REPUBLIKA.CO.ID, TAIPEI -- Badan Pengawas Obat dan Makanan Taiwan (FDA) mengumumkan bahwa calon vaksin Covid-19 yang diproduksi bersama oleh Taiwan dan Amerika Serikat telah memasuki tahap akhir. Vaksin MVC-COV1901 sedang dikembangkan bersama oleh Medigen Vaccine Biologics Corp. Taiwan dan Institut Kesehatan Nasional AS, dan telah mendapat persetujuan untuk uji coba pada manusia, lansir harian Taiwan News, Kamis (1/10). Itu adalah calon vaksin ketiga yang diproduksi di negara kepulauan itu. Perusahaan lainnya, Adimmune Corp. dan United Biomedical Inc. juga sedang mengembangkan vaksin Covid-19 lainnya. Vaksin itu telah menerima persetujuan bersyarat untuk uji klinis pada 31 Agustus, tetapi mendapat persetujuan penuh pada Rabu setelah Medigen menyerahkan dokumen teknis untuk tinjauan tambahan. Pengembang vaksin sedang bekerja untuk uji coba keamanan dengan 45 peserta sehat dan uji coba akan dilakukan di Rumah Sakit Universitas Nasional Taiwan. Taiwan telah melaporkan 515 kasus virus korona sejak wabah - dengan 423 di antaranya diimpor, termasuk satu dari Indonesia. Sementara itu, tujuh orang tewas akibat Covid-19 di negara itu.
COVID-19 vaccine candidate jointly developed by Taiwan's Medigen Vaccine Biologics Corp. and the U.S. National Institutes of Health (NIH) has been authorized to begin human trials, Taiwan's Food and Drug Administration (FDA) said Wednesday (Sept. 30).
This makes it the third vaccine in the country to receive approval.
The MVC-COV1901 vaccine injection received conditional approval for clinical testing on Aug. 31 and was given full approval on Wednesday after Medigen submitted technical documents for additional review, the FDA said.
The first stage of the trial, to test for safety, is expected to take place at National Taiwan University Hospital with about 45 healthy participants, Pan Hsiang-ying (潘香櫻), a specialist in the FDA's Medicinal Products Division, told CNA.
Medigen will become the third company in Taiwan to begin human trials for a COVID-19 vaccine, after Adimmune Corp. and United Biomedical Inc.
After Medigen received conditional approval last month, FDA official Wu Ming-mei (吳明美) said the vaccine is the first targeted at COVID-19 to be jointly developed by Taiwan and the U.S.
According to Wu, the NIH has partnered with two companies -- Medigen and the U.S.-based Moderna Inc. -- to develop two different types of COVID-19 vaccine.
The vaccine developed by Moderna injects messenger RNA into the body, while the one developed by Medigen injects proteins, both of which are aimed at triggering the production of antibodies, Wu said.
Moderna's COVID-19 vaccine has already progressed to a phase 3 clinical study, which evaluates both safety and efficacy, Wu added
Actually this mou defintely cant implement.Why? The market price for vaccine is 10-20usd, Malaysia goverment and others country goverment will free injection for all their citizen and all the goverment will direct buy from the manufacturer like pfizer. The vaccine you cant put and sell at pharmacy because the storage environment problem of the vaccine. How this MOU can be implement?
Aurora13, yes agree, only the vaccine manufactuer make money, all the goverment will byy direct with them with huge volume. What distributir or dealer cant even gain one cents.
Hero76, yup maybe on monday can gain fast money , i want to know the show too. Bintai is price flying first than news come out, this counter is price droping but news come out, diff show.
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moneykj
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Posted by moneykj > 2020-11-20 16:09 | Report Abuse
Wow....Mudajya very near to my target