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China approved SINOPHARM COVID-19 vaccines for 3-17 year old teens
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China approved SINOPHARM COVID-19 vaccines for 3-17 year old teens.
A few days ago, after a demonstration organized by the relevant departments of the joint prevention and control mechanism of the State Council of China, the new coronavirus inactivated vaccine of the Beijing Institute of Biological Products of Sinopharm Group was approved for emergency use in people aged 3-17.
What are the phase I and phase II clinical trial data of the COVID-19 vaccine for people aged 3-17 years?
Are there any adverse reactions after vaccination?
What do people of this age need to pay attention to when vaccinating the COVID-19 vaccine?
A reporter from Central Broadcasting Corporation of China Central Television interviewed Zhang Yuntao, chief scientist and vice president of SINOPHARM Group China Biotechnology.
Zhang Yuntao, chief scientist and vice president of SINOPHARM Group China Biotechnology.
Carry out expanded clinical trials for people aged 3 to 17 years old, and the test data showed that the safety and immunogenicity meet the expected requirements
Zhang Yuntao, chief scientist and vice president of Sinopharm China Biotech, told reporters from Central Taiwan that after the conditional marketing approval of Sinopharm’s China Bio-COVID-19 Inactivated Vaccine, after adult use, it continued to carry out expanded clinical trials for people aged 3 to 17 years old.
Zhang Yuntao: We subdivided the 3-17 years old age group into three age groups, 3-5 years old, 6-12 years old, and 13-17 years old, and systematically conducted safety and immunogenicity observations at the Henan site.
According to Zhang Yuntao, from the Phase I/II clinical trials completed in Henan by Sinopharm’s China Bio-COVID-19 Vaccine Group 3-17 years old, the positive conversion rate of neutralizing antibodies for the 3-17 year olds after immunity was 100%, and the neutralizing antibodies were as good as There was no significant difference in the positive conversion rate compared with the adult group, and no serious adverse reactions were seen.
Zhang Yuntao: Judging from the data we have observed, the security data meets the expected requirements and is relatively good. Compared with the adult group, there is no increased safety risk. In terms of immunogenicity, compared with the adult group and the elderly group, it also meets the requirements. Therefore, the data formed during the first and second clinical studies prove that the vaccine can be used in the age group of 3 to 17 years old.
Zhang Yuntao told the Central Broadcasting Corporation reporter that the experiment for the 3-17-year-old population was carried out in an orderly manner according to the age group from older to younger. The purpose of this was to ensure the safety of the experimental population of this age group. “In fact, when we did this experiment, we started doing it at the age of 13-15, then pushed it down to 6-12 years old, and then pushed it down to 3-5 years old in order to ensure safety.”
China’s COVID-19 inactivated vaccine is officially approved for emergency use in people aged 3-17
On June 6, the immuno-bridging clinical trial of the COVID-19 inactivated vaccine developed by the Beijing Institute of Biological Products of Sinopharm Group in the 3-17-year-old group was launched in Abu Dhabi, UAE, evaluating 900 people of different nationalities aged 3-17 Immunogenicity and safety after vaccination in healthy people. Zhang Yuntao said that overall data shows that the security is relatively high.
Zhang Yuntao: Only when the domestic and foreign test data show good safety and the immunogenicity also meets the expected requirements, we will report to the drug regulatory department. The relevant departments of the joint prevention and control mechanism have undergone strict expert approval and defense based on our data. Now Finally approved the emergency use of the COVID-19 vaccine for this age group.
In the interview, Zhang Yuntao mentioned many times that children and adolescents are the key populations for the construction of immune barriers, and the safety of vaccines is the most important consideration in clinical trials for such populations. This is why the COVID-19 in the 3-17 age group The reason for the “final” of the vaccine.
Zhang Yuntao: During the growth and development of adolescents, people aged 3-17 years have a process of gradual improvement of the immune system. Only after the safety and effectiveness of the vaccine are verified by adults and the elderly, will it be considered for promotion to children and adolescents. This practice is actually a responsible attitude. Vaccines from foreign manufacturers also use this technical route.
What should people pay attention to when vaccinating the COVID-19 vaccine for 3-17 years old?
Generally speaking, the requirements for the injection of the COVID-19 vaccine for the age group of 3-17 years are exactly the same as the instructions for the injection of the vaccine for the age group over 18 years.
For example, there are 16 cautious use, etc., people of this age group can use it normally according to the instructions. Zhang Yuntao said, “As long as the requirements are met, I think they can be vaccinated. There are no special requirements.”
This time, the new coronavirus inactivated vaccine of SINOPHARM Beijing Institute of Biological Products was approved for emergency use in people aged 3-17. Zhang Yuntao said that the vaccine is expected to be officially launched in one year.
(source:internet, reference only)