Janssen vaccine was confirmed to maintain an immune response

Immune response is maintained for up to 12 weeks after one vaccination, severe preventive effect 85.4% after 28 days

The COVID-19 vaccine license verification advisory group composed of external experts recognized the preventive effect of Janssen's COVID-19 vaccine.

 

Janssen vaccine was confirmed that the immune response was maintained for up to 12 weeks with only one administration.

 

The COVID-19 vaccine safety and effectiveness verification advisory group held a meeting on the 28th and made such a conclusion about the clinical trial results of Janssen's COVID-19 vaccine.

 

Six people including infectious medicine specialists, vaccine specialists and clinical statistics specialists attended the conference.

 

In the data submitted on the preventive effect of the vaccine, the advisory group confirmed the effect 14 days and 28 days after one dose of 18 years of age or older, and the immune response (conjugated antibody and neutralizing antibody) is maintained for up to 12 weeks.

 

It was judged that the preventive effect was acceptable.

 

The advisory group determined that the safety profile in the clinical trial was acceptable in relation to the abnormal case that occurred in the clinical trial, and additionally observed the abnormal cases that appeared during the clinical trial through the 'risk management plan' after approval.

 

They expressed the opinion that it is reasonable to collect and evaluate information.

 

Clinical trial data submitted to the MFDS include 1 clinical trial conducted in the United States and Belgium (Phase 1 and 2), 1 case in Japan (Phase 1), 1 case in multi-country such as Germany (Phase 2), and 8 countries including the United States ( Phase 3) was conducted in a total of 4 cases, including one multinational clinical trial, and safety and effectiveness were evaluated through a phase 3 clinical trial conducted in the United States.

 

As a result of the efficacy evaluation, after 14 days of vaccine administration, 116 people in the vaccine group and 348 people in the control group showed a preventive effect of about 66.9%, and after 28 days, 66 people in the vaccine group and 193 people in the control group showed about 66.1.

 

% Of the preventive effect was shown.

 

After 14 days of vaccine administration, there was a prophylactic effect of more than 60% regardless of age and underlying disease.

 

In addition, about 76.7% of the vaccine group 14 people and 60 control people after 14 days of vaccine administration, about 85.4% of the vaccine group after 28 days of vaccine administration, and 34 control people.

 

In the case of the binding antibody that binds to COVID-19 antigen, the serum conversion rate was 95% or more, in which the antibody value increased by more than 4 times from 4 weeks after the vaccine was administered compared to before administration.

 

In the case of neutralizing antibody, which can induce a preventive effect by binding to the surface of virus particles and neutralizing the infectivity of the virus, the serum conversion rate after one vaccine administration was more than 90%.

 

Of all 43,783 subjects enrolled in the clinical trial, significant adverse events were reported in 0.4% (83) of the vaccine group and 0.4% (96 people) of the control group, and significant adverse drug reactions that cannot be excluded from being related to vaccine administration were brachial neuromyositis, Guillain-Barre syndrome, pericarditis, brachial neuromyositis, post-inoculation syndrome, hypersensitivity reaction in 1 each, and facial paralysis in 2 cases.

 

However it was recovering at the time of submission of clinical trial data.

 

The MFDS is planning to conduct another expert review by holding the Central Pharmaceutical Affairs Review Committee, a legal advisory body, on April 1, combining the results of this review.

 

The results will be released in the afternoon of the day.