Big data to monitor vaccine adverse events, the United States does!

The problem of falsification of the design and production records of the rabies vaccine for human freeze-dried human rabies vaccine in the rabies vaccine case, and the problem of substandard potency in the case of the “rabies vaccine”, is affecting the hearts of millions of people. On July 23, 2018, President xi jinping issued an important instruction on the long life biologic vaccine case in changchun, jilin province, stressing the seriousness and accountability of the investigation, so that the issue of vaccine safety once again becomes the focus of society and continues to grow. The issue of vaccine safety is not new. There was the shanxi vaccine before, and the shandong illegal vaccine after, and now there is the problem of falsification of the vaccine. As early as the two sessions in 2010, wang yu, a former director of the Chinese center for disease control and prevention, said, “some vaccines are not up to standard in quality, and regulators lack systematic evaluation of these vaccines after they are released on a large scale. Some vaccines do not meet the criteria for mass use in the population, and their quality is very different from imported vaccines. So how do you collect the systematic evaluation after mass marketing of vaccines? How do you take advantage of collected evaluations?

Every country has more or less the same problems, so what does the United States do when it comes to similar vaccine adverse events?

What does the United States do?

For vaccines in the United States, was established in 1990, the vaccine adverse event reporting system (VAERS), it is a national early warning system, used to detect possible security problems, licensed vaccines in the United States by the centers for disease control and prevention (CDC) and the United States food and drug administration (FDA) joint management of a passive reporting system.

Anyone can report to the VAERS vaccine adverse events, when the vaccine adverse event log in the system, declare the vaccine adverse event occurs, the system will be asked to fill in the vaccine issues related to the important information, as complete as possible, after will have special staff to verify that health care professionals must report some adverse events, and ask the vaccine manufacturers report they noticed that all the adverse events

All declaration of vaccine adverse event, the system according to the years statistical integration, anyone can download after all integrated in the system view of vaccine adverse event data, greatly improve the transparency of the vaccine data information, provides a reliable U.S. vaccine safety supervision system, supervision range extends to the whole society, and all vaccine manufacturers are under the supervision of people.

VAERS collected data on a large number of vaccine adverse events for the United States and oversaw the U.S. vaccine market, leaving no room for information about vaccine adverse events.

Simple analysis of VAERS system data

1、Distribution of vaccine manufacturers

As can be seen from the figure, among all the drug manufacturers involved, MERCK & CO. Inc. accounted for the largest proportion, accounting for 46.2%, and the number of cases was as high as 44,900. Then came GLAXOSMITHKLINE BIOLOGICALS (15.8 percent) and SANOFI PASTEUR (15.6 percent), which the government could focus on to see if they had problems.

4、Adverse Numbers of diphtheria and rabies vaccines occurred in each year

The “DTP” vaccine stands for diphtheria, and the “RAB” stands for rabies vaccine. According to the data in the figure, the number of adverse events of the two vaccines decreased with the year, and the number of adverse events of the “RAB” vaccine was significantly higher than that of the “DTP” vaccine.

5、Vaccine batches for diphtheria and rabies vaccine adverse events

The largest number of adverse events resulting from rabies vaccine was obtained from the table. The manufacturers with the highest number of adverse events were SANOFI PASTEUR and U5235AA batches

6、Age distribution of rabies vaccination

The number of adverse events caused by rabies virus vaccine was obtained by dividing the age into 5 groups. The age group in which the rabies virus vaccine was found to have the most adverse events was between 18 and 36 years old.

2、The number of fatal and disabling events in the past three years

The results of adverse events in the past three years were further analyzed to observe the changes in the number of fatal and disabling accidents.

The number of deaths recorded increased from 462 in 2016 to 573 in 2017 to 326 in the first half of 2018, a curious trend that may indicate something may be happening or some hidden problem with the U.S. vaccine; The number of reported results of disability and death after disability decreased, which was more consistent with the overall situation.

3、The number of adverse events has changed in each of the past three years

Data of the VAERS system were recorded to June 14, 2018, and the number of records in 2016, 2017 and the first half of 2018 were summarized. In the case of the VAERS system operation, the number of vaccine-related adverse events was decreasing year by year. The number of reported adverse events to the system dropped from 45,715 in 2016 to 38,900 in 2017, with 12,482 reported incidents in the 2018 half year, only one third of the recorded events in 2017, and the total recorded events in 2018 will still maintain a downward trend without any accidents.

This suggests that the VAERS system is indeed effective in alleviating vaccine safety problems.

Establishing a data disclosure system that gives the general public complete access to information and allows them to participate in the monitoring of vaccine quality is a fundamental solution.

The issue of vaccine safety, which affects not only the health of the next generation but also the future of the country, destroys the little trust that has been built up over the years for domestic vaccines.

The development process of domestic vaccines is not easy, and the supervision of vaccines is very strict. There is a formal process for the approval and issuance of vaccines. The subsequent transport process is also under strict supervision. How will the public’s waning confidence pick up?

Analysis of VAERS data suggests that vaccines can cause side effects and even death, even in the United States. So why don’t they have so many “vaccine incidents”? By establishing a data disclosure system that gives the general public complete access to information and allows them to participate in the monitoring of vaccine quality, it is a fundamental solution.

The safety of vaccines has been put to the test, largely because of their lack of transparency and limited supervision. Mentioned in this article the American VAERS system and its operation mechanism, we can take its essence, a set of their own vaccine regulatory system, let more people involved, both to ensure the information disclosure, strengthens the populace to supervise, and to increase a certain deterrent to criminals, and in today’s information age, in supervision at the same time also can collect a large number of valid data, make good use of the collected data, using the tool of data analysis for a series of analysis, can timely found problems and deal with the vaccine, can also provide valuable data support for the development of vaccine follow-up.

 

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