[사회][현장영상] “Pfizer vaccine is valid for administration over 16 years of age”

[앵커]

The Ministry of Food and Drug Safety, which is in the process of approving Pfizer’s COVID-19 vaccine, announced the results of the first verification advisory group meeting.

This is the first stage of the three-stage external expert meeting for vaccine approval, and the results of discussions on the safety and effectiveness of Pfizer vaccines will be presented.

Let’s listen to the presentation.

[김상봉 / 식약처 바이오생약국장]

It was mild to moderate and disappeared within a day or two after it occurred. Systemic reactions were mostly mild to moderate in the order of fatigue, headache, muscle pain, chills, joint pain, and fever, and also started within 2-3 days after vaccination and disappeared within a day.

Most of the systemic reactions were incidence and severity higher in the younger age group than in the older age group, and overall incidence and severity increased after the second dose than the first dose.

Unexpected adverse events related to vaccine administration, evaluated in a total of 37586 people, occurred in about 20.8% of the vaccine group, and the main symptoms were injection site pain, fever, fatigue, chills, headache, and muscle pain.

There was one drug-related hypersensitivity reaction in the vaccine group, and no drug-related anaphylactic reaction was reported during the clinical trial. In addition, serious adverse events were reported in 0.6% of the vaccine group and 0.5% of the control group out of 43,448 registered subjects in the clinical trial, but serious adverse drug reactions that cannot be excluded from the vaccine administration include shoulder wounds related to vaccine administration. It was a case.

This is an evaluation of effectiveness and safety for 16 and 17 years old. As a result of evaluating the preventive effect and safety of adolescents aged 16 and 17, there were no cases of COVID-19 infection in both the vaccine group and the control group.

Adverse events were fever, pain at the injection site, chills, and headache, similar to those reported in other age groups, namely 18 to 55 years old, and over 56 years of age, and there were no serious adverse drug reactions.

The contents and results of the advisory. Adequate dose for 16 to 17 years old. We asked if it would be appropriate to include in the age of administration for 16 and 17 years old.

The verification advisory group is designed to confirm the safety and effectiveness of clinical trials in subjects over 16 years of age, confirming the preventive effect, points that it is judged that the immune response of adolescents aged 16 to 17 will not be different from those of adults, and clinical trial data of adults Considering the availability of and the fact that a number of countries such as the United States, Europe, the United Kingdom, and Japan have allowed them to be 16 years of age or older, they were opinions that it would be appropriate to permit them to those aged 16 or older.

This is an overall view of safety. Regarding abnormal cases that occurred in clinical trials, the verification advisory group suggested that the stability profile, that is, the tendency, was judged to be acceptable in clinical trials, but that careful monitoring after vaccination was necessary for those with a history of anaphylaxis.

This is an overall view of the effectiveness of the vaccine. Regarding the preventive effect of the vaccine, the Verification Advisory Board determined that the effect was confirmed in the submitted data, and the immune response was maintained higher than that of the plasma antibody of the natural infection cure, so the preventive effect was sufficient.

※’Your report becomes news’ YTN awaits your valuable report.
[카카오톡] Search YTN to add a channel [전화] 02-398-8585 [메일] [email protected] [온라인 제보] www.ytn.co.kr

[저작권자(c) YTN & YTN plus 무단전재 및 재배포 금지]