EMA

ECDC and EMA highlight considerations for additional and booster doses of COVID-19 vaccines

Based on current evidence, there is no urgent need for the administration of booster doses of vaccines to fully vaccinated individuals in the general population, according to a technical report issued by the European Centre for Disease Prevention and Control (ECDC). The report also notes that additional doses should already be considered for people with severely weakened immune systems as part of their primary vaccination.

Artificial Intelligence in Medicine Regulation

The International Coalition of Medicines Regulatory Authorities (ICMRA) sets out recommendations to help regulators to address the challenges that the use of artificial intelligence (AI) poses for global medicines regulation, in a report published today.

EMA issues advice on use of sotrovimab (VIR-7831) for treating COVID-19

EMA's human medicines committee (CHMP) has completed its review on the use of the monoclonal antibody sotrovimab (also known as VIR-7831 and GSK4182136) to treat patients with COVID-19. This review was undertaken to provide a harmonised scientific opinion at EU level to support national decision-making on the possible use of the antibody prior to marketing authorisation.

EMA and ECDC join forces for enhanced post-marketing monitoring of COVID-19 vaccines in Europe

The European Medicines Agency (EMA) and the European Centre for Disease Prevention and Control (ECDC) kicked off a new initiative aimed at strengthening post-marketing monitoring of the safety, effectiveness and impact of COVID-19 vaccines in the European Union (EU) and the European economic Area (EEA).

AstraZeneca's COVID-19 vaccine: EMA finds possible link to very rare cases of unusual blood clots with low blood platelets

EMA's safety committee (PRAC) has concluded today that unusual blood clots with low blood platelets should be listed as very rare side effects of Vaxzevria (formerly COVID-19 Vaccine AstraZeneca).

In reaching its conclusion, the committee took into consideration all currently available evidence, including the advice from an ad hoc expert group.

Increase in vaccine manufacturing capacity and supply for COVID-19 vaccines from AstraZeneca, BioNTech/Pfizer and Moderna

EMA's human medicines committee (CHMP) has adopted several important recommendations that will increase manufacturing capacity and supply of COVID-19 vaccines in the EU.

EMA's safety committee continues investigation of COVID-19 Vaccine AstraZeneca and thromboembolic events

Several authorities responsible for national vaccine campaigns in EU countries have temporarily paused vaccination with COVID-19 Vaccine AstraZeneca. This is a precaution taken in the light of their national situation while EMA investigates a number of events of blood clots in people who had received the vaccine, as previously reported.

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