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Celltrion treatment is enforced without deliberation on mutation side effects

김종찬안보 2021. 2. 11. 21:49
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Although it was confirmed that Celltrion Corona treatment had no therapeutic effect on the South African mutation, the government announced on the 11th that it was forced to supply it.
In the efficacy evaluation conducted by the National Infectious Disease Research Center, the Central Defense Response Headquarters (Daebon Bang) did not go through the review process of the Food and Drug Administration about the result that Celltrion's'Rekironaju' was found to have little neutralizing ability against the South African mutant virus. It was announced on the day that it was decided to take medication upon request of a doctor.
Kwon Joon-wook, head of the 2nd vice president of Bang Dae-bon, said, "(The neutralizing ability of Lekkirona against the South African mutant virus) appeared to be hard to find." "Before the genetic analysis of the confirmed person entering the South African mutant region was confirmed as a South African mutant. Until then, it was formalized in a briefing, saying, "If there is a request from the medical staff, the antibody therapy supply plan"
Director Kwon said, “We plan to recommend restrictions on the use of the antibody treatment to patients with confirmed mutant strains in South Africa,” and revealed that “supply until confirmation” is “the responsibility of the medical staff”, and the government seems to have given priority to guaranteeing compulsory supply.
On the other hand, the government has confirmed that'remdesivir', which has been specially imported as a corona treatment and used for patients, has an inhibitory effect on the South African mutant virus, and appears to be irrelevant to the emergency use special case for celltrion treatment.

On the 5th, the head of the Ministry of Food and Drug Safety said, "Neutralizing antibodies can bind to mutant viruses to help cell invasion and proliferation, or to be more harmful to severely ill patients with unwanted immune responses." Jointly, it is testing whether it is effective against the British or South African mutation. According to the results, we will also respond if necessary measures are requested.” However, the KFDA's response was not announced on this day.
Director Kim visited Celltrion Plant 2 on the 8th, and Chairman Seo Jeong-jin said, "You are curious about the mutant virus, but the Korean Disease Administration, South Africa, the United Kingdom, and the United States are running Rekkirona (verification). The Agency for Disease Control and Prevention will be faster than South Africa." "Our role is to respond quickly to mutations and reduce the damage to the people," said the Minister of Food and Drug Safety, and said, "There will be a regrettable aspect for the company as we only allow the results of phase 2 clinical trials."
As for the celltrion treatment developed as a mild treatment, the verification advisory group said, "It is difficult to make a definite conclusion on whether it significantly reduces the transition from mild to moderate, and the effect of reducing mortality on mortality was not known." Because it was difficult to conclude on the clinical significance of the patient, the administration was changed to “limited to high-risk, mild and moderate patients”. In the announcement of the drug approval of the Ministry of Food and Drug Safety, an inquiry about the'mutagenic side effect' came out, and Director Kim responded'after confirming the effect of mutation ', and on the first day of the Lunar New Year holiday, the script revealed'supply even to the incompetence of mutation'.
On the 11th, Deputy Prime Minister Hong Nam-gi visited Cellid, a vaccine developer, saying, "We will provide 152.8 billion won to the development of new corona infection treatment and vaccines, a 37% increase from the previous year." We know that we are waiting for the results after completing phases 1 and 2 of this corona treatment. If special drugs are developed, it will be an important opportunity for our country to successfully overcome Corona 19."