Drug approval for vaccine approval… The domestic medical system
Pfizer Vaccine This month, medical staff vaccination… Celltrion treatment can be administered’immediately’
(Seoul = Yonhap News) Reporter Seung-Hyun Gye = As the vaccination of the new coronavirus infection (Corona 19) and the domestic administration of the treatment are becoming visible, there is a growing expectation that the medical system will be breathless.
According to the Ministry of Food and Drug Safety on the 6th, following Pfizer vaccine’s special import approval, Celltrion’s antibody treatment’Rekironaju’ also received conditional approval.
It is encouraging that treatments and vaccines that can be used in the medical field have emerged amid concerns that a’pandemic’ may occur again due to group infections that still occur everywhere.
On the 3rd of this month, at the request of the Korea Centers for Disease Control and Prevention, the Ministry of Food and Drug Safety approved a special import of about 60,000 Pfizer vaccines (117,000 doses), which will be supplied through the international project’COVAX facility’.
The special import of medicines is a system in which medicines that are not approved domestically are imported from abroad to cope with the public health crisis. It is expected that rapid on-site input is expected as the’national shipment approval’ step, which is a quality verification before vaccination, can be omitted.
This quantity is distinct from the quantity of vaccines that the Korean government will import through Pfizer Korea through formal product licensing procedures.
On the previous day, the Ministry of Food and Drug Safety also approved Celltrion’s Rekirona, the first domestic COVID-19 treatment, for patients with mild and moderate symptoms in high-risk groups.
Food and Drug Administration Chief Kim Kang-rip explained at a briefing that “(Rekkironaju) products are prepared in the form of a finished product and can be commercialized after approval today (5th).”
Celltrion has already completed the production of a quantity that can be administered to 100,000 domestic Corona19 patients last year, so it is expected to be used immediately according to the demand of the medical field.
In a call with Yonhap News, Jeong Jae-hoon, a professor of preventive medicine at Gachon University, said, “There is a difference between having and not having a cure, but I feel that there is a treatment that can be given to patients with mild symptoms.”
However, there is a limit that the efficacy of the mutant corona 19 virus from the UK and South Africa, which has recently infiltrated the domestic community, has not been confirmed.
Health authorities are working with Celltrion to test the efficacy of Rekirona against the mutant virus.
Currently, there are 15 (13 ingredients) COVID-19 treatments that are currently being developed with approval for a clinical trial plan in Korea. Seven vaccine products are in clinical trials.
[email protected]
(End)
<저작권자(c) 연합뉴스, 무단 전재-재배포 금지>