The Paper:
There have been media reports that people in some countries have experienced rare and serious adverse reactions such as headaches and allergies after receiving the COVID-19 vaccine. What should people do in this kind of situation? How will medical institutions deal with this situation? Who will be responsible for the monitoring and reporting of adverse reactions? And what role will such monitoring and reporting play? Thank you.
Zeng Yixin:
Since these questions involve several aspects, I would like to first invite Ms. Jiao Yahui to answer, and then ask Mr. Wang Huaqing to provide some additional remarks.
Jiao Yahui:
Thank you for your questions. First of all, I think that vaccine safety is a very important issue for many people. We know that vaccination is an effective way to prevent infectious diseases because it can protect our body. However, since the vaccine is actually an external antigen, some people will experience adverse reactions after it is administered. There are two different types of reactions which require a distinction. One type is adverse reactions. This refers to some damage responses not related to the purpose of the vaccination or which occur incidentally after the standard inoculation of a qualified vaccine, and includes both general and abnormal reactions. All medicines and vaccines can cause some adverse reactions, which is within the scope of permit. The other type is coupled reactions. This means that the person being inoculated just so happens to be in the incubation period or early stages of another disease, and the disease comes on coincidentally at the time of vaccination. This kind of reaction has nothing to do with either the vaccination or the quality of the vaccine, and so is not classified as an adverse reaction.
From what was previously observed, those who received Chinese COVID-19 vaccines reported no severe adverse reactions, which cannotbe said for vaccines in someforeign countries. The common adverse reactions for the Chinese vaccines include the following: headache, fever, redness and lumps at the injection site, as well as coughing, loss of appetite, vomiting and diarrhea.
We attach high importance to the safety of COVID-19 inoculations. In order to ensure safety, several measures have been taken across the country. First, we require that the vaccination sites, including inoculation clinics and temporary vaccination sites, should meet two requirements: providing both inoculation services and medical treatment. We provide technical training for the relevant medical staff at these vaccination sites until they are well-qualified to start work. We will ensure that these people not only have the skills to give vaccines, but also the ability to quickly identify and cope with common adverse reactions. Recently, we have carried out training for those in charge of administering vaccines and the relevant medical staff. This is the first measure.
The second measure is that we divide up areas and designate secondary and tertiary hospitals with a higher level of medical care capacity to provide medical support for vaccination sites in certain areas. Experienced emergency medical personnel with necessary first-aid equipment and medicines sent by designated hospitals shall be put on standby at the vaccination sites to deal with any emergencies that arise. When people show severe adverse reactions to the vaccine and need further treatment, we will work to ensure there are ambulances to quickly transfer the patients. The high-level hospital must open a "green channel" to provide multi-disciplinary treatment, and we will do our best to ensure the safety of those getting vaccinated.
In addition, we would like to remind the recipients that during the vaccination process, they must truthfully report their personal health status, including underlying diseases, allergy history and whether they are ill. In addition, based on previous experience, adverse reactions often appear within 30 minutes of vaccination, so vaccine recipients are advised to stay for half an hour at injection sites to monitor their condition for 30 minutes after being administered so medical workers at the vaccination sites can handle any emergency that might occur. The recipients can go home 30 minutes later if there are no problems. If the signs of adverse reactions I mentioned earlier occur, the recipients should seek medical treatment immediately. What's more, I also want to remind the vaccine recipients to have a healthy diet, rest, and keep the injection spot clean and dry, so as to help the body return to normal as soon as possible. Thank you.
Wang Huaqing:
I'll add a few points. People are very concerned about adverse reactions. In fact, it is also an important part of our vaccination work. We have introduced a complete set of laws and regulations regarding monitoring and reporting adverse reactions of vaccine. These include provisions in the Vaccine Management Law, the monitoring program for suspected adverse reactions to vaccination, and the identification methods for abnormal reactions. I will introduce our practice in accordance with these regulations. Maybe you are very concerned about who will report the adverse events. In fact, it is clearly stipulated in the Vaccine Management Law and our surveillance plan that medical institutions, vaccination sites, the disease control authorities, adverse reaction monitoring institutions, and vaccine manufacturers are all responsible for reporting adverse events and all the personnel engaged in related work in these units also shoulder the responsibility. You may also concern about what we will report.
There are clear regulations in our monitoring plan regarding what to report after vaccination, including what diseases should be reported and how long the recipients might show vaccination-related symptoms after vaccination. After reporting the events, we will conduct an investigation if required, according to the standards in the monitoring plan. Based on the investigation, we will make a judgment on whether a further diagnosis is needed or not. The diagnosis will be made by an expert group in charge of the diagnosis of abnormal reactions established under the disease control authorities and the identification will be made by our medical associations.
In addition, I want to say that abnormal reaction monitoring entails an information system. The China CDC has established a system that monitors abnormal vaccine reactions. We will conduct regular analysis based on the data reported by various institutions and personnel, including investigations and diagnoses. We will also promptly analyze and evaluate risks that may arise during the vaccination process if major events happen.
I also want to introduce to you that after the Regulation on the Administration of Circulation and Inoculation of Vaccines were promulgated in 2005, the monitoring of vaccine-related adverse reactions in China has been standardized. After 15 years of work, under the leadership of governments at all levels and with the efforts of professionals, our overall monitoring capacity has been greatly improved. In 2011 and 2014, the WHO conducted assessments of China's vaccine supervision situation, one important part of which involved the monitoring of vaccine adverse reactions. According to the assessment results, we have met the standards of the WHO. Therefore, we now have such a system and working mechanisms to ensure the smooth progress of vaccination. Thank you.
