5-11 years of age vaccinated the vaccine is available 19 Corona received a national license.
KFDA (hereinafter sikyak destination) is Pfizer Pharmaceuticals Korea is a 5-11 flushing corona virus 19th, Komi Recanati share 0.1mg / mL (5-11 flushing), a permit application to imports two authorized 23rd.
Komi is the main Recanati 0.1mg / mL (5-11 flushing) mRNA vaccine is the development in Germany and the United States, Pfizer Bio Entech joint income and Pfizer Korea. And inoculated twice at 3 week intervals, in the case of immunocompromised children with severe after the second immunization may be given after the third four weeks.
Prior sikyak destination is authorized, Komi Recanati week (March 5 approval, more than 12 years, used to dilute, 30㎍ administration in 2021), “Cormier Recanati share 0.1mg / mL ‘(January 2022 the 28th license, 12 years old, not used immediately, 30㎍ administration) with an effective ingredient (land Tokoname is not diluted) is gateuna usage, the capacitance is different. Take the US ‧ ‧ EU UK ‧ ‧ Switzerland ‧ Australia, Canada and 62 countries in the permit or authorization to use emergency vaccination being used in the corona prophylaxis in children aged 5-11.
The vaccine can be used for the injection liquid is diluted with sodium chloride injection solution (1.3mL) per 1 vial (1.3mL) to use it diluted in 0.9% sodium chloride injection to 10 people, and is administered to 0.2mL per 1. The amount of the active ingredient of a single dose (Tokoname land section) is one-third of the 10㎍ existing Cormier Recanati state and Cormier Recanati main 0.1mg.
I can not better describe the adverse reactions because the children, it is important that careful observation of the parents and institutions. The choeeunhwa Seoul National University School of Medicine Department of Pediatrics, Professor for “The vaccine will be vaccinated at least after the reaction must be guided so that parents can observe,” he said “there child hurts a head, etc., or is reported fatigue, fever, a very rare attack two days should be closely monitored, “he said.
Another “not recommended for national vaccine and simultaneous immunization. If the situation does not have a national immunization is highly recommended to observe the reaction is not more than 19 after the corona vaccination, to get around well, “he added.
In the past year 12 January 2021, Pfizer Pharmaceuticals Korea is a place sikyak clinical trials for children 5-11 years of age related to “Komi Recanati share 0.1mg / mL ‘targeting approximately 3,000 people in four countries, including the United States and the result apply for a review of prior-quality materials and the like, and on February 4 this year, the Marketing authorization application.
In clinical trials the overall safety information when evaluating compare the safety targets aged 5-11 people 3109 was similar to the 16 to 25 years (1,064 people). The main case was over, including injection site pain, fatigue, headache, injection site redness, swelling, muscle aches, chills, symptoms were reported missing within three days after a mostly mild to moderate in level.
However, injection site redness, swelling is was shown in more than 16 to 25-year-old case of ‘voluntary’ 5-11 years of age (26.4%) were aged 16-25 more than doubled compared to (10.3%), followed, swelling Figure 5-11 in years to 20.4% compared to 11.4% from 16 to 25 years old were twice as close.
Or more cases were confirmed to have not occurred had natjiman did not receive much more in the second than the first dose vaccination deaths, myocarditis and pericarditis, including anaphylaxis, or more serious drugs such as hospitalization or death associated with drug response.
In the corona 19 preventive effects of vaccination were compared with the second vaccination one month time to complete 5-11 years old and 16-25 years old in the immune response after neutralizing antibody appeared to have been proven both percentage and serum reactivity effects.
Further corona 19 1968 people not infected with (test group 1305 people, the control group 663 patients) secondary inoculation complete targeting a result of analyzing the protective effect after 7 days, the prevention effect of the vaccine was 90.7%. In the group who received the vaccine in three, and the control group occurred self diagnosis corona 19 16 people.
Sikyak wife said that a comprehensive review of the consultation, including the results of the examination and the Central Pharmaceutical Committee (Central yaksim) for the Komi State Recanati 0.1mg / mL (5-11 flushing), confirm the effectiveness and safety of its products.
Experts can recognize the safety and effectiveness identified in the clinical trial data from the central yaksim, medication error prevention plan for the overall safety plan and 5-11 years was deemed appropriate. He also observe the safety for the like did not occur in clinical trials after approval to “risk management plan” preventive dimension, myocarditis, pericarditis, and decided to collect and evaluate over cases arising from use after clinical trials and approval of progress.
Sikyak put forward the “Komi Recanati share 0.1mg / mL (5-11 flushing), manufactured by the manufacturer of the manufacturing units. Will check one more time analyzing test results and the quality of direct national certification examination shipment approvals.