HOT TOPICS :
Gosip | COVID-19 | Ayo Vaksin
|
Thread Terpopuler
-
Senin, 2024/04/24 11:29 WIB
KPU Tetapkan Prabowo Jadi Presiden dan Gibran Wakil Presiden Baru RI
-
Senin, 2024/04/24 11:47 WIB
Ganjar Mengaku Tak Diundang ke Penetapan Prabowo-Gibran
-
Senin, 2024/04/24 11:43 WIB
Mooryati Soedibyo, Pendiri Mustika Ratu, Meninggal Dunia Dalam Usia 96 Tahun
-
Senin, 2024/04/24 16:41 WIB
2 Bule Nyasar ke Halalbilahal, Kesengsem Magelang Sampai Batalkan ke Bromo
-
Sabtu, 2024/04/23 14:49 WIB
PAN Siapkan Eko Patrio-Zita Anjani Pilkada Jakarta, Desy Ratnasari di Jabar
-
Kamis, 2024/04/21 10:11 WIB
Cak Imin Balas Wasekjen PBNU soal Bela Gus Ipul: Nggak Nanggepi Pengangguran
|
Thread Tools |
14th January 2021, 09:10 |
#11
|
|
Mania Member
|
Quote:
Untuk konsolidasi uji klinis pemilik vaksin lah yang berhak dan punya izin untuk mengeluarkan hasil interim ataupun hasil akhir dari uji klinis tersebut. Moderna dan Pfizer-BioNtech adalah pemilik vaksin, dan mereka punya hak untuk mengeluarkan hasil interim mereka. Begitu mereka selesai meng-konsolidasikan hasil interim global mereka, setelah melewati fase "peer review", lalu mereka minta untuk di-publish ke jurnal medis/kesehatan ternama seperti NEJM, JAMA, Lancet, BMJ dan sebagainya. Sinovac, sebagai pemilik vaksin CoronaVac, punya hak yang sama. Jadi Indonesia, Brazil, Turki dan Chili tidak bisa mengeluarkan hasil interim secara detil tanpa persetujuan Sinovac. Karena Sinovac BELUM SELESAI meng-konsolidasikan hasil uji klinis Fase III mereka, bahkan untuk yang tingkat hasil interim global. Jadi dengan sendirinya Butantan [di Brazil], BPOM/BioFarma [di Indonesia] tidak bisa mengeluarkan detil dari hasil interim mereka TANPA persetujuan Sinovac, pastinya itu salah satu point yang diteken oleh masing-masing pihak sebelum Uji Klinis ini dilakukan. Mengapa? Yang pasti karena studinya memang belum selesai, ditambah lagi hasil efikasi yang berbeda-beda didapat di Turki [91%], Indonesia [65%] dan Brazil [50%], yang membutuhkan analisa yang lebih dalam. Apa sebabnya? Apakah karena terjai kesalahan penghitungan? Apakah karena vaksin CoronaVac tidak mempan ke varian COVID-19 yang tertentu? Apakah karena terjadi kesalahan teknis dalam dalam pengujian? Apakah karena populasi yang dipakai mayoritasnya tidak disiplin untuk mengikuti prosedur? Jadi banyak sekali persoalan yang harus dijawab. Kedua, kalau melihat aplikasi Sinovac di clinicaltrials.gov, disitu terlihat bahwa estimasi hasil interim Studi Fase III-nya bisa keluar adalah di sekitar Januari 2021. Jadi Sinovac harus diberikan waktu, karena mereka sekarang pasti lagi pusing melihat data efikasi yang berbeda-beda di 3 negara yang berbeda [mungkin malah di 4 negara yang berbeda, karena Studi Fase III di China untuk sekitar 1000 subjek, Sinovac mulai menstudi efikasi CoronaVac pada kaum manula]. Perlu diketahui bahwa SEMUA VAKSIN YANG DIPAKAI SEKARANG [Oxford-Astrazeneca, Pfizer-BioNtech, Moderna dan Sinovac] ADALAH HASIL KARBITAN SEMUA KARENA SEMUANYA HANYA DIDASARKAN KEPADA HASIL INTERIM FASE III. Semuanya digunakan tanpa sempat mengetahui dan mempelajari efek-efek sampingan jangka panjang nya. Jadi hasil final studi Fase III yang ditargetkan bisa selesai dalam 1 tahun normalnya baru bisa selesai bertahun-tahun kemudian. Tetapi memang saat ini kita berada dalam situasi Pandemi. Sekarang secara kumulatif paling sedikit 100 juta orang sudah terinfeksi dan minimal 2 juta orang sudah meninggal karena COVID-19. Jadi memang kita tidak berada dalam situasi dan kondisi normal. |
|
|
14th January 2021, 15:21 |
#12
|
Mania Member
|
Explainer: What's behind varying efficacy data for Sinovac's COVID-19 vaccine?
14 January 2020 New efficacy data from Brazil on Sinovac's COVID-19 vaccine, for which there are now four widely different success rates, raised more questions than answers, as many developing countries pin their hopes on the CoronaVac to end the pandemic. Here are potential factors contributing to CoronaVac's varying efficacy rates and expert interpretations. HOW EFFECTIVE IS CORONAVAC? Researchers in Turkey said it is 91.25% effective. Turkish trials had included over 7,000 volunteers, but the efficacy result was based on data from 1,322 people. Indonesia said the vaccine is 65% effective based on trials involving some 1,600 people. Researchers in Brazil said it was 50.4% effective at preventing symptomatic infections, barely enough for regulatory approval and below the 78% announced a week earlier. Brazil has run the biggest trials so far with around 13,000 participants. WHAT CONTRIBUTES TO DIFFERENT EFFICACY RATES? Trial size, patient criteria, duration of post-vaccination observation, target groups, prevalence of the virus in each site are among the factors that could impact efficacy, experts said. More rampant infections in Brazil than in other trial sites and its study design to focus on medical workers could have led to more mild infections in trials, thus lowering efficacy data, a person familiar with the matter said. The new lower efficacy finding included people with very mild symptoms who did not need clinical assistance, while the earlier reading was based on patients with symptoms that needed some assistance, Brazilian researchers said. IMPACT OF TARGET GROUPS Brazil conducted trials with healthcare workers only, while Turkey and Chile recruited both medical workers and general public, and Indonesia general public only. Medical workers could be more alert to mild symptoms and report those more proactively than general public, which Sinovac suspects may be among the reasons behind the less robust 50% reading, the person said. False positive results delivered by high-sensitivity COVID-19 tests may have also worsened the reading, the person added. HOW EXPERTS INTERPRET IT? Experts say it is difficult to interpret the efficacy results as the full datasets are not out. "This highlights the problem of issuing data by press release rather than publication in a peer-reviewed journal", Lawrence Young, a virologist and professor at Britain's University of Warwick, said. Paul Hunter, professor in Medicine at University of East Anglia, noted the dosage interval of two weeks was very short and may have contributed to the less-than-impressive efficacy. POSSIBLE TO COMBINE TRIAL RESULTS? Sinovac said its trial designs are not identical among countries, but the results are sufficient to prove that the vaccine is safe and effective. Jerome Kim, head of vaccine research group International Vaccine Institute said it would be possible to combine data from multiple studies with varied trial designs but it could involve additional statistical manipulation. "That could compromise the clean interpretation of the results, and may impact the chance for these data to be accepted by regulatory bodies." ARE RECIPIENT COUNTRIES WORRIED? Indonesia and Turkey have approved the vaccine this week to begin mass inoculation, with Indonesia's president taking the shot on Wednesday to encourage vaccinations. Philippine president defended the country's decision to buy Chinese made vaccines, saying they are as good as the shots developed by the Americans and the Europeans. In Brazil, a decision on the use of CoronaVac will be made on Saturday. SINOVAC NOT ALONE WITH VARYING SUCCESS RATES A vaccine developed by Oxford University and AstraZeneca Plc has two different success rates. It showed 62% efficacy when two full doses were administered to adult participants of all age groups, but it rose to 90% in a sub-group of smaller number of participants not older than 55 who were given a half-dose followed by a full dose booster. On average its vaccine prevented 70% of COVID-19 cases in late stage trials in Britain and Brazil. A vaccine developed by an affiliate of China's state-backed Sinopharm showed 79.34% efficacy, lower than 86% announced by the United Arab Emirates based on preliminary data from trials there. ======= - https://www.reuters.com/article/heal...-idUSL4N2JO0UD |
|
15th January 2021, 20:33 |
#14
|
Groupie Member
|
|
King of Losers |
16th January 2021, 08:54 |
#15
|
Mania Member
|
yamg penting kaga ada efek sampingnya...apalagi dlm jangka panjang..
wong obat yang effisiensinya aja cuma 10% dipakai buat ngobatin dan menyebabkan kerusakan ginjal.. dipakai terus untuk ngobatin covid ini... apalagi harganya super duper mahal... tapi itu usaha terahir.. hasilnya pasien sembuh dari covid tapi tetap meninggal karena kerusakan ginjal... menyedihkan memang... |
16th January 2021, 09:49 |
#16
|
Mania Member
|
pake vaksin the Pfizer/BioNTech, dan kena covid padahal sudah disuntik dosis ke 2.
Rep. Adriano Espaillat diagnosed with COVID-19 after getting vaccine |
Last edited by Makmun; 16th January 2021 at 10:19.. |
16th January 2021, 09:57 |
#17
|
|
Groupie Member
|
Quote:
Tapi kalau tertular, apakah sakit parah atau tidak? Kalau tidak berarti mungkin vaksinnya sudah membantu. Tapi itu juga sulit dibuktikan karena 90% orang tertular tidak sakit parah walaupun tanpa vaksin. |
|
King of Losers |
16th January 2021, 11:41 |
#18
|
||
Mania Member
|
Quote:
Dia terperosok kedalam celah-celah proteksi dari vaksin Pfizef-BioNTech... __________________________________________________ . . Dari hasil preliminary uji studi Fase III Pfizer-BioNTech... Selengkapnya disini. Dalam studinya pihak Pfizer-BioNTech mencuci tangan terhadap kasus-kasus COVID-19 yang asimptomatik... Quote:
[Note: Gejala-gejala "primer", ataupun 5-besar gejala-gejala COVID-19 ada termasuk didalamnya: diare dengan kelesuan/kelelahan tanpa disertai demam, batuk, sesak/susah bernafas, anosmia (hilangnya indra penciuman) yang parsial maupun total, ageusia (hilangnya indra perasa)] Tetapi entah mengapa, Pfizer-BioNtech MEMILIH UNTUK TIDAK/BELUM MELAKUKANNYA pada saat mereka me-release hasil preliminary studi Fase III mereka. Timbul pertanyaan besar, mengapa begitu? Silakan berspekulasi sendiri-sendiri... Moderna juga melakukan trik yang sama, tetapi mereka lebih jauh menyatakan bahwa mereka sedang melakukan studi lanjutan tentang efikasi vaksin mereka dalam mencegah kasus-kasus COVID-19 yang asimptomatik maupun yang bergejala-gejala sub-klinis. [Baca selengkapnya disini]. Yang SUDAH PASTI kalau angka subjek yang asimptomatik maupun yang bergejala sub-klinis dimasukkan, angka efikasi vaksin Pfizer-BioNTech dan Moderna akan merosot secara signifikan. |
||
|
16th January 2021, 19:13 |
#19
|
Mania Member
|
|
16th January 2021, 19:55 |
#20
|
|
Groupie Member
|
Quote:
|
|
King of Losers |
detikNews
- detikNews · Berita · Internasional · Kolom · Wawancara · Lapsus · Tokoh · Pro Kontra · Profil · Indeks
- detikSport · Basket · MotoGP · F1 · Raket · Sepakbola · Sport Lain · Galeri · Profil · Fans Area · Indeks
- Sepakbola · Italia · Inggris · Spanyol · Jerman · Indonesia · Uefa · Bola Dunia · Fans Area · Indeks
- detikOto · Mobil · Motor · Modifikasi · Tips & Trik · Konsultasi · Komunitas · OtoTest · Galeri · Video · Forum · Indeks
- detikHot · Celebs · Music · Movie · Art · Gallery · Profile · KPOP · Forum · Indeks
- detikInet · News · Gadget · Games · Fotostop · Klinik IT · Ngopi · Produk Pilihan · Forum · Indeks
- detikFinance · Ekonomi Bisnis · Finansial · Properti · Energi · Industri · Sosok · Peluang Usaha · Pajak · Konsultasi · Foto · TV · Indeks
- detikHealth · Health News · Sexual Health · Diet · Ibu & Anak · Konsultasi · Health Calculator · Foto Balita · Bank Nama Bayi
- detikTravel · Travel News · Destinations · Photos · d'Trips · Hotels · Flights · ACI · d'Travelers Stories
- Wolipop · Fashion · Photos · Beauty · Love & Sex · Home & Family · Wedding · Entertainment · Sale & Shop · Hot Guide · d'Lounge · Indeks
- detikFood · Resep · Tempat Makan · Kabar Kuliner · Halal · Komunitas · Forum · Konsultasi · Galeri · Indeks
- detikSurabaya · Berita · Bisnis · Society · Foto · TV · Indeks
- detikBandung · News · Sosok · Info · Pengalaman Anda · Lifestyle · Iklan Baris · Foto · TV · Info Iklan · Forum · Indeks
Iklan Baris · Blog · Forum · adPoint · Seremonia · Sindikasi · Info Iklan · Suara Pembaca · Surat dari Buncit · detikTV · Cari Alamat
Copyright © 2019 detikcom, All Rights Reserved · Redaksi · Pedoman Media Siber · Karir · Kotak Pos · Info Iklan · Disclaimer