Category: European Medicines Agency

EU: Vaccine Targeting Omicron COVID-19 Variant Could be Approved Within 3-4 Months If Needed

The European Union drug regulator said Tuesday it will be prepared to approve a new COVID-19 vaccines targeting the Omicron variant within three to four months. European Medicines Agency (EMA) executive director Emer Cooke told the European Parliament that the EMA is prepared if pharmaceutical companies need to modify the existing COVID-19 vaccines for them…


EU Signs Deal With GSK for Supply of Potential COVID-19 Drug

BRUSSELS—The European Union has signed a contract with GlaxoSmithKline (GSK) for the supply of up to 220,000 treatments of its investigational monoclonal antibody therapy sotrovimab against COVID-19, it said on Wednesday. The drug, which is developed together with U.S. firm Vir Biotechnology, can be used for the treatment of high-risk coronavirus patients with mild symptoms…


EU Regulator Endorses Use of Moderna’s 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 adolescent use in the bloc. The use of the vaccine, branded Spikevax, will be the same in adolescents as in people above 18 years, the…


EU Lists Rare Nerve Disorder as Side-Effect of J&J COVID-19 Vaccine

Europe’s medicines regulator said on Thursday it had added a rare nerve-degenerating disorder, Guillain-Barré syndrome, as a possible rare side effect from Johnson & Johnson’s COVID-19 vaccine after it reviewed 108 cases reported worldwide. “After assessing the available data, PRAC considered that a causal relationship between COVID-19 vaccine Janssen and GBS is possible,” the European…


AstraZeneca Shots Should Be Halted for Over-60s Too: EU Official

MILAN, Italy—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 fears over rare blood clotting and as more vaccines become available. The European Medicines Agency (EMA) considers the AstraZeneca shot safe for all age…


EU Regulator Finds ‘Possible Link’ Between J&J Vaccine and Blood Clots

The European Union’s medicines regulator said on Tuesday that there is a “possible link” between Johnson & Johnson’s COVID-19 vaccine and blood clots, but said its “overall benefit-risk remains positive.” At a meeting on Tuesday, the safety committee of the European Medicines Agency (EMA) concluded that a warning about unusual blood clots should be added…


EU and Vietnam to Exclude China-Made Vaccines

The European Union is expected to exclude Chinese-made vaccines from its “vaccine passport” certification program because they are not approved by the European Medicines Agency (EMA). At the same time, Vietnam is reportedly buying large quantities of COVID-19 vaccines from Western counties and Russia, but not China. On March 12, Euronews reported that the EU is…


EU and Vietnam Exclude China-Made Vaccines

The European Union is expected to exclude Chinese-made vaccines from its “vaccine passport” certification program because they are not approved by the European Medicines Agency (EMA). At the same time, Vietnam is reportedly buying large quantities of COVID-19 vaccines from Western counties and Russia, but not China. On March 12, Euronews reported that the EU is…