Clinical results for Janssen Vaccine to be submitted

by the end of this year

Pharmaceutical Affairs Review Committee held prior to authorization to respond, potential change of authorization

Members of the Central Pharmaceutical Affairs Review Committee, "Careful monitoring of the effects of underlying patients aged 65 and older on rare thrombosis

If Janssen COVID-19 Vaccine, the third-largest licensed clinical trial in Korea, is completed by the end of this year, the permits will also be subject to change.

 

Janssen COVID-19 Vaccine was approved on April 7 for the prevention of COVID-19 in adults aged 18 and older.

 

However it has not been officially introduced in South Korea yet.

 

According to the Central Pharmaceutical Affairs Review Committee minutes, a court expert advisory body that determines whether Janssen COVID-19 Vaccine is licensed, the company plans to complete two inoculation trials by the end of this year and submit the results to the MFDS.

 

The Central Pharmaceutical Affairs Review Committee meeting was held at 10 a.m.

 

on April 1 at Osong Food and Drug Administration headquarters.

 

During the meeting, the commissioners connected with the company and asked about future plans.

 

The company explained, "Phase 1 and Phase 2 clinical trials are scheduled to be followed for two years, and phase 3 clinical trials plan to further analyze immunogenicity by 18 months." "The immunogenicity subgroup is scheduled to be monitored for 24 months, and the fastest immunogenicity results in Phase III clinical trials are expected to be available in the third quarter of this year," it added.

 

"Although it is difficult to give an accurate answer, it is expected to be possible by this year." Janssen COVID-19 Vaccine designed and conducted clinical trials with the first dose of inoculation, but since the end of last year, phase 3 clinical trials have been underway twice.

 

The vaccination effect was 66% at one time, and it is expected that the effect will increase at the second time.

 

At the meeting, an official from the MFDS replied, "According to the results of the clinical trial of two doses, we can consider changing the permits if necessary." Officials at the Central Pharmaceutical Affairs Review Committee said that it is reasonable to grant permission on the condition that the final results of clinical trials are submitted because the vaccination profit from Jansen vaccine is generally high.

 

Product licensing also followed the Central Pharmaceutical Affairs Review Committee's opinion.

 

There were some concerns about its effectiveness and safety.

 

In terms of effectiveness, the lack of preventive effectiveness and safety in subjects aged 65 and older were about thrombotic risks, such as AstraZeneca vaccines.

 

The Janssen vaccine has a preventive effect of 44% since the 28th for those aged 65 or older.

 

In response, the MFDS said, "Foreign regulators also considered the fact that it was a subgroup analysis, it was difficult to confirm statistically meaningful effects due to the small number of cases in the subgroup, and 0.52% 8 days later." "If there was a risk factor, it was 67% effective in severe patients." "The prevention effect is less than 50% after 28 days in subjects with general risk factors such as high blood pressure," a member said.

 

"The same hypothesis cannot be applied to subgroup analysis, but is the validity of the submitted data appropriate considering that most subjects are risk factors?" In response, the MFDS said it would give conditions to South Koreans after marketing them.

 

He also mentioned the need to strengthen monitoring of thrombosis risks.

 

"CVST (cerebral sinus thrombosis) is a rare disease, but it is a problem because the prevalence rate has increased in Germany, and the incidence rate is very low, so continuous monitoring is needed." Since its approval in Korea, the U.S.

 

has temporarily suspended vaccinations against Janssen due to concerns over side effects such as CVST.

 

However, the EMA and the CDC resumed vaccination, saying that the benefits of vaccination outweigh the risks.

 

The MFDS plans to continue to monitor abnormal reactions such as CVST through a risk management plan after approval.

 

Meanwhile, Janssen COVID-19 Vaccine is the third-largest licensed vaccine in Korea, a viral vector vaccine such as AstraZeneca.

 

Janssen COVID-19 Vaccine is a recombinant viral vector vaccine that utilizes Ad26 as a vector (or carrier) of the genetic code for the SARS-CoV-2 antigen (called the spike protein) to create an immune response.