Archiv: European Medicines Agency / Europäische Arzneimittel-Agentur (EMA)


15.02.2021 - 22:34 [ BMJ.com ]

Why did a German newspaper insist the Oxford AstraZeneca vaccine was inefficacious for older people—without evidence?

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.

15.02.2021 - 22:20 [ ORF.at ]

WHO erteilte Notfallzulassung für AstraZeneca

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.

29.01.2021 - 16:50 [ Tagesschau.de ]

EMA gibt AstraZeneca-Vakzin frei

Die europäische Arzneimittelagentur EMA hat die Zulassung des Corona-Impfstoffs von AstraZeneca in der EU empfohlen. Die finale Entscheidung liegt nun bei der EU-Kommission. Die Zustimmung gilt als Formsache.

29.01.2021 - 05:12 [ theGuardian.com ]

Why has Germany advised against Oxford/AstraZeneca jab for over-65s?

Prof Andy Pollard, of the University of Oxford, said the lack of data is understandable. “In our trials, the older adults were recruited later and, because they were recruited later there has been less time for cases to occur, and, older adults are known to be more cautious in the pandemic, meaning the ‘attack rate’ is lower,” he said.

AstraZeneca has stressed that older adults were recruited later because the team wanted to be sure the vaccine was safe before administering it to older age groups.

29.01.2021 - 05:10 [ Dr. ASeidler - Infektiologie / Twitter ]

#STIKO des #RKI empfiehlt den #Impfstoff von #AstraZeneca nicht für Personen über 65 Jahre. Die #Zulassung seitens der #EMA #EU steht noch aus.

28.01.2021 - 15:07 [ DailyMail.co.uk ]

Germany blocks Oxford jab for over-65s: Panel says data on older people is insufficient – but does not support ‚8% effectiveness‘ claim – amid EU row with Britain over AstraZeneca supplies

AstraZeneca’s vaccine has not been granted approval yet for general use in the European Union, but the bloc’s medicines regulator EMA is poised to authorise it on Friday.

The German panel, STIKO did not detail the data from clinical trials on the vaccine on older people, but two prominent German media outlets had reported that the efficacy on above-65s was below 10 per cent.

27.01.2021 - 01:34 [ theGuardian.com ]

Why experts say there is no basis to claims in Germany about efficacy of AstraZeneca vaccine

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.

27.01.2021 - 01:12 [ DailyMail.co.uk ]

German media doubles-down on AstraZeneca vaccine stats: Handelsblatt newspaper REPUBLISHES widely rubbished claim that Oxford jab is only 8% effective in Over-65s and says there was NOT a mix-up in its reporting

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‘.

26.01.2021 - 19:49 [ BBC ]

Coronavirus: Germany rejects ‚mixed up‘ reports on AstraZeneca jab

The reports emerged in Handelsblatt, a respected financial daily, and the mass-circulation Bild, quoting sources within Germany’s governing coalition.

26.01.2021 - 19:38 [ ORF.at ]

Begrenzte Zulassung laut EMA grundsätzlich möglich

Die EU-Arzneimittelagentur (EMA) schließt nicht aus, dass der Coronavirus-Impfstoff von AstraZeneca in Europa nur für eine bestimmte Altersgruppe zugelassen wird. „Ich werde der Entscheidung nicht vorgreifen“, sagte EMA-Chefin Emer Cooke heute in einer Anhörung im Europaparlament. Eine begrenzte Zulassung sei aber grundsätzlich möglich. Das werde genau geprüft.

26.01.2021 - 16:39 [ Reuters ]

EU to monitor vaccine exports, but says it’s not a ban

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.

22.01.2021 - 08:01 [ Tagesschau.de ]

Corona-Impfstoff: Pfizer liefert weniger Ampullen

Pfizer begründete das gegenüber der Nachrichtenagentur AFP mit einer Stellungnahme der EU-Arzneimittelbehörde EMA, wonach aus jedem Fläschchen bis zu sechs statt der ursprünglich kalkulierten fünf Impfdosen gezogen werden können.

„Wir halten unsere Lieferverpflichtungen gegenüber den Staaten ein“, teilte Pfizer mit. Die Bestellungen hätten „immer auf einer Gesamtzahl von Dosen beruht und nicht von Ampullen“.

22.01.2021 - 07:57 [ ORF.at ]

Pfizer-Impfstoff: Schwierigkeiten bei zusätzlichen Impfdosen

Pfizer wird jedenfalls künftig weniger Ampullen ausliefern: In einer Stellungnahme gegenüber der Nachrichtenagentur AFP hieß es am Donnerstag, dass man sich bei der Auslieferung an die Bestellerländer nun an der Empfehlung der EMA orientiere. Die Bestellungen hätten „immer auf einer Gesamtzahl von Dosen beruht und nicht von Ampullen“, hieß es.

12.01.2021 - 13:08 [ Ben Mulcahy / Twitter ]

AstraZ did not apply for approval until now. EMA cannot approve what they do not get.

(…)

12.01.2021 - 13:01 [ Ursula von der Leyen, President of the @EU_Commission / Twitter ]

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.

12.01.2021 - 12:54 [ KleineZeitung.at ]

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.

06.01.2021 - 20:03 [ ZDF ]

EU lässt Moderna-Impfstoff zu

Am Mittag hatte die Europäische Arzneimittelbehörde EMA die Zulassung des Corona-Impfstoffs des US-Herstellers Moderna empfohlen. Nun hat ihn die EU-Kommission zugelassen.

06.01.2021 - 10:00 [ Ian Cornwell / Twitter ]

Ireland. Just had a 16 Billion Euro COVID bill, that it gets 1.5 back from. Waits patiently for the EMA to approve its vaccines. No sign of the EMA approving Oxford any time soon. 2009 – gets another Lisbon ref, whilst being threatened with perdition. „Independence“

06.01.2021 - 09:53 [ Giles Maybe / Twitter ]

EU land news. EMA who sign off vaccine has not even began to look at the AZ Oxford vaccine while its own curevac vaccine is still months away from approval. The eu failed to buy needles & its vaccine distributions hit a brick wall yesterday (accept holland They not yet started)

06.01.2021 - 09:47 [ Max Roser / Twitter ]

Good article in The Economist trying to explain why the vaccination campaigns across Europe are so very slow and why this ‚risks extending the pandemic for months.‘

02.01.2021 - 19:11 [ ORF.at ]

EU-Kommissarin verteidigt Impfstrategie

Gleichzeitig habe man mit anderen Herstellern Verträge geschlossen. „Wir waren uns in der EU einig, dass wir nicht alles auf eine Karte setzen dürfen“, so die Kommissarin. Sonst wären die EU-Staaten womöglich ohne wirksamen Impfstoff dagestanden.

02.01.2021 - 19:06 [ DailyMail.co.uk ]

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.

01.01.2021 - 08:50 [ Firstpost.com ]

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.

30.12.2020 - 12:14 [ thehindubusinessline.com ]

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.”

30.12.2020 - 11:55 [ ntv Nachrichten / Twitter ]

Wohl keine Zulassung im Januar: EMA: Astrazeneca hat noch nichts beantragt

15.12.2020 - 22:20 [ ZDF ]

Ema zieht Entscheidung zu Impfstoff vor

Die EU-Medikamentenbehörde Ema prüft die Zulassung der Impfstoffe von Biontech und Pfizer gegen Corona am 21. Dezember, also noch vor Weihnachten. Es lägen alle nötigen Daten vor.

15.12.2020 - 10:15 [ ORF.at ]

D: Regierung drängt auf schnelle Impfstoffzulassung

Das deutsche Bundeskanzleramt und das Gesundheitsministerium verlangten intern von der EMA, das Vakzin bis 23. Dezember zur Verimpfung auf EU-Ebene und damit auch in Deutschland freizugeben, meldete die „Bild“ (Dienstag-Ausgabe) unter Berufung auf Regierungs- und EU-Kreise.

12.12.2020 - 20:00 [ CNN ]

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.

26.10.2020 - 17:19 [ CNN ]

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.

26.10.2020 - 17:17 [ Statnews.com ]

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.

25.06.2020 - 18:43 [ theGuardian.pe.ca ]

Gilead’s remdesivir set to become Europe’s first COVID-19 therapy

The European Medicines Agency (EMA) said on Thursday its human medicines committee (CHMP) recommended conditionally approving the drug for adults and adolescents from 12 years of age who are also suffering from pneumonia and require oxygen support. (https://bit.ly/3i3O6Ck)

European Union conditional marketing authorisation allows a treatment to be sold for a year in the 27-nation bloc before all necessary data on its efficacy and side-effects are available. Gilead has until December to submit this data.