AstraZeneca tarik balik vaksin COVID-19 di seluruh dunia
AstraZeneca tarik balik vaksin COVID-19 di seluruh dunia
Foto fail AGENSI
LONDON: Syarikat farmaseutikal global Britain-Sweden, AstraZeneca menarik balik vaksin COVID-19 di seluruh dunia, lapor Telegraph semalam.
Vaksin itu tidak lagi boleh digunakan di Kesatuan Eropah selepas syarikat itu secara sukarela menarik balik "kebenaran pemasaran", menurut laporan itu.
Permohonan untuk menarik balik vaksin itu dibuat pada 5 Mac dan berkuat kuasa pada 7 Mei.
Permohonan serupa akan dibuat di United Kingdom dan negara lain yang telah meluluskan vaksin itu dikenali sebagai Vaxzevria, pada bulan depan.
Sementara itu menurut AstraZeneca ia telah memulakan penarikan vaksin COVID-19 di seluruh dunia kerana lebihan vaksin terkini yang tersedia sejak pandemik itu.
Syarikat itu juga berkata ia akan meneruskan untuk menarik balik kebenaran pemasaran vaksin Vaxzevria di Eropah.
"Memandangkan pelbagai jenis vaksin COVID-19 telah dibangunkan, terdapat lebihan vaksin dikemas kini yang tersedia," kata syarikat itu, sambil menambah bahawa ini telah menyebabkan penurunan permintaan untuk Vaxzevria, yang tidak lagi dikeluarkan atau dibekalkan.
AstraZeneca yang tersenarai di London mula beralih ke vaksin virus pernafasan dan ubat obesiti melalui beberapa urus niaga tahun lalu selepas pertumbuhan yang perlahan apabila jualan ubat COVID-19 merosot.
Keputusan menarik balik itu dipercayai dibuat selepas syarikat itu mengakui dalam dokumen mahkamah bahawa vaksin berkenaan boleh menyebabkan kesan sampingan yang jarang berlaku dan berbahaya.
Dalam dokumen undang-undang yang dikemukakan kepada Mahkamah Tinggi pada Februari, ia membuat beberapa pengakuan, antaranya, ia menyatakan vaksin COVID-19 buatannya 'boleh, dalam kes yang sangat jarang berlaku, menyebabkan TTS atau 'Thrombosis with Thrombocytopenia Syndrome' iaitu pembekuan darah dan kiraan platelet darah menjadi rendah.
Media bulan lalu melaporkan AstraZeneca buat kali pertama mengakui dalam dokumen mahkamah bahawa vaksin COVID-19 mereka boleh menyebabkan kesan sampingan yang jarang berlaku.
Pengakuan itu secara langsung boleh membuka jalan untuk pampasan undang-undang bernilai jutaan pound, dengan 51 kes dikemukakan di Mahkamah Tinggi setakat ini, menuntut ganti rugi dianggarkan bernilai sehingga £100 juta (RM512 juta).
Gergasi farmaseutikal itu menghadapi saman atas dakwaan vaksin yang dibangunkan mereka bersama Universiti Oxford boleh menyebabkan kematian dan kecederaan serius dalam puluhan kes.
Peguam berhujah bahawa vaksin Itu menghasilkan kesan sampingan yang memberi kesan buruk kepada sebilangan kecil individu.
AZ ialah syarikat senarai awam kedua terbesar di UK, dengan modal pasaran melebihi £170 bilion (RM870 bilion).
AstraZeneca tarik balik vaksin COVID-19 di seluruh dunia, berbulan selepas sedar ada kesan sampingan
Agensi
Mei 7, 2024 23:15 MYT
AstraZeneca tarik balik vaksin COVID-19 di seluruh dunia, berbulan selepas sedar ada kesan sampingan
AstraZeneca menarik balik vaksin COVID-19 di seluruh dunia selepas syarikat tersebut secara sukarela menarik balik "kebenaran pemasarannya." - Gambar fail
SYARIKAT farmaseutikal gergasi vaksin COVID-19, AstraZeneca menarik balik vaksin keluarannya dalam pasaran dunia.
Ini selepas syarikat itu mengakui dalam dokumen mahkamah bahawa vaksin berkenaan boleh menyebabkan kesan sampingan yang jarang berlaku dan berbahaya.
Bagaimanapun, syarikat gergasi farmasi itu berkata bahawa vaksin itu dikeluarkan daripada pasaran atas sebab komersial.
Vaksin itu juga tidak lagi dibenarkan untuk digunakan di Kesatuan Eropah (EU) memandangkan syarikat itu secara sukarela menarik balik "kebenaran pemasarannya."
Permohonan pengeluaran telah dikemukakan pada 5 Mac dan berkuat kuasa pada hari Selasa.
Permohonan pengeluaran yang sama akan dikemukakan di United Kingdon (UK) dan negara lain yang sebelum ini telah meluluskan vaksin, yang dikenali sebagai Vaxzevria.
Menyebut keputusan itu "semata-mata kebetulan", gergasi farmasi itu menegaskan bahawa penarikan vaksin tidak dikaitkan dengan pengakuannya bahawa ia boleh menyebabkan Sindrom Thrombosis Thrombocytopenia (TTS).
AstraZeneca withdraws COVID-19 vaccine, Vaxzevria, citing commercial reasons after links to serious blood-clotting illnesses
The AstraZeneca COVID-19 vaccine, linked to extremely serious health conditions and restricted in Australia last year, will be discontinued worldwide amid its ongoing court case against 51 victims.
Pharmaceutical giant AstraZeneca is withdrawing its COVID-19 vaccines worldwide, starting with immediate effect in the European Union before applications are lodged for other countries.
The company was granted its request to pull back the vaccine, known as Vaxzevria, on Tuesday, after having applied on March 5.
It had come a week following a court admission on April 30, that Vaxzevria had induced the dangerous side effects of thrombosis – caused by excessive blood clotting – and a rare condition called thrombocytopenia syndrome (TTS) in some people.
As of May 7, the vaccine has been banned from Europe and had its “marketing authorisation” revoked, British newspaper The Telegraph reported.
A pharmacist holding a vial of the AstraZeneca COVID-19 vaccine. Picture: NCA NewsWire / Dan Peled
In the United Kingdom, the manufacturer was sued by dozens of affected victims after Vaxzevria was linked to almost 450 thrombosis and TTS cases and resulted in more than 80 deaths.
The country’s High Court received 51 lawsuits from families who claimed having experienced irreversible side effects, but the pharmaceutical company did not pin its decision of withdrawal on these cases.
In February, AstraZeneca told the court the COVID jab had the ability to cause TTS “in very rare cases”, however, claimed the move to kill the product was because of commercial, not health-related reasons.
It has not, however, conceded the vaccine directly caused serious injury or death, an admission which could lead to a hefty legal payout.
Making the announcement on Tuesday, AstraZeneca took credit for Vaxzevria saving more than 6.5 million lives during its first year of use alone, along with being supplied for more than three billion dozes globally.
AstraZeneca no longer provides Vaxzevria in Australia after it was linked to a rare but serious health condition TTS. Picture: Lisa Maree Williams/Getty Images
“Our efforts have been recognised by governments around the world and are widely regarded as being a critical component of ending the global pandemic,” the statement to the Telegraph read.
“As multiple, variant COVID-19 vaccines have since been developed, there is a surplus of available updated vaccines. This has led to a decline in demand for Vaxzevria, which is no longer being manufactured or supplied. AstraZeneca has therefore taken the decision to initiate withdrawal of the marketing authorisations for Vaxzevria within Europe.
“We will now work with regulators and our partners to align on a clear path forward to conclude this chapter and significant contribution to the Covid-19 pandemic.”
AstraZeneca has been discontinued in Australia since March 21 last year, upon advice to the federal government by the Australian Technical Advisory Group on Immunisation (ATAGI).
ATAGI noted while side effects of the vaccine were extremely rare and affected only about two to three people per 100,000, the severity of illness in those impacted could be extreme and, in some cases, fatal.
COVID-19 vaccines manufactured by multinational drug-maker Pfizer have replaced AstraZeneca in Australia. A number of alternatives are also widely used based on the circumstances of the patient.
Skynews.com.au could not get in touch with AstraZeneca’s Australian branch when contacted for comment.
Post time 8-5-2024 09:21 AMFrom the mobile phone|Show all posts
Aah dengar kat radio lagi tadi dalam kereta
Akhirnya radio pun keluarkan statement
Tapi apa boleh buat..benda dah cok..
Nak saman pun tak leh..benda dah sign
Tapi beribu2 tahniah la yg masih bertahan Ritu
Aku suka thread ni
The AstraZeneca COVID vaccine is being withdrawn worldwide after the pharmaceutical giant admits it causes a rare and dangerous side effect.
AstraZeneca admitted the claims in court documents lodged in February.
Parent company Vaxzevria has come under intense scrutiny in recent months over a rare side effect, which causes blood clots and low blood platelet counts.
AstraZeneca told the court that it can, in very rare cases, cause clots in the kidney.
AstraZeneca withdrawing Covid vaccine, months after admitting rare side effect
Company says decision is purely commercial as jab has been superseded by alternatives
Robert Mendick,
CHIEF REPORTER and
Patrick Sawer,
SENIOR NEWS REPORTER
7 May 2024 • 9:22pm
A woman holding a vial of the Oxford-AstraZeneca vaccine
The Oxford-AstraZeneca Covid vaccine is being withdrawn worldwide, months after the pharmaceutical giant admitted for the first time in court documents that it can cause a rare and dangerous side effect.
The vaccine can no longer be used in the European Union after the company voluntarily withdrew its “marketing authorisation”. The application to withdraw the vaccine was made on March 5 and came into effect on Tuesday.
Similar applications will be made in the coming months in the UK and in other countries that had approved the vaccine, known as Vaxzevria.
The decision to withdraw it brings to an end the use of the jab, which was heralded by Boris Johnson as a “triumph for British science” and credited with saving more than six million lives.
AstraZeneca said the vaccine was being removed from markets for commercial reasons. It said the vaccine was no longer being manufactured or supplied, having been superseded by updated vaccines that tackle new variants.
Vaxzevria has come under intense scrutiny in recent months over a very rare side effect, which causes blood clots and low blood platelet counts. AstraZeneca admitted in court documents lodged with the High Court in February that the vaccine “can, in very rare cases, cause TTS”.
TTS – which stands for Thrombosis with Thrombocytopenia Syndrome – has been linked to at least 81 deaths in the UK as well as hundreds of serious injuries. AstraZeneca is being sued by more than 50 alleged victims and grieving relatives in a High Court case.
But AstraZeneca has insisted the decision to withdraw the vaccine is not linked to the court case or its admission that it can cause TTS. It said the timing was pure coincidence.
In a statement the company said: “We are incredibly proud of the role Vaxzevria played in ending the global pandemic. According to independent estimates, over 6.5 million lives were saved in the first year of use alone and over three billion doses were supplied globally.
“Our efforts have been recognised by governments around the world and are widely regarded as being a critical component of ending the global pandemic.
“As multiple, variant Covid-19 vaccines have since been developed, there is a surplus of available updated vaccines. This has led to a decline in demand for Vaxzevria, which is no longer being manufactured or supplied. AstraZeneca has therefore taken the decision to initiate withdrawal of the marketing authorisations for Vaxzevria within Europe.
“We will now work with regulators and our partners to align on a clear path forward to conclude this chapter and significant contribution to the Covid-19 pandemic.”
The Telegraph has been told that the company will withdraw marketing authorisations in other countries, including the UK, where it has regulatory approval. AstraZeneca never had approval for the vaccine to be used in the US.
The company said: “We will partner with regulatory authorities globally to initiate marketing authorisation withdrawals for Vaxzevria, where no future commercial demand for the vaccine is expected.”
The Government largely stopped using the Oxford-AstraZeneca vaccine by the autumn of 2021, by which time it had supplied about 50 million doses in the UK. It was replaced in the UK with Pfizer and Moderna jabs in time for the winter booster campaign at the end of 2021.
Marco Cavaleri, head of vaccines at the European Medicines Agency, the body which is responsible for drug and medicine safety within the EU, told Italian media: “The authorisation of the anti-Covid vaccine Vaxzevria by AstraZeneca will be withdrawn and the process has already officially started with the European Commission. This is in line with the expectations that no-longer-used and updated vaccines will be withdrawn, as per our indication.”
Mr Cavaleri said he expected all the “monovalent” vaccines – which dealt only with the original Wuhan strain – to be withdrawn in time.
AstraZeneca accepted the vaccine can cause TTS in a legal document in February this year. The causal mechanism is not known.
Workers producing the vaccine in October 2021 CREDIT: JOHN LAWRENCE
Lawyers for claimants in the High Court case argue that the drug caused vaccine-induced immune thrombocytopenia and thrombosis (VITT) – a subset of TTS – and that it was not as safe as individuals were entitled to expect. AstraZeneca has always insisted that “patient safety is our highest priority”.
The company has said: “From the body of evidence in clinical trials and real-world data, the AstraZeneca-Oxford vaccine has continuously been shown to have an acceptable safety profile and regulators around the world consistently state that the benefits of vaccination outweigh the risks of extremely rare potential side effects.”
But Kate Scott, whose husband Jamie was left with a permanent brain injury after having the vaccine and who was the first person in the UK to bring a legal action, said: “AstraZeneca’s Covid vaccine no longer being used in the UK or Europe, and soon the rest of the world, means no one else will suffer from this awful adverse reaction.
“They say it is for commercial reasons, but maybe it’s because it can no longer be seen as being within the acceptable safety parameters, with 445 confirmed cases of VITT, 81 of these fatal in the UK alone.”
Mr Scott, 47, a father of two who has had to give up work, said: “This is good news, but I will always wish they had, like they did in other countries, paused it in the UK after just one case. More lives could have been saved and I would not be suffering the way I am.”
James and Kate Scott
Mr Scott, pictured with his wife, wishes the vaccine had been withdrawn much earlier CREDIT: ANDREW FOX
Sarah Moore, a partner at law firm Leigh Day, which is bringing the legal claims, said: “To those who we represent, all of whom have suffered bereavement or serious injury as a result of the AstraZeneca vaccine, this decision to withdraw marketing authorisation, ending the usage of the AstraZeneca vaccine in the EU, will be welcomed.
“It will be seen as a decision linked with AstraZeneca’s recent admission that the vaccine can cause TTS, and the fact that regulators across the world suspended or stopped usage of the vaccine following concerns regarding TTS.
“This is an important regulatory step, but still our clients remain without fair compensation. We will continue to fight for the compensation our clients need and campaign for reform of the vaccine damage payment scheme.”
The scheme, run by the Government, has paid out to victims. But it has been branded inadequate, prompting them to bring separate civil claims against AstraZeneca, which the drugs firm is contesting.
Post time 8-5-2024 11:57 AMFrom the mobile phone|Show all posts
Pasey bakcin abeh pecah belah umah mulayu isley.
Komen sekor² mcm tadak iman.
Baru bakcin.. Lom turun sang mata satu lg tuh
Paling lucu duktur² sampai la masih gigih karang cerpen.
Spin kot lain pulak
Trobek utk yg hilang ingatan
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Post time 8-5-2024 12:54 PMFrom the mobile phone|Show all posts
kembar i dpt az pastu dia xp sbb tkt...
anti vaks tersenyum sinis..
i serahkn semua pdNya sbb kalau x vaksin i kena resign..ini dr boss i tau....tp lps vaksin i punya bdn mcm lg lemah...dlu i jrg sakit...
i mmg sht je orgnya..demam pun xpnh..
sejak vaksin ni dah pandai amek mc..
masa memula vaksin dlu tgh masak i nk pengsan..ingt nk mati dh masa tu..dua kali jd gitu..
then ada satu mlm mcm jantung berdegup..i menngis tkt mati
tp pastu dah ok...
itu je l beza irg xpnh sakit..sakit sikit dah banjir satu umh
Post time 8-5-2024 08:22 AM
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