5-11 years old Corona 19 vaccine vaccination “Around the first quarter of next year after approval twice”


Pfizer applies for children’s license after undiluted vaccine approval
Quarantine authorities expect around the first quarter of next year… Preparatory work such as profit comparison

On the morning of the 21st, a corona19 test is being conducted at an elementary school in Nam-gu, Gwangju. yunhap news

As schools are repeatedly suspended due to the spread of the COVID-19 epidemic, quarantine authorities are preparing vaccinations for 5-11 year olds. Considering the approval process, the time is expected to be around the first quarter of next year, when the new semester begins. An official from Pfizer Korea told The Hankyoreh on the 22nd, “The approval review for a new formulation for use without dilution over 12 years of age is currently in progress. The Ministry of Food and Drug Safety formally approves vaccines produced overseas after going through the ‘prior review → approval’ process. It was on the 30th of last month that Pfizer applied for an import item license for an undiluted vaccine (cominati 0.1 mg/ml) rather than a conventional vaccine used by dilution. If the Ministry of Food and Drug Safety approves this product, Pfizer is expected to go through the process of changing the license to extend the age of administration to 5 to 11 years old. This is because additional review is required because the dosage is different for 5-11 year olds, such as administering only one-third of the adult dose. The reason that the Ministry of Food and Drug Safety (MFDS) entered into preliminary review of clinical trial data for ages 5-11 from the 1st of this month with Pfizer’s application is interpreted to shorten the approval period. The quarantine authorities expect that official approval will be granted in Korea in the first quarter of next year (January to March), considering that the 5-11 year-olds started vaccinated abroad, such as the United States and Europe, and the Ministry of Food and Drug Safety is reviewing it. However, considering that the Pfizer vaccine is administered twice at three-week intervals and it takes about two weeks for the vaccination effect to appear, in order for students to return to school in March next year, it is arithmetic to require vaccination at the end of January next year. . Pfizer’s COVID-19 vaccine has been approved and approved for use by children in the United States and Europe. The U.S. Food and Drug Administration (FDA) granted emergency use approval at the end of October, and the European Medicines Agency (EMA) also approved vaccination for children aged 5-11 at the end of November. European countries such as Israel and Canada as well as France and Belgium are conducting or preparing to vaccinate 5 to 11 years old. According to the clinical trial data submitted by Pfizer to the European Medicines Agency, vaccination was effective in preventing infection by 90.7%, and common adverse reactions such as pain at the injection site, fatigue, headache, muscle pain, and chills were common, just like those over 12 years of age. In Korea, as the spread of COVID-19 continues, the number of children and adolescents who are not subject to vaccination, such as elementary school students, is increasing. During the week of December 12-18, the number of confirmed cases under the age of 12 was 7,420 (3095 under the age of 6, 4325 between the ages of 7 and 12). Compared to the 3,024 people (1,189 people under the age of 6, 1835 people between the ages of 7-12) from November 21st to 27th, it increased nearly 2.5 times in one month. In the end, the government stopped all schools in the metropolitan area and overcrowded schools in the non-metropolitan area until the winter vacation on the 20th of this month. The Korea Centers for Disease Control and Prevention (KCDC), which administers vaccinations, is preparing Pfizer vaccinations for ages 5-11. According to the contract between the government and Pfizer, the vaccine for use without dilution can be substituted for the amount previously signed, so there is no problem with the supply of vaccines for children. However, they are examining not only the safety of vaccination, but also whether the benefits of vaccination for those aged 5 to 11 outweigh the risks of being infected with COVID-19. By Lim Jae-hee, staff reporter [email protected]


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