Extra European nations pause AstraZeneca vaccine use as blood clot studies investigated
Denmark introduced a two-week suspension on Thursday following plenty of studies of clotting within the nation, together with one deadly case. Iceland and Norway adopted swimsuit, however didn’t say how lengthy their suspensions would final.
Danish Well being Minister Magnus Heunicke made clear the pause was a “precautionary measure,” saying it was not potential but to attract conclusions.
“We act early, it must be completely investigated,” he mentioned in a tweet.
The Danish Well being Authority additionally confused that the choice was short-term.
“We’re in the course of the biggest and most vital vaccination rollout in Danish historical past. And proper now we’d like all of the vaccines we are able to get. Due to this fact, placing one of many vaccines on pause isn’t a straightforward choice. However exactly as a result of we vaccinate so many, we additionally want to reply with well timed care when there’s information of potential critical uncomfortable side effects. We have to make clear this earlier than we are able to proceed to make use of the vaccine from AstraZeneca,” Søren Brostrøm, director of the Nationwide Board of Well being, mentioned within the assertion.
“You will need to emphasize that we’ve got not opted out of the AstraZeneca vaccine, however that we’re placing it on maintain. There’s good proof that the vaccine is each secure and efficient. However each we and the Danish Medicines Company need to react to studies of potential critical uncomfortable side effects, each from Denmark and different European nations. It exhibits that the monitoring system works. “
Chatting with CNN Kjartan Njálsson, assistant to the director of well being in Iceland, mentioned that though there had been no studies of sufferers creating blood clots within the nation, they had been ready for recommendation from the European Medicines Company (EMA). “It is the dearth of information proper now that issues us,” he added.
The EMA mentioned later Thursday that it didn’t advocate suspending use of the vaccine.
The company mentioned it was conscious that Denmark had suspended use however that there was “presently no indication that vaccination has brought about these situations, which aren’t listed as uncomfortable side effects with this vaccine.”
“The vaccine’s advantages proceed to outweigh its dangers and the vaccine can proceed to be administered whereas investigation of circumstances of thromboembolic occasions is ongoing,” the company added.
The EMA additionally famous that the variety of blood clots seen in vaccine recipients was no increased than the speed amongst individuals who had not obtained the shot in Europe.
The Norwegian Institute of Public Well being issued an announcement saying the nation had additionally chosen to “pause” inoculations following report of a demise in Denmark because of a blood clot. It additionally famous there had been reported circumstances of blood clots shortly after receiving Covid-19 vaccinations in Norway however “primarily within the aged the place there’s usually one other underlying illness as nicely.”
Spain’s Public Well being Fee introduced Thursday that it was delaying the vaccination of individuals aged between 55 and 65 years previous with the AstraZeneca vaccine till “there’s a full evaluate and conclusion of uncomfortable side effects by the European Medicines Company (EMA)”, in accordance with a fee assertion issued on Thursday night.
Spanish well being minister Carolina Darias known as for calm earlier on Thursday. “I’d to ship a message of calm and warning. In Spain we’ve got not been notified of any case associated to blood clots,” Darias informed native TV station La Sexta.
The Public Well being Fee contains the nation’s Ministry of Well being and representatives of Spain’s 17 areas.
AstraZeneca defends shot’s security
In an announcement on Thursday, AstraZeneca mentioned that affected person security was its “highest precedence.”
“Regulators have clear and stringent efficacy and security requirements for the approval of any new drugs, and that features COVID-19 Vaccine AstraZeneca. The protection of the vaccine has been extensively studied in Section III scientific trials and peer-reviewed knowledge confirms the vaccine is usually nicely tolerated,” the corporate mentioned in an announcement.
Within the UK, the Medicines and Healthcare merchandise Regulatory Company (MHRA) mentioned Danish authorities had taken a “precautionary measure” and suggested individuals to nonetheless take their vaccine when instructed to.
The Dutch well being minister additionally mentioned there was no motive to cease utilizing the vaccine.
“Our specialists say there isn’t a trigger for concern, we are able to merely proceed vaccinating,” Hugo de Jonge mentioned Thursday.
Austria, Estonia, Lithuania, Luxembourg and Latvia have suspended using doses from batch ABV5300. Danish officers didn’t specify whether or not its reported demise was related to the identical batch.
The EMA mentioned that batch ABV5300 had been delivered to 17 EU nations, comprising 1 million doses of the vaccine.
“Some EU nations have additionally subsequently suspended this batch as a precautionary measure, whereas a full investigation is ongoing. Though a high quality defect is taken into account unlikely at this stage, the batch high quality is being investigated,” EMA mentioned in an announcement.
The investigation is the most recent hassle in Europe for British-Swedish drugmaker AstraZeneca, which has come underneath stress to supply extra vaccines after it fell tens of hundreds of thousands of doses quick in deliveries to the European Union.
On Thursday, Italian medicines company AIFA additionally banned use of one other batch of AstraZeneca vaccines. The company mentioned it was responding to “some critical adversarial occasions” happening across the time of vaccinations from batch ABV2856. It didn’t say what the occasions had been and mentioned no causal hyperlink between the occasions and the vaccine had been established.
The corporate has additionally confronted resistance within the bloc, the place regulatory our bodies in member nations have been gradual or hesitated to advocate the vaccine in individuals over the age of 65, citing an absence of information.
Regulatory our bodies in a number of nations, together with Germany and France, have since modified suggestions to incorporate over-65s as real-world knowledge has since proven that the AstraZeneca vaccine is extremely efficient at stopping hospitalization in older populations. France limits the shot to individuals underneath the age of 74.
Correction: A earlier model of this story reported that Italy banned batch ABV5300. It has been corrected to indicate that Italy banned a special AstraZeneca batch over issues round unspecified adversarial reactions.
CNN’s Angela Dewan contributed to this report.