[Photo provided by Celltrion Inc.]
South Korea is on track to start cure and vaccine program for Covid-19, although it remains uncertain if people feel safe to go along with vaccination.
Rekirona (CT-P59), Celltrion’s Covid-19 cure, will enter clinical supply as early as this week after health authorities approved the use of the neutralizing antibody therapy in high-risk patients with moderate symptoms on condition of Phase 3 data submission in the future.
The government will directly purchase Rekirona from Celltrion on a temporary basis to distribute it to hospitals from this month. The government plans to complete necessary steps for health insurance coverage for the therapy.
Celltrion is ready to ship the therapy out for 100,000 patients and plans to produce more to cover up to 2 million depending on demand at home and abroad. The company is also in talks with health authorities in the U.S. and Europe for filing for emergency use authorization of Rekirona. Talks are also in progress over the sale of Rekirona in OECD members, Southeast Asia and Latin American countries.
The Korea Agency for Disease Control and Prevention announced Monday that will start vaccination trial training from Tuesday, ahead of the vaccination with Pfizer jabs later this month.
The Central Pharmaceutical Affairs Review Committee under the Ministry of Food and Drug Safety however has not concluded whether to grant approval of AstraZeneca’s Covid-19 vaccine in 65 years or older amid a growing controversy over its efficacy in old patients in Europe.
The European Union okayed AstraZeneca’s vaccine in all age groups over the age of 18 at the recommendation of the European Medicines Agency (EMA) on Jan. 29, but several countries recently joined to limit the vaccine’s use to people under 65 due to insufficient efficacy data.
The ministry plans to convene a final checking committee soon to determine a target group of the vaccine.
Korea is scheduled to vaccinate the elderly aged 65 or older, who are the first priority group, from the end of this month mostly with AstraZeneca’s Covid-19 vaccine. The number of people in this age group exceeds 8 million.
Under a contract, up to 20 million doses of AstraZeneca’s coronavirus vaccine will be shipped to Korea from this month. Another 2.59 million doses will be added during the first half of this year through COVAX Facility. Of these, doses for 300,000 people may arrive in February or March, suggesting that day care facility people will receive vaccines from AstraZeneca.
By Kim Byung-ho, Lee Byung-moon, Kim Deok-shik and Minu Kim
[ⓒ Pulse by Maeil Business Newspaper & mk.co.kr, All rights reserved]