H1N1 Vaccine: Is it safe How did this influence health care today - Research Paper Example

?AH1N1 Vaccine: Is it safe? How did this influence health care today? Introduction Influenza A (H1N1) virus is ified as a subtype of the influenza A virus. This virus hit its peak in 2009 with a variety of reported cases in the world. Some strains of the virus are endemic among humans and they lead to influenza-like diseases, some others manifest is as seasonal flu (CDC, 2005). This subtype of the influenza A virus caused some flu infections among humans from 2004-2005. Other strains of the H1N1 virus are endemic to pigs (swine flu) and some are endemic among birds (avian flu) (CDC, 2005). In June of 2009, the WHO declared that the strain H1N1 which was of pig origin rose to pandemic proportions. It spread in various parts of the world, causing the deaths of about 17,000 individuals by early 2010. Fortunately, the disease returned to seasonal patterns by August of 2010. In 2011 April however, an H1N1 alert was issued by the WHO for the Americas (CDC, 2005). This alert has since been recalled as the cases were subsequently managed. Since vaccines for this disease have already been released to the market, concerns on its safety and efficacy have emerged. Some reports have even pointed out that the H1N1 vaccine may be losing its efficacy. However, health professionals are quick to point out that these vaccines are doing their job in preventing the spread of this disease. This study shall now discuss the H1N1 flu vaccine, its formulations, applications, and its use. Its safety shall also be discussed based on current applications and usages. It shall also discuss how the vaccine has influenced health care today. This study is being carried out in order to establish a clear and comprehensive understanding of the virus as well as the vaccine. Its goal is to establish clear guidelines for the general medical practice. Body The AH1N1 influenza pandemic was seen in 2009 with the virus spreading from sick patients in the US. The virus was studied and was discovered to include elements from four different flu viruses: North American swine influenza, North American avian influenza, human influenza, and swine influenza usually seen in Asia and Europe (New Scientist, 2009). This was considered a new strain caused by the reassortment of the human flu and the swine flu viruses in the four subtypes of H1N1. In 2009, this influenza-like virus was seen in Mexico and the US and the CDC saw seven cases of this new A/H1N1 flu virus. The outbreak in Mexico and the southwest of US was later established to be of the same flu-like illness (WHO, 2009a). The cases of the disease increased rapidly and the WHO struggled to stem the spread of the disease. One of the measures implemented by the WHO in order to address this issue is the widespread vaccination against this disease. AH1N1 Vaccine In 2009, about 65 million vaccines were administered to over 16 states. In general, the vaccine has proven to be safe and effective and it has exhibited a strong response against potential infection (Greenberg, et.al., 2009). Although the trivalent seasonal flu vaccine did not increase or decrease the risk of infection with H1N1, the vaccines were able to fight off the new strain of the infection (Greenberg, et.al., 2009). All in all the safety profile of the vaccine is the same as that of the seasonal flu vaccine, and improvements in its administration and composition have caused lesser incidents of Guillain-Barre syndrome after vaccination (CDC, 2009). Few cases were seen relating to the vaccination and in general only temporary illnesses were seen. This is very much different from the 1976 swine flu outbreak when mass vaccinations in the US led to over 500 cases of Guillain-Barre syndrome, cases which later led to 25 deaths (Roan, 2009). Safety concerns for the vaccines were mostly related to individuals with egg allergies. This concern was based on the fact that the pandemic flu vaccines were cultured in chicken-egg-based media. Those with egg allergies were only allowed administration of this vaccine after consultation with their GP and under graded doses. Cases of anaphylactic shock from this vaccine were confirmed in Canada, one death was reported from this group (Flu Treatments, n.d). Since then, the GlaxoSmith, the company distributing the vaccine withdrew its batch of vaccines and since then investigations on these deaths have been launched. The above discussion presents a general oversight of the safety of the H1N1 vaccine. More specific details on its use shall be presented forthwith. Most of the H1N1 vaccines contain inactivated viruses and these vaccines are administered either through injections in the upper arm (for most adults) or in the thigh (for younger children and infants) (WHO, 2009a). Other types of this vaccine are made up of live viruses; and this type is given through nasal sprays. Both of these types are meant to protect against AH1N1. Most of the experts recommend that this vaccine be administered as a single dose among adults and adolescents 10 years old and above, so long as its use is based on recommendations of regulatory authorities (WHO, 2009a). More studies have been recommended on the efficient dosages for individuals with compromised immune systems; for these individuals, two doses of the vaccine are needed. In areas where government authorities have made children as priorities in the vaccination program, one dose has been recommended to the children over six months of age and those below 10 years of age (WHO, 2009a). The WHO also recommends that the following individuals must not have the inactivated pandemic vaccine: those with a history of anaphylaxis to any of the elements or constituents of the vaccine; those with a history of severe reaction to a previous flu vaccine; those who developed Guillain-Barre syndrome within 6 weeks following administration of the flu vaccine; children less than 6 months of age; and those who have moderate to severe illnesses with a fever (vaccination after recovery) (WHO, 2009a). In relation to other vaccines, the inactivated flu vaccine can be administered simultaneously with other injectable, non-influenza vaccines. The vaccines however must be administered at varying injection sites (McIntosh, 2010). Moreover, the seasonal flu and pandemic flu vaccines can be given simultaneously. Due to the limited number of vaccines made available to the public, national health authorities are burdened with the decision of how the national pandemic influenza immunization would proceed. These authorities are the individuals who would know best on where the vaccinations would be carried out and to whom the vaccines would be administered (McIntosh, 2010). In terms of protection against other flu viruses, the pandemic flu vaccines are not actually expected to ensure protection against the other flu viruses (CDC, 2010). The seasonal flu vaccines do not contain protection against AH1N1, therefore, patients must receive both pandemic and seasonal vaccines in order to ensure protection against both diseases (CDC, 2010). Inactivated vaccines contain the dead viruses or some parts of the viruses, therefore, these viruses cannot cause the disease (WHO, 2009b). The live flu vaccine includes the weakened flu virus which then multiplies poorly in the body but is unable to lead to infection from the disease. These vaccines can lead to various flu-like symptoms, however, the symptoms are less pronounced than the actual flu (WHO, 2009b). Individuals who are vaccinated against the flu may still become afflicted with the flu because the vaccines are not considered a 100% protection against the disease. However, the vaccines do their part in decreasing the risk of being afflicted with the disease. Moreover, flu vaccines are usually fully effective only after two weeks from the administration (WHO, 2009b). Exposure to the flu virus 1-3 days from the immunization may still make one vulnerable to the effects of the disease. Those vaccinated against flu can also be infected by a different strain of the flu virus. Moreover, those who were vaccinated against the flu can later be afflicted with the illness which is caused by other common diseases, not the flu, but mistaken for the flu (WHO, 2009b). In these instances, a person may believe that he has not been protected by the flu vaccine (WHO, 2009b). Such conclusion is actually inaccurate and unfounded. The health regulatory agencies have approved pandemic vaccines in various countries and the process of approval is dependent on the country’s regulations, the kind of vaccine being licensed, and the stage of the manufacturer’s readiness in establishing sufficient data to the regulation authorities (WHO, 2009b). As of October of 2010, the WHO has declared that the global production of the flu vaccines is at three billion doses. Most of the technology being used in producing these vaccines is that of chicken eggs; other manufacturers are using cell cultures (WHO, 2009b). The production of the pandemic influenza vaccines are still very much continuing, however, in some parts, the demand is still great while supply is low. As more vaccines are being produced, the supply will hopefully suffice in the future. Health workers have been declared by the WHO as first priority recipients of this vaccine (WHO, 2009b). They need to be protected from patients who may be afflicted with the disease and they also need to stay healthy in order to meet the challenges of the health care system. Different groups who have a higher risk for severe illness must also be considered as priorities. Moreover, based on the country, vaccination plans would depend on the regulations set forth by national authorities (WHO, 2009b). Other priority individuals include: pregnant women; those aged above 6 months with atleast one chronic disease; healthy young adults aged 15-49 years; healthy children; healthy adults 50 to 64 years; and healthy adults 65 years and above (WHO, 2009b). In relation to the distribution of the vaccine in developing countries, the WHO has called for the fair and equitable distribution of the vaccine for all countries. In the current context, the WHO has managed to ensure that donations from countries and partners have been secured for low and middle-income countries to support pandemic vaccines (WHO, 2009b). The primary goal of the WHO has been to secure the administration of the pandemic vaccine in atleast 10% of the population in low income countries. These donated vaccines have been released from 2009 to 2010 (WHO, 2009b). The national health authorities have been tasked to decide on the implementation of national vaccination programs. These authorities are the foremost authorities on who shall be vaccinated, and where the pandemic vaccine would best be distributed. Safety In considering the safety features of the pandemic vaccines, there are various elements to be evaluated for such a determination. In general however, as was mentioned at the beginning of this paper, the outcomes of the use of these vaccines are as safe as the use of the seasonal vaccines. The side effects mostly seen are also similar to the effects apparent in the administration of seasonal vaccines (WHO, 2009c). Current studies on the pandemic vaccine reveal that no side effects on pregnancy, fertility, or on the developing embryo or fetus, or on post-natal development have been seen (WHO, 2009c). In line with the increased risk for severe illness among pregnant women affected by the pandemic flu, these pregnant women are one of the priority groups for vaccination against the disease. Studies also reveal that infected pregnant women are more likely to be admitted in the ICUs due to the grave impact of the disease; most of these women may be in their second or third trimester of pregnancy. All in all, the benefits of the immunization seem to be more than the risks of the vaccination (WHO, 2009c). In order to secure more accurate results on this affected patient group, more studies on the impact of the pandemic vaccine on pregnant women are still being carried out. In relation to children’s safety, most of the reactions in the administration of vaccines seen among children are those also seen in other childhood vaccinations. Side effects include soreness at the injection site and fever. The health providers for these children are the most appropriate individuals to advise parents on the immediate relief of these side effects (WHO, 2009c). Concerns on child’s safety from the vaccine are often appropriately directed to the health providers. It is important to note also that children may suffer from conditions which are not in any way related to the vaccine, and coincidentally may have become apparent after the vaccination (WHO, 2009c). Testing and approval Since the pandemic virus is a new virus, the current testing of the virus and of the vaccine is being carried out in order to establish crucial data on the vaccine’s response and safety. The results of these studies so far indicate that the vaccine is as safe as the seasonal flu vaccine. However, in order to establish its actual safety, a significant population has to be included in its clinical testing. And even then, rare events which can occur from the administration of the vaccine can still manifest and emerge in the actual application of the virus (WHO, 2009c). The In order to make allowances for unforeseen effects of these vaccines, the WHO has advised countries administering the vaccines to carry out extensive monitoring on the safety of these vaccines and report these outcomes immediately to the pertinent health authorities (WHO, 2009c). The approval of the use of the pandemic vaccines is based on the national authorities’ approval and licensing (WHO, 2009c). Such national authorities review and assess the current and suspected risks and benefits for vaccines before their licensing. Expeditious licensing processes in some countries have assisted in the licensing of new vaccines. However, the manufacturing processes in the use of new vaccines are similar to the processes seen in the licensing and testing for seasonal flu vaccines; these processes are in place in order to ensure the quality and safety of these vaccines (WHO, 2009c). In relation to side effects, some of these are expected with the administration of flu vaccines. The frequency of these side effects usually depends on the kind of vaccine, how it is administered, and the age of the patient to be vaccinated (WHO, 2009c). There are two main types of H1N1 vaccines, and these are: those manufactured with inactivated viruses, and the other one are those manufactured with live viruses. The inactivated viruses are carried out via injections. Reactions seen in these vaccines include soreness, swelling, redness at the injection site. Fever, muscle aches and headache are the less common side effects seen with this type of vaccine. These side effects are mostly mild, they do not require medical attention, and may last about 1-2 days (WHO, 2009c). The fevers, aches, and headaches may be seen more commonly among children, not so much among elderly individuals. Allergic reactions, such as hives, rapid swelling of deeper skin layers, asthma, and severe multisystemic allergies are rare for flu vaccines. For live vaccines given through nasal sprays, common side effects include nasal congestions, runny nose, low grade fever, irritability, headaches, muscle aches, and in some instances, sore throat (WHO, 2009c). In some children, wheezing and vomiting have also been seen. Clinical studies, even those carried out on the large scale, have not been able to establish the possible rare events which may manifest with the administration of the pandemic flu vaccine. Such rare events can only actually be established after the widespread use of the vaccine is seen (WHO, 2009c). The trials which have been taken out are meant to establish the safety of the general population. Subsequent monitoring for some special groups is important in order to establish specific safety data for such population. Close and comprehensive monitoring on the administration of the pandemic flu vaccine are being considered and already being implemented around the world. The WHO also recommends for the countries involved that the administration of the pandemic vaccines requires intensive monitoring and reporting on safety and on adverse events (WHO, 2009c). In relation to adverse events, since October 2010, no unusual adverse events have been seen in the aftermath of the vaccinations. More vigilance has been called for in the evaluation of health authorities in terms of the administration of this vaccine. The serious adverse events have been instructed by health authorities as matters to be reported immediately to them. So far, no major adverse events have been seen in the use of the pandemic vaccines (WHO, 2009c). In instances when adverse events are seen within the national level, individual reports are to be assessed for content and possible errors. In some cases, these reports have to be validated and additional information also re-established and re-investigated. The reports and findings are to be analyzed and common data shall be evaluated. Faulty analysis shall be reconsidered and re-assessed. After the report is finalized, the national authorities and other concerned authorities shall be informed (WHO, 2009c). The decisions in relation to continuing safety shall also be made. Inasmuch as there are actual risks related to the use of this vaccine, there are also false risks associated with its use. Thiomersal is one of the commonly used preservatives for this vaccine. It is used in order to prevent the bacterial contamination of the vaccine. Inactivated vaccines would include thiomersal if they are supplied in the multi-dose vials containers. Some of these products can have traces of thiomersal when the chemical utilized during the process of manufacturing is an antibacterial agent, later eliminated during purification (WHO, 2009c). Thiomersal does not contain methyl mercury, a naturally occurring compound which is toxic to humans. Thiomersal includes a different form of mercury, which is known as ethyl mercury. This type of mercury does not metabolize and is removed from the body easier than methyl mercury (WHO, 2009c). The safety in the use of thiomersal has been significantly reviewed by various researchers. And there seems to be no evidence of the toxicity of the chemical for infants, children, adults, and even pregnant women. Some pandemic vaccines may contain adjuvants and others may not. Adjuvants are considered to be substances which improve the immune response of vaccines, making them more effective. These adjuvants have been commonly used for vaccines for many years now. And scientific studies support the safety of these adjuvants in the production of pandemic vaccines (WHO, 2009c). The vaccines which are meant for individuals with poor immune responses to vaccination include this adjuvant. This adjuvant is included in order to reduce the amount of virus antigen. The manufacturers themselves decide whether their product would include an adjuvant or not. These adjuvants used with pandemic flu vaccines are already being licensed for application in other vaccines. So far they have a strong and safe record in vaccine use (WHO, 2009c). Current evidence on the pandemic influenza vaccine and its relationship with chronic diseases indicate that the seasonal flu and the pandemic flu vaccines increase the impact or aggravate chronic diseases among vaccinated patients (WHO, 2009c). There is a need to establish clear studies and results on adverse events occurring after vaccination in order to determine if they are really caused by the administration of the flu vaccine. Significant issues have been raised about Guillain Barre Syndrome and its relationship to the pandemic flu vaccine. This syndrome is a fast-developing and immune-mediated disorder of the peripheral nervous system which then causes muscle weakness (WHO, 2009c). Many people can recover almost completely from this disorder, however, for some individuals, some chronic weaknesses may remain. This disorder can develop after various infections, including flu. For some who receive flu vaccines, the risk of GBS is usually the same as those who have not been vaccinated (WHO, 2009c). The 1976 swine flu vaccination was definitively able to manifest with a significant number of Guillain-Barre cases. In the current pandemic flu vaccination cases, no clear link has been seen with the administration of seasonal flu and pandemic flu vaccines (WHO, 2009). In a comprehensive study by Abelin, et.al., (2011), the authors established that vaccines are an important tool in fighting the pandemic influenza and the vaccine manufacturers also have a crucial role to play in reducing the impact of this disease. The role of manufacturers have been made clear in this regard as the burden of rapidly developing and producing safe and effective pandemic flu vaccines is placed on their shoulders. The fulfillment of such role is however very much challenging. The manufacturing of flu vaccines is a challenging and time consuming activity and calls for special facilities and highly trained personnel to carry out (Abelin, et.al., 2011). Moreover, the timely administration of vaccines is not often controlled by manufacturers; instead, it involves the cooperation of government authorities and other organizations involved in their regulation and distribution. With the emergence of the pandemic influenza, institutions governments, public health authorities, scientists, and vaccine producers have come together to consider and resolve the above-mentioned challenges (Ngwanaamotho, 2010). Through the coordination of the above groups, an increased supply of pandemic vaccines was seen. Within three months from the declaration of the influenza pandemic, manufacturers of the inactivated and the live attenuated vaccines were able to complete their vaccine development; and subsequently, they were also able to receive authorization from the regulatory authorities (Abelin, et.al., 2011). With the manufacture of these vaccines, health authorities were able to establish immunization programs and soon after these programs were linked to manufacturers. About 50 countries soon implemented their vaccine programs and the manufacturers also supplied pandemic vaccines to various countries, while still supplying seasonal vaccines to meet local demands (Abelin, et.al., 2011). The speed of the vaccine manufacturing is attributed to the fact that years of preparation have already been made prior to the pandemic. Before the 2009 influenza pandemic, manufacturers were able to gain many years of experience in producing flu vaccines, and they were also able to develop prototypes for the pandemic virus. Based on these preparations, the manufacturers were able to carry out clinical tests with new flu vaccines in order to ensure that they were able to meet the regulatory requirements of the safety authorities (Abelin, et.al., 2011). Consequently, the safety of the vaccines was confirmed through extensive surveillance of the vaccine used by millions of people in the world. All in all, the safety of the vaccines has been confirmed through various reports around the world and with the positive response of the vaccine recipients. The vaccine has been tried and clinically tested to be safe for a great majority of people (CDC, 2011). Although it contains a dead virus, it is not possible to get the virus from the vaccine. What the dead virus does is to prompt the body to produce an antibody against the flu and therefore ensures that the body would be able to fight off the virus if it ever afflicts the patient (CDC, 2011). Vaccines may not always work immediately, and it is important for the recipient to protect himself at all times from the impact of diseases and viruses. Moreover, for the high risk groups, this precaution is particularly important. Conclusion The discussion above specifies details on the AH1N1 virus which was declared a pandemic in June 2009 by the World Health Organization. This is a variety of the influenza virus, but is more potent in its impact on the individual. It has claimed many lives since the first reports of the disease were seen in Mexico in April of 2009. Since then, vaccines against the disease were manufactured and distributed around the globe, and so far reports on the efficacy and the safety of its administration and use have been favorable. Side-effects have mostly been the side effects also seen with the administration of other vaccines, with some of these effects including localized redness or swelling. Hives and other deeper allergic reactions have not been reported. Individuals who are strong candidates for the use of these vaccines have reported few adverse reactions, if at all. The issue of Guillain-Barre syndrome was not apparent in the pandemic vaccinations. Other adverse symptoms have been rare and incidents were soon resolved. In general, these results therefore indicate a strong endorsement for the safety and the efficacy of the AH1N1 vaccines. Works Cited Abelin, A., Colegate, T., Gardner, S., Hehme, N., Palache, A. (2011). Lessons from pandemic influenza A(H1N1): The research-based vaccine industry’s perspective. Vaccine, volume 29, pp. 1135–1138. Centers for Disease Control. (2005). CDC – Influenza (Flu): Weekly Report: Influenza Summary Update 20, 2004–2005 Season. 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