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September 20, 2021updated 02 Dec 2021 9:46am

Coronavirus company news summary – South Korea approves Celltrion’s regdanvimab to treat Covid-19 – FDA authorises Comirnaty booster shots in over-65s and high-risk populations

By Chris Lo

South Korea’s Ministry of Food and Drug Safety (MFDS) has approved Celltrion Group’s monoclonal antibody, regdanvimab (CT-P59), to treat mild Covid-19 in patients aged 50 years and above with a minimum of one underlying medical condition, and moderate symptoms of the disease in adults. This is the first monoclonal antibody Covid-19 therapy to receive approval from the MFDS. The drug previously obtained conditional approval in the country and as of this month has been used to treat more than 14,857 Covid-19 patients at 107 South Korean hospitals.

The US Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee has voted in favour of Emergency Use Authorization (EUA) of Pfizer-BioNTech’s Comirnaty booster shot in people aged 65 years and above, as well as those at increased risk of severe Covid-19. The panel, which recommended booster doses be given a minimum of six months following the two-dose regimen, said that healthcare workers and people at high occupational exposure risk should also be covered by the authorisation. However, the panel did not recommend a booster for the full population aged 16 and over, for which the companies sought approval.

The European Medicines Agency (EMA) has said that the limitations of data collection methods did not allow it to confirm if women and young adults were at an increased risk of rare blood clots related to low platelets after vaccination with AstraZeneca’s Covid-19 vaccine, Vaxzevria. The European Commission requested a scientific opinion from the agency after reports of thrombocytopenia syndrome (TTS) linked to Vaxzevria earlier this year. Following the analysis of all available data, EMA said that the information did not enable the identification of specific risk factors that made TTS more likely.

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