AstraZeneca's COVID-19 vaccine: EMA finds possible link to very rare cases of unusual blood clots with low blood platelets
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- Category: EMA
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
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- Category: EMA
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
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- Category: EMA
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.
EMA recommends COVID-19 Vaccine Janssen for authorisation in the EU
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- Category: EMA
EMA has recommended granting a conditional marketing authorisation for COVID-19 Vaccine Janssen to prevent COVID-19 in people from 18 years of age.
After a thorough evaluation, EMA’s human medicines committee (CHMP) concluded by consensus that the data on the vaccine were robust and met the criteria for efficacy, safety and quality.
EMA starts rolling review of the Sputnik V COVID-19 vaccine
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- Category: EMA
EMA's human medicines committee (CHMP) has started a rolling review of Sputnik V (Gam-COVID-Vac), a COVID-19 vaccine(1) developed by Russia's Gamaleya National Centre of Epidemiology and Microbiology. The EU applicant for this medicine is R-Pharm Germany GmbH.
FDA issues Emergency Use Authorization for third COVID-19 vaccine
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- Category: FDA
Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the third vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The EUA allows the Janssen COVID-19 Vaccine to be distributed in the U.S for use in individuals 18 years of age and older.
FDA Authorizes Monoclonal Antibodies for Treatment of COVID-19
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- Category: FDA
Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for bamlanivimab and etesevimab administered together for the treatment of mild to moderate COVID-19 in adults and pediatric patients (12 years of age or older weighing at least 40 kilograms [about 88 pounds]) who test positive for SARS-CoV-2 and who are at high risk for progressing to severe COVID-19.
More Pharma News ...
- EMA receives application for conditional marketing authorisation of COVID-19 Vaccine AstraZeneca
- FDA takes additional action in fight against COVID-19 by issuing Emergency Use Authorization for second COVID-19 vaccine
- Update on assessment of the BioNTech and Pfizer BNT162b2 vaccine marketing authorisation application
- FDA takes key action in fight against COVID-19 by issuing Emergency Use Authorization for first COVID-19 vaccine
- EMA receives application for conditional marketing authorisation of COVID-19 mRNA vaccine BNT162b2
- EMA receives application for conditional marketing authorisation of Moderna COVID-19 vaccine
- FDA authorizes monoclonal antibodies for treatment of COVID-19