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The Lancet publishes a new study: 3-17 age children can receive same dose of COVID-19 inactivated vaccine as adults
3-17 age children can receive same dose of COVID-19 inactivated vaccine as adults. On June 29, “The Lancet-Infectious Diseases” published online the world’s first clinical safety and immunogenicity data on the inactivated COVID-19 vaccine for people aged 3-17 years.
The Paper (www.thepaper.cn) noted that the results of this study support that children and adolescents aged 3-17 will be vaccinated with a dose of 3µg (0.5ml) of the COVID-19 vaccine, which is the same as the current adult vaccination of Kexing’s nCOVID-19nactivated vaccine. The dosage is the same.
The results of the study showed that the immune response of children and adolescents was better than that of adults aged 18-59 and those aged 60 and over following the same immunization schedule with two doses of the vaccine. This provides data support for the further research and immunization strategy of the COVID-19 inactivated vaccine Kellyf developed by Beijing Kexing Zhongwei Company in children and adolescents.
The author of the above study is Gao Qiang, general manager of Beijing Kexing Zhongwei, and others. The title of the paper is “Safety, tolerability and immunogenicity of the inactivated COVID-19 vaccine Kelafol in healthy children and adolescents: one Randomized, double-blind, controlled phase I/II clinical trial.”
At present, some countries has approved the emergency use of the inactivated COVID-19 vaccine developed by the Beijing Research Institute of Sinopharm Zhongsheng and Beijing Kexing Zhongwei Company in the 3-17 age group. How many doses of COVID-19 vaccine for children? How safe and effective is the vaccine in people aged 3-17 years? These questions can be answered in the clinical trial research of the COVID-19 vaccine.
The study is a clinical trial conducted in healthy children and adolescents aged 3-17 years in Zanhuang County, Hebei Province, China.
According to the study, from October 31 to December 2, 2020, 72 subjects were included in the phase I clinical study; from December 12 to December 30, 2020, 480 subjects were included in the phase II clinical study Clinical research. The subjects were injected intramuscularly twice with vaccine (1.5μg/dose or 3μg/dose) or control substance on day 0 and 28 respectively. In previous studies on adults aged 18-59 and people over 60 years of age, Kellyford has evaluated the immunological effects of two doses of different doses of vaccine (including 3 doses of 1.5 µg, 3 µg or 6 µg). The research results support the choice. A 3µg dose of vaccine was used for follow-up studies.
The safety results of the paper showed that among 550 subjects who received at least one dose of test vaccine or control, the incidence of adverse reactions in the 1.5ug vaccine group, 3ug vaccine group and control group from the start of vaccination to the second dose within 28 days after vaccination They were 26% (56/219), 29% (63/217) and 24% (27/114). Most adverse reactions were mild or moderate in severity, and pain at the injection site (13%, 73/550) was the most common symptom. As of June 12, 2021, only one serious adverse event had been reported in the control group, which was not related to vaccination.
The immunogenicity results of the thesis showed that 100% of the subjects in the 1.5 µg vaccine group and 3 µg vaccine group in the phase I clinical trial had a positive conversion of neutralizing antibodies against SARS-CoV-2 after 28 days of full vaccination; 1.5 µg vaccine group and 3 µg vaccine group The geometric mean GMT titers of neutralizing antibodies in the vaccine group were 55 and 117, respectively. Compared with the 1.5 μg vaccine group, the 3 μg vaccine group detected a stronger immune response. In the phase II clinical trial, the positive conversion rates of neutralizing antibodies against SARS-CoV-2 in the 1.5 µg vaccine group and 3 µg vaccine group were 97% and 100%, respectively; the immune response of the 3 µg vaccine group was still higher than that of the 1.5 µg vaccine group (GMT was 142, respectively). And 86).
The study pointed out that the immune response of children and adolescents was higher than the results of the study 28 days after 18-59-year-old adults and 60-year-olds and older people received two doses of 3ug vaccine following the same immunization schedule (GMT 44 and 42 respectively). Age plays an important role in vaccine-induced antibody response, and in some other vaccines, it has also been shown that the antibody response decreases with age.
Further analysis of age groups showed that there was no significant difference in immune response between different ages. After 3-5 years old, 6-11 years old and 12-17 years old subjects received 1.5µg and 3µg doses of vaccine, the positive conversion rate can reach 93% and above (GMT 78-146); at the same time, except for stage I 12 Except for the -17-year-old population, the GMT of subjects in other age groups was better than 1.5 µg vaccine after being vaccinated with 3 µg dose of vaccine.
Based on the above results, the author suggests that children and adolescents aged 3-17 years will use the vaccine at a dose of 3 µg in future studies.
The study also has some limitations. The paper pointed out that the T cell response plays an important role in the COVID-19 infection. Although the T cell response has been explored in other related studies, this study did not evaluate it. The number of subjects in this study is small, and all subjects are Han nationality. It is necessary to carry out larger-scale studies involving multi-ethnic populations in other regions. Although the study will follow up subjects for at least one year, long-term safety and immune response data are not yet available. Finally, due to the small number of subjects in this study, strong statistical conclusions cannot be drawn, so the interpretation of the results should be cautious.
(source:internet, reference only)