[현장연결] Ministry of Food and Drug Safety “Sufficient Pfizer vaccine preventive effect, suitable for adolescents aged 16-17”
The Ministry of Food and Drug Safety is announcing the results of the verification advisory group meeting for Pfizer’s COVID-19 vaccine.
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[김상봉 / 식품의약품안전처 바이오생약국장]
We will explain the progress of Pfizer’s COVID-19 vaccine coma item approval as follows.
The Ministry of Food and Drug Safety held a meeting of the Corona 19 Vaccine Safety and Effectiveness Verification Advisory Committee on Monday, February 22, regarding the results of clinical trials in Pfizer Korea.
The verification advisory group is a procedure for the Ministry of Food and Drug Safety to collect advisory opinions on clinical, nonclinical, quality, and other fields from various experts prior to the consultation of the Central Pharmacy Review Committee. 7 people attended.
Results of clinical trials.
The submitted clinical trial data were two cases: one clinical trial conducted in Germany and one multinational clinical trial conducted in six countries including the United States. The safety and effectiveness were evaluated through multinational clinical trials conducted in the United States.
In clinical trials conducted in the U.S., 43,448 people received at least one vaccine or control drug, with an average age of 50 years old, 49.1% for women, 20.7% for patients with underlying diseases such as lung disease and diabetes, and 34.7 for obesity. %, and 41.1% over the age of 55 were included.
The preventive effect was evaluated in 36,523 people who had not been confirmed to be infected with Corona 19 7 days before the two doses of the vaccine or control drug.
The preventive effect is a comparison and analysis of the proportion of patients infected with COVID-19 in each group from the 7th day after administration of the vaccine or control drug twice.One or more clinical symptoms such as fever and cough are expressed, and the result of the corona 19 virus test is positive. If this was confirmed, the infection was defined as confirmed.
As a result of the evaluation, 8 people in the vaccine group and 162 people in the control group had a preventive effect of about 95%, and showed a preventive effect of more than 94% regardless of age and underlying disease.
In addition, with regard to the severe COVID-19 prevention, one case occurred in the vaccine group, such as a decrease in oxygen saturation, whereas three cases occurred in the control group, showing a tendency to prevent, but the number of occurrences was small, so there was no statistical significance.
Immunogenicity assessment.
As an indirect indicator that can predict vaccine effectiveness, immune responses such as the amount and termination of antibodies produced in the body after vaccine administration were evaluated.
In the case of the conjugated antibody that binds to the Corona 19 virus antigen, compared to before administration, the amount of antibody increased by 4 times or more in all subjects, resulting in a 100% serum conversion rate.
In the case of neutralizing antibodies that bind to the surface of the virus particles and induce a preventive effect by neutralizing the infectivity of the virus, the serum conversion rate was 100% because the antibody increased more than 4 times in all subjects after the vaccine was administered twice.
It is safety.
The predicted abnormal cases after vaccination were investigated in a total of 8,183 people for 1 week after vaccination.
Local reactions were mostly mild to moderate due to pain, swelling and seizures at the injection site and disappeared within a day or two after the onset.
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 to 3 days after vaccination and disappeared within a day.
The incidence and severity of systemic reactions were higher in the younger age group than in the older age group. Overall, the incidence and severity of systemic reactions increased after the second dose than the first dose.
Unexpected adverse events related to vaccine administration, evaluated in a total of 37,586 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 all 43,448 enrolled subjects in the clinical trial, but serious adverse drug reactions that cannot be excluded from vaccine administration include wounds in the shoulder area related to vaccine administration. It was a case.
This is an evaluation of effectiveness and safety for ages 16-17
As a result of evaluating the preventive effect and safety for adolescents aged 16-17 years, there were no cases of COVID-19 infection in both the vaccine group and the control group.
The abnormal cases were fever, pain at the injection site, chills, and headache, similar to those reported in other age groups 18 to 55 years old and over 56 years old, and there was no fever.
These are the contents and results of the advisory.
It is the appropriateness of administration for 16-17 years old.
We asked if it would be appropriate to include in the target age for 16-17 years of age.
The verification advisory group was designed to confirm the safety and effectiveness of clinical trials in subjects over 16 years of age, and the preventive effect was confirmed.
It is judged that the immune response of adolescents aged 16-17 will not be different from that of adults.
Considering the availability of clinical trial data for adults and the fact that many countries such as the United States, Europe, the United Kingdom, and Japan have allowed them to be 16 years of age or older, the opinion was that it was reasonable to authorize those aged 16 or older.
This is an overall view of safety.
Regarding abnormal cases that occurred in clinical trials, the verification advisory board suggested that the safety profile, or trend, was judged to be acceptable in clinical trials, but that careful monitoring after vaccination was necessary for people 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 confirmed the effectiveness of the submitted data and determined that the preventive effect was sufficient as the immune response was maintained higher than the antibody in the plasma of the cure during natural infection.
In addition, the opinion was that it is reasonable to continuously monitor the safety of anaphylaxis and other abnormal cases through the hazard management plan after approval, and to continuously collect and evaluate information about abnormal cases that appeared during clinical trials.
I plan on this week.
The Ministry of Food and Drug Safety examines the quality data related to Pfizer’s coma in Korea, and synthesizes the expert opinions and recommendations obtained through this verification advisory meeting, as well as the review results, which should be considered when applying for safety, effectiveness, and approval The matters, etc., will be consulted by the Central Pharmacist Review Committee, the legal advisory body of the Ministry of Food and Drug Safety, on Thursday, February 25, and the results will be disclosed on Friday, the 26th.
That is all.
Yonhap News TV article inquiries and reports: katok/line jebo23
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