Nachrichtenagentur Radio Utopie
Nachrichten direkt von der Quelle. Im Kontext sehen. News Agency of Radio Utopie. News directly from the source. There is context in life. Deutsch, English. 24 h. – Democracy First!
(23 November 2020)
The virus from chimps is genetically modified so it cannot cause an infection in people. It can then be modified again to contain the genetic blueprints for whatever you want to train the immune system to attack. This target is known is an antigen.
ChAdOx1 is in essence a sophisticated, microscopic postman. All the scientists have to do is change the package.
„We drop it in and off we go,“ said Prof Gilbert.
(10.06.2021)
Although the new vaccine variants shows considerable promise, Prof Gilbert said there was no guarantee it would be mass-produced since existing jabs are proving effective against new strains – so it may make more sense to carry on producing those rather than manufacturing different ones.
Vaccines minister Nadhim Zahawi insists 31 July target for offering doses to all adults will be hit despite ‘tight’ supplies of Pfizer
Meanwhile, NHS figures show the number of infected patients in hospitals across England has dropped into three figures for the first time since the second wave spiralled out of control nine months ago. Daily admissions are now below 100.
The data follows on from promising statistics from Public Health England and a symptom-tracking app yesterday, which showed the easing of restrictions on April 12 has not triggered any spike in the disease.
(4. Dezember 2020)
1. Dieser sogenannte „Impfstoff“ schützt weder vor Infektion von SARS II (dem aktuellen Coronavirus), noch vor dessen Verbreitung. Er schützt, heisst es, lediglich vor der Krankheit Covid-19. Und das auch nur ca. 3 Monate. Es können allerdings trotzdem „Symptome“ wie Müdigkeit auftreten. Eine Immunität gegen SARS II gibt es durch diesen Impfstoff nicht.
Über diese Informationen herrscht weltweit faktisch Nachrichtensperre.
(4. Dezember 2020)
Fazit Nr.1: neben allem anderen läuft dieser „Impfstoff“ darauf hinaus, dass man ihn alle paar Monate nehmen soll / muss und dafür natürlich entsprechend bezahlt wird, wohl bis zum Lebensende.
2. Sowohl die „Impfstoffe“ der Konzerne Pfizer und BioNTech, als auch Moderna, basieren auf Gentechnologie rund um das „messenger ribonucleic acid“ Molekül, abgekürzt mRNA (hier dazu alle Artikel auf der Nachrichtenagentur mit diesem Schlüsselbegriff). Diese „Impfstoffe“ verändern das menschliche Erbgut. Nie zuvor ist eine derartige Technologie auf die Menschheit losgelassen bzw ein derartiger „Impfstoff“ zugelassen worden.
By the morning of March 23, officials at the National Institute of Allergy and Infectious Diseases released a letter from its data and safety monitoring board that’s been examining the AstraZeneca trial, Andrew Joseph reports for STAT News. The letter stated that AstraZeneca had used outdated data to reach its efficacy number. The move was unprecedented; usually, monitoring boards keep their correspondence with companies private.
“We just felt we could not remain silent. Because if we did remain silent, we could be understandably accused of covering something up. And we definitely didn’t want to be in that position,” says Anthony Fauci, director of the NIAID, to STAT News. “In my mind, it’s an unforced error by the company.”
Britain negotiated a better contract to secure vaccine supplies with AstraZeneca that trumps the EU’s agreement with the company, the health secretary has said.
EU leaders will today discuss European Commission proposals for export bans if there are new supply shortages this spring amid a dispute over who gets a stock of four million doses made by AstraZeneca’s Dutch factory.
Mit Blick auf den Streit zwischen der EU und AstraZeneca über gekürzte Liefermengen sagte Hancock der „Financial Times“: „Unser Vertrag übertrumpft deren. Das nennt sich Vertragsrecht und ist eindeutig.“ Die EU habe einen Vertrag, der lediglich „beste Bemühungen“ seitens des Impfstoffherstellers zusichere, London habe sich hingegen Exklusivität zusichern lassen.
(31.01.2021)
First, the parties.
The agreement is between the European Commission, acting on behalf of European Union member states, and AstraZeneca AB, incorporated in Sweden.
That this is the AstraZeneca entity that is party to the agreement may be significant, for (all other things being equal) only that entity will be bound by obligations on AstraZeneca in the agreement – and not any other AstraZeneca entity.
Ms von der Leyen said Brussels had the right to ban the export of vaccines to the UK. But according to a UK Government official, such a move would be illegal.
The source told the Daily Mail: “The reality is our contract with AstraZeneca is rock-solid and better than the EU’s.
“And we’re only getting what we helped to develop and paid for.”
(19.03.2021)
The United Kingdom (UK) will have to slow its Covid-19 vaccine rollout in April due to a supply crunch caused by a delay in a shipment of millions of AstraZeneca vaccines from the Serum Institute of India.
Von der Leyen said Anglo-Swedish pharma giant AstraZeneca had delivered only 30 percent of the 90 million vaccine doses it had promised for the first quarter of the year.
The company has blamed production delays at its EU plants, but European officials are furious that AstraZeneca has been able to deliver its United Kingdom contract while falling short on the continent.
(12.03.2021)
But the 180 million doses expected in the second quarter are now also in jeopardy, since half of these doses were planned to be sourced from the global supply chain.
The Serum Institute of India (SII) has told Brazil, Saudi Arabia and Morocco that further supplies of the Oxford/AstraZeneca Covid-19 vaccine will be delayed because of surging demand at home and work on capacity expansion, a source with direct knowledge of the matter said.
– Matt Hancock under fire for raising hopes of huge ramp up in vaccines only for supplies setback to emerge
– Serum Institute of India has been told it must hand jabs to its own citizens before exporting vaccine stocks
– One batch of five million doses of the AstraZeneca jab bound for the UK has been delayed by a month
. Confusingly Boris Johnson insisted Indian government has not blocked any exports, as he prepares to visit
And data from the Medicines and Healthcare products Regulatory Agency (MHRA) regulator in the UK show more people have reported blood clots after having Pfizer’s vaccine than the Oxford one — even though Pfizer’s jab has not been suspended anywhere.
Up to February 28 there were 38 reports from approximately 11.5million doses of Pfizer’s jab, compared to 30 from 9.7m AstraZeneca doses. However, neither figure – the equivalent of one blood clot seen in every 367,000 jabs – is thought to be higher than the risk expected in the general population.
Die Entscheidung zur Aussetzung ist keine wirkliche Überraschung – angesichts dessen, dass sich andere Länder, zuerst Dänemark, dann Norwegen, Island, Bulgarien, Irland, die Niederlande und – auf bestimmte Chargen begrenzt – auch Österreich, Estland, Lettland, Litauen, Luxemburg, Italien und Rumänien zu einem solchen Schritt entschlossen hatten und dazu auch Fälle von schweren Blutgerinnseln zur Begründung angegeben wurden.
Der Konzern begründete dies gestern so: „Leider werden Exportbeschränkungen die Lieferungen im ersten Quartal nun reduzieren, und werden dies wahrscheinlich auch im zweiten Quartal.“ Weitere Details wurden nicht genannt
Die US Regierung wehrt sich gegen Vorwürfe, sie würden Hersteller mit einem Exportstopp daran hindern, zugesagten Impfstoff nach Europa zu liefern. Es gebe kein Exportverbot. Der Impfstoff im Kühlschrank gehöre den USA, sei gekauft und bezahlt, den gebe man nicht einfach ab. Das habe nichts mit Exportverbot zu tun.
Damit ist die Wirkungsweise von Johnson & Johnson die gleiche, wie die des Impfstoffs von AstraZeneca, nur dass beide unterschiedliche Trägerviren verwenden.
Bei den neuartigen mRNA-Impfstoffen von BioNTech/Pfizer und Moderna werden hingegen keine Viren oder Teile von Viren geimpft, sondern direkt ein Teil des Coronavirus-Erbgutes. Diese genetische Information funktioniert wie ein Bauplan
„Wir haben bis zu 150 Millionen Dosen Impfstoff in Auftrag gegeben, davon 50 Millionen Dosen, die hier in Australien produziert werden sollen“, sagte er. Die Welt befinde sich derzeit in einem ziemlich unerforschtem Gebiet, da sei es wenig überraschend, „dass einige Länder das Regelbuch zerreißen werden“.
Italien hatte EU-Kreisen zufolge die Lieferung von 250.000 Dosen Impfstoff des britisch-schwedischen Herstellers AstraZeneca an Australien verhindert –
Erstmals ist die Ausfuhr von Corona-Impfstoff aus der Europäischen Union in einen Drittstaat gestoppt worden. Italien verhinderte die Lieferung von 250.000 Dosen Impfstoff des britisch-schwedischen Herstellers AstraZeneca nach Australien, wie das Außenministerium in Rom mitteilte. Die Dosen stammen demnach aus einer Fabrik in Italien, die von AstraZeneca betrieben wird. Die EU habe der Anordnung aus Rom zugestimmt.
Der britisch-schwedische Konzern habe in internen Gesprächen erklärt, im zweiten Quartal „weniger als 90 Millionen Einheiten“ zu liefern, so der EU-Vertreter, der nach eigenen Angaben in die Gespräche eingebunden war.
Wie aus einer Mitteilung des Unternehmens hervorgeht, will AstraZeneca nun bis Ende März 4,2 Millionen Dosen liefern. Die Regierung hatte mit acht Millionen Dosen für die ersten drei Monate gerechnet.
Die ansteckendere Corona-Variante aus Großbritannien macht bei den Neuinfektionen in Deutschland mittlerweile einen deutlich größeren Anteil aus. Laut Gesundheitsminister Spahn könnte sie bald dominierend sein.
(09.02.2021)
It expects to have a vaccine designed to address the variant discovered in South Africa ready by autumn.
(14.02.2021)
The Anglo-Swedish company, which makes a vaccine developed by the University of Oxford, said it is working with the university’s scientists to adapt the shot to combat new variants.
(12.02.2021)
SAGE member Professor John Edmunds painted a darker picture and suggested the measures could last even longer.
He told ITV’s Peston face masks could be required „probably forever“ if COVID-19 becomes endemic in the UK.
Dr Dix added: ‚I think 40 days would be a real stretch but we would aim for something as good as that.
‚But certainly within 60 days and then, after that, we would start the manufacturing.‘
Manufacturing vaccines takes different amounts of time depending on the type of jab.
With huge global public health implications, Handelsblatt’s story rapidly became international news—and was rapidly rebuffed. Calls for the underlying data filled social media. An AstraZeneca spokesperson described the reported figure as “completely incorrect.”
The controversy came at a moment of intense finger pointing between the European Commission and AstraZeneca over unfulfilled vaccine shipments, and in the week that the European Medicines Agency (EMA) was expected to decide whether to recommend authorisation.
Für Länder wie Großbritannien, die USA oder die Mitglieder der EU und viele weitere spielt die WHO-Notfallzulassung keine Rolle. Sie machen selbst Risikoanalysen und entscheiden über eine Zulassung.
„We continue to call for Covid-19 vaccine developers to submit their dossiers to WHO for review at the same time as they submit them to regulators in high-income countries,“ he said.
A WHO statement said it had approved the vaccine as produced by AstraZeneca-SKBio (Republic of Korea) and the Serum Institute of India.
(10.02.2021)
AstraZeneca subcontracted the plant — previously owned by Novasep — to produce the drug substance of its vaccine. Volanti would not say how many doses the plant was contracted to provide. He said the plant sends its drug substance to an Italian company to be put into vials and packaged for distribution.
AstraZeneca declined to comment on Thermo Fisher’s remarks, according to Reuters.
(09.02.2021)
AstraZeneca has said it could take between six and nine months to produce Covid-19 vaccines that are effective against new variants of the coronavirus, and begin administering them to the public.
Der britisch-schwedische Pharmahersteller AstraZeneca will die Produktion von Corona-Impfstoffen in Europa ausweiten. Der Konzern wird dafür mit der Firma IDT Biologika in Sachsen-Anhalt zusammenarbeiten.
Both companies plan to invest in capacity expansion at IDT Biologika’s production site in Dessau, Germany to build up to five 2,000-litre bioreactors capable of making tens of millions of doses per month of AstraZeneca’s COVID-19 vaccine.
It expects to have a vaccine designed to address the variant discovered in South Africa ready by autumn.
Production BioNTech has said it can produce a fresh vaccine within six weeks of a decision being made. But the Oxford/AstraZeneca team, which uses more traditional viral vector technology, says that while it can make a new formulation in days, it takes much longer to produce
The study from South Africa suggested that two doses of the AstraZeneca vaccine provided „substantially reduced“ protection against mild to moderate Covid-19 disease from the new virus variant first identified there, known as B.1.351.
The study has not yet been peer reviewed or published in full, so many unknowns remain. What we do know is that it included a relatively small number of volunteers who were predominantly young and healthy and therefore not likely to suffer from severe Covid-19 disease.
(20.01.2021)
“This lineage exhibits complete escape from three classes of therapeutically relevant monoclonal antibodies,” the team of scientists from three South African universities working with the National Institute for Communicable Diseases (NICD) wrote in a paper in bioRxiv, a website that publishes scientific research prior to its being peer-reviewed and submitted to journals.
“Unfortunately, viruses mutate. Sometimes this is by accident. But often the reason is that the virus wants to become more adept to infect the host.”
This, Madhi explained, was what had happened with the South African variant as well as another variant that was first identified in the United Kingdom.
Einer Liste des Gesundheitsministeriums zufolge erhalten die Bundesländer insgesamt knapp 350.000 Impfdosen von dem britisch-schwedischen Hersteller. Für die kommende Woche ist eine weitere Lieferung von 390.000 Dosen des jüngst zugelassenen Wirkstoffs angekündigt.
If there was no impact of a vaccine on asymptomatic infection, it would be expected that an efficacious vaccine would simply convert severe cases to mild cases and mild cases to asymptomatic, with overall PCR positivity unchanged. A measure of overall PCR positivity is appropriate to assess whether there is a reduction in the burden of infection. Analyses presented here show that a single standard dose of the vaccine reduced PCR positivity by 67%, and that, after the second dose, the SD/SD schedule reduced PCR positivity by 49.5% overall. These data indicate that ChAdOx1 nCoV-19, used in the authorised schedules, may have a substantial impact on transmission by reducing the number of infected individuals in the population.
Meanwhile, analysis of PCR positive swabs carried out on nearly 7,000 patients in the UK arm of Oxford’s trial suggests the vaccine may reduce transmission by 67 per cent.
Aufhorchen ließ in diesem Zusammenhang die Zusage des britisch-schwedischen Pharmakonzerns AstraZeneca, seinen Corona-Impfstoff zum „Selbstkostenpreis“ abzugeben, damit also keinen Gewinn machen zu wollen. Allerdings ist dieses Versprechen offenbar zeitlich begrenzt. Wie die „Financial Times“ unter Berufung auf ein internes Dokument berichtete, verfällt dieses Angebot im Juli. Ein kleiner, aber wichtiger Zusatz der Aussage von Konzernchef Pascal Soriot hatte darauf hingedeutet, dass der Selbstkostenpreis nur gelte, „solange die Pandemie andauert“.
The Oxford AstraZeneca vaccine will not be recommended for over-65s in France or Sweden, the countries‘ health ministries announced today.
It comes after Germany advised against administering the jab to those over 65 and Emmanuel Macron claimed it was ‚almost ineffective‘ for the age bracket.
Continental objections to the jab last week came amid a furious row between the Bloc and AstraZeneca over lagging supply, which has seen newly-unshackled Brexit Britain storm ahead in its immunisation roll-out.
Following the renewed request from the European Commission on 27 January 2021, pharmaceutical company AstraZeneca has agreed to publish the redacted contract signed between the two parties on 27 August 2020.
The Commission welcomes the company’s commitment towards more transparency in its participation in the rollout of the EU Vaccines Strategy.
Astrazeneca hat nun zugestimmt, den Vertrag, der am 27. August zwischen EU und dem Pharmaunternehmen unterzeichnet wurde, zu veröffentlichen. Die Brüsseler Behörde stellte das 41 Seiten lange Dokument am Freitag auf ihre Webseite. [Hier können Sie die den Vertrag, der von der EU veröffentlicht wurde, im englischen Original einsehen.]
Nicola Sturgeon has been accused of siding with the EU in its battle with the UK over vaccine doses, with the Scottish First Minister pledging to publish confidential vaccine data despite warnings that the information could jeopardise the UK’s supply.
Ms Sturgeon promised to publish the data – which reveals how many vaccine doses her nation expects each week – to counter claims that she is failing to rollout the vaccine in Scotland at speed.
Despite the PM warning that the information must be confidential to protect the rollout, Ms Sturgeon told Holyrood she will release it from next week ‚regardless of what they say‘.
The timing of Ms Sturgeon’s intervention was particularly provocative given that it came as Mr Johnson was on an official visit to Scotland to make the case for the Union.
AstraZeneca gehört zu den Pharmaunternehmen, die von der Europäischen Union mit mehreren Hundert Millionen Euro unterstützt werden. 336 Millionen sind allein für AstraZeneca reserviert. Damit sollte die Forschung am Impfstoff beschleunigt und die schnelle Produktion gesichert werden. Ein Teil des Geldes ist schon geflossen, vollständig ausgezahlt ist der Beitrag noch nicht.
Man habe viel vorfinanziert, sagt Kommissionschefin Ursula von der Leyen beim digitalen Weltwirtschaftsforum von Davos, jetzt müsse auch geliefert werden
Die EU sieht das anders: Man habe dem Unternehmen einen Vorschuss gewährt, um auf Halde zu produzieren. Vor der erwarteten Zulassung des Impfstoffs am Freitag durch die Europäische Arzneimittelbehörde hätte AstraZeneca also längst Impfdosen zurückstellen müssen. Stattdessen habe das Unternehmen die für Europa bestimmten Ampullen nach Großbritannien ausgeliefert.
The Novasep’s factory in the town of Seneffe is part of the European production chain for the Oxford-AstraZeneca coronavirus vaccine.
Beamte der belgischen Arzneimittelbehörde statteten dem AstraZeneca-Standort in Seneffe einen Besuch ab. Die EU-Kommission hatte die Untersuchung angefordert. Sie will wissen, ob auf EU-Gebiet produzierte Dosen nach Großbritannien umgeleitet wurden.
The meeting comes as a row escalates over the supply of its coronavirus vaccine. #sabcnews
(25.01.2021)
Pascal Soriot said world leaders “could and should have been better prepared for this pandemic” and criticised what he called the “me first” attitude many have adopted in tackling the crisis.
“Globally, it’s fair to say we could and should have been better prepared for this pandemic,” AstraZeneca boss Soriot said during an appearance on a virtual panel on Monday.
In der EU herrscht Impfstoff-Knappheit. Verfolgen Sie die Pressekonferenz mit der EU-Gesundheitskommissarin Stella Kyriakides jetzt hier im Livestream.
Die britische Regierung hatte sich mit dem Konzern im Alleingang bereits im Mai 2020 auf die Produktion und Lieferung des Impfstoffes geeinigt. Einen Monat später gab es zwar eine vorläufige Absprache von AstraZeneca mit Deutschland, Frankreich, den Niederlanden und Italien. Doch der im Juni von diesen Ländern ausgehandelte Vertrag wurde nicht abgeschlossen, sondern von der EU erst Ende August unterzeichnet. Das habe den Aufbau der Produktion der Impfdosen in Belgien entsprechend verzögert, argumentiert man bei AstraZeneca.
Embarrassingly for the bloc, it appears that Germany, the Netherlands, France and Italy had originally been looking to do a deal with AstraZeneca in May alongside the UK – but were blocked by the EU, which insisted it take over negotiations.
According to ITV’s Robert Peston: ‚The extra talks with the European Commission led to no material changes to the contract, but wasted time on making arrangements to make the vaccine with partner sites.‘
(21.01.2021)
SII has licensed the vaccine developed by Oxford University and AstraZeneca. Many low- and middle-income countries, from Bangladesh to Brazil, are depending on SII delivering the vaccine, known as COVISHIELD in India, to fight the COVID-19 epidemic.
Under this program, 250,000 front line workers will be vaccinated – Lalith Weeratunga
AstraZeneca says it has not pulled out of talks with the EU on vaccine deliveries, plans meeting later Wednesday.
The cancellation follows an explosive interview with AstraZeneca CEO Pascal Soriot on Tuesday night, in which he insisted the company didn’t have a contractual obligation but rather a „best effort“ to supply the EU with its vaccine.
Instead of the meeting, the company will respond in writing to Health Commissioner Stella Kyriakides‘ demand for more information, the Commission official said. AstraZeneca did not immediately confirm this plan.
A University of Oxford spokesperson said clinical trials showed similar immune responses in younger and older adults, a good safety profile and high efficacy in younger adults. “There is no basis for the claims of very low efficacy of the Oxford/AstraZeneca vaccine which have been circulating in the media,” they said.
While it is true that there was less data from older adults involved in the trials, the team say early figures were promising: “Preliminary efficacy data in older adults supports the importance of this vaccine for use in this population,” they said.
Handelsblatt was still running the original story today with the headline: ‚Setback to coronavirus vaccine: AstraZeneca vaccine appears to hardly work on seniors‘.
A subheading noted that Germany’s health minister Jens Spahn had been ‚circumspect‘ about the claim, without mentioning the ministry’s subsequent denial.
Gregor Waschinski, one of the journalists behind the story, stood by it on Monday night and said it was confirmed by ‚multiple sources familiar with the German vaccination policy‘.
EXCLUSIVE-ASTRAZENECA HAS PROPOSED TO THE EU TO BRING FORWARD START OF SUPPLIES OF ITS COVID-19 VACCINE TO FEB 7 FROM FEB 15 – EU SOURCES
EU countries learnt late last week that deliveries of the vaccine from AstraZeneca, which is expected to be approved on Friday, would be some 60% lower in the first quarter than initially indicated.
There have also been reduced deliveries of a vaccine jointly produced by Pfizer and BioNTech.
„Wir sehen, dass Dosen anderswohin geliefert werden“, sagte der Kommissionssprecher. Da die EU Vorauszahlungen für die Produktion geleistet habe, „sollten diese Dosen eigentlich für die Lieferung verfügbar sein“, sobald die EMA grünes Licht gebe.
AstraZeneca konnte bei zwei Treffen mit der EU-Kommission und den Mitgliedsstaaten gestern Brüssel zufolge nicht ausreichend erklären, wie es zu den Lieferengpässen gekommen ist.
The health ministry insisted the claims made in German media last night were based on confused analysis of a study into the effectiveness of the AstraZeneca jab.
Another Westminster official said: “The efficacy claims circulating in the German media are unsubstantiated and incorrect.”
Speaking to Politico, a third added: “After this, support for Brexit will be at about 90 percent.”
The claims in the German media were made on the same day a row broke out between the European Union and AstraZeneca over supplies of the vaccine to the continent.
(15.06.2020)
Novasep brings to AstraZeneca more than 20 years of expertise in viral vector production. Novasep’s investment strategy in the large-scale production of biopharmaceutical products for immunotherapy and gene therapy enables Novasep to support the alliance for the production of the vaccine active substance in Europe.
The production operations will be carried out at Novasep’s Belgian site in Seneffe. Furthermore, the biopharmaceutical ecosystem in the region allows Novasep to rapidly mobilize the additional human resources needed to achieve this project.
Meanwhile, there is another row raging after two German newspapers claimed the EU’s regulator could refuse to give the Oxford/AstraZeneca jab full approval, with officials anonymously briefing its efficacy for pensioners was just eight per cent.
However, the claim was branded ‚absolutely incorrect‘ and ‚unsubstantiated‘ by the pharmaceutical company – and No10 sources told MailOnline it was ‚rubbish‘. One Whitehall source told Playbook it was the kind of tactics ‚you expect from the Russians‘.
Möglicherweise wird es Einschränkungen bei der Anwendung des Impfstoffs geben, denn Zeitungsberichten zufolge ist die Wirksamkeit bei älteren Menschen eingeschränkt. AstraZeneca weist das zwar zurück, einen Gegenbeweis bleibt das Unternehmen in seinen Veröffentlichungen bisher aber schuldig.
Good evening.
You know that AstraZeneca’s vaccine is currently in the final stages of the approval process with the European Medicines Agency.
If all requirements are met, the European Medicines Agency could recommend market authorisation by the end of this week.
But there is a problem on the supply side.
Last Friday, the company AstraZeneca surprisingly informed the Commission and the European Union Member States that it intends to supply considerably fewer doses in the coming weeks than agreed and announced.
This new schedule is not acceptable to the European Union.
n a sign of the EU’s frustration – after Pfizer also announced a temporary slowdown in vaccine supplies earlier in January – EU health commissioner Stella Kyriakides proposed forcing drug makers to register in advance their Covid-19 vaccine exports, so the bloc can keep track of what they are doing.
In der ersten Gesprächsrunde zwischen AstraZeneca, Vertretern der EU-Kommission und den Mitgliedsländern gab es dem Vernehmen nach keine Fortschritte. Man hat die Positionen ausgetauscht. Es sei jedoch nicht sicher, ob AstraZeneca den Ernst der Lage verstanden hat, hieß es aus der Kommission. Am Abend soll eine zweite Gesprächsrunde folgen.
(21.01.2021)
Brazil is set to collect two million doses of Serum Institute’s (SII) Covishield vaccine, two weeks after Brazilian President Jair Bolsonaro requested Prime Minister Narendra Modi for their “urgent” clearance, sources confirmed to The Hindu.
(23.01.2021)
Health Minister Zweli Mkhize announced on Friday that the South African Health Products Regulatory Authority (SAHPRA) has granted approval to the SII, which is producing the vaccine in collaboration with the University of Oxford and AstraZeneca, to supply the drug to the country.
Gesundheitsminister Roberto Speranza habe nun das Management von AstraZeneca getroffen, die die Einschränkungen bei den Lieferungen bestätigten. „All das ist unannehmbar“, so Conte, der mit Klagen gegen die Pharmakonzerne drohte.
The @EU_Commission will continue to insist with @AstraZeneca on measures to increase predictability and stability of deliveries, and acceleration of the distribution of doses/3.
The company was expected to deliver around 80 million doses to the 27 EU countries by the end of March, an EU official told the agency.
However, it now expects that to be cut to 31 million doses due to „production problems“ at a vaccine factory in Belgium run by its partner Novasep.
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.
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.
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.
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.”
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.
(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.
(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.
(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.
(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.
(…)
Once the vaccine receives a positive scientific opinion, we will work full speed to authorise its use in Europe.
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.
(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.
(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.
„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.
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.
(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.
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.”
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 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.
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.
(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.
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.
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.
. 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.
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.
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.
(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.
(28.11.2020)
In fact, AZ has already produced a bulk vaccine that’s kept at freezing temperatures.
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.
– 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
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.
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.
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.
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.
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.
The UK has ordered 100 million doses of the Oxford AstraZeneca vaccine – enough for the entire population
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.
Welcome to profit first, morals later America.
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.
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.
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.
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.
(06.11.2020)
(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.
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.
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.
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 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.
(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 …
(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
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.
“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.
(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.
(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.
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.
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.
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.
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.
How the race to develop treatments and a vaccine will create a historic windfall for the industry — and everyone else will pay the price
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.
“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.
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.