Heavy weight! Safety data of large scale emergency use of Sinopharm China Biological New Crown vaccine

In April 21st, China’s core academic journal China Journal of epidemiology published a paper entitled “safety assessment of large-scale inpatient use of New Coronavirus inactivated vaccine (Vero cell)”

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It issued a large-scale emergency use safety evaluation based on the national biological products Beijing Institute of the National Pharmaceutical Group and the Wuhan inactivated vaccine New Coronavirus Institute

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Studies have shown that after the large-scale new inactivated coronavirus vaccine (Vero cells) is used in emergency, the incidence of general reactions is low, no serious adverse reactions are found, and the vaccine has good safety

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The results of phase I / II clinical phase studies of Xinguan vaccine of Sinopharm Group Beijing Institute of biological products and Wuhan Institute of biological products showed that the safety of Xinguan inactivated vaccine was good and no serious adverse reactions were found

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At 28 days after two doses of vaccine, the growth rate of neutralizing antibody against NCV was nearly 100%

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The joint defense and joint control mechanism of the State Council respectively introduced China’s two biological vaccines into the emergency use of the national New Coronavirus vaccine in June 30th and July 23rd

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In China, one belt, one road, and 519543 overseas students (as of December 1, 2020), who have recorded emergency use of the system, are analyzed by using the “vaccination information collection system” developed by China’s Bio Science

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Medical staff of medical institutions and front-line staff of CDC; Customs border inspectors and port traffic personnel; Staff of government departments at all levels, enterprises and institutions involved in prevention and control, public security and high risk of exposure to new coronavirus; In order to provide an important basis for the safety evaluation of Xinguan inactivated vaccine after it is put on the market

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There was no serious adverse reaction, and the overall adverse reaction rate was low

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Based on the 519543 person time vaccination information, 5164 adverse reaction information were monitored

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The total adverse reaction rate of Xinguan inactivated vaccine produced by Beijing Institute of biological products and Wuhan Institute of biological products was 1.06%, the local adverse reaction rate was 0.37%, and the systemic adverse reaction rate was 0.69%

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The incidence of local adverse reactions was 0.24% and 0.05% respectively

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The main systemic adverse reactions were fatigue, headache, fever, cough and loss of appetite

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Compared with phase II clinical trial, the overall adverse reaction rate of Xinguan inactivated vaccine produced by Beijing Institute of biological products was 13%, and the overall adverse reaction rate of Xinguan inactivated vaccine produced by Wuhan Institute of biological products was 19%

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The results showed that the adverse reaction rate of inactivated vaccine was much lower than that of phase II clinical results

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According to the results of safety analysis of enterovirus 71 (EV71) inactivated vaccine in large population after marketing, the total adverse reaction rate of EV71 inactivated vaccine was 1.079% ~ 3.310%

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The incidence of adverse reactions of inactivated hepatitis A vaccine in adults and children was 2.90% ~ 35.56% respectively

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According to the information collected by the “vaccination information collection system”, the pain in the vaccination site mainly occurred on the day of vaccination and within 24 hours after vaccination; Induration occurred mainly in 1-4 days after inoculation; Swelling, erythema, pruritus and skin rash occurred mainly within one week after inoculation

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In the systemic reaction, post inoculation fatigue mainly occurred on the day of inoculation and within 2 days after inoculation; Headache mainly occurred in 0 ~ 3 days after inoculation; Muscle pain mainly occurred in 0-3 days after inoculation, and most occurred on the first day; Fever, cough, loss of appetite, diarrhea and allergy mainly occurred within one week after vaccination

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The adverse reaction rate of people over 60 years old was the lowest

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According to gender, 297996 male vaccinations were recorded in vaccination information collection system, and 2149 adverse reaction data were recorded; There were 190418 female vaccinations, and 3015 adverse reactions were recorded

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The incidence of adverse reactions in women (1.58%) was higher than that in men (0.72%)

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According to age, the lowest incidence of adverse reactions was in people over 60 years old (0.32%), followed by people aged 30-39 years old (1.18%), and the highest incidence of adverse reactions was in people aged 12-18 years old (11.31%)

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The incidence of adverse reactions in the first dose was higher than that in the second dose, and the adverse reactions in the second dose were lower than that in the first dose

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The adverse reactions were consistent with the overseas clinical studies, but the incidence was lower than the mid-term analysis results of overseas phase III clinical trials

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Compared with the results of phase I / II clinical trials and the mid-term analysis results of overseas phase III clinical trials, the local adverse reactions after vaccination were mainly pain, swelling and dizziness, and the systemic adverse reactions were headache, muscle pain and dizziness Diarrhea, cough, fever and fatigue were the main causes

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The incidence of adverse reactions in this study is consistent with that 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 that in overseas phase III clinical trials

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In general, inactivated vaccine is the most traditional and classic vaccine preparation method in all research and development technology routes

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The application of inactivated vaccines such as hepatitis A inactivated vaccine, rabies vaccine and Sabin strain poliomyelitis inactivated vaccine in large-scale population has proved that inactivated vaccine has good safety and effectiveness

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In the novel coronavirus pneumonia, two novel coronavirus inactivated vaccines developed by China biological Beijing biological products research institute and Wuhan biological products research institute have proved that they have shown good safety through large-scale, emergency vaccination and follow-up data after phase I, phase II clinical studies and large-scale emergency use

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It provides strong support for conditional marketing of vaccine and large-scale population vaccination after marketing

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Source: Global Times.

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