CDE News - The Dispatch

EU says Novavax COVID shot must carry heart side-effect warning

(Reuters) - The European Medicines Agency (EMA) is recommending Novavax's COVID-19 vaccine carry a warning of the possibility of two types of heart inflammation, an added burden for a shot…

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Bavarian Nordic monkeypox vaccine gets preliminary nod from EU drug regulator

COPENHAGEN, July 22 (Reuters) - Danish biotechnology company Bavarian Nordic said on Friday the European Union's drug regulator had recommended its Imvanex vaccine be approved to also include protection against…

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UPDATED: EU backs second COVID booster for over-60s, before variant-adapted vaccines are ready

BRUSSELS/LONDON, July 11 (Reuters) - European Union health agencies on Monday recommended a second COVID-19 booster for everyone over 60, as well as medically vulnerable people, amid a new rise in infections…

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New wave of Omicron mutations spreading across Europe, EU Medicines Agency warns

A new wave of Covid-19 is sweeping across Europe driven by Omicron mutations, an EU Medicines Agency official has warned. Head of vaccines at the agency, Marco Cavaleri, has said…

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EU ramps up collection of public health data to improve drug reviews

Feb 9 (Reuters) - The European Medicines Agency has set up a new centre to collect and mine more public health data from EU member states to improve the review…

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EU regulator begins real-time review of Valneva’s COVID-19 shot

Dec 2 (Reuters) - The European Union's (EU) drug regulator said on Thursday it had started a rolling review of the protein-based COVID-19 vaccine from French biotech firm Valneva ,…

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EU’s health agency says vaccine boosters should be considered for all adults

BRUSSELS, Nov 24 (Reuters) - The head of the European Union's public health agency Andrea Ammon said on Wednesday that COVID-19 vaccine boosters should be considered for all adults, with…

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EU says decision on J&J COVID-19 vaccine booster dose ‘within weeks’

Nov 22 (Reuters) - The European Union's drug regulator said on Monday it was evaluating data on booster doses of the COVID-19 vaccine by Johnson & Johnson and a decision…

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EU advises on Merck COVID pill as reviews rival from Pfizer

The European Union's drug regulator has issued advice on using Merck's COVID-19 pill for adults and began a review of a rival tablet from Pfizer to help member states decide…

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EU watchdog to announce view on vaccine for children next week- Austria

Nov 17 (Reuters) - Europe's drug regulator is likely to disclose its view on the use of Pfizer and BioNTech's COVID-19 vaccine in five to 11 year-old children around Wednesday…

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EU regulator lists new side-effect of J&J COVID-19 shot

Europe's drug regulator on Thursday recommended adding a rare type of spinal inflammation called transverse myelitis as a side-effect of Johnson & Johnson's single-dose COVID-19 vaccine. Reports of this serious…

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Europe drug regulator backs use of Moderna’s COVID-19 booster vaccine

The European Union's drug regulator on Monday said it has concluded in its review that Moderna's COVID-19 booster vaccine may be given to people aged 18 years and above, at least six…

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EU regulator starts real-time review of Merck’s COVID-19 pill

Oct 25 (Reuters) - U.S. drugmaker Merck & Co Inc said on Monday the European Union's drug regulator has initiated a real-time review of its experimental COVID-19 antiviral drug for…

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EU finds J&J COVID shot possibly linked to another rare clotting condition

Oct 1 (Reuters) - The European Union's drug regulator said on Friday there is a possible link between rare cases of bloods clots in deep veins with Johnson & Johnson's…

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UPDATED: EU reviewing cases of rare body inflammation after COVID-19 shots

Europe's medicines regulator said on Friday it was reviewing if there was a risk of a rare inflammatory condition after inoculation with COVID-19 vaccines, following a report of one case…

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EU regulator backs AstraZeneca drug for rare blood disorder in children

AstraZeneca said on Monday the European Medicines Agency (EMA) recommended approving a medicine from its U.S.-based Alexion unit for treating a rare, deadly blood disorder in children and adolescents aged…

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UPDATED: EU regulator endorses use of Moderna COVID-19 vaccine in teens

Europe's medicines regulator on Friday recommended approving the use of Moderna's COVID-19 vaccine in 12- to 17-year olds, paving the way for it to become the second shot okayed for…

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EMA to assess use of immunosuppressant drug Kineret in adult Covid patients

The European medicines regulator said on Monday it is evaluating an application to use arthritis drug, Kineret, to treat COVID-19 in adult patients with pneumonia who are at risk of…

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EU-approved COVID-19 vaccines protect against Delta variant, says official

Europe's drug regulator said on Thursday the COVID-19 vaccines approved in the European Union offered protection against all coronavirus variants, including Delta, but called for active monitoring by vaccine manufacturers…

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EU drug regulator EMA records 415 cases of possible rare blood clotting

The EU drug regulator said on Thursday it has received reports of 415 possible cases of rare blood clotting with a low platelet count in the European Economic Area, out…

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EU approval of Russia’s Sputnik V vaccine delayed

European Union approval of Russia's Sputnik V coronavirus vaccine will be delayed because a June 10 deadline to submit data was missed, two people familiar with the matter told Reuters,…

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AstraZeneca shots have good risk-benefit profile for over 60s, says EMA official

The head of the EU drug regulator's COVID-19 task force said on Sunday that AstraZeneca's coronavirus vaccine had a favourable risk-benefit profile for all age groups and particularly for those…

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AstraZeneca shots should be halted for over-60s too – EMA official

Countries should also avoid giving the Astrazeneca coronavirus vaccine to people over 60, the head of the EU drug regulator's COVID-19 task force was quoted on Sunday as saying, amid…

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EU adds another rare blood condition as side effect of AstraZeneca shot

Europe's drug regulator on Friday identified another very rare blood condition as a potential side effect of AstraZeneca's COVID-19 vaccine and said it was looking into cases of heart inflammation…

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EMA highlights guidance not to use heparin for COVID-19 vaccine-linked clots

The European Medicines Agency (EMA) on Monday pushed guidance for doctors not to use the blood thinner heparin to treat rare blood clots and low blood platelets in people who…

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EU regulator oks Pfizer-BioNTech COVID-19 vaccine for 12-year-olds

Europe's medicines regulator on Friday backed the use of Pfizer's COVID-19 vaccine for children as young as 12, paving the way for a broader roll-out in the region after similar…

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EMA advices against second AstraZeneca shot in those with blood clots

The European medicines regulator said on Friday a COVID-19 antibody treatment developed by GSK and Vir Biotechnology can be used to treat patients who are at risk of severe disease…

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EU regulator begins real-time review of GSK-Vir’s COVID-19 antibody drug

Europe's medicines regulator said on Friday it has begun a real-time review of the COVID-19 antibody treatment developed by GSK and Vir Biotechnology , formally kicking off the process for…

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EU regulator begins real-time review of first Chinese COVID-19 vaccine

Europe's medicines regulator said it has started a real-time review of Sinovac's COVID-19 vaccine, based on preliminary results from animal and human trials that suggested the vaccine produces an immune…

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EU reviews J&J COVID-19 vaccine for blood clots, expands AstraZeneca probe

April 9 (Reuters) - Europe's drug regulator said on Friday it had started reviewing reports of a bleeding condition in people who had received AstraZeneca's COVID-19 vaccine and was also…

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EU regulator finds possible link between AstraZeneca vaccine and rare blood clots – UPDATE

BRUSSELS, April 7 (Reuters) - The European Medicines Agency (EMA) said on Wednesday it had found a possible link between AstraZeneca's coronavirus vaccine and reports of very rare cases of…

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EU expects impact on vaccination plans after EMA announcement on AstraZeneca

European Union health ministers have been told the EU drug regulator's decision on the safety of the AstraZeneca vaccine is expected to have an immediate impact on vaccination plans and…

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EU regulator to probe ethical standards of Sputnik vaccine trials

The EU drug regulator will begin investigations next week on whether clinical trials of Russia's Sputnik V COVID-19 vaccine followed global clinical and scientific guidelines, the Financial Times reported on…

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EMA official sees clear ‘association’ between AstraZeneca vaccine and rare blood clots in brain – UPDATE

A senior official at Europe's medicines regulator has said there is a clear "association" between AstraZeneca's COVID-19 vaccine and very rare blood clots in the brain, though the direct cause…

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EU drug regulator investigating 62 reports of rare clotting worldwide – chief

Europe's drug regulator is investigating 62 cases worldwide of a rare blood clotting condition which has prompted some countries to limit the use of AstraZeneca's COVID-19 vaccine, its chief Emer…

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All eyes on EU regulator as AstraZeneca decision to be released

The European Medicines Agency (EMA) is due to provide an assessment on Thursday of the safety of Astrazeneca's vaccine against Covid-19 after several countries temporarily suspended use of the jab…

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Explainer: How worried should we be about reports of blood clots and AstraZeneca’s vaccine?

FRANKFURT/PARIS (Reuters) - Europe’s drug watchdog is reviewing a small number of reports of bleeding, blood clots and low platelet counts in people who have received AstraZeneca’s coronavirus vaccine. The…

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European Medicines Agency: Benefits of AstraZeneca vaccine continue to outweigh the risks – UPDATED

AMSTERDAM (Reuters) - Europe's medicines watchdog on Tuesday said the benefits of AstraZeneca's COVID-19 vaccine continue to outweigh the risks after several countries halted its use due to concerns about…

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EMA gives green light to J&J’s single-shot COVID-19 vaccine

March 11 (Reuters) - The European Union's drugs regulator on Thursday recommended conditionally approving Johnson & Johnson's single dose COVID-19 vaccine, as the bloc seeks to speed up a stuttering…

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EU Commission considering emergency approvals for COVID-19 vaccines

BRUSSELS, March 2 (Reuters) - The European Commission said on Tuesday that it was considering emergency approvals for COVID-19 vaccines as a faster alternative to more rigorous conditional marketing authorisations…

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Johnson & Johnson submits vaccine for EMA’s approval for use in Europe

Anadolu - Johnson & Johnson on Tuesday applied for conditional marketing authorization of its COVID-19 vaccine, the European Medicines Agency (EMA) said in a statement. “EMA’s human medicines committee (CHMP)…

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German health minister open to using Russia, Chinese vaccines

Berlin (dpa) - German Health Minister Jens Spahn has said he is open to the use of coronavirus vaccines from Russia or China in Germany, as a debate over the availability of vaccines…

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EMA – Gap between Pfizer doses should be three weeks

Amsterdam (dpa) - The European Medicines Agency (EMA) has tightened its guidelines for the use of the Pfizer/BioNTech vaccine in a resolution published on Thursday, according to which the second dose has to…

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Germany pushes EU to approve vaccine before Christmas

Germany continued to pile pressure on the EU's regulatory agency, asking it to approve a coronavirus vaccine before Christmas, The Guardian reported this morning. “Our goal is an approval before…

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EU agency assessing COVID vaccines hit by cyberattack

The European Medicines Agency (EMA) has launched an investigation after being hit by a cyberattack, the agency said in a brief statement. "EMA has been the subject of a cyberattack.…

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EU drug regulator to use UK data on adverse effects in assessment of Pfizer vaccine

BRUSSELS (Reuters) - The European Union drug regulator will use data from Britain and other countries outside the EU on the safety of Pfizer-BioNTech's COVID-19 vaccine before deciding whether to…

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UPDATE – Hackers steal Pfizer/BioNTech COVID-19 vaccine data in Europe, companies say

LONDON, Dec 9 (Reuters) - U.S. drugmaker Pfizer and its German partner BioNTech said on Wednesday that documents related to their development of a COVID-19 vaccine had been "unlawfully accessed"…

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Europe lays ground for fast-tracking COVID-19 vaccine reviews

The European health regulator has started reviewing data on AstraZeneca and Oxford University's potential COVID-19 vaccine in real time, the first of such moves aimed at speeding up any approval…

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EU drugs agency evaluates potential coronavirus treatment

The European Medicines Agency said Thursday it will start a rolling review of remdesivir, an investigational therapy for COVID-19 originally developed by drugmaker Gilead to treat Ebola. EMA’s human medicines committee…

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UN Committee says Ebola in DR Congo still an international public health emergency

The Ebola outbreak in the eastern Democratic Republic of the Congo (DRC) officially remains a Public Health Emergency of International Concern, experts meeting in Geneva said. The World Health Organization…

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World’s biggest anti-malaria vaccine campaign begins in Africa

Some 360,000 children a year in three African countries are to receive a powerful anti-malaria drug as part of a pilot project to help reduce the incidence of the…

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