Janssen vaccine domestically approved for’one shot’… the timing of introduction and vaccination is undecided

The Janssen vaccine, which only needs to be hit once, has been approved for use in Korea. ‘Covid-19 vaccine Jansenju’ (Jansen), a novel coronavirus infection (Corona 19) vaccine of Johnson & Johnson (Jansen) in the U.S. under the condition that the Ministry of Food and Drug Safety (Ministry of Food and Drug Safety) submits a report on the final results of clinical trials, etc. I decided to approve the item. It is expected to enter Korea in the second quarter (April-June), but the timing of its introduction has not been confirmed.

On the 7th, the Ministry of Food and Drug Safety held a final inspection committee in which the chairman of the Central Pharmacist Review Committee Yoo-hwan, Kim Kang-lip, and external experts participated and made this decision. Janssen officially applied for permission to import items on February 27th.

Janssen recombines the surface antigen gene of the Corona 19 virus with a viral vector vaccine, puts it in a human adenovirus template, and injects it into the body. Through this, antigenic proteins are synthesized, and these proteins induce the production of neutralizing antibodies, thereby neutralizing and removing the virus when the Corona 19 virus enters the human body. It is the same method as the AstraZeneca (AZ) vaccine that is being vaccinated in Korea.

Janssen is the third approved vaccine in Korea. It has received conditional approval or emergency use approval from 35 countries including Europe (EMA), the United States, Switzerland, and the World Health Organization (WHO).

A permit has been issued that it can be vaccinated in Korea, but it is not known when domestic vaccination will be possible. The government initially announced that 6 million Janssen vaccines would be introduced within the second quarter, but the timing of introduction is still undecided. At a briefing on the day of the promotion team, Bae Sang-taek Bae, head of the situation general manager of the Corona 19 Vaccination Promotion Group, said, “To pull out the fact that the amount of introduction has not been confirmed in the second quarter, a vaccine introduction TF (Task Force) was created within the government, and the Ministry of Health and Welfare and related ministries We are working hard. If there is any further progress, I will tell you. I will introduce it as soon as possible.”

In order to introduce a safe vaccine, the Ministry of Food and Drug Safety is operating a triple advisory procedure for the COVID-19 vaccine safety and effectiveness verification advisory group, the central pharmacist review committee, and the final inspection committee. There has been an opinion that product approval is possible.

The’Corona 19 Treatment/Vaccine License Examination Team,’ composed of experts in each field within the Ministry of Food and Drug Safety, intensively reviewed the data necessary for approval, such as non-clinical, clinical, and quality. Non-clinical examination review includes efficacy tests (viral neutralizing potency, immune response, symptoms, etc.) to determine the effectiveness of vaccines in animals, pharmacokinetic tests to determine drug distribution, and toxicity tests to confirm drug toxicity (repeated dose toxicity, reproductive toxicity). Etc.).

Clinical trial review was conducted in one clinical trial conducted in the United States and Belgium (Phase 1 and 2), 1 case in Japan (Phase 1), 1 case in multiple countries (Phase 2) such as Germany, and 8 countries (Phase 3) including the United States. A total of 4 cases, including one multinational clinical trial, were reviewed, and safety and effectiveness were evaluated through phase 3 clinical trials conducted in the United States and other countries.

The Ministry of Food and Drug Safety said that prevention of COVID-19 is the efficacy and effectiveness of the vaccine for those over 18 years of age. As with the results of the previous two consultations, the Final Inspection Committee also decided that the vaccine prevention effect was acceptable and recommended that long-term immunogenicity be monitored.

As a result of clinical trials, after 14 days, 116 patients in the vaccine group and 348 people in the control group occurred after 14 days, showing 66.9% of the preventive effect, and after 28 days, 66 people in the vaccine group and 193 people in the control group, 66.1% of the cases. Showed the effect. This is the result of a multinational clinical trial conducted in the U.S. and the like, evaluating 39321 people aged 18 years or older (19,630 vaccine groups, 19,691 controls) who were negative for the corona19 virus.

The Janssen vaccine has a dose of 0.5 mL and the inoculation mode is one inoculation. Storage conditions are at -25~15℃ for 24 months.

The final review committee determined that most of the reported adverse events related to vaccine stability were predicted adverse events due to vaccine administration, and were generally good. After vaccination, more than 10% of the most common abnormal cases were injection site pain, headache, fatigue, and muscle pain, and most of the symptoms were mild to moderate and recovered after 2 to 3 days after vaccination.

Of all the 43,783 patients enrolled in the clinical trial, only 0.4% (83 patients) in the vaccine group and 0.4% (96 patients) in the control group reported’significant abnormalities’. Among them,’significant adverse drug reactions’ that cannot be excluded from vaccine administration are Guillain-Barre syndrome (a nervous system disease that causes paralysis by destroying peripheral nerves by antibodies in the body due to infection), pericarditis, brachial neuritis, and after vaccination. There were 7 cases including syndrome, hypersensitivity reaction (1 case each), and facial paralysis (2 cases). It is said that most were recovering at the time of submission of clinical trial data.

The final inspection committee decided to continue to observe safety such as tinnitus and sinus thrombosis through the’Risk Management Plan’ even after approval, and to collect and evaluate abnormal cases arising from clinical trials in progress and use after approval.

Reporter Lee Tae-yoon [email protected]