EMA Public stakeholder meeting: approval, safety monitoring and impact of COVID-19 vaccines in the EU

A Phar­ma­covig­i­lance Med­ical Writer from ICRC-WEYER attend­ed the pub­lic meet­ing host­ed by the Euro­pean Med­i­cines Agency (#EMA) last Fri­day, the 26th of March. The pub­lic meet­ing pro­vid­ed an update on the approval, safe­ty mon­i­tor­ing and impact of #COVID-19 vac­cines in the Euro­pean Union (EU) and ongo­ing work to address new COVID-19 variants.

Cur­rent­ly, 4 COVID-19 vac­cines from AstraZeneca, BioNTech/Pfizer, Janssen and Mod­er­na have been autho­rised in the EU. All 4 vac­cines have shown a pos­i­tive ben­e­fit-risk bal­ance in the pre­ven­tion of COVID-19 dis­ease and a good safe­ty pro­file. The most com­mon side-effects are mild or mod­er­ate and tem­po­rary and include pain and ten­der­ness at the injec­tion site, headache, tired­ness, mus­cle pain, a gen­er­al feel­ing of being unwell, chills, fever, joint pain and nausea.

Very rare but severe aller­gic reac­tions have occurred in peo­ple receiv­ing the COVID-19 vac­cine (in less than 1 in 100,000 peo­ple). Very rare events of severe throm­bo­sis com­bined with throm­bo­cy­tope­nia have occurred after AstraZeneca vac­ci­na­tion (in approx­i­mate­ly 1 in one mil­lion peo­ple), and these events are the top­ic of cur­rent investigations.

The EMA’s safe­ty com­mit­tee, the Phar­ma­covig­i­lance Risk Assess­ment Com­mit­tee (#PRAC), con­clud­ed a pre­lim­i­nary review of cas­es of blood clots occur­ring after #AstraZeneca vac­ci­na­tion. This pre­lim­i­nary review con­firmed that the vac­cine is not asso­ci­at­ed with an increase in the over­all risk of blood clots and that the ben­e­fits of the vac­cine in com­bat­ing the still wide­spread threat of COVID-19 con­tin­ue to out­weigh the risk of side-effects. Updat­ed rec­om­men­da­tions are expect­ed at PRAC’s April ple­nary meet­ing (6–9 April).

You can view the record­ed meet­ing and down­load the speak­ers’ pre­sen­ta­tions here:
https://www.ema.europa.eu/en/events/public-stakeholder-meeting-approval-safety-monitoring-impact-covid-19-vaccines-eu