The developers of Russia’s Sputnik V coronavirus vaccine have repeatedly failed to provide data that regulators deem to be standard requirements of the drug approval process, according to five people with knowledge of EU efforts to assess the drug.
Before a drug makes it onto the market it is vigorously tested and needs to be authorized, either by a national competent authority or EMA, the European Medicines Agency. All the information on when a medicinal product can and cannot...
The European Union's drug regulator said it is reviewing the death of a woman in Belgium who suffered a blood clot and low platelets after receiving Johnson & Johnson's COVID-19 vaccine, the first report of a fatality following the vaccine.
Russian and Chinese media are systematically seeking to sow mistrust in Western COVID-19 vaccines in their latest disinformation campaigns aimed at dividing the West, a European report said on Wednesday (29 April).
European countries prepared on Wednesday (21 April) to start using Johnson & Johnson's COVID-19 vaccine and speed up their vaccination campaigns after Europe's drug regulator backed the shot and deliveries started trickling in after a week-long pause.
The European Commission is seeking clarification from Johnson & Johnson about the company's "completely unexpected" announcement of delays in COVID-19 vaccine deliveries to the EU, an EU official told Reuters on Tuesday (13 April).
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.
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.
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".
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.
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 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.
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.
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.
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.
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.