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Safety data on large-scale emergency use of SINOPHARM COVID-19 Vaccine
Safety data on large-scale emergency use of SINOPHARM COVID-19 Vaccine. This study is consistent with the occurrence of adverse reactions observed in the phase III clinical studies outside China, but compared with the interim analysis results of the overseas phase III clinical trials, the incidence of adverse reactions in this study is significantly lower than the interim analysis results of the overseas phase III clinical trials.
On April 21, 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)”, and published a paper based on SINOPHARM’s China Bio-Beijing Products Safety evaluation of the large-scale emergency use of the new coronavirus inactivated vaccine of the Institute and Wuhan Institute of Biological Products.
Studies have shown that after emergency use of a large-scale inactivated new coronavirus vaccine (Vero cells), the incidence of general reactions is low, no serious adverse reactions have been seen, and the vaccine has good safety.
▲ Screenshot of the release of the paper in the Chinese Journal of Epidemiology
The results of phase I/II clinical trials of COVID-19 vaccine of the Sinopharm Beijing Institute of Biological Products and the Wuhan Institute of Biological Products all show that the COVID-19 inactivated vaccine is safe after vaccination and no serious adverse reactions have been seen.
28 days after the two doses of vaccination, the 4-fold growth rate of neutralizing antibodies against the new coronavirus approached 100%. The State Council’s joint prevention and control mechanism included two Chinese biological vaccines into the emergency use of the national new coronavirus vaccine on June 30 and July 23, respectively.
This research uses the “Vaccination Information Collection System” independently developed by China Biotech to analyze the data of 519,543 people (data as of December 1, 2020) used in emergency situations recorded in the system. The research objects mainly include: diplomatic missions and “Belt and Road” construction personnel and international students who are out of the country by Chinese-funded enterprises; medical staff in medical institutions and front-line staff of the CDC; customs border inspection personnel, port traffic personnel; people involved in prevention and control, public security, and high risk of exposure to the COVID-19 virus Staff from government departments at all levels, various enterprises and institutions; urban first-line life service security personnel, etc., initially evaluate the safety of the emergency use of the COVID-19 inactivated vaccine in key populations, and provide an important basis for the safety evaluation of the COVID-19 inactivated vaccine after it is marketed .
No serious adverse reactions, the overall adverse reaction rate is low
Based on the 519,543 vaccination information monitored, a total of 5164 pieces of adverse reaction information were monitored. The total adverse reaction rate of the COVID-19 inactivated vaccine produced by the Beijing Institute of Products and the Wuhan Institute of Biological Products was 1.06%, and the incidence of local adverse reactions was 0.37%. The incidence of systemic adverse reactions was 0.69%.
The main manifestations of local adverse reactions were pain at the inoculation site and swelling at the inoculation site, with incidences of 0.24% and 0.05%, respectively. The main manifestations of systemic adverse reactions were fatigue, headache, fever, cough, and loss of appetite. No serious adverse reactions were seen.
Comparing the phase II clinical trials, the overall adverse reaction rate of the inactivated COVID-19 vaccine produced by the Beijing Institute of Biological Products was 13%, and the overall adverse reaction rate of the COVID-19 inactivated vaccine produced by the Wuhan Institute of Biological Products was 19%.
The results of the study show that the adverse reaction rate of China’s new biological COVID-19 inactivated vaccine is far lower than the phase II clinical results.
With reference to the safety analysis of inoculation in a large population after the inactivated enterovirus 71 (EV71) vaccine is on the market, the total adverse reaction rate of the EV71 inactivated vaccine is 1.079%~3.310%. The incidence of adverse reactions of inactivated hepatitis A vaccine in adults and children was 2.90%-35.56%, respectively.
Adverse reactions after vaccination are usually relieved within 3-4 days
According to the statistics collected by the “Vaccination Information Collection System”, the pain at the inoculation site in local reactions mainly occurs on the day of vaccination and within 24 hours after vaccination; induration at the vaccination site mainly occurs within 1 to 4 days after vaccination; Itching and rash mainly occur within 1 week after vaccination.
In the systemic reaction, fatigue after vaccination mainly occurs on the day of vaccination and within 2 days after vaccination; headache after vaccination mainly occurs within 0~3 days after vaccination; muscle pain mainly occurs within 0~3 days after vaccination, with the most occurring on the first day; fever, Cough, loss of appetite, diarrhea and allergies mainly occur within 1 week after vaccination.
Analysis of adverse reactions after vaccination in populations with different characteristics， The lowest rate of adverse reactions among people over 60
Divided by gender, the “Vaccination Information Collection System” has recorded a total of 297,996 male vaccinators, 2149 adverse reaction data after male vaccination; 190,418 female vaccinators, 3015 adverse reaction data after female vaccination, and the incidence of adverse reactions among women ( 1.58%) higher than men (0.72%).
According to age, the incidence of adverse reactions is lowest among people ≥60 years old, with an adverse reaction incidence rate of 0.32%, followed by people aged 30 to 39 years, with an adverse reaction incidence rate of 1.18%, and the highest incidence of adverse reactions among people aged 12 to 18 years old. It was 11.31%, mainly fatigue and pain at the inoculation site.
In terms of the difference in the number of inoculation doses, the incidence of adverse reactions in the first dose was higher than that in the second dose, while the adverse reactions of the second dose were lower than the first dose.
Adverse reactions are consistent with overseas clinical studies, but the incidence is lower than the interim analysis results of overseas phase III clinical trials
Comparing the results of the Phase I/II clinical phase study of the COVID-19 inactivated vaccine and the interim analysis results of the overseas phase III clinical trial, the local adverse reactions after vaccination are mainly pain, swelling and flushing at the injection site, and the systemic adverse reactions are headache, muscle pain, and diarrhea. (Emergency use did not observe diarrhea related conditions), cough, fever, and fatigue. This study is consistent with the occurrence of adverse reactions observed in overseas phase III clinical trials, but compared with the interim analysis results of overseas phase III clinical trials, the incidence of adverse reactions in this study is significantly lower than the interim analysis results of overseas phase III clinical trials.
Taken together, inactivated vaccines are the most traditional and classic vaccine preparation method among all R&D technical routes. Inactivated vaccines such as hepatitis A vaccine, rabies vaccine, and Sabin strain polio vaccine are used in large-scale populations. The application of inactivated vaccines has proven to have good safety and effectiveness.
In this COVID-19 pneumonia epidemic, the two COVID-19 inactivated vaccines quickly developed by Sinopharm Beijing Institute of Biological Products and Wuhan Institute of Biological Products have been certified by Phase I and Phase II clinical studies and large-scale emergency use. According to the large-scale emergency use of vaccination and follow-up data, it shows good safety, and provides strong support for the conditional listing of the vaccine and the widespread vaccination of the nationwide population after the market.
(source:internet, reference only)