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anthrax vaccine side effects:The State Drug Administration issued an announcement stating that it was discovered through unannounced inspections that Changchun Changsheng Biologics had recorded fraudulent records during the production of freeze-dried rabies vaccines for human use, including serious violations of the "Quality Management Regulations for Drug Production", and ordered the Jilin Provincial Food and Drug Administration The "Drug GMP Certificate" related to Changchun Changsheng was withdrawn.
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In October last year, the DPT vaccine produced by Changchun Changsheng was found to have a potency index that did not meet the standard requirements during the drug sampling test conducted by the China Food and Drug Control Institute. Surprisingly, the Jilin Provincial Food and Drug Administration did not issue an administrative penalty decision until recently.
This incident once again exposed the current status of my country's vaccine field: from production to supervision, there are many vaccine problems. How can these problems be completely solved so that the Chinese people, especially infants and young children,
can receive safe and effective vaccines?
In terms of the safety supervision of preventive vaccines and drugs, the United States is the most stringent in the world. Researching and learning from the country’s successful experience may help our country to avoid detours when formulating relevant policies. . This article is mainly based on the relevant vaccine safety supervision content of the US Centers for Disease Control (CDC) website to introduce how vaccine safety in the United States is supervised.
CDC headquarters
The most successful case in the field of public health in the world should be regarded as the use of vaccination to greatly reduce the incidence of infectious diseases. It is precisely because of the use of vaccines that smallpox, which seriously threatened human health in those years, was completely extinct globally, and polio (poliomyelitis) was almost eradicated.
Before the US Food and Drug Administration (FDA) approved the vaccine for marketing, the vaccine had been rigorously tested and tested by scientists and proved to be safe and effective. Vaccines are currently the best and most economical weapon for humans to deal with infectious diseases. However, no vaccine is 100% safe or effective. The differences in the immune system between individuals cause some people (including children) to have no protective effect or have side effects (severe ones may be fatal) after vaccination. However, unlike medicines, vaccines are for healthy people (many of whom are children) because strict safety standards are necessary.
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Because vaccination is a common and easy-to-remember thing for people, any disease that occurs after vaccination may be attributed to the vaccine. In fact, many diseases have nothing to do with vaccination, they just happen to be concurrent after vaccination. . Therefore, it is especially important to use scientific methods and research to identify the true vaccine side effects.
National Children's Vaccine Injury Compensation Act
In the United States in the mid-1970s, there was a significant increase in legal proceedings for injuries (probably, possibly) caused by vaccination against Diphtheria, pertussis, and tetanus, making vaccine safety issues a public focus.
This situation is somewhat similar to China now.
Although there is a lack of scientific evidence to prove that the injury suffered by the plaintiff or his guardian was caused by the vaccination, the US court still awards compensation. The results of these court judgments directly led to a significant increase in the risk of vaccine manufacturers, and the price of vaccines naturally also soared. Several vaccine manufacturers could not stand it and simply closed their doors.
In order to reduce the risks and public health concerns of vaccine manufacturers, the U.S. This bill has significant effects on vaccine regulation in the United States in many aspects. With far-reaching impact, the passage of this bill is a milestone for vaccine safety in the United States. China is also in urgent need of passing similar special laws. Now many families in China (although the proportion is not high, the absolute number is not small) due to their children There is no way to claim for disability or even death caused by vaccination, and the whole family is plunged into poverty and suffering due to medical treatment and childcare.
On November 15, 1986, the New York Times reported that Reagan signed the NCVIA Act.
The passage of the NCVIA Act in the United States directly produced the following results:
1. Establish the National Vaccine Project Office (NVPO) to coordinate the activities of all vaccination-related departments under the United States Department of Health and Human Services (DHHS), including CDC, FDA, and Health Resources and Services Administration .
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