About: European Medicines Agency
Johnson and Johnson vaccine probe deepens Europe’s COVID woes
Europe's stuttering vaccine rollout faced multiple hurdles as EU regulators said they were reviewing side effects of the Johnson & Johnson (Janssen) shot and France further limited its use of the AstraZeneca jab.
EU countries fail to reach a common position on how to use the AstraZeneca jab
EU member countries have adopted different tactics on how to use the AstraZeneca vaccine, despite the Commission’s push for a coordinated approach.
No data currently available on mixing COVID vaccines, says EMA
There are currently no guidelines on the "mixing and matching" of COVID-19 vaccines, the European Medicines Agency (EMA) clarified on Wednesday (7 April), as several European countries are now considering mixed vaccination strategies.
UK warns EU vaccine export ban would be ‘counter-productive’
Britain on Sunday (21 March) warned the European Union against halting exports of AstraZeneca's Covid-19 vaccines if the bloc does not receive promised deliveries, saying such a move would be "counter-productive".
Cyprus to purchase Russia’s Sputnik vaccine
The Cypriot government will purchase 50,000 doses of Russia’s Sputnik V vaccine once it’s approved by the European Medicines Agency (EMA), a government official in Nicosia has said.
Major EU nations halt AstraZeneca while WHO insists the jab is safe
The EU's largest countries joined a stream of states halting their rollouts of AstraZeneca jabs on Monday (15 March) over blood clot fears, as the World Health Organization and Europe's medicines watchdog insisted it was safe to use.
Bulgaria suspends AstraZeneca vaccine use
Bulgarian Prime Minister Boyko Borissov on Friday (12 March) suspended use of AstraZeneca's Covid-19 vaccine, following similar steps in Denmark, Iceland and Norway over safety concerns.
Spain’s Zendal interested in producing Sputnik V vaccine, government says
Spanish biopharmaceutical group Zendal wrote to Spain's industry minister declaring its interest in producing Russia's Sputnik V coronavirus vaccine in the country, an industry ministry spokeswoman said on Wednesday (10 March).
Russia’s Sputnik V could be made in Europe for first time after Italy deal signed
Russia's Sputnik V vaccine against COVID-19 could be produced in Europe for the first time after a commercial deal to produce it in Italy was signed by the Moscow-based RDIF sovereign wealth fund and Swiss-based pharmaceutical company Adienne.
EU regulator urges caution on Sputnik COVID-19 vaccine
A senior European Medicines Agency (EMA) official urged European Union members on Sunday (7 March) to refrain from granting national approvals for Russian COVID-19 vaccine Sputnik V while the agency reviews its safety and effectiveness.
EU to clear Johnson and Johnson vaccine in March, says French minister
A single-shot Covid-19 vaccine by US drugmaker Johnson and Johnson is likely to be approved for use in the European Union in early March, a French minister said Sunday (28 February).
Slovak party derails plan to buy Russian vaccine without EU registration
Slovakia has dumped a plan to negotiate with Russia to buy the Sputnik V vaccine, after a junior coalition partner vetoed buying a product which has not been registered by the European Medicines Agency, Prime Minister Igor Matovič said.
EU to approve extraction of sixth dose from Pfizer-BioNTech vaccine vials
The European drugs regulator could soon give the go ahead for an extra sixth dose to be extracted from Pfizer-BioNTech COVID-19 vaccine vials, lifting the number of available shots at a time when supplies are short.
EU watchdog gives green light for second Covid jab
The EU's medicines watchdog approved on Wednesday (6 January) a coronavirus jab by US firm Moderna, giving a shot in the arm for Europe's slow-moving vaccine roll-out.
EU could authorise a second vaccine ‘in coming hours’
The European Union could authorise a second coronavirus vaccine "in the coming hours", European Council chief Charles Michel said Tuesday (5 January), adding that leaders would hold a virtual summit on the health crisis later this month.
No EU decision on Moderna shot as blame game mounts
The EU's drugs watchdog held off authorising Moderna's coronavirus jab on Monday (4 January), as criticism mounts of the bloc's slow vaccine roll-out.
Five key things about EMA’s vaccine decision
The European Medicines Agency (EMA) will decide on Monday (21 December) whether to give the green light for the Pfizer-BioNTech coronavirus vaccine within the EU.
Pressure mounts on EU drug regulator to speed-up approval of COVID-19 vaccine
Europe's drug regulator is under increasing pressure to quickly approve the COVID-19 vaccine developed by US giant Pfizer and Germany's BioNTech, officials said, as inoculations get started in Britain and the United States.
Vaccine documents hacked at EU medicines agency
Two pharmaceutical companies in line for first conditional approval for their Covid-19 vaccine by the EU's medicine regulator said Wednesday (9 December) their documents were "unlawfully accessed" during a cyberattack on a European Medicines Agency server.
EU criticises, US cheers UK approval of Pfizer-BioNTech COVID-19 vaccine
The European Union criticised Britain’s rapid approval of Pfizer and BioNTech’s COVID-19 vaccine on Wednesday (2 December), saying its own procedure was more thorough, while US health experts welcomed the British move as a sign US regulators should follow suit.
Conditional authorisation ‘most likely’ for COVID-19 vaccine, EMA says
The most likely scenario for COVID-19 vaccine candidates in the EU is a one-year conditional marketing authorisation (CMA), European Medicines Agency (EMA) sources have told EURACTIV.
Vaccine hesitancy creates concern in the fight against COVID-19
Scepticism about adverse effects and actual lack of efficacy in immunisation practices can become an important negative factor when a vaccine against coronavirus becomes available, according to the head of the EU's medicines agency (EMA), Guido Rasi.
Europe dodges US fentanyl crisis but for how long?
When 18-year-old Joseph bought a pill at a fun fair in the French Riviera resort of Cannes, he was convinced it was morphine.