How do countries around the world regulate vaccination?
Recently, the illegal operation of vaccines in Jinan, Shandong Province has caused great concern. Undoubtedly, the safety of vaccines is a livelihood issue that must be paid attention to in the public health field of every country, it's about the healthy growth of vaccine recipients. Throughout the world, the “toxic vaccine” incident has also appeared in different periods. How did they deal with this situation? What kind of relief system does the government have for the victims? Parents who face fear and refuse to vaccinate their children, what measures have countries taken? In developing countries, how does the government use vaccines to improve child survival?
United States: The most abundant vaccine regulatory experience, a leading position in the world.
In the past two decades, the US anti-vaccine campaign has always existed, Americans are arguing about whether or not to vaccinate their children.
The cause of this campaign is that people believe that “the leprosy vaccine (measured by measles, rubella, mumps triple vaccine) causes autism”. Because the first vaccination of leprosy vaccine is about one year old, because the symptoms of autism occur between the ages of one and three years old, coincidence this time attracted the concern of parents vaccine.
The real fuse is an academic article. In 1998, British scientist Andrew Wakefield intestinal authority in the British medical journal “The Lancet” published an article about the MMR vaccine can cause intestinal inflammation, which in turn leads to autism.When the American people see this article, they will have a psychological resistance to the MMR vaccine. Coupled with the neurotoxin in the leprosy vaccine containing the preservative thiomersal, the American public is more convinced that the leprosy vaccine will damage the nervous system of young children and cause children to suffer from autism.
Since then, rumors have begun to spread in the United States. Some lawyers and journalists also began to get involved and opened fire on the US government and related research institutions. Questioning the US government and research institutions to defend the interests of large pharmaceutical companies, thereby concealing the dangers of vaccines and exaggerating their role.
Later, many epidemiological studies have shown that leprosy vaccine doesn’t cause autism. Andrew Wakefield's article was also taken down by The Lancet magazine in 2010 because of serious academic errors, his medical license was revoked. At the same time, thimerosal has long been banned, the US High Court has vetoed the parents of children with autism to prosecute vaccination structures and vaccine manufacturers. However, the American public prejudice against the MMR vaccine was deeper, various forces, along with some public figures and public opinion, have made this anti-vaccine campaign intensifying.
According to a survey conducted by the American Academy of Pediatrics, parents who resist vaccination still believe that child autism is related to vaccination. 81% of parents disagreed with what doctors say “no vaccine will harm children's health”, and more than 10% of American parents refuse to take their children to get any vaccine.
Vaccine contamination: Cutter Lab Incident
In 1955, the Cutter laboratory prepared a polio vaccine. Because not thorough enough when the corresponding virus inactivated with formalin, did not kill all viruses. As a result, 40,000 of the 120,000 children who received the vaccine were infected, 56 of whom suffered from paralytic polio. Make this acute infectious disease that seriously endangers children's health have a chance to re-transmit in young children. The final 113 people paralyzed for life, five people were killed. The case verdict by the jury, although Cutter did not have a criminal offence, it was responsible for civil losses, the injured person and family received huge amounts of monetary compensation. Meanwhile, Cutter Institute of Microbiology Laboratory director was fired, the US Department of Health and Director of the Secretary-General Hobby NIH Sebrell resign.
The Cutter laboratory event has led to stricter standards for vaccines in the United States and more stringent controls. For example, vaccine shipments and vaccine arrivals are less than 48 hours apart, when the vaccine is stored daily, the temperature of the refrigerator should be between 2 ° C and 8 ° C, keep the temperature of the freezer at minus 15 ° C or lower. At the same time, a large bottle of water should be placed in the refrigerator so that the internal temperature remains the same when the refrigerator is opened. The US Centers for Disease Control and Prevention and the Federal Food and Drug Administration have also established a “vaccine adverse event reporting system”, vaccine manufacturers are obliged to report adverse events, such as power failures, such as violations of cold chain temperature, vaccine allergies, or the resulting hospitalization, lifelong disability and other consequences.
Vaccine injury relief system: about 1,000 victims have received about $1.2 billion in fund relief.
In 1986, the US government introduced the National Child Vaccine Injury Act, which established a legal basis for vaccine victims to receive relief. In 1988, the US Congress passed and implemented the Vaccine Injury Compensation Procedure. This procedure is a specific no-fault liability system to address vaccine injury claims.
The Vaccine Injury Compensation Procedure stipulates that the applicant may be the victim himself, or the parent, legal guardian or attorney. Applicants are required to submit medical information, medical and emergency records, adverse drug reaction reports, personal growth records and other materials before vaccination. The maximum amount of compensation can reach 250,000 US dollars, including hospital inspection fees, nursing expenses, labor loss fees, legal fees, and mental damages.
So where does the vaccine relief fund come from? The National Child Vaccine Injury Act lists a list of vaccine injuries, including diphtheria vaccine, pertussis vaccine, and mumps vaccine. For each vaccination dose sold, these vaccines are subject to a tax of $0.75 as a source of relief funds. In the United States today, thousands of victims have received approximately $1.2 billion in fund relief through appeals.
Australia & Italy: If the parents refuse to vaccinate their children, the government takes action
Australia: No vaccination, no childcare or welfare allowance
In 2006, 18899 children under the age of seven were not vaccinated in Australia because of their “private, religious or medical reasons”, accounting for 1.03% of the total number of children of the same age in Australia. This number surged to 29,968 in 2011 and rose to 39,523 by the end of 2014, more than double the number of people compared to 2006. Faced with this situation, the Australian government passed legislation, the comprehensive welfare and childhood vaccines linked.
The Australian Federal Government announced that the “no vaccine, no subsidy” policy will take effect from January 1, 2016. Parents who refuse to have their child vaccinated will not be eligible for taxpayer-funded childcare or welfare benefits. Includes a $200 a week parental allowance, a $7,500 childcare rebate per year, and a $726 A Family Tax benefit. In this way, if a family has two young children who are not vaccinated, the annual loss of childcare and welfare benefits may be as high as AU$30,000.
Australian Prime Minister Albert said that anyone who cancels a child’s vaccination will be disqualified. Unless they are exempted for medical or religious background, this immunity will remain in effect. The government’s “no vaccine, no subsidy” policy is a very important public health measure and is essential for protecting children and their families.
At the same time, in Victoria, on the southeast coast of Australia, the vaccination rate has stagnated at around 92%. From January 1, 2016, the Victorian government has implemented a new policy of “no vaccine, no game”, preschool children who are not vaccinated will be banned from entering child care centres or kindergartens.
Health Minister Hennessy said that on the issue of vaccination, we must be tough, because it can save lives. For example, pertussis in 2015 increased by 1,000 compared to 2014, which is not for the benefit of a child, but for all, for the safety of the community.
Italy: “coercion” Doctor improve vaccination rates?
At present, the proportion of children vaccinated against measles in Italy is less than 86%. In order to increase the vaccination rate, the Italian government launched the 2016-2018 National Vaccine Plan at the end of 2015. In response, Italian Health Minister Lorenzin said that the new plan is very important for public health and national security. The plan requires doctors working in the public health system to support this new vaccine promotion measure. If the doctor doesn’t cooperate, he will be sanctioned. In this regard, Troise, director of Anaao Assomed, a public health system with 22,000 doctors, said: “This is too horrible. It is impossible to carry out such complicated work of vaccination by coercing doctors.”
The plan sparked protests from doctors and the public health department, they are worried about the influence of pharmaceutical companies behind them. Because the vaccine program only contains a series of vaccine lists, it is completely “invisible to any national strategy”.
Germany & UK & Japan: Strictly regulated vaccination
Germany: recall of suspected contaminated vaccine
In October 2012, in the flu vaccine produced by Swiss pharmaceutical giant Novartis, white granules were found in some batches of injection. Upon learning of this situation, the German vaccine approval agency immediately reviewed the flu vaccine circulating in the market. Although white particles are not really found, in order to protect patients, it is possible to prevent adverse reactions such as allergies and other side effects, Germany is still recalling the vaccine. According to the German “Der Spiegel” weekly report, Germany released 14.2 million kinds of vaccines free of charge in 2012, and the number of vaccines ordered to be recalled in October reached 100,000.
UK: Ministry of Health is the only legal vaccine seller
In order to ensure the safety and stability of the vaccine, the UK strictly controls the qualification of vaccine manufacturers. The manufacturer's research capabilities, production equipment, funds, etc. must be strictly assessed by the British Ministry of Health. At the same time, the UK Ministry of Health is the only legal seller of the UK vaccine, and its purchasing power is monopolistic. Therefore, the UK Ministry of Health is dominant in cooperation with producers, the contract price agreed by both parties is lower than the market price. Due to the meager profits of vaccine production, many companies are discouraged, which makes vaccine manufacturers less and less, but the variety of vaccines is increasing.
Japan: The government is responsible for compensation for injuries caused by vaccination
In 1977, Japan established a remedy system for vaccination against health. In 1994 and 1999, Japan made two revisions to the State Responsibility section of the Vaccination Law. According to the regulations, the state adopts the principle of responsibility for results. As long as the Minister of Health, Labour and Welfare determines that the damage has occurred as a result of vaccination, the victim should be compensated, including medical expenses, hospitalization allowance, child care support for disabled children or disabled persons, one-time death allowance, funeral expenses, etc. This is done to alleviate the public’s concerns about the side effects of the vaccine. For example, if the vaccinated person dies, the government will compensate 42.1 million yen and pay the funeral expenses.
Rwanda: Integrate ten vaccines into routine immunization programmes to improve child survival.
On June 6, 2012, in the Kigali Rutunde area of Rwanda, when Elie, who was eight months old, arrived at the local clinic, he was confirmed to be infected with pneumonia because he had high fever, poor breathing, and no appetite. Elie gradually recovered after 24 hours of antibiotic infusion. Elie's mother listened to the advice of the clinic doctor and decided to give another son in the family a pneumococcal vaccine to prevent pneumonia, meningitis and sepsis.
In 2009, with the support of funding and development partners from the International Vaccine Initiative, Rwanda reached one of the first countries to introduce pneumococcal vaccines in sub-Saharan Africa. At the same time, Rwanda has also established a primary health care system. The government has included ten vaccines in routine immunization services. These include a new rotavirus vaccine that can prevent diarrhoea, as deaths from diarrhoea account for one fifth of Rwanda’s child mortality.
UNICEF Representative in Rwanda Noala Skinner believes that it is necessary to introduce a new vaccine. At the same time, strengthening the overall medical system and working closely at the local level through community medical centers, village committees, and regional hospitals have all had a miraculous effect on improving child survival.
Argentina: Vaccine trials lead to child deaths, pharmaceutical companies are fined 400,000 pesos
In 2007 and 2008, an international pharmaceutical company conducted a pneumonia vaccine trial on 14,000 children in poor families in the provinces of Santiago, Mendoza, and San Juan, Argentina, nine of the children who participated in the vaccine trial died shortly after vaccination. After the incident was disclosed by the media, the Argentine National Medicine, Food and Medical Technology Administration immediately launched an investigation. Although there is no evidence that the child's death is directly related to the vaccination, the pharmaceutical company was found to have violated the vaccine experiment in Argentina. The doctor from the pharmaceutical company did not explain to the parents the possible side effects of vaccination, makes it impossible for parents to make a comprehensive assessment of the potential risks of vaccination. Some parents who signed the consent form did not meet the age of vaccination prescribed by Argentine law. Some parents who signed the document did not understand the illiteracy of the agreement. In addition, an agreement was signed by a mother with a mental illness. In response, the Argentine National Medicine, Food and Medical Technology Administration imposed a fine of 400,000 pesos on the pharmaceutical company, two doctors participating in the vaccine trial each paid a fine of 300,000 pesos. Subsequently, the pharmaceutical company appealed to the Argentine Economic Court, it is believed that the above vaccines have been approved by 85 countries and regions including the European Union, and there is no problem with safety. However, the Argentine judge who heard the case dismissed his appeal and found that the pharmaceutical company had irregularities and fraud during the vaccine trial. The results of the punishment of the Argentine National Medicine, Food and Medical Technology Authority were maintained.
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