Grund dafür sind laut AstraZeneca „reduzierte Erträge der Impfsubstanz an einem Produktionsstandort“, hieß es. Insgesamt werde man im Februar und März „mehrere zehn Millionen Dosen“ in die EU liefern.
Archiv: AstraZeneca Plc (corporation / production and distribution of Oxford vaccine ChAdOx1 nCoV-19)
Denkt Boris Johnson mit?
Wir berichteten am 4. Dezember, dass der bereits im Frühjahr 2020 von der Oxford Universität entwickelte Impfstoff ChAdOx1 nCoV-19 (später AZD1222 oder Covishield) „jederzeit allen weiteren Varianten“ von SARS II angepasst werden kann. Wie der britische „Telegaph“ nun berichtet, geschieht dies jetzt.
Premierminister Boris Johnson, ansonsten umflutet von Myraden von Experten und sicherlich auch privat als Daddy gefordert, soll sich nun ausnahmsweise mit den Wissenschaftler.innen der Oxford Universität „intensiv“ unterhalten.
Es wurde auch Zeit.
Bericht: AstraZeneca-Impfstoff wird überarbeitet
Wissenschaftlerinnen und Wissenschaftler der Universität Oxford überarbeiten den zusammen mit dem Konzern AstraZeneca entwickelten CoV-Impfstoff, damit dieser gezielt gegen die neuen, hochansteckenden Coronavirus-Mutationen eingesetzt werden kann, die in Großbritannien, Südafrika und Brasilien entdeckt wurden.
AstraZeneca: ‘Manufacturing should take lion’s share of credit for vaccine success’
Back in March, Oxford University had “a limited manufacturing and supply capacity so they needed a partner,” Srinivasan said. “We decided to immediately offer our capacity in terms of the global reach. But that was only the beginning. Then we had to establish various alliances whether public partnerships that have been governments, or with for profit organizations or CMOs [some of which can be found here, here, and here], or not for profit organizations such as The Gates Alliance, GAVI, CEPI, and other organizations.”
Slow vaccine rollout could make lockdown last PAST Easter as Priti Patel blames AstraZeneca and Pfizer for causing ’supply issues‘ by ‚upgrading their factories‘ – even though ’21m doses are already in UK‘ and Scotland is ’sitting on 400k‘
Priti Patel today blamed AstraZeneca and Pfizer for an alarming slowdown in the UK’s vaccine rollout – amid warnings the target of giving jabs to the 14million most vulnerable people by mid-February is now ‚very tight‘.
The Home Secretary pointed the finger at the firms after the daily rate fell for a third consecutive day, saying ‚upgrades‘ at factories and ‚reconfiguring‘ of supply chains were causing delays.
China’s Kangtai starts mid-stage trial of its COVID-19 vaccine candidate
(29.10.2020)
Apart from developing its own vaccine, Kangtai also has a deal to make and supply mainland China with the vaccine candidate developed by AstraZeneca and researchers at the University of Oxford.
China’s ‘King of Vaccines,’ a partner to AstraZeneca, is plagued by scandal.
(Dec. 7, 2020)
Kangtai will be the exclusive manufacturer in mainland China for the vaccine made by AstraZeneca, and the companies could work together on deals for other countries. Kangtai is also in early trials for its own candidate.
UPDATE 1-Brazil’s Fiocruz says AstraZeneca vaccine ingredients may be delayed weeks
(08.01.2021)
A source with knowledge of the situation said the active
ingredient is ready to be shipped to Brazil, but is still
waiting for an export license from China, where it is produced.
AstraZeneca vaccine likely won’t be authorized in US until April
(30.12.2020)
The coronavirus vaccine developed by AstraZeneca and Oxford University is not likely to be authorized for use in the U.S. until April, a top Trump administration health official said Wednesday.
“We project, if everything goes well, that the readout and emergency use authorization may be granted somewhere early in the month of April,” Moncef Slaoui, the chief science adviser for the administration’s Operation Warp Speed, told reporters.
AstraZ did not apply for approval until now. EMA cannot approve what they do not get.
(…)
Good news! @AstraZeneca has applied to @EMA_News to have its vaccine authorised in the EU. @EMA_News will assess the vaccine’s safety & efficacy.
Once the vaccine receives a positive scientific opinion, we will work full speed to authorise its use in Europe.
Zulassung beantragt: EU-Entscheidung über Astrazeneca-Vakzine folgt noch im Jänner
Für die EU und Österreich soll der ChAdOx1 nCoV-19-Impfstoff mit 400 Millionen vorbestellten Dosen das Rückgrat für die Durchimpfung der breiten Bevölkerung darstellen. Das wird auch dadurch erleichtert, dass die Vakzine bei normaler Kühlschranktemperatur von zwei bis acht Grad Celsius länger aufbewahrt werden kann.
Global partnership COVAX secures two billion COVID-19 vaccine doses
(19.12.2020)
UNITED NATIONS: Global vaccine partnership COVAX has lined up almost two billion doses of existing and candidate COVID-19 vaccines for use worldwide, including 200 million doses of the AstraZeneca/Oxford vaccine through an agreement between the Vaccine Alliance Gavi, the Serum Institute of India and the Bill and Melinda Gates Foundation.
EU bureaucracy is accused of ‚costing lives‘ after European regulators said they cannot approve the Oxford vaccine before February
(31.12.2020)
Mr Wathion told Belgian newspaper Het Nieuwsblad the EMA was ‘in the dark’ about what kind of data was being used for Britain to approve the use of the Oxford vaccine.
The EU has already bought 400million doses of the jab while awaiting regulatory approval.
EU still holds out on granting approval to Oxford-AstraZeneca’s COVID-19 vaccine
„Additional scientific information on issues related to quality, safety and efficacy of the vaccine is deemed necessary to support the rigour required for a conditional marketing authorisation (CMA) and this has been requested from the company,“ the EMA said in a statement. „Further information from the ongoing clinical trials is also expected from January.“
The Amsterdam-based agency earlier told AFP that it had not yet received any formal marketing authorisation and that it had set no timetable for approving the vaccine.
PROFESSOR ANGUS DALGLEISH: The Oxford AstraZeneca coronavirus vaccine is as close to a miracle as medicine ever gets
Everyone can see what a serious emergency this is. We have to act. Bin the bureaucracy, and get this miracle vaccine to work right now.
AstraZeneca and Oxford University announce landmark agreement for COVID-19 vaccine
(30.04.2020)
The collaboration aims to bring to patients the potential vaccine known as ChAdOx1 nCoV-19, being developed by the Jenner Institute and Oxford Vaccine Group, at the University of Oxford. Under the agreement, AstraZeneca would be responsible for development and worldwide manufacturing and distribution of the vaccine.
AstraZeneca’s Covid-19 vaccine may have to wait for EU’s approval
The EMA’s deputy executive director Noel Wathion told Belgian newspaper Het Nieuwsblad that the pharmaceutical company “has not even filed an application” with the European drug regulators yet.
He further said that EMA “did not even have enough to warrant a conditional marketing license.”
Wohl keine Zulassung im Januar: EMA: Astrazeneca hat noch nichts beantragt
Boris Johnson’s future as Prime Minister rests on the Oxford vaccine being approved
The hope in Downing Street is that the Oxford vaccine will get the green light by the end of the year. This would allow the Prime Minister to start laying out plans for restrictions to be lifted.
India likely to approve AstraZeneca vaccine by next week
India is likely to approve Oxford/AstraZeneca’s coronavirus vaccine for emergency use by next week after its local manufacturer submitted additional data sought by authorities, two sources with knowledge of the matter told Reuters on Tuesday.
How the Oxford-AstraZeneca Vaccine Works
The Oxford-AstraZeneca team used a modified version of a chimpanzee adenovirus, known as ChAdOx1. It can enter cells, but it can’t replicate inside them. (…)
The Oxford-AstraZeneca vaccine for Covid-19 is more rugged than the mRNA vaccines from Pfizer and Moderna. DNA is not as fragile as RNA, and the adenovirus’s tough protein coat helps protect the genetic material inside. As a result, the Oxford vaccine doesn’t have to stay frozen.
It took AstraZeneca researchers 1 month to get vaccine trial data to FDA, source tells CNN
(14.10.2020)
The source said the root of the delay is that the participant was in the United Kingdom, and the European Medicines Agency and the FDA store data differently.
„They had to convert data from one format to another format. It’s like taking stuff off a PC and putting it onto an Apple. They had to spend a lot of hours to get what they wanted,“ the source said.
Blunders Eroded U.S. Confidence in Early Vaccine Front-Runner
AstraZeneca was in part to blame for the delay, said the people with knowledge of the F.D.A. talks. The company was slow to provide the F.D.A. with all the data that regulators wanted to review before allowing the trial to start up again.
In late October, after 47 days, the F.D.A. cleared the U.S. trial to restart.
It was now even further behind the late-stage trials that Pfizer and Moderna had begun in the United States about a month before AstraZeneca’s trial started.
How does Oxford University’s coronavirus vaccine work and how is it different to Pfizer and Moderna’s?
Does it differ to PFizer and Moderna’s vaccines?
Yes. The jabs from Pfizer and Moderna are messenger RNA (mRNA) vaccines.
Conventional vaccines are produced using weakened forms of the virus, but mRNAs use only the virus’s genetic code.
First peer-reviewed results of phase 3 human trials of Oxford coronavirus vaccine demonstrate efficacy
. These data indicate that the low dose / standard dose vaccine may provide a protection against asymptomatic infection, but stress that these data are at an early phase, with too high a level of uncertainty to be certain that this vaccine will protect against asymptomatic infection.
Safety and immunogenicity of ChAdOx1 nCoV-19 vaccine administered in a prime-boost regimen in young and old adults (COV002): a single-blind, randomised, controlled, phase 2/3 trial
ChAdOx1 nCoV-19 appears to be better tolerated in older adults than in younger adults and has similar immunogenicity across all age groups after a boost dose.
Oxford confirms its Covid vaccine is 70% effective and safe – but scientists warn regulators face ‚dilemma‘ in approving jab to be given as 1.5 doses (which they accidentally found is 90% protective)
The MHRA has been considering whether to approve the vaccine since November 27 and is expected to reach a decision before the end of the year.
Oxford AstraZeneca Covid vaccine: everything we know so far
(23.11.2020)
No mRNA vaccine has ever been approved by regulators, but the Oxford approach has been used in vaccines given safely to thousands of people of all ages for diseases ranging from TB and malaria to Mers (another coronavirus) and Ebola, for which it is now being used in Uganda and the Democratic Republic of the Congo. Oxford opted for the chimp virus because it has the potential to generate a strong immune response and, since it cannot grow in humans, it should be safe.
Two other frontrunner vaccines, from BioNTech (developed with Pfizer) and Moderna (developed with the US National Institute of Allergy and Infectious Diseases), perform well, according to interim results from phase 3 human trials, achieving more than 90% efficacy. These are based on technology that is new to the vaccine field. Both use genetic material called mRNA, or messenger RNA, which tells human cells how to make coronavirus spike proteins.
How many willing to bet that this case is part of pharma wars to sabotage Oxford vaccine?
(28.11.2020)
AstraZeneca CEO blames trial delays, not manufacturing, for COVID-19 vaccine delivery shortfall
In fact, AZ has already produced a bulk vaccine that’s kept at freezing temperatures.
Delivery timetable for Oxford/AstraZeneca vaccine slips, UK official says
UK Vaccine Taskforce Chair Kate Bingham said that the vaccine was being made in bulk first, known as „drug substance“, but could not yet be put into vials until more was known on the timing of late-stage trial data.
„We’ve not yet put them into vials because as soon as you put them into vials you start the clock for the… shelf life, or how quickly you have to use the vaccine,“ she told lawmakers.
‚I’m so thrilled that you’ve cracked it!‘: Prince William congratulates Oxford scientists via Zoom as their Covid vaccine is proved to be 90 per cent effective
– The Duke of Cambridge hailed the team’s ‚amazing achievement‘ this morning
– Three Oxford professors told how the vaccine is based on decades of research
– It emerged this month that William caught coronavirus in April but didn’t reveal it
AstraZeneca to seek FDA authorization for vaccine based on foreign trial data
The company halted its U.S. trial in early September over safety concerns, after a trial participant reported neurological problems. The study resumed earlier this month after FDA concluded that no evidence linked the volunteer’s symptoms to the shot.
AstraZeneca shares slip after analyst says vaccine will struggle to get green light in US – live updates
SVB Leerink analyst Geoffrey Porges said the treatment may never gain approval from US regulator the FDA, and said Astra had highlighted results from a “relatively small” number of patients.
Oxford AstraZeneca Covid vaccine: everything we know so far
No mRNA vaccine has ever been approved by regulators, but the Oxford approach has been used in vaccines given safely to thousands of people of all ages for diseases ranging from TB and malaria to Mers (another coronavirus) and Ebola, for which it is now being used in Uganda and the Democratic Republic of the Congo. Oxford opted for the chimp virus because it has the potential to generate a strong immune response and, since it cannot grow in humans, it should be safe.
Two other frontrunner vaccines, from BioNTech (developed with Pfizer) and Moderna (developed with the US National Institute of Allergy and Infectious Diseases), perform well, according to interim results from phase 3 human trials, achieving more than 90% efficacy. These are based on technology that is new to the vaccine field. Both use genetic material called mRNA, or messenger RNA, which tells human cells how to make coronavirus spike proteins.
Studienergebnisse von AstraZeneca: Britischer Impfstoff wirkt zu 70 Prozent
Das Ergebnis bleibt zwar hinter den Werten der Präparate von Pfizer/Biontech und Moderna zurück. Wenn man aber zunächst nur eine halbe Dosis verabreiche und erst einen Monat später eine volle, dann erreiche der Impfstoff eine Effektivität von 90 Prozent, lässt AstraZeneca wissen. Er soll zudem deutlich preiswerter sein, sich sehr viel leichter lagern und weltweit transportieren lassen als andere Vakzine.
Oxford University breakthrough on global COVID-19 vaccine
he University of Oxford, in collaboration with AstraZeneca plc, today announces interim trial data from its Phase III trials that show its candidate coronavirus vaccine, ChAdOx1 nCoV-2019, is effective at preventing COVID-19 (SARS-CoV-2) and offers a high level of protection.
UK’s Covid-19 Oxford AstraZeneca vaccine on course to be ready by end of 2020
The UK has ordered 100 million doses of the Oxford AstraZeneca vaccine – enough for the entire population
Top Scots academic warns ministers not to prioritise Pfizer vaccine
The vaccine, which is thought to be effective against Covid-19 in nine out of 10 people, could be ready for distribution by next month but it needs to be stored at -80C for it to work.
This ‚ultra-cold‘ state is part of the logistical challenge facing the country, particularly if the vaccine is manufactured overseas.
The professor, from the university’s Centre for Sustainable Road Freight, explained that it may make more sense to prioritise the AstraZenica Oxford vaccine which can be made in the UK.
So the Pfizer vaccine is expected to be up to seven times more expensive than the Oxford one, reports the Times.
Welcome to profit first, morals later America.
Oxford v Pfizer: how costs and logistics could still see Oxford’s vaccine win out
Matt Hancock has warned the mass distribution would be a “colossal exercise” involving not just the NHS but the Armed Forces.
The Health Secretary acknowledged there was “enormous complexity” in administering the Pfizer vaccine.
Oxford-AstraZeneca COVID-19 vaccine production begins in Australia
The Sydney Morning Herald reported that it will take CSL about 50 days to completely process the vaccine. According to the newspaper, the company has separate contracts with AstraZeneca and the Australian government for the production of the vaccine.
The AstraZeneca vaccine still needs to be approved by Australia’s Therapeutic Goods Administration (TGA). Phase three clinical trials of the vaccine are expected to wrap up by the end of this year.
The tube that could change the world: First vial of COVID-19 vaccine ’starting material‘ after Australian breakthrough – with millions to be made from tomorrow
Biotechnology giant CSL announced they would start producing the AstraZeneca AZD1222 coronavirus vaccine at its factory in Melbourne this week.
About 30million doses will be manufactured as part of a first-of-its-kind agreement with the Australian government, with the company hoping to release them in the first half of 2021 pending clinical trials and approval.
The jab, which was produced at the University of Oxford, is seen as the leading candidate across the globe and is in final-stage trials.
Coronavirus Vaccine Update: India shifts focus on indigenous vaccine as AstraZeneca deliveries run late
India seems to have shifted focus on its indigenous novel coronavirus vaccine soon after AstraZeneca said earlier this week that it was holding back deliveries of its Covid-19 vaccine.
Thank you to all of our brilliant scientists at @UniOfOxford , @AstraZeneca & across the UK who are working tirelessly to find a vaccine and to all those who have volunteered to take part in a clinical trial. This government – and the whole country – are backing you 100%
(06.11.2020)
COVID vaccine deliveries on ice as AstraZeneca awaits trial data
(05.11.2020)
A summer dip in UK coronavirus infections has pushed back test results for AstraZenca’s potential COVID-19 vaccine, leading the drugmaker to delay deliveries of shots to the UK government.
Britain starts accelerated review for AstraZeneca’s potential COVID-19 vaccine
Work began on the Oxford vaccine in January. Called AZD1222 or ChAdOx1 nCoV-19, the viral vector vaccine is made from a weakened version of a common cold virus that causes infections in chimpanzees.
German Pfizer vaccine could be ready before Oxford-AstraZeneca injection and be given to Brits before Christmas
Ms Bingham was appointed chair of the UK’s Vaccine Taskforce for Covid-19 in May and reports directly to the Prime Minister on the progress of a coronavirus vaccine, which experts say is key to controlling the pandemic.
The taskforce, which Ms Bingham says was the ‚brainchild of Sir Patrick Vallance‘ — Number 10’s chief scientific adviser, is at the forefront of putting plans in place to get the UK population vaccinated.
University Hospitals and CWRU join global study of AstraZeneca’s COVID-19 vaccine
AstraZeneca paused its trial in early September to review safety data because a British trial participant developed a neurological condition.
Last week, the Food and Drug Administration authorized the resumption of the company’s U.S. trials after reviewing global safety data. The trial had already resumed in other countries.
Astrazeneca Scores $286.9M US Army Contract For Covid Vaccine
Astrazeneca Pharmaceuticals (AZN) has been awarded a $286.9 milllion firm-fixed-price contract for the delivery of 200 million doses of AZD1222 vaccine for COVID- 19.
Bids were solicited via the internet with one received, the US Department of Defense revealed.
EU warns not enough COVID vaccines for all in Europe until 2022
(27.10.2020)
The EU has so far secured doses of the potential vaccines being developed by AstraZeneca, Sanofi and Johnson & Johnson. It has also said it is in talks with …
Germany to include Israel in EU deal for vaccine, citing ‘special relationship’
(14.10.2020)
Berlin’s foreign minister reportedly tells Gabi Ashkenazi that Israel will get AstraZeneca COVID-19 inoculation when it is sold to European countries
European Commission say that AstraZeneca has sold its jab at about $3 to $4 a dose in deals with the EU
Astra-Oxford Vaccine Stays Near Front of Line Despite U.S. Delay
A seven-week halt to a U.S. trial of the Covid vaccine developed by AstraZeneca Plc and the University of Oxford bumped it from pole position in the race for a protective shot, but it’s still in the leading pack.
AstraZeneca says its coronavirus vaccine triggers immune response among adults
“It is encouraging to see immunogenicity responses were similar between older and younger adults and that reactogenicity was lower in older adults, where the COVID-19 disease severity is higher,” an AstraZeneca spokesman told CNBC via email.
“The results further build the body of evidence for the safety and immunogenicity of AZD1222,” the spokesman said, referring to the technical name of the Oxford-AstraZeneca vaccine.
It took AstraZeneca researchers 1 month to get vaccine trial data to FDA, source tells CNN
(14.10.2020)
The source said the root of the delay is that the participant was in the United Kingdom, and the European Medicines Agency and the FDA store data differently.
„They had to convert data from one format to another format. It’s like taking stuff off a PC and putting it onto an Apple. They had to spend a lot of hours to get what they wanted,“ the source said.
As AstraZeneca’s Covid-19 vaccine trial remains on hold in U.S., participants waiting on a second dose are in limbo
(06.10.2020)
Still, such participants occupy an unusual position in a trial shutdown that is being closely watched as a potential indicator of the prospects of a frontrunner in the race to develop a vaccine to curb the devastation of the Covid-19 pandemic.
For the participant who spoke with STAT — and others in his same position who can’t currently get their booster shot — the trial halt has become a waiting game. “Now, we’re waiting as the lab rats in the corner,” said the participant, who requested anonymity because he was worried he could face consequences if study investigators found out he had spoken to the press.
AstraZeneca, J&J resuming US tests of COVID-19 vaccines
The two coronavirus vaccines are among several candidates in final-stage testing, the last step before seeking regulatory approval.
The drugmakers said they got the go-ahead Friday from the Food and Drug Administration to restart tests in the U.S.
Oxford COVID-19 vaccine follows its programmed genetic instructions, independent analysis finds
The AstraZeneca Oxford COVID-19 vaccine (ChAdOx1 nCoV-19 and also known as AZD1222) now undergoing Phase III clinical trials, has already undergone rigorous testing to ensure the highest standards of quality and safety. Now a team at Bristol University has used recently developed techniques to further validate that the vaccine accurately follows the genetic instructions programmed into it by the Oxford team. This novel analysis provides even greater clarity and detail about how the vaccine successfully provokes a strong immune response.
Five US military facilities are among the locations selected for final coronavirus vaccine trials
The military medical facilities chosen in Texas, California and the Washington D.C. area were among dozens of locations across the country selected to participate in Phase III testing of drug maker AstraZeneca’s AZD1222, one of four vaccine candidates undergoing testing. In Phase III, thousands of volunteers are given the potential vaccines to study its effectiveness and safety, according to the National Centers for Disease Control and Prevention.
In change of tack, EU leaves door open to COVID vaccines purchase through WHO
The move could allow EU governments to secure vaccines from companies that are not negotiating with Brussels, such as U.S. firms Merck, Inovio and Novavax. They are all in talks with the WHO scheme, dubbed COVAX, but have so far not been reported to be involved in negotiations with the EU Commission.
Big Pharma’s Covid-19 Profiteers
How the race to develop treatments and a vaccine will create a historic windfall for the industry — and everyone else will pay the price
AstraZeneca to be exempt from coronavirus vaccine liability claims in most countries
July 30, 2020
AstraZeneca has been granted protection from future product liability claims related to its COVID-19 vaccine hopeful by most of the countries with which it has struck supply agreements, a senior executive told Reuters.
U.K. Orders 90 Million Vaccine Doses from Pfizer and Valneva
“It’s the right thing to be doing to be at the absolute front of the queue to make sure we’re in a position to get those vaccines first when they become available,” Education Secretary Gavin Williamson told the BBC during the government’s media round on Monday.
Oxford coronavirus vaccine is safe and induces immune reaction, findings suggest
Initial trials on 1,077 British adults found that the vaccine induced strong antibody and T-cell responses, which may improve further after a booster jab, as reported by the Telegraph.
There were found to be no serious adverse events, and minor side effects could be controlled by paracetamol, two papers in The Lancet reported.