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Enam Orang Temui Ajal Dalam Ujian Vaksin Covid-19 Pfizer

9-12-2020 03:40 PM| Diterbitkan: CARI-MRO| Dilihat: 9831| Komen: 71

Description: Enam individu meninggal dunia dalam fasa terakhir ujian klinikal vaksin Covid-19 yang dibangunkan oleh syarikat farmaseutikal Amerika Syarikat (AS), Pfizer dan rakan niaganya dari Jerman, BioNTech.
Enam individu meninggal dunia dalam fasa terakhir ujian klinikal vaksin Covid-19 yang dibangunkan oleh syarikat farmaseutikal Amerika Syarikat (AS), Pfizer dan rakan niaganya dari Jerman, BioNTech.


Ia didedahkan oleh Pentadbiran Makanan dan Ubat-ubatan Amerika Syarikat (FDA) beberapa jam sebelum United Kingdom (UK) menjadi negara pertama yang meluluskan penggunaan vaksin berkenaan.

Bagaimanapun, kadar kematian itu tidak membangkitkan isu keselamatan atau keberkesanan vaksin berkenaan memandangkan ia berlaku ke atas populasi umum pada kadar yang sama.


Dalam laporan setebal 53 muka surat yang dikeluarkan pada Rabu itu, vaksin berkenaan didapati mempunyai tahap keberkesanan 95 peratus dalam mencegah jangkitan Covid-19.


Foto: AFP

Menurut laporan sama, dua individu yang menerima vaksin itu ketika tempoh percubaan, meninggal dunia, manakala empat lagi meninggal dunia ketika peringkat plasebo.

Selain itu, ia menunjukkan bahawa vaksin berkenaan mempunyai tahap keberkesanan 95 peratus, sekurang-kurangnya tujuh hari selepas individu menerima suntikan kedua.

Data juga menunjukkan bahawa vaksin itu berkesan pada tahap 52 peratus selepas dos pertama.

Laporan itu merumuskan keberkesanan data memenuhi jangkaan FDA bagi kebenaran kegunaan kecemasan. -CARI

Sumber: Harian Metro
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Quote Eliadaisy83 9-12-2020 03:42 PM
Haiyo...lebih baik tak payah ambil vaksin klau kesannya camni..
Quote makneng 9-12-2020 04:02 PM
Berapa kali kena amik vaksin ni? 2@3?
Quote batusembilan 9-12-2020 04:04 PM
scary sungguh ni
Quote kuzaime 9-12-2020 04:24 PM
X mati kena covid tapi mati sebab vaksin..serammm
Quote babynina30 9-12-2020 04:28 PM
Tiba2 i jd antivax
Quote stingerclaw 9-12-2020 04:29 PM
Tengok lepas berita ini, bung mukhtar  kenabatangan mahu terus mengoffer diri to be the first one be put to the test bila vaksin ini arrives here...

Kahkahkahkahkahkah
Quote Artemesiaa 9-12-2020 04:33 PM
Hasil yang membuat orang ramai tambah bimbang
Quote mawarika 9-12-2020 04:37 PM
I nak borang antivax satu
Quote hatikudus 9-12-2020 04:38 PM
Alamak...seramm
Quote mbhcsf 9-12-2020 04:41 PM
6 out of  100 i would say CLINICALLY SIGNIFICANT
if 6 out of 10 000 itu lain

so article kena bagi konteks betul that is why bebenda macam ni kena tengok.

Quote highcastle 9-12-2020 04:42 PM
stingerclaw replied at 9-12-2020 04:29 PM
Tengok lepas berita ini, bung mukhtar  kenabatangan mahu terus mengoffer diri to be the first one be ...

Kalau dia berani mmg den tabik spring kat dia.......... Di sini kita boleh tengok mana dia ahli politik yg betul2 berani.. setakat cakap berdegar2 buang masa jer.........
Quote stingerclaw 9-12-2020 04:44 PM
highcastle replied at 9-12-2020 04:42 PM
Kalau dia berani mmg den tabik spring kat dia.......... Di sini kita boleh tengok mana dia ahli po ...


Halkom termasuk aku rasa bila dia baca perkembangan terkini ...kahkahkahkah...

Gilos dok mau risks isteri gebus macam jiji ijet itewww jadi janda...

Kahkahkahkahkah
Quote mbhcsf 9-12-2020 04:46 PM
Edited by mbhcsf at 9-12-2020 04:47 PM

Pfizer vaccine raises 'no specific safety concerns': US regulator

https://www.nst.com.my/world/wor ... ncerns-us-regulator
WASHINGTON: The US Food and Drug Administration (FDA) issued a briefing document Tuesday saying the Pfizer-BioNTech Covid-19 vaccine is safe and effective, raising expectations the regulator is poised to grant emergency approval.

An independent committee advising the FDA will meet Thursday on the matter, after Britain became the first country to approve the vaccine last week.

Data from 38,000 US trial participants revealed "suggest a favorable safety profile, with no specific safety concerns identified that would preclude issuance of an EUA (emergency use authorization)," the FDA document said.

It added that the vaccine's efficacy in preventing Covid-19 was 95 percent, worked uniformly across age groups, genders, and racial groups, as well as people with underlying conditions who are at high risk.


The FDA said more research was needed to confirm evidence that the vaccine prevents even the worst cases of Covid-19, that it offers protection after the first of two doses and that it works for people previously been infected.

The companies have previously released some of their data in press statements but the FDA has access to a much more detail.



In a larger group of 43,000 volunteers which included additional adults and adolescents who signed up later, the most common side effects were injection site reactions (84 percent), fatigue (63 percent), headache (55 percent), muscle pain (38 percent), chills (31 percent), joint pain (23.6 percent), fever (14 percent).

Reactions graded as "severe" were more common after the second dose and less frequent in participants aged 55 and older.

There were some adverse events classed as "serious" -- the highest grade -- but there was no meaningful imbalance in the frequency these occurred in the vaccine and placebo arms.


There were four cases of Bell's palsy -- a non-serious form of facial paralysis that generally resolves -- in the vaccine group and none in the placebo group, but the document said this was in line with the frequency seen in the general population.

The advisory group will also consider what additional studies the manufacturers will need to undertake after issuance of an EUA.

Notably, the FDA is not in favor of immediately offering the vaccine to people in the placebo group, which is currently a heated area of discussion among the scientific community. -- AFP
Quote highcastle 9-12-2020 04:51 PM
stingerclaw replied at 9-12-2020 04:44 PM
Halkom termasuk aku rasa bila dia baca perkembangan terkini ...kahkahkahkah...

Gilos dok mau  ...

Tapi kalau dia berani amik mmg aku tabik ler....... Kurang2 dia dah buktikan bukan ckp kosong........
Quote nazzse 9-12-2020 04:57 PM
Kat mana boleh dapatkan report tu. Mcm menarik je.

Now i nak tahu apa plak keberkesanan vaksin buatan China yg Indon dah terima tu
Quote stingerclaw 9-12-2020 05:05 PM
highcastle replied at 9-12-2020 04:51 PM
Tapi kalau dia berani amik mmg aku tabik ler....... Kurang2 dia dah buktikan bukan ckp kosong..... ...

Terlajak perahu boleh engage reverse gear terlajak beri commitment utk jadi kambing bertompok hitam? Kehkehkehkeh

Tapi aku yakin bung mukhtar ini ada image brutal... dan sebagai pahlawan negeri dibawah bayu...dia akan laungkan semangat alang alang menyeluk pekasam biar sampai kepangkal lengan....

Yehaaaaaaa
Quote stingerclaw 9-12-2020 05:06 PM
nazzse replied at 9-12-2020 04:57 PM
Kat mana boleh dapatkan report tu. Mcm menarik je.

Now i nak tahu apa plak keberkesanan vaksin b ...

China? The mention of this nation aja dah send shivers down my spine...

Kahkahkahkahkah
Quote annehuda 9-12-2020 05:10 PM
Edited by annehuda at 9-12-2020 05:18 PM
Menurut laporan sama, dua individu yang menerima vaksin itu ketika tempoh percubaan, meninggal dunia, manakala empat lagi meninggal dunia ketika peringkat plasebo.

aku ni bkn saintis so kalau ade  yg salah sila betulkan.  ok imagine mcm ni, 100 org test subjek, kene amek vaksin 3 dos.

vaccine ni trial die ada banyak jenis.  mcm plasebo. masa phase ni, 50  amek dos ke2, 50 lagi amek dos utk vaksin utk sakit lain tapi bkn vaksin sebenar. why? 1 sebab nk buktikan yg vaksin tu btul2 berkesan, ke2 sbb nak tgk adakah vaksin tu cukup utk membentuk perlindungan yg aku tak ingat pggl ape, tapi kalau lg ramai org dah divaksinkan dalam komuniti tu ianya akan dpt melindungi sebilangan kecil yg tak amek vaksin. ni aku tak ingat ape. kemungkinan masa peringkat plasebo tu adalah test subject yg amek bukan vaksin sebenar.
fasa percubaan selalunye la, randomly selected test subjects yg disuntik dengan vaksin sebenar pastu dibebaskan mcm tu utk tgk adakah diorg ni akan kene covid spt org yg tak divaksinkan.  kemungkinan yg mati tu bukan la yg dh disuntik dgn vaksin.

tapi jgn keliru semua 100 org tu masih lg test subject ye

kalau dos pertama dan dos kedua tu berjaya baru akan pegi ke trial ke3, sbb in science sebarang ujikaji akan dibuat dlm nombor ganjil utk mengelakkan peratus seri masa keputusan (sorry aku tak reti nak explain mcm mane)

sbb aku terperasan pada ayat yg ni

Bagaimanapun, kadar kematian itu tidak membangkitkan isu keselamatan atau keberkesanan vaksin berkenaan memandangkan ia berlaku ke atas populasi umum pada kadar yang sama.

yg volunteer utk test vaksin covid ni sampel diambil secara rawak. maksudnye sesama volunteer pun tak tau diorg ni volunteer.  

kalau ade yg salah sila betulkan. tq

Quote Meiizu 9-12-2020 05:12 PM
stingerclaw replied at 9-12-2020 04:29 PM
Tengok lepas berita ini, bung mukhtar  kenabatangan mahu terus mengoffer diri to be the first one be ...

meraung ziziezet

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