The preventive effect of Moderna vaccine is 94%

Verification Advisory Group by the MFDS, "Acknowledged Safety and Validity" The Central Pharmaceutical Affairs Review Committee meets on the 13th

The MFDS' verification advisory group, consisting of outside experts, has recognized the prevention effect of Moderna COVID-19 vaccine for permission.

 

The Central Pharmaceutical Affairs Review Committee, a court advisory body, will seek permission advice on the Moderna COVID-19 vaccine on Wednesday.

 

COVID-19 vaccine safety and effectiveness verification advisory group by the MFDS held a meeting on the 9th and made this decision.

 

The meeting of the verification advisory group is one of the procedures in which the MFDS collects advice from experts in various fields, including clinical, non-clinical, and quality, prior to consulting the Central Pharmaceutical Affairs Review Committee.

 

At the meeting, the verification advisory group judged on the effectiveness of the Moderna vaccine, "The submitted data confirmed the effectiveness 14 days after the second dose of 18 years of age or older, so preventive effects for permission can be recognized." In addition, safety profiles were judged to be acceptable in clinical trials.

 

They also said that it is reasonable to additionally observe abnormal cases that occurred during clinical trials through the "risk management plan" to secure safety after permission, and collect and evaluate information.

 

In clinical trials, the Moderna vaccine was evaluated for its preventive effectiveness in 28,207 people (14,134 in vaccine groups and 14,073 in control group) who did not contract COVID-19 before administering a vaccine or control drug (0.9% in physiological saline).

 

Since the 14th day of the second dose of the vaccine, 11 people have been confirmed with COVID-19 and 185 controls, showing 94.1% prevention effect, and more than 86% prevention effect regardless of age or presence of underlying disease.

 

In addition, there were 31 cases of severe death due to COVID-19 in the control group (30 confirmed severe cases and 1 death) and none in the vaccine group.

 

In the case of "Neutralizing antibodies," which can be combined on the surface of the COVID-19 virus particle to neutralize the infection of the virus, the "seroconversion rate," which means the proportion of people who have more than quadrupled since the second dose, was 100%.

 

Of the 33,351 people eligible for clinical trials, 1.0% (147 people) of the vaccine group and 1.0% (153 people) of the control group reported "significant abnormal cases." There were nine cases of significant drug-abnormal reactions (including facial welling, nausea, vomiting, rheumatoid arthritis, autonomic nervous system imbalance, peripheral oedema, dyspnoea, and small B-cell lymphoma).

 

However, most of them were recovering at the time of submitting clinical trial data.

 

The MFDS plans to hold a Central Pharmaceutical Affairs Review Committee on the 13th to receive permission advice.

 

The results are expected to be released later in the day.