EU Medicines Agency @EMA_News@respublicae.eu

At its June meeting, EMA's #safety committee, the #PRAC, carried out its work to assess all aspects of risk management related to the use of #medicines.

More information in our meeting highlights: https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-5-8-june-2023

#SafetyOfMedicines

🐦🔗: https://n.respublicae.eu/EMA_News/status/1667127819984306176

Just published!

A new scientific paper 📰on #clinicaltrial designs and statistical approaches applied in COVID-19 vaccine efficacy trials is now available.

It focuses on the first 4⃣ approved #COVID19vaccines.

Click to read the full paper 👇
https://doi.org/10.1080/19466315.2023.2211538.

🐦🔗: https://n.respublicae.eu/EMA_News/status/1666798759320211456

RT @ECDC_EU: #JustPublished!
A joint #ECDC - @EMA_News statement on updating #COVID19 vaccines composition for new #SARSCoV2 virus variants.

Read full here:
https://www.ecdc.europa.eu/en/news-events/ecdc-ema-statement-updating-covid-19-vaccines-composition-new-sars-cov-2-virus-variants https://t.co/8EDIYlBk97

🐦🔗: https://n.respublicae.eu/EMA_News/status/1666389827669950476

RT @ECDC_EU: In line with the outcome of recent meetings of international regulators and the @WHO, @EMA_News Emergency Task Force recommends updating vaccines to target #XBB strains (a subgroup of #Omicron), which have become dominant in Europe and other parts of the world. https://t.co/gas97lAmW6

🐦🔗: https://n.respublicae.eu/EMA_News/status/1666389806585184257

RT @ECDC_EU: Both agencies (@ECDC_EU & @EMA_News) note that monovalent vaccines (vaccines targeting only one strain such as XBB.1.5) are a reasonable choice to provide protection against current dominant and emerging strains.

#COVID19 https://t.co/7szyGfVoiZ

🐦🔗: https://n.respublicae.eu/EMA_News/status/1666389773240377346

Have you been affected by the shortage of the medicine Visudyne ❓ #Myopia

Participate in our #survey and help us improve our communication!

The aim is to collect information on how patients were informed about the recent medicine #shortages.

📩 Send your feedback by 9 June

🐦🔗: https://n.respublicae.eu/EMA_News/status/1666331656641454080

EMA and the EU network will keep monitoring the #safety of #COVID19vaccines and therapeutics, as we do for all authorised medicines in the 🇪🇺. #EMAPresser

🐦🔗: https://n.respublicae.eu/EMA_News/status/1666080323002839046

The available data confirm that the #COVID19vaccines are safe and add to the evidence from the clinical trials.

Most of the side effects of the vaccines are mild and short-lived. Serious side effects are very rare.

#EMAPresser

🐦🔗: https://n.respublicae.eu/EMA_News/status/1666080218505940996

If an unusual pattern emerged, the #PRAC performed an in-depth analysis of the reports to quickly identify potential safety issues with #Covid19vaccines.

The 🇪🇺 pharmacovigilance system showed that it can detect and manage emerging #safety issues quickly.

#EMAPresser

🐦🔗: https://n.respublicae.eu/EMA_News/status/1666080058241581057

We have encouraged people who received the #Covid19vaccine and healthcare professionals to report suspected side effects.

Out of nearly 1 billion vaccines administered, Eudravigilance received more than 1.7 million reports in the EU.

#EMAPresser

🐦🔗: https://n.respublicae.eu/EMA_News/status/1666079807732580361

To ensure #transparency regarding the results of the assessment of the monthly #safetyreports of #Covid19vaccines and keep the public informed, we published 5⃣0⃣ monthly safety updates providing an up-to-date overview of the safety profile of the vaccines. #EMAPresser

🐦🔗: https://n.respublicae.eu/EMA_News/status/1666079623208370182

We placed extra obligations on the #Covid19vaccine makers.

They had to provide us with detailed monthly reports on the #safety of their vaccine ➡️ 5⃣6⃣monthly reports were assessed by our safety committee, the #PRAC, until December 2022.

#EMAPresser

🐦🔗: https://n.respublicae.eu/EMA_News/status/1666079498784366597

To fight the pandemic the #Covid19vaccineshad to be rolled out quickly across the 🇪🇺.

So we made sure that we put in place enhanced #safetymonitoring and a comprehensive plan which guided us in analysing the data from vaccination campaigns.

#EMAPresser

🐦🔗: https://n.respublicae.eu/EMA_News/status/1666079359399235592

EMA's Emergency Task Force discussed 3⃣0⃣0⃣ therapeutics and 7⃣0⃣ vaccines in more than 2⃣5⃣0⃣ meetings held during the #publichealth emergency.

It continues its work to be prepared for any new emerging health threats.

#EMAPresser

🐦🔗: https://n.respublicae.eu/EMA_News/status/1666079159830073353