Provided by the Association of American Medical Colleges (AAMC)
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The Ministry of Food and Drug Safety’s new coronavirus infection (COVID-19, Corona 19) vaccine safety and effectiveness verification advisory group evaluated on the 23rd that the Pfizer vaccine’Cominatiju’ in the United States has “sufficient preventive effect”. It is considered that there is sufficient preventive effect for adolescents aged 16-17 and the elderly over 65 years old. In fact, it was judged that there was a preventive effect for all age groups over 16 years old.
However, vaccination was not recommended for those under 16 years of age. The evidence suggests that the clinical trial did not include age groups under 16 years of age. Pfizer’s vaccine has conducted phases 1, 2, and 3 of multinational clinical trials conducted in six countries including the United States, Brazil and Germany. The number of clinical subjects was 43,445, and the average age was 50. Among them, the preventive effect was evaluated in 3,6523 people who had not been confirmed to be infected with Corona 19 7 days prior to 7 days after receiving the vaccine or placebo twice, with 8018 people aged 65 years old, 390 people aged 16-17 years old, and the remaining 18. It was made up of adults over the age of three. There is no under 16 years old.
Most of the vaccines that have obtained urgent use approval or are undergoing approval procedures worldwide, including Korea, such as Modena and AstraZeneca, were clinically tested in adults over the age of 18. The reason is safety. In the case of genetically susceptible children, the vaccine can cause a distressing reaction, so safety cannot be guaranteed. Cody Meissner, a pediatric infectious disease specialist at Tufts Children’s Hospital, told USA Today in October that “if I was a member of the Food and Drug Administration (FDA), I would not approve clinical trials in children until the safety of the vaccine is proven.”
In the case of children and adolescents with Corona 19, there are many analyzes that there are few cases of infection or serious symptoms. As of the 23rd, the number of cumulative corona 19 confirmed cases in Korea was 86,801. Among them, 5883 confirmed patients aged 10-19 years old and 3530 patients aged 0-9 years. Those between the ages of 20 and 60 account for more than 75% of the cumulative domestic cases. There are no cases of death or death among confirmed patients aged 0-19. There are various analyzes, such as an analysis by a research team at Massachusetts General Hospital in the United States on the 22nd that antibodies that respond to illness are different between children and adult patients with COVID-19.
However, as vaccine safety for adults has been proven to some extent, vaccine pharmaceutical companies in countries are expanding the targets of clinical trials. According to Israeli local media such as Winet News on the 19th (local time), the Israeli Ministry of Health has allowed children under the age of 16 who have not yet obtained clinical data for the past few weeks to receive the Corona 19 vaccine. Under the approval of the Ministry of Health, about 100 adolescents and children under the age of 16 who received the Corona 19 vaccine. AstraZeneca also announced on the 13th (local time) that it plans to start a clinical trial for the Corona 19 vaccine in about 300 volunteers aged 6 to 17 years old.
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