The European Medicines Agency (EMA) gives the green light to the use of the anticovid pill that halves the risk of death and hospitalisation. The EMA’s Committee for Medicinal Products for Human Use (CHMP) has endorsed the use of Merk and Ridgeback’s ‘Lagevrio’ (molnupiravir) to treat Covid-19. With this approval, Merk takes the lead in the […]
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EMA clears Pfizer’s third dose for the general adult population
EMA recommendations on extra doses and boosters EMA’s human medicines committee (CHMP) has concluded that an extra dose of the COVID-19 vaccines Comirnaty (BioNTech/Pfizer) and Spikevax (Moderna) may be given to people with severely weakened immune systems, at least 28 days after their second dose. The recommendation comes after studies showed that an extra dose of these vaccines increased […]
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Use of antibiotics in animals is decreasing
Use of antibiotics has decreased and is now lower in food-producing animals than in humans, says the latest report published by the European Food Safety Authority (EFSA), the European Medicines Agency (EMA) and the European Centre for Disease Prevention and Control (ECDC). Taking a One Health approach, the report from the three EU agencies presents data on […]
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AstraZeneca’s vaccine: benefits and risks
Vaxzevria (formerly COVID-19 Vaccine AstraZeneca) is authorised in the EU to prevent COVID-19, which can cause severe disease and death. The disease can also have long-term consequences in people of all ages, including in otherwise healthy people. The benefits of Vaxzevria outweigh its risks in adults of all age groups; however, very rare cases of […]
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Vaccine Janssen: assessment of very rare cases of unusual blood clots with low platelets continues
EMA’s safety committee (PRAC) is reviewing very rare cases of unusual blood clots that occurred in the United States following the use of Janssen’s COVID-19 vaccine. The type of blood clot reported, cerebral venous sinus thrombosis (CVST), occurred in most cases in combination with low levels of blood platelets (thrombocytopenia). The US FDA and CDC […]
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Vaccine (in)equity – no right of way for persons with disabilities in the EU
Faced with many barriers and less able to maintain social and physical distance, persons with disabilities are at greater risk of contracting COVID-19 and falling severely ill as a result of the disease. However, in the EU they have not been explicitly included in priority groups for vaccination. National vaccination strategies do not have clear-cut […]
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Commission strengthens transparency and authorisation mechanism for exports of COVID-19 vaccines
The European Commission has introduced the principles of reciprocity and proportionality as new criteria to be considered for authorising exports under the transparency and authorisation mechanism for COVID-19 vaccine exports. This system has significantly improved the transparency of exports. Nevertheless, the objective to ensure timely access to COVID-19 vaccines for EU citizens is still not […]
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COVID-19 Vaccine AstraZeneca: PRAC investigating cases of thromboembolic events
EMA is aware that the Danish Health Authority has paused its vaccination campaign with COVID-19 Vaccine AstraZeneca. This was decided as a precautionary measure while a full investigation is ongoing into reports of blood clots in people who received the vaccine, including one case in Denmark where a person died. Some other Member States have […]
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European Commission authorises fourth vaccine against COVID-19: Janssen
The European Commission has granted a conditional marketing authorisation (CMA) for the COVID‑19 vaccine developed by Janssen Pharmaceutica NV, one of the Janssen Pharmaceutical Companies of Johnson & Johnson, and the fourth COVID-19 vaccine authorised in the EU. This authorisation follows a positive scientific recommendation based on a thorough assessment of the safety, effectiveness and […]
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