EMA finds AstraZeneca vaccine to be ‘safe and effective’

&Tab;&Tab;<div class&equals;"wpcnt">&NewLine;&Tab;&Tab;&Tab;<div class&equals;"wpa">&NewLine;&Tab;&Tab;&Tab;&Tab;<span class&equals;"wpa-about">Advertisements<&sol;span>&NewLine;&Tab;&Tab;&Tab;&Tab;<div class&equals;"u top&lowbar;amp">&NewLine;&Tab;&Tab;&Tab;&Tab;&Tab;&Tab;&Tab;<amp-ad width&equals;"300" height&equals;"265"&NewLine;&Tab;&Tab; type&equals;"pubmine"&NewLine;&Tab;&Tab; data-siteid&equals;"111265417"&NewLine;&Tab;&Tab; data-section&equals;"1">&NewLine;&Tab;&Tab;<&sol;amp-ad>&NewLine;&Tab;&Tab;&Tab;&Tab;<&sol;div>&NewLine;&Tab;&Tab;&Tab;<&sol;div>&NewLine;&Tab;&Tab;<&sol;div><p>The European Medicines Agency &lpar;EMA&rpar; has said there is clear scientific evidence that the AstraZeneca Covid-19 vaccine is &&num;8220&semi;safe and effective&&num;8221&semi; following an investigation into reported side effects&period;<&sol;p>&NewLine;<p>A number of EU countries&comma; including Ireland&comma; had paused the use of the AstraZeneca vaccine due to concerns that recipients had experienced blood clots after being inoculated&period;<&sol;p>&NewLine;<p>In a press briefing today&comma; the EMA said&colon; &&num;8220&semi;We cannot rule out a definitive link between these cases and the vaccine&&num;8221&semi;&comma; adding the number of incidents of blood clots after vaccination was lower than would be expected in the general population&period;<&sol;p>&NewLine;<p>The regulatory body said it was aware that a number of EU countries had been waiting for today&&num;8217&semi;s announcement&comma; adding they could now make an informed decision regarding how they proceed with the use of the AstraZeneca vaccine&period;<&sol;p>&NewLine;<p>EMA executive director Emer Cooke said over 7 million people in the EU have now been vaccinated using the AstraZeneca vaccine and over 11 million people in the UK&period;<&sol;p>&NewLine;<p>Ms Cooke told the press briefing&colon; &&num;8220&semi;The committee has come to a clear scientific conclusion&period;<&sol;p>&NewLine;<p>&&num;8220&semi;This is a safe and effective vaccine&period; Its benefits in protecting people from Covid-19&comma; with the associated risks of death and hospitalisation&comma; outweigh the possible risks&period;<&sol;p>&NewLine;<p>&&num;8220&semi;The committee also concluded that the vaccine is not associated with an increase in the overall risk of thromboembolic events&comma; or blood clots&period;&&num;8221&semi;<&sol;p>&NewLine;<p>Ms Cooke said the AstraZeneca vaccine &&num;8220&semi;demonstrated at least 60 per cent efficacy in clinical trials in preventing coronavirus disease and&comma; in fact&comma; the real world evidence suggests that the effectiveness could be even higher than that&&num;8221&semi;&period;<&sol;p>&NewLine;<p>&&num;8220&semi;We are very much aware that some &lpar;EU&rpar; member states have paused vaccinations&comma; waiting for EMA’s outcome of a review&period;<&sol;p>&NewLine;<p>&&num;8220&semi;Given that thousands of people in the EU die every day – in fact over 2&comma;500 were reported one day last week – it really was crucial for EMA to review rapidly and thoroughly all the available evidence&comma; so we made this review our highest priority&period;&&num;8221&semi;<&sol;p>&NewLine;<p>She said the EMA had worked closely with European medical experts and the regulator’s UK counterpart the Medicines and Healthcare products Regulatory Agency &lpar;MHRA&rpar; during their work&period;<&sol;p>&NewLine;<p>&&num;8220&semi;The scientific conclusions adopted today provide member states with the information they need to take an informed decision regarding the use of the AstraZeneca vaccine in their vaccination campaigns&period;&&num;8221&semi;<&sol;p>&NewLine;<p>The head of the EMA’s Pharmacovigilance Risk Assessment Committee &lpar;PRAC&rpar;&comma; Dr Sabine Straus reiterated the group had concluded there was no overall risk of blood clots with the AstraZeneca vaccine&period;<&sol;p>&NewLine;<p>She said the number of blot clots reported after vaccination was &&num;8220&semi;lower than expected in the general population&&num;8221&semi;&comma; adding&colon; &&num;8220&semi;PRAC has concluded that there is no overall increase in the risk of blood clots with this vaccine&period;&&num;8221&semi;<&sol;p>&NewLine;<p>Seeing as the vaccine was effective in preventing Covid-19 – which itself can lead to blood clots – Dr Straus said the shot &&num;8220&semi;likely reduces&&num;8221&semi; the risks of clots overall&period;<&sol;p>&NewLine;<p>However&comma; she said there were still &OpenCurlyDoubleQuote;some uncertainties” with a few cases where tiny clots had developed in multiple vessels or in vessels draining blood from the brain&period;<&sol;p>&NewLine;<p>&&num;8220&semi;The evidence that we have is at the moment not sufficient to conclude with certainty whether these events are indeed caused by the vaccine or not&comma;&&num;8221&semi; she said&period;<&sol;p>&NewLine;<h2>Raising Awareness<&sol;h2>&NewLine;<p>Dr Straus said a warning will be added to the AstraZeneca vaccine to raise awareness of possible risks&period;<&sol;p>&NewLine;<p>Ms Cooke elaborated&colon; &&num;8220&semi;During the investigation and review&comma; we began to see a small number of cases of rare and unusual&comma; but very serious&comma; clotting disorders&comma; and this then triggered a more focused review&period;<&sol;p>&NewLine;<p>&&num;8220&semi;Based on the evidence available&comma; and after days of in-depth analysis of lab results&comma; clinical reports&comma; autopsy reports and further information from the clinical trials&comma; we still cannot rule out definitively a link between these cases and the vaccine&period;<&sol;p>&NewLine;<p>&&num;8220&semi;What the committee has therefore recommended is to raise awareness of these possible risks&comma; making sure that they are included in the product information&period;<&sol;p>&NewLine;<p>&&num;8220&semi;Drawing attention to these possible rare conditions and providing information to health care professionals and vaccinated people will help to spot and mitigate any possible side effects&period;&&num;8221&semi;<&sol;p>&NewLine;&Tab;&Tab;&Tab;<div style&equals;"padding-bottom&colon;15px&semi;" class&equals;"wordads-tag" data-slot-type&equals;"belowpost">&NewLine;&Tab;&Tab;&Tab;&Tab;<div id&equals;"atatags-dynamic-belowpost-68e21914eea85">&NewLine;&Tab;&Tab;&Tab;&Tab;&Tab;<script type&equals;"text&sol;javascript">&NewLine;&Tab;&Tab;&Tab;&Tab;&Tab;&Tab;window&period;getAdSnippetCallback &equals; 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