![Two vials labelled 'Janssen COVID-19 Vaccine' [Credit: oasisamuel/Shutterstock.com].](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/Janssen-COVID-19-Vaccine-300x278.jpg)
![Two vials labelled 'Janssen COVID-19 Vaccine' [Credit: oasisamuel/Shutterstock.com].](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/Janssen-COVID-19-Vaccine-e1619436264802.jpg)
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Janssen COVID-19 Vaccine approved for continued use in US
The US FDA and CDC have confirmed that the single-shot COVID-19 vaccine’s benefits continue to outweigh the risks of clotting and have given approval for its use to resume.
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The European Medicines Agency (EMA)
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Highlights of the EMA’s human medicine committee meeting, April 2021
The Committee for Medicinal Products for Human Use (CHMP) recommended eight drugs for approval and nine indication extensions.
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EMA board confirms the EU clinical trial portal and database is fit for purpose
The adoption of the 2014 Clinical Trial Regulation moves one step closer as the EMA confirms a key aspect, the EU trials database and portal, is on track for implementation.
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EMA confirms Janssen COVID-19 Vaccine benefits outweigh clotting risks
The EMA’s drug safety committee has concluded that the Janssen COVID-19 Vaccine is safe for continued use, so Johnson & Johnson will resume shipments to the EU.
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US pauses administration of Janssen COVID-19 Vaccine
The FDA and CDC have decided to temporarily suspend use of Janssen’s single dose vaccine while reports of rare and severe blood clots are investigated.
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Highlights of the EMA’s drug safety committee April meeting
In the April meeting the Pharmacovigilance Risk Assessment Committee began two new reviews of adverse events that could be caused by COVID-19 vaccines.
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Global Pharmacovigilance Observatory to aid pharma’s understanding of regulatory decisions
The observatory will collate drug safety data, analyses and decisions into a single source to help pharma identify regional differences in decision-making.
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Celonic to produce 100 million doses of CureVac’s COVID-19 vaccine candidate
Production of CureVac’s CVnCoV vaccine will take place in Germany, with over 50 million doses expected to be produced in 2021.
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What strains should be in this year’s seasonal influenza vaccines?
The European Medicines Agency has published its recommendations for 2021-2022 seasonal influenza vaccine composition.
![sign of the European Medicines Agency building in Amsterdam [Credit: martinbertrand.fr/Shutterstock.com].](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/EMA-1-300x278.jpg)
![sign of the European Medicines Agency building in Amsterdam [Credit: martinbertrand.fr/Shutterstock.com].](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/EMA-1-e1617017465349.jpg)
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European Medicines Agency’s CHMP meeting highlights March 2021
In its March meeting the EMA’s human medicines committee recommended five medicines for approval and concluded its review of regdanvimab as a treatment for COVID-19.
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EMA approves increased manufacturing capacity for COVID-19 vaccines
The approval of at least one new manufacturing site based in Europe for each of the approved COVID-19 vaccines should increase supply for the EU.
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EMA accepts regulatory submission for Takeda’s dengue vaccine candidate
The submission is the first in a series that will include dengue-endemic countries, it includes long-term Phase III safety and efficacy data for the TAK-003 vaccine candidate.
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Could viral vector shortages disrupt the COVID-19 vaccine roll-out?
According to GlobalData, AstraZeneca’s and Janssen’s COVID-19 vaccines could be impacted by global viral vector shortages.
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EMA clears use of COVID-19 Vaccine AstraZeneca
The EMA’s drug safety committee concluded that the vaccine is not associated with an increased risk of thromboembolic events and that its benefits still outweigh its risks.
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Janssen COVID-19 Vaccine authorised for use in EU
After a positive recommendation from the EMA, the European Commission has granted the single-dose vaccine conditional marketing authorisation.
