At present, the new crown vaccination campaign has been widely launched in China.
Since the new crown vaccine may be used in hundreds of millions of healthy people, its safety is an issue that cannot be ignored.
Yesterday, China’s core academic journal "Chinese Journal of Epidemiology" published a paper entitled "Safety Evaluation of Large-scale Emergency Use of Novel Coronavirus Inactivated Vaccine (Vero Cells)".
An analysis of more than 510,000 vaccination data showed that, Inactivated vaccines caused a low rate of adverse reactions during large-scale emergency use, and no serious adverse reactions were found.
The researchers said in the paper that the vaccine has good safety.
Click on "Read more" at the end of the article, you can visit the official website of "Chinese Journal of Epidemiology" to download the full text of the paper.
The new crown inactivated vaccine developed by the Wuhan Institute of Biological Products and Beijing Institute of Biological Products under Sinopharm China Biotechnology Co.
adopts the traditional and classic inactivated vaccine preparation methods in the vaccine research and development technology route.
This technology has been used in hepatitis A.
Inactivated vaccines, inactivated rabies vaccines, and Sabin strain inactivated polio vaccines have been widely used in vaccines, and have shown good safety and effectiveness.
Two new inactivated vaccines developed by the Wuhan Institute of Biology and Beijing were approved to be included in the emergency use of China's new crown vaccine in June and July 2020.
This paper provides safety data generated during emergency use.
During this period, most of the high-risk personnel who were vaccinated during this period received two doses of vaccine 14 or 28 days apart, and the vaccinators filled in the safety monitoring information online through the "vaccination information collection system".
The safety data reported in the paper is the data collected as of December 1, 2020.
Security data analysis shows:
The overall adverse reaction rate is low, and no serious adverse reactions have been found
The system monitored a total of 519,543 vaccination information and found 5164 pieces of adverse reaction information.
The total adverse reaction rate of the new crown inactivated vaccine produced by Beijing Institute of Products and Wuhan Institute of Biological Products was 1.
06%, and the local adverse reaction rate was 0.
The systemic adverse reaction rate was 0.
Local adverse reactions are mainly pain and swelling at the site of inoculation, and systemic adverse reactions are mainly fatigue, headache, fever, cough and loss of appetite.
No serious adverse reactions were found.
The frequency of different adverse reactions is shown in the figure below.
Adverse reactions of vaccination can generally be relieved within 3-4 days
Safety information shows that local reactions after vaccination mainly occur on the day of vaccination and within 24 hours after vaccination.
In systemic reactions, fatigue after vaccination mainly occurs within 2 days after vaccination; headache and muscle pain mainly occur within 3 days after vaccination; fever, cough, loss of appetite, diarrhea and allergies mainly occur within 1 week after vaccination.
Please see the figure below for statistics on the number of episodes of local and systemic reactions.
The lowest adverse reaction rate among the elderly over 60
Analyzing the incidence of adverse reactions according to population characteristics, it was found that the incidence of adverse reactions in women was 1.
58%, which was higher than that in men (0.
According to age, the incidence of adverse reactions was the highest among people aged 12-18, reaching 11.
31%, mainly fatigue and pain at the site of the inoculation.
The incidence of adverse reactions among people over 60 years old is the lowest, only 0.
Some discussionSome discussion
During the discussion of the paper, the researchers pointed out that the safety data obtained during this emergency use process was significantly better than the safety results of the inactivated vaccine in the phase 2 clinical trial.
In the phase 2 clinical trial, the adverse reaction rate of the inactivated vaccine produced by China Bio-Beijing was 13%, and the adverse reaction rate of the inactivated vaccine produced by China Bio-Wuhan was 19%.
The reason for this significant difference may be that in clinical trials, the monitoring of adverse reactions is active monitoring, and the researchers ask the vaccinators about the adverse reactions.
In the process of emergency use, the report of adverse reaction information is collected passively, and the vaccinators need to log in to the WeChat mini program to fill in the adverse reaction information.
Because the filling of safety information is not a mandatory requirement, the compliance of the vaccinators, the awareness of reporting, and the timeliness of online reports may affect the sensitivity of the test.
This is the limitation of this research.
The study found that the incidence of adverse reactions reported by men was significantly lower than that of women, which may be related to women's better feedback compliance and greater sensitivity to the discomfort caused by adverse reactions.
The types of adverse reactions found in this study are similar to those in clinical trials, and compared with other types of inactivated vaccines, the adverse reaction rate of the new coronavirus inactivated vaccine is also relatively low.
For example, the safety analysis of large population vaccination after the inactivated enterovirus 71 (EV71) vaccine is on the market shows that the overall adverse reaction rate of the vaccine is 1.
The adverse reaction rates of inactivated hepatitis A vaccine in adults and children were 2.
56% and 3.
The author pointed out at the end of the paper that increasing the vaccination rate and gradually establishing herd immunity is one of the most effective ways to stop the spread of the new crown epidemic.
The new crown inactivated vaccine developed by Sinopharm China Biotech has shown good safety in large-scale emergency use, and supports its widespread vaccination among large-scale populations across the country.