Adverse reactions in the elderly are lower than in the adult group
Conditional permission recommendation for all age groups, including the elderly
Some people in the medical world say, “Elderly people should get the Pfizer vaccine.”
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The vaccine advisory group for the novel coronavirus infection (Corona 19) recommended conditional approval of the AstraZeneca vaccine, and said that the vaccine should be given to the elderly over the age of 65. There is controversy about the efficacy of the AstraZeneca vaccine in the elderly, mainly in some European countries, but experts gathered opinion that “the administration of the elderly cannot be excluded just because there are few elderly participants in the clinical trial”. It was important to judge that the preventive effect was confirmed in all subjects including 65 years of age or older. However, some in the medical community have argued that the elderly should be vaccinated with Pfizer Moder or vaccines, which are known to be effective and safe.
According to the Ministry of Food and Drug Safety on the 2nd, the’Corona 19 Vaccine Safety and Effectiveness Verification Advisory Panel’ announced the results. The advisory group recommended vaccinations for 65-year-olds, and said, “It is possible to authorize interim analysis data on ongoing clinical trials in the United States after approval.” After consulting, the vaccine will be approved for domestic vaccination.
The advisory group noted that the results of clinical trials confirmed the preventive effect in all subjects, including those over 65 years old. A clinical trial of 8,895 adults over 18 years of age confirmed 62% of the preventive effects. This is a result that satisfies ‘50% or more’, the standards of the World Health Organization (WHO), etc. related to the evaluation of the effectiveness of the Corona 19 vaccine. The’neutralizing antibody’, which binds to the surface of virus particles and induces a preventive effect, increased 8.5 times (compared to pre-administration) after the vaccine was administered twice.
It is believed that the effectiveness and safety have been proven even for the elderly. The’binding antibody value’, which indicates the amount of antibody that binds to the corona 19 virus antigen, was higher in the elderly at 100% of the elderly compared to 99.3% of adults. The incidence of adverse events was similar to or lower than that of the adult group. Of the 23,745 patients who participated in the four clinical trials examined by the advisory group in the safety evaluation, 8.9% (2,109 patients) were aged 65 or older. Of the 8,895 patients who participated in the clinical trial that confirmed the effectiveness, 7.4% (660 patients) were 65 years or older. As the number of elderly people who participated in clinical trials is small, as in some European countries, vaccination should be restricted to elderly people. According to the European Medicines Agency’s licensing system, member states are subject to the European Medicines Agency’s licensing requirements.” However, the advisory group did not recommend administering the vaccine to pregnant women, and suggested that nursing mothers state in the approval matters that the effect of the vaccine on breastfeeding was unknown.
Unlike the advisory group, some of the medical community said that it should be prudent to inoculate the AstraZeneca vaccine to the elderly. Chairman of the Korean Medical Association, Choi, argued, “Elderly people should get the Pfizer Modena vaccine, which has proven to be the most effective, as it is highly likely to become severe when infected with Corona 19.” Kim Woo-joo, a professor at Korea University’s medical school, also said, “The elderly who participated in the clinical trials are insufficient.
The government has opened up the possibility of changes to future vaccination plans. Director Kim said, “We have not concluded or agreed on the administration of the elderly,” and said, “We will make a final decision after reconsideration at the Central Pharmacy Review Committee (second reviewer).” The next advisory, the Central Pharmacy Review Committee, will be held on the 4th and the results will be released on the same day.
Meanwhile, Jung Eun-kyung, head of the Central Defense Countermeasures Headquarters, said at a briefing the day before, “1.25 million batches of the individual contracts with AstraZeneca will be supplied in February.” I’m holding it.” In addition, the government has decided to import Pfizer’s Corona 19 vaccine specially to be administered to medical staff. In the case of special importation, vaccination is possible without permission from the Food and Drug Administration. General Manager Jung said, “117,000 doses of Pfizer vaccine (about 60,000 people) will be delivered after mid-month through COVAX Facility,” he said. “This vaccine will be given priority to medical staff treating corona19 patients.”
/ Reporter Woo Young-tak [email protected]
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