Oxford University announced Saturday it was resuming a trial for a coronavirus vaccine it is developing with pharmaceutical company AstraZeneca, a move that comes days after the study was suspended following a reported side-effect in a U.K. patient.
In a statement, the university confirmed the restart across all of its U.K. clinical trial sites after regulators gave the go-ahead following the pause on Sunday.
“The independent review process has concluded and following the recommendations of both the independent safety review committee and the U.K. regulator, the MHRA, the trials will recommence in the U.K.,” it said.
The vaccine being developed by Oxford and AstraZeneca is widely perceived to be one of the strongest contenders among the dozens of coronavirus vaccines in various stages of testing around the world.
British Health Secretary Matt Hancock welcomed the restart, saying in a tweet that it was “good news for everyone” that the trial is “back up and running.”
The university said in large trials such as this “it is expected that some participants will become unwell and every case must be carefully evaluated to ensure careful assessment of safety.”
It said globally some 18,000 people have received its vaccine so far. Volunteers from some of the worst affected countries — Britain, Brazil, South Africa and the U.S. — are taking part in the trial.
Brazil’s health regulator Anvisa on Saturday said it had approved the resumption of tests of the “Oxford vaccine” in the South American country after receiving official information from AstraZeneca.
Although Oxford would not disclose information about the patient's illness due to participant confidentiality, an AstraZeneca spokesman said earlier this week that a woman had developed severe neurological symptoms that prompted the pause. Specifically, the woman is said to have developed symptoms consistent with transverse myelitis, a rare inflammation of the spinal cord.
The university insisted that it is “committed to the safety of our participants and the highest standards of conduct in our studies and will continue to monitor safety closely.”
Pauses in drug trials are commonplace and the temporary hold led to a sharp fall in AstraZeneca's share price following the announcement Tuesday.
The Oxford-AstraZeneca study had been previously stopped in July for several days after a participant developed neurological symptoms that turned out to be an undiagnosed case of multiple sclerosis that researchers said was unrelated to the vaccine.
During the third and final stage of testing, researchers look for any signs of possible side effects that may have gone undetected in earlier patient research. Because of their large size, the studies are considered the most important study phase for picking up less common side effects and establishing safety. The trials also assess effectiveness by tracking who gets sick and who doesn’t between patients getting the vaccine and those receiving a dummy shot.
Dr. Charlotte Summers, a lecturer in intensive care medicine at the University of Cambridge, said the pause was a sign that the Oxford team was putting safety issues first, but that it led to “much unhelpful speculation.”
“To tackle the global COVID-19 pandemic, we need to develop vaccines and therapies that people feel comfortable using, therefore it is vital to maintaining public trust that we stick to the evidence and do not draw conclusions before information is available,” she said.
Scientists and others around the world, including experts at the World Health Organization, have sought to keep a lid on expectations of an imminent breakthrough for coronavirus vaccines, stressing that vaccine trials are rarely straightforward.
Italy’s health minister, Roberto Speranza, welcomed the resumption of the vaccine trial, but warned that prudence was still necessary.
“Science is at work to give the world efficient and secure treatments and vaccines,” he said. “In the meantime, the key continues to be our behavior.”
Italy, which was ground zero for Europe's outbreak, is one of the main countries investing in the AstraZeneca vaccine.
Two other vaccines are in huge, final-stage tests in the United States, one made by Moderna Inc. and the other by Pfizer and Germany’s BioNTech.
AP Newsroom
Sun Sep 13 2020
![Oxford and AstraZeneca resume coronavirus vaccine trial Oxford and AstraZeneca resume coronavirus vaccine trial](https://resizer-awani.eco.astro.com.my/tr:w-177,h-100,q-100,f-auto/http://img.astroawani.com/2020-09/41599964717_AstraZaneca.jpg)
AstraZeneca offices and the corporate logo in Cambridge, England - AP Photo/Alastair Grant
![Penggunaan dron tingkat keberkesanan pemantauan pencemaran - Nik Nazmi Penggunaan dron tingkat keberkesanan pemantauan pencemaran - Nik Nazmi](https://resizer-awani.eco.astro.com.my/tr:w-177,h-100,q-100,f-auto/https://img.astroawani.com/2024-07/71721102997_SimposiumDronKeban.jpg)
Penggunaan dron tingkat keberkesanan pemantauan pencemaran - Nik Nazmi
Penggunaan dron membolehkan pemantauan pencemaran alam sekitar dan hidupan liar serta pencerobohan hutan dilaksanakan dengan lebih berkesan.
![Bekas pengawal peribadi Wan Azizah cedera kemalangan Bekas pengawal peribadi Wan Azizah cedera kemalangan](https://resizer-awani.eco.astro.com.my/tr:w-177,h-100,q-100,f-auto/https://img.astroawani.com/2024-07/51721109015_bekaspengawalperib.jpg)
Bekas pengawal peribadi Wan Azizah cedera kemalangan
Bekas anggota polis wanita yang kini bekerja sebagai pengawal peribadi cedera setelah motosikal ditunggangnya melanggar sebuah SUV di lebuh raya PLUS.
![Rang Undang-undang Kebebasan Maklumat dijangka dibentang akhir tahun ini - Kulasegaran Rang Undang-undang Kebebasan Maklumat dijangka dibentang akhir tahun ini - Kulasegaran](https://resizer-awani.eco.astro.com.my/tr:w-177,h-100,q-100,f-auto/https://img.astroawani.com/2024-07/81719996195_MKulasegaran.jpg)
Rang Undang-undang Kebebasan Maklumat dijangka dibentang akhir tahun ini - Kulasegaran
RUU Kebebasan Maklumat dijangka dibentangkan di Parlimen pada akhir tahun ini selepas cadangan ketetapan bagi penggubalan Akta Kebebasan Maklumat dibawa ke Jemaah Menteri untuk kelulusan.
![Azizi dilantik Ketua Polis Perak baharu Azizi dilantik Ketua Polis Perak baharu](https://resizer-awani.eco.astro.com.my/tr:w-177,h-100,q-100,f-auto/https://img.astroawani.com/2024-07/51721108438_azizi.jpg)
Azizi dilantik Ketua Polis Perak baharu
Timbalan Ketua Polis Perak Datuk Azizi Mat Aris dilantik sebagai Ketua Polis Perak yang baharu hari ini.
![ADUN Rembia sertai Pas, tak 'lompat parti' - Takiyuddin ADUN Rembia sertai Pas, tak 'lompat parti' - Takiyuddin](https://resizer-awani.eco.astro.com.my/tr:w-177,h-100,q-100,f-auto/https://img.astroawani.com/2024-07/51721108165_ADUNRembiaPN.jpg)
ADUN Rembia sertai Pas, tak 'lompat parti' - Takiyuddin
Menurut Takiyuddin, keahlian Muhamad Jailani yang juga wakil rakyat UMNO diterima pada 10 Jun tahun lalu, namun diumumkan secara rasmi hari ini.
Kita perlu belajar hidup dengan COVID-19 - Pakar
Itu kata Pakar Perubatan Kesihatan Awam, Bahagian Kawalan Penyakit, Kementerian Kesihatan Malaysia (KKM), Dr Aznida Mohamad Zaki yang berkata pihaknya akan berusaha semampu mungkin dalam menggalakkan praktis kendiri dikalangan orang awam bagi mencegah penularan wabak seperti mana yang pernah dilakukan sebelum ini.
LHDN lulus 141,406 permohonan PKPS 2.0
Lembaga Hasil Dalam Negeri (LHDN) telah meluluskan sebanyak 141,406 permohonan program khas pengakuan sukarela (PKPS) 2.0 yang melibatkan 102,572 bilangan kes pembayar cukai individu, 27,707 bilangan kes syarikat dan selebihnya melibatkan lain kategori seperti pertubuhan.
![Pelan Transformasi Air sasar tingkatkan air bersih, liputan sistem kumbahan - Fadillah Pelan Transformasi Air sasar tingkatkan air bersih, liputan sistem kumbahan - Fadillah](https://resizer-awani.eco.astro.com.my/tr:w-177,h-100,q-100,f-auto/https://img.astroawani.com/2024-07/81721017239_TBFADILLAH.jpg)
Pelan Transformasi Air sasar tingkatkan air bersih, liputan sistem kumbahan - Fadillah
Pelan Transformasi Air sasar tingkatkan air bersih, tingkatkan liputan sistem kumbahan - Fadillah
![Warga Thailand mengaku tidak bersalah seleweng diesel Warga Thailand mengaku tidak bersalah seleweng diesel](https://resizer-awani.eco.astro.com.my/tr:w-177,h-100,q-100,f-auto/https://img.astroawani.com/2024-07/41721103547_WargaThailandWitt.jpg)
Warga Thailand mengaku tidak bersalah seleweng diesel
Seorang warga Thailand mengaku tidak bersalah di Mahkamah Sesyen Alor Setar atas pertuduhan menyeleweng 322 liter minyak diesel.
Lilitan reben putih tak langgar peraturan - Timbalan Speaker
Ramli berkata, perkara itu juga adalah merupakan keputusannya dan bukan dibuat oleh Yang Dipertua Dewan Rakyat, Tan Sri Johari Abdul.
![‘Kes darah beku, serangan jantung tiada kaitan dengan vaksin AstraZeneca’ ‘Kes darah beku, serangan jantung tiada kaitan dengan vaksin AstraZeneca’](https://resizer-awani.eco.astro.com.my/tr:w-177,h-100,q-100,f-auto/https://img.astroawani.com/2022-03/71647054545_DatukDrNoorHisham.jpg)
‘Kes darah beku, serangan jantung tiada kaitan dengan vaksin AstraZeneca’
Golongan berisiko tinggi adalah individu yang mempunyai sejarah pembekuan darah dan mereka tidak dibenarkan menerima vaksin jenis AZ.
![KKM keluar kenyataan berkaitan vaksin AstraZeneca dalam masa terdekat KKM keluar kenyataan berkaitan vaksin AstraZeneca dalam masa terdekat](https://resizer-awani.eco.astro.com.my/tr:w-177,h-100,q-100,f-auto/https://img.astroawani.com/2024-05/51714998751_Dzulkefly.jpg)
KKM keluar kenyataan berkaitan vaksin AstraZeneca dalam masa terdekat
KKM akan mengeluarkan kenyataan berhubung isu penarikan balik vaksin COVID-19 keluaran AstraZeneca dalam masa terdekat.
![Berita antarabangsa pilihan sepanjang hari ini Berita antarabangsa pilihan sepanjang hari ini](https://resizer-awani.eco.astro.com.my/tr:w-177,h-100,q-100,f-auto/https://img.astroawani.com/2024-03/71709993909_TBBERITAx.jpg)
Berita antarabangsa pilihan sepanjang hari ini
Antara pelbagai berita luar negara yang disiarkan di Astro AWANI, berikut adalah antara yang paling menjadi tumpuan sepanjang hari ini.
![AstraZeneca tarik balik vaksin COVID-19 di seluruh dunia, berbulan selepas sedar ada kesan sampingan AstraZeneca tarik balik vaksin COVID-19 di seluruh dunia, berbulan selepas sedar ada kesan sampingan](https://resizer-awani.eco.astro.com.my/tr:w-177,h-100,q-100,f-auto/https://img.astroawani.com/2021-09/51632498837_TBCOVIDVACCINE.jpg)
AstraZeneca tarik balik vaksin COVID-19 di seluruh dunia, berbulan selepas sedar ada kesan sampingan
Vaksin itu tidak lagi boleh digunakan di EU selepas syarikat itu secara sukarela menarik balik "kebenaran pemasarannya."
![KKM beri jaminan dedah data AEFI vaksin COVID-19 - Dr Dzulkefly KKM beri jaminan dedah data AEFI vaksin COVID-19 - Dr Dzulkefly](https://resizer-awani.eco.astro.com.my/tr:w-177,h-100,q-100,f-auto/https://img.astroawani.com/2024-05/51714998751_Dzulkefly.jpg)
KKM beri jaminan dedah data AEFI vaksin COVID-19 - Dr Dzulkefly
KKM memberi jaminan akan mendedahkan semua data berhubung kesan sampingan susulan imunisasi (AEFI) yang berpunca daripada vaksin COVID-19 pada satu waktu yang akan ditetapkan.
![Tiada kesan sampingan daripada vaksin COVID-19 AstraZeneca di Indonesia - Suruhanjaya Tiada kesan sampingan daripada vaksin COVID-19 AstraZeneca di Indonesia - Suruhanjaya](https://resizer-awani.eco.astro.com.my/tr:w-177,h-100,q-100,f-auto/https://img.astroawani.com/2021-09/51632498837_TBCOVIDVACCINE.jpg)
Tiada kesan sampingan daripada vaksin COVID-19 AstraZeneca di Indonesia - Suruhanjaya
Suruhanjaya Nasional untuk Kajian dan Pencegahan Peristiwa Mudarat Berikutan Imunisasi dan BPOM melakukan pemantauan bagi membuat rumusan.
![Kesan sampingan vaksin: KKM akan dapatkan penjelasan AstraZeneca Kesan sampingan vaksin: KKM akan dapatkan penjelasan AstraZeneca](https://resizer-awani.eco.astro.com.my/tr:w-177,h-100,q-100,f-auto/https://img.astroawani.com/2024-05/81714645375_AstraZeneca.jpg)
Kesan sampingan vaksin: KKM akan dapatkan penjelasan AstraZeneca
Kementerian Kesihatan (KKM) akan mendapatkan penjelasan daripada firma farmaseutikal AstraZeneca berhubung kesan sampingan vaksin COVID-19 seperti yang dilaporkan media antarabangsa baru-baru ini.
![AstraZeneca berjaya batalkan saman 12 individu berhubung isu suntikan vaksin COVID-19 AstraZeneca berjaya batalkan saman 12 individu berhubung isu suntikan vaksin COVID-19](https://resizer-awani.eco.astro.com.my/tr:w-177,h-100,q-100,f-auto/https://img.astroawani.com/2023-07/71690377692_gaveltukulmahkam.jpg)
AstraZeneca berjaya batalkan saman 12 individu berhubung isu suntikan vaksin COVID-19
Hakim Mahkamah Tinggi Dr Suzana Muhamad Said membenarkan permohonan Astrazeneca untuk membatalkan saman itu selepas mendengar hujahan kedua-dua pihak.
![AstraZeneca rintis inisiatif kesaksamaan akses dalam perkhidmatan kesihatan AstraZeneca rintis inisiatif kesaksamaan akses dalam perkhidmatan kesihatan](https://resizer-awani.eco.astro.com.my/tr:w-177,h-100,q-100,f-auto/https://img.astroawani.com/2023-10/71697864703_mySihatPal.jpg)
AstraZeneca rintis inisiatif kesaksamaan akses dalam perkhidmatan kesihatan
Portal mySihatPal menutup jurang akses kepada penyelesaian penjagaan kesihatan.
![AstraZeneca tumpu kepada kepada penyakit jarang jumpa, teruskan pelaburan tempatan AstraZeneca tumpu kepada kepada penyakit jarang jumpa, teruskan pelaburan tempatan](https://resizer-awani.eco.astro.com.my/tr:w-177,h-100,q-100,f-auto/https://img.astroawani.com/2021-09/71632796213_AstraZenecasthera.jpg)
AstraZeneca tumpu kepada kepada penyakit jarang jumpa, teruskan pelaburan tempatan
AstraZeneca berhasrat menjadi pengupaya penyelesaian yang bekerjasama dalam aspek berbeza kepada pesakit.