The EMA’s Committee for Medicinal Products for Human Use (CHMP) has given the green light on Thursday to EU countries to vaccinate children between 5 and 11 years of age against Covid, considering that the benefits outweigh the risks, especially in children with health problems that increase the risk of serious disease. The Comirnaty vaccine, […]
EMA evaluating data on booster dose of COVID-19 Vaccine Janssen
EMA has started evaluating an application for the use of a booster dose of COVID-19 Vaccine Janssen to be given at least two months after the first dose to people aged 18 years and older. EMA’s human medicines committee (CHMP) will carry out an accelerated assessment of data submitted by the company that markets the vaccine. These […]
European Medicines Agency (EMA) gives go-ahead for use of anticovid tablet
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 […]
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 […]
First COVID-19 vaccine approved for children aged 12 to 15 in EU
EMA’s human medicines committee (CHMP) has recommended granting an extension of indication for the COVID-19 vaccine Comirnaty to include use in children aged 12 to 15. The vaccine is already approved for use in adults and adolescents aged 16 and above. Comirnaty is a vaccine for preventing COVID-19. It contains a molecule called messenger RNA (mRNA) with instructions for […]
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 […]
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 […]
EMA finds possible link to very rare cases of unusual blood clots with low blood platelets
EMA confirms overall benefit-risk remains positive 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 […]
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 […]