Janssen Vaccine Approval... "66.9% Effectiveness 14 Days After Single Dose"

Illustration of Janssen (a subsidiary of Johnson & Johnson) COVID-19 vaccine [Image source=AFP Yonhap News]

[Asia Economy Reporter Chunhee Lee] Janssen (a subsidiary of Johnson & Johnson)'s COVID-19 vaccine has received product approval from the Ministry of Food and Drug Safety (MFDS). It is the third vaccine to be approved after AstraZeneca and Pfizer, and is expected to be a vaccine completed with a single dose.

On the 7th, the MFDS announced, "A final review committee including external experts was held, and product approval was granted for the COVID-19 vaccine ‘COVID-19 Vaccine Janssen’ imported by Janssen Korea, which applied for product approval on February 27, on the condition of submitting the final clinical trial report."

Previously, the MFDS received advisory opinions from the verification advisory group on the 29th of last month and the Central Pharmaceutical Affairs Deliberation Committee on the 1st. The final product approval was decided at today's meeting, the last stage of the approval review process. The meeting held this morning was attended by three external experts including Oh Il-hwan, chairman of the Central Pharmaceutical Affairs Deliberation Committee, and five internal members including the MFDS director.

The Janssen vaccine is a viral vector vaccine developed by Janssen in the United States. It recombines the COVID-19 surface antigen gene and inserts it into a human adenovirus, which is injected into the body to synthesize antigen proteins, and these proteins induce the production of neutralizing antibodies that neutralize and eliminate the virus when the COVID-19 virus invades the human body.

The MFDS decided the dosage and administration of the Janssen vaccine as 0.5 ml, single dose. Previously approved AstraZeneca and Pfizer vaccines require two doses at intervals, and other vaccines scheduled for domestic introduction such as Novavax and Moderna were also developed as two-dose vaccines. The efficacy and effectiveness are for the prevention of COVID-19 in individuals aged 18 and older, and the storage condition was set at -25 to -15 degrees Celsius for 24 months.

The Janssen vaccine is the third vaccine approved domestically and has received conditional approval or emergency use authorization from three countries including the European Medicines Agency (EMA), the United States, Switzerland, and the World Health Organization (WHO).

Shows 66.9% preventive effect after 14 days, 66.1% after 28 days

Janssen (a subsidiary of Johnson & Johnson) COVID-19 vaccine
[Image source=Reuters Yonhap News]

The final review committee judged that most of the reported adverse events related to safety were expected adverse events related to vaccine administration and were generally favorable.

Commonly reported adverse events included injection site pain, headache, fatigue, and muscle pain, with symptoms mostly mild to moderate and recovering within 2 to 3 days after vaccination.

Among all 43,783 registered subjects in the clinical trial, serious adverse events were reported in 0.4% (83 people) of the vaccine group and 0.4% (96 people) of the control group. Among these, seven cases of ‘serious adverse drug reactions’ that could not exclude a causal relationship with vaccine administration were reported: brachial neuritis, Guillain-Barr? syndrome, pericarditis, post-vaccination syndrome, hypersensitivity, and two cases of facial paralysis. However, most of these were recovering at the time of clinical trial data submission.

The final review committee also recognized the vaccine’s preventive efficacy. In a multinational clinical trial conducted in the United States and other countries involving 39,321 people aged 18 and older, 116 confirmed COVID-19 cases occurred in the vaccine group and 348 in the control group after 14 days, showing a 66.9% preventive effect. After 28 days, 66 cases in the vaccine group and 193 in the control group showed a similar preventive effect of 66.1%.

The final review committee stated, "The overall safety assurance measures are appropriate," but added, "After approval, through a ‘Risk Management Plan,’ safety will be continuously monitored for tinnitus, cerebral venous sinus thrombosis, and other issues, and adverse events occurring in ongoing clinical trials and post-approval use will be continuously collected and evaluated."

This content was produced with the assistance of AI translation services.