challenges surround vaccine access and research and development (R&D), however: first, the newest vaccines are often prohibitively expensive, in part because of a lack of adequate competition in the market, hindering their use in developing countries. Second, because there is little incentive for pharmaceutical companies to conduct R&D for diseases that affect populations with limited purchasing power, some diseases continue to be unaddressed by vaccines altogether, while many other vaccines are not well-adapted for people in developing countries. R&D for vaccines adapted for developing countries needs to consider specific requirements, including affordability, protection against prevalent disease serotypes, and improved heat stability (products that remain stable outside of the cold chain for limited periods). Developing oral vaccines or vaccines that can be delivered through mechanisms other than needles, such as patches, would also increase their reach in countries with limited health care infrastructure. When needed vaccines aren’t being developed, alternative models can help provide the financial incentives for companies to make and tailor them to the specific needs in developing countries. Such models include “push” funding, where funds are offered up front to encourage R&D, and “pull” funding, where companies are lured into R&D with the promise of a guaranteed market for their developed product. However, the incentives chosen in a particular situation have enormous consequences on how affordable and well-adapted a vaccine is when it reaches the market. A good example of a “push” mechanism is the Meningitis A vaccine project mentioned earlier, where up-front funding pushed for the development of a vaccine that addresses the specific strains prevalent in the 25 countries of Africa’s Meningitis Belt. The project involved the transfer of existing technology from the US National Institutes of Health to the Serum Institute of India and was backed by funding administered through the organization PATH. Price and product specifications—the vaccine’s effectiveness and serotypes it should cover—were set at the start of the project (the vaccine costs just $0.40 per dose. Development of the vaccine, including clinical trials, required only $87 million in donor support—a fraction of what multinational vaccine producers claim the development of a new vaccine costs. And it was an improvement, providing much longer protection against meningitis than previous vaccines, and suitable for use with younger children. Vaccines Adapted to Unstable and Isolated Settings Not surprisingly, vaccine coverage breaks down in areas that are especially isolated, areas that are particularly impoverished, and areas where instability creates barriers to access for those who want to get vaccinated—or get their children vaccinated—and those looking to provide vaccinations. As mentioned earlier 70 percent of the world’s unimmunized children live in ten countries: Afghanistan, Chad, DRC, Ethiopia, India, Indonesia, Nigeria, Pakistan, Philippines, and South Africa. Even the most effective vaccine will not work in places like these, or many other nations and regions, unless they are adapted to the conditions on the ground. This means that vaccines must be developed that can be transported without extensive cold chain requirements, because electricity and ice can be hard to come by in many tropical countries with limited infrastructures, and it can take many hours or many days to reach isolated communities now vulnerable to preventable diseases. It means that unskilled health workers must be able to administer these vaccines, because there are many regions in the world where trained health workers, to say nothing of specialists, are very hard to find, and parents may not be able to leave work or collect the money they need to make the trip to the nearest health center or hospital. Having an oral vaccine for polio, for instance, has made a huge difference in the campaign to increase vaccine coverage for that disease, with dramatic and demonstrable results. Furthermore, it means that these vaccines must be available in limited doses, because this limits the number of times a family must bring their child in to get vaccinated and the number of times they might have to pay for the vaccine. And it means that prices must be controlled, with a clear eye on the economic realities in individual countries, lest the vaccines become simply too expensive for health systems and nations to purchase, much less administer. Vaccine Pricing The prices of vaccines are affected by a variety of factors, including the number of suppliers, the technology needed to produce the vaccine, the length of time a product has been available, and the volumes a supplier can expect will be purchased over a period of time. Lower vaccine prices mean that countries can afford to protect more people against life-threatening diseases. More affordable vaccine prices are also critical for creating national immunization programs that are sustainable in the long term. Traditional vaccines are generally inexpensive—for example, low-income countries only paid between $0.19 and $0.30 per dose for measles vaccines purchased from the United Nations Children’s Fund (UNICEF) in 2010. But the past decade has seen new vaccines come to market that are far more expensive. Pneumococcal conjugate vaccines, which protect against forms of pneumonia and meningitis, cost a minimum of $3.50 per dose, or $10.50 per child vaccinated with the recommended three doses. Rotavirus vaccines, which protect against forms of diarrhea, cost between $5.00 and $10.50 per child vaccinated, at a minimum. To enable developing countries to gain access to new vaccines against diseases like hepatitis B, pneumonia, diarrhea and meningitis, some low-income countries are eligible to receive financial support through GAVI, which uses the money given by donor governments and organizations to purchase most of its vaccines for eligible developing countries through UNICEF. By pooling vaccine demand and purchasing in bulk, UNICEF can obtain lower prices from suppliers than would be possible if these countries negotiated individually. Still, prices of most new vaccines could be lower. In June 2011, GAVI was facing a $3.7 billion funding shortfall, due in part to its inability to negotiate low enough prices with vaccine manufacturers. This contributed to the decision to exclude from GAVI support 16 countries with slightly higher income levels, including Timor-Leste, Honduras, and the Democratic Republic of Congo, and to call of those countries to pay the full price of vaccines on their own by 2015. Honduras, for example, will face a nearly 1,000% price increase to vaccinate a child with these two new vaccines when the country loses donor funding in 2015. Demand for new vaccines continues to rise, so it is crucial that GAVI and others work harder to ensure vaccines are affordable for donors and for those countries that will be obliged to procure vaccines independently. One key step in getting prices down to affordable levels can be achieved through price transparency: if countries know how much UNICEF and GAVI are paying through their bulk procurement schemes, they have a benchmark against which to negotiate. But until recently, these prices were kept secret. UNICEF took an important step in May 2011, when it published the vaccine prices it has paid suppliers for the past decade and announced that it would publish future prices. This price transparency showed that quality-assured suppliers in countries like India, Senegal, and Indonesia offer the same vaccines at significantly lower prices than multinational companies; for example, Serum Institute of India sells its pentavalent vaccine, which protects against five childhood diseases, at almost half the price of Swiss manufacturer Crucell. MSF’s Access Campaign built on this in May 2012, when it released its report, “The Right Shot,” that discussed pricing at length and published the prices for a host of different vaccines. Another price-reducing move is to ensure more vaccine manufacturers make similar products so there are both a guaranteed vaccine supply and competition among producers. The WHO has been doing quality assurance for products manufactured in developing countries, including India, and will soon be accepting applications from Chinese manufacturers as well. Taking advantage of these manufacturers with lower cost structures and promoting a competitive market is more sustainable than waiting for multinational companies to voluntarily reduce the prices for low-income countries. |
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