Problems+and+Solutions+F

**‍‍‍Identified Problems and Solutions‍‍‍ **

 xxxxx﻿ The biggest problem facing world wide vaccine administering is its a vailability. It is mostly rooted in the economics of it all. Production costs, weak markets/3rd world countries, poor need reporting, and liability concerns are some of the financial issues that limit vaccine availability or lack thereof. The following are problems or hinderences to vaccine availablity and several solutions.

**Problem 1: ** **__High Cost of Production__**  xxxxx The price of vaccine doses is a result of the cost of vaccine research and development, clinical trials, regulatory requirements and the high costs of capital investment needed for 'biologics' manufacturing. Vaccine doses are also driven by the costs manufacturing companies have incurred due to the requirements of such agencies as the Food and Drug Administration (FDA). To be able to maintain their licensing, the FDA has required many of these companies to undergo extensive plant upgrades and increased maintenance. As an example, in 2002, Wyeth stop producing an influenza vaccine because the costs of plant upgrades and maintenance would be $250 million (Poland and Marcuse, 2004).

**Solution:**  xxxxx The most effective way to decrease production cost it to provide these manufacturing companies with incentives from the government, especially private manufacturers. Such incentives could include tax breaks or subsidies to encourage the building of new manufacturing plants and upgrading of existing plants;extending patenet protection for intellectual property related to vaccines of public health importance;working with industry to find ways to reduce the costs of meeting US FDA regulatory and new product application costs; and allowing tiered pricing whereby vaccines can be sold at higher prices in developed countries and lower prices in underdeveloped countries, which increases the market size for US vaccine manufacturers (Poland and Marcuse, 2004). One such incentive has already been inacted. In 2004, President George W. Bush signed into law the Project BioShield Act which encourage private industry to develop medical countermeasures to bioterrosim threats (U.S. Congressional Research Service, 2005).

**Problem 2:** **__Liability__**  xxxxx Especially in the US, vaccine manufacturers are becoming more and more reluctant to develop or atl east market them in America. As an example, a large number of lawsuits were filed against fortuitous vaccine manufacturers when allegations arouse that that vaccine caused sudden infant death syndrome. Many of those manufacturers undoubtedly stop producing and marketing that particular vaccine (Poland and Marcuse, 2004). A more troubling example is that currently there is no company producing a Lyme disease vaccine. Allegations, unproven and without merit, have led to class action lawsuits which in turn have cause all manufacturers to stop development and marketing. Today, there is no vaccine for Lyme disease.

**Solution:**  xxxxx Some manufacturers have named liability as the reason why they forgo vaccine production. In simple terms, what they need is protection. Protection of manufacturers, seen as a necessary incentive ﻿ to participation, was included in the Homeland Security Act of 2002 and the Smallpox Emergency Personnel Protection Act of 2003. The American Jobs Creation Act of 2004 added the influenza vaccine to those that the National Vaccine Injury Compensation Program covers (U.S. Congressional Research Service, 2005). Unfortunately, not all vaccines are covered under these programs. In fact, because of such liability issues, over the past 30 years, the number of companies distributing vaccines in the US has decreased from 30 to 5 (see Table 1). If all vaccines would be covered, these programs effectively shield manufacturers from lawsuits related to unanticipated effects of vaccines, as long as they are produced, packaged, and administered properly.

**Table 1 Vaccine availability in the US in 2004**
Table from the Committee in the Evaluation of Vaccine Purchase Financing in the United States, Board on Health Care Services, <span style="font-family: 'Times New Roman',Times,serif; font-size: 80%;">Institue of Medicine of the National Academies. //Financing vaccines in the 21st century: assuring access and availability// <span style="font-family: 'Times New Roman',Times,serif; font-size: 80%;">(National Academy Press, Washington, DC, 2003).
 * < <span style="font-family: 'Times New Roman',Times,serif;">Vaccine ||< <span style="font-family: 'Times New Roman',Times,serif;">Manufacturers ||< <span style="font-family: 'Times New Roman',Times,serif;">Comment ||
 * < <span style="font-family: 'Times New Roman',Times,serif;">**Vaccines with no manufacturer** ||<  ||< <span style="font-family: 'Times New Roman',Times,serif;">All mainly of military importance ||
 * < <span style="font-family: 'Times New Roman',Times,serif;">Adenovirus ||<  ||<   ||
 * < <span style="font-family: 'Times New Roman',Times,serif;">Cholera ||<  ||<   ||
 * < <span style="font-family: 'Times New Roman',Times,serif;">Plague ||<  ||<   ||
 * < <span style="font-family: 'Times New Roman',Times,serif;">Smallpox ||<  ||<   ||
 * < <span style="font-family: 'Times New Roman',Times,serif;">Tularemia ||<  ||<   ||
 * < <span style="font-family: 'Times New Roman',Times,serif;">**Vaccines with a single manufacturer** ||<  ||<   ||
 * < <span style="font-family: 'Times New Roman',Times,serif;">Anthrax ||< <span style="font-family: 'Times New Roman',Times,serif;">BioPort ||<  ||
 * < <span style="font-family: 'Times New Roman',Times,serif;">Polio, inactivated ||< <span style="font-family: 'Times New Roman',Times,serif;">AVP ||<  ||
 * < <span style="font-family: 'Times New Roman',Times,serif;">Pneumococcal Polusaccharide ||< <span style="font-family: 'Times New Roman',Times,serif;">MRL ||<  ||
 * < <span style="font-family: 'Times New Roman',Times,serif;">Live, attenuated influenza vaccine ||< <span style="font-family: 'Times New Roman',Times,serif;">Medimmune ||<  ||
 * < <span style="font-family: 'Times New Roman',Times,serif;">Varicella ||< <span style="font-family: 'Times New Roman',Times,serif;">MRL ||<  ||
 * < <span style="font-family: 'Times New Roman',Times,serif;">Pneumococcal conjugate ||< <span style="font-family: 'Times New Roman',Times,serif;">Wyeth ||<  ||
 * < <span style="font-family: 'Times New Roman',Times,serif;">Tetanus toxoid ||< <span style="font-family: 'Times New Roman',Times,serif;">AVP ||<  ||
 * < <span style="font-family: 'Times New Roman',Times,serif;">Tetanus-diphtheria toxoid ||< <span style="font-family: 'Times New Roman',Times,serif;">AVP ||<  ||
 * < <span style="font-family: 'Times New Roman',Times,serif;">Measles-mumps-rubella ||< <span style="font-family: 'Times New Roman',Times,serif;">MRL ||<  ||
 * < <span style="font-family: 'Times New Roman',Times,serif;">Varicella ||< <span style="font-family: 'Times New Roman',Times,serif;">MRL ||<  ||
 * < <span style="font-family: 'Times New Roman',Times,serif;">Yellow Fever ||< <span style="font-family: 'Times New Roman',Times,serif;">AVP ||<  ||
 * < <span style="font-family: 'Times New Roman',Times,serif;">**Vaccines with two manufacturers** ||<  ||<   ||
 * < <span style="font-family: 'Times New Roman',Times,serif;">Hepatitis A ||< <span style="font-family: 'Times New Roman',Times,serif;">MRL, GSK ||<  ||
 * < <span style="font-family: 'Times New Roman',Times,serif;">Hepatitis B ||< <span style="font-family: 'Times New Roman',Times,serif;">MRL, GSK ||<  ||
 * < <span style="font-family: 'Times New Roman',Times,serif;">Influenza, inactivated ||< <span style="font-family: 'Times New Roman',Times,serif;">AVP, Chiron ||< <span style="font-family: 'Times New Roman',Times,serif;">Chiron not distributing vaccine in 2004 ||
 * < <span style="font-family: 'Times New Roman',Times,serif;">Tetanus-diphtheria-pertussis ||< <span style="font-family: 'Times New Roman',Times,serif;">AVP, GSK ||<  ||
 * < <span style="font-family: 'Times New Roman',Times,serif;">Rabies ||< <span style="font-family: 'Times New Roman',Times,serif;">AVP, Chiron ||<  ||
 * < <span style="font-family: 'Times New Roman',Times,serif;">Typhoid ||< <span style="font-family: 'Times New Roman',Times,serif;">AVP, Berna ||<  ||
 * < <span style="font-family: 'Times New Roman',Times,serif;">**Vaccines with three manufacturers** ||<  ||<   ||
 * < <span style="font-family: 'Times New Roman',Times,serif;">H. influenzae type b ||< <span style="font-family: 'Times New Roman',Times,serif;">AVP, MRL, Wyeth ||<  ||
 * < <span style="font-family: 'Times New Roman',Times,serif;">**Vaccines with four or more manufacturers** ||<  ||< <span style="font-family: 'Times New Roman',Times,serif;">None ||

<span style="font-family: 'Times New Roman',Times,serif; font-size: 120%;"> xxxxx Besides the financial aspect, and probably the most important problem for the public, is the safety and effectiveness of the vaccines. The FDA's main goal is the protection of the individuals who use these vaccines. That is why the FDA does not license a product until they are satisfied that a vaccine is safe and effective to give to the masses. However, not all vaccines that are licensed are 100% safe or 100% effective.

<span style="font-family: 'Times New Roman',Times,serif; font-size: 120%;">**Problem 3:** <span style="font-family: 'Times New Roman',Times,serif; font-size: 120%;">**__Side Effects and Inadequate Risk Communication __** <span style="font-family: 'Times New Roman',Times,serif; font-size: 120%;"> xxxxx "Some scientists, parents, and consumer advocates raise concerns that U.S. vaccine policy, with its recommended 20 shots to infants by age two endangers the children it aims to protect" (U.S. Congressional Research Service, 2005). In fact, there are hypothesis that some of these vaccines at that age might cause autism and other neurodevelopmental disorders. Such side effects, even though the science is not definitive, decrease their production and their use as it is connected to liability issues. <span style="font-family: 'Times New Roman',Times,serif; font-size: 120%;"> xxxxx With that said, the decision whether vaccines are safe or not doesn't revolve around actual risk and side effects but the perception of risk. This is another problem facing vaccines, misinformation. Some parents refuse pertussis (whooping cough) and measles vaccines for their children out of concern about vaccine safety (reportedly based on misinformation about side effects) (U.S. Congressional Research Service, 2005).

<span style="font-family: 'Times New Roman',Times,serif; font-size: 120%;">**Solution:** <span style="font-family: 'Times New Roman',Times,serif; font-size: 120%;"> xxxxx Proper information and knowledge is the best cure for risk ignorance. Websites for Health and Human Services offices, including the Center for Disease Control, the National Immunization Program, the Advisory Committee on Immunization Practices, and the National Vaccine Program Office, and others have hundreds of links to consumer-oriented health information, addressing reasons to immunize, common misconceptions, safety, and even evaluating immunization information on the internet (U.S. Congressional Research Service, 2005). All healthcare provided are also encouraged, if not required, to hand out Vaccine Information Statements each time a vaccine is administered. <span style="font-family: 'Times New Roman',Times,serif; font-size: 120%;"> xxxxx Another effective solution to such public apprehension towards vaccination can come in the way of compensation. There will always be times were safety efforts to make vaccines as close to 100% safe and efficient will not work. There is a feeling that some vaccines are so important to the greater good that it is acceptable when some are injured and even killed by the vaccine and its side effects. Some compensation efforts are already in place. On April 30, 2003, President Bush signed the Smallpox Emergency Personnel Protection Act of 2003. It inlcudes provisions to pay for smallpox vaccine injury-related medical care, lost employment income under specified circumstances, and death benefits (U.S. Congressional Research Service, 2005). Such programs and proper vaccine education in regards to risks can be instituted for other vaccines and putting the public at ease.

<span style="font-family: 'Times New Roman',Times,serif; font-size: 120%;">**Transition Statement:** <span style="font-family: 'Times New Roman',Times,serif; font-size: 120%;">Next we will explore some ethical and religious issues presented by the use of vaccines.

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