France pauses AstraZeneca vaccine rollout ahead of European regulator's report
The European Medicines Agency will deliver its report on Thursday into the investigation of blood clots in patients who have received the AstraZeneca vaccine, and France will extend its 24-hour suspension of the vaccine until the report is delivered.
French president Emmanuel Macron announced on Monday afternoon that the country's AstraZeneca vaccine programme would be paused after concerns were raised over side effects.
🔴 Emmanuel Macron annonce la suspension "par précaution" de la vaccination avec AstraZeneca "jusqu'à demain après-midi" pic.twitter.com/pwcqkMAIiz
— BFMTV (@BFMTV) March 15, 2021
Speaking at a press conference in south west France, he said the suspension should be in place for just 24 hours, pending a new opinion from the European Medicines Agency on the safety of the vaccine.
However in a statement on Tuesday, the EMA said it would deliver the report of a group of experts on Thursday.
Emer Cooke, Director of the EMA, said that she had set up a group of experts to investigate each case of complications.
"We remain firmly convinced that the benefits of AstraZeneca's vaccine in preventing Covid-19, with its associated risk of hospitalisation and death, outweigh the risk of these side effects," she said.
"There is no evidence that the vaccine is responsible for these side effects," Cooke said, pointing out that the 30 or so cases of thrombosis reported in Europe in recent days appear to be proportionally similar to the clotting problems seen in the placebo group (i.e. those who did not receive AstraZeneca) during the vaccine's clinical trials.
Explaining that the EMA will be holding a number of meetings dedicated to this vaccine in the coming hours, Emer Cooke announced that the European Agency would be issuing its conclusions this Thursday, "in complete transparency".
The director of the body concluded her speech by asking people who have received the AstraZeneca vaccine "who think they may have side effects to report them to their doctor".
A total of 14 European countries have now suspended use of the vaccine from the Anglo-Swedish company, including Sweden.
READ ALSO Which European countries have suspended use of the AstraZeneca vaccine?
Earlier on Monday, firefighters in the southern département of Buches-du-Rhône announced they would pause the staff vaccination programme after one firefighter was hospitalised with cardiac symptoms after receiving the vaccine.
Last week, French Health Minister Olivier Véran said that the benefits of the vaccine still outweighed the risks, saying that in Europe around 5 million people have received the AstraZeneca jab and there had been just 30 reports of blood clots, well within the normal range of reports within the general population.
AstraZeneca is only licensed for use on under 74-year-olds in France and has so far been administered only by GPs, while vaccine centres have used Pfizer and Moderna vaccines.
French pharmacies are scheduled to begin vaccinating this week, and have already received large numbers of AstraZeneca doses.
Anyone who has an appointment at a vaccine centre in the coming days should go as normal, since vaccine centres use the Pfizer and Moderna vaccine, but GP appointments on Wednesday and Thursday will likely be affected by the AstraZeneca suspension.
The World Health Organisation, the EMA and experts have stressed that no causal link has been established between the vaccine and blood clotting and insisted that the vaccine is safe.
On March 11th the European Medicines Agency (EMA) told AFP that information available so far indicated the risk of blood clots in those vaccinated against Covid-19 was “no higher than that seen in the general population.”
It also said that European countries could keep using the AstraZeneca vaccine while the issue was investigated, concluding that “the vaccine’s benefits continue to outweigh its risks”.
Stephen Evans, a professor of pharmacoepidemiology at the London School of Hygiene and Tropical Medicine said: “The risk and benefit balance is still very much in favour of the vaccine.”
Referrring to the suspensions he said: “This is a super-cautious approach based on some isolated reports in Europe.”
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French president Emmanuel Macron announced on Monday afternoon that the country's AstraZeneca vaccine programme would be paused after concerns were raised over side effects.
🔴 Emmanuel Macron annonce la suspension "par précaution" de la vaccination avec AstraZeneca "jusqu'à demain après-midi" pic.twitter.com/pwcqkMAIiz
— BFMTV (@BFMTV) March 15, 2021
Speaking at a press conference in south west France, he said the suspension should be in place for just 24 hours, pending a new opinion from the European Medicines Agency on the safety of the vaccine.
However in a statement on Tuesday, the EMA said it would deliver the report of a group of experts on Thursday.
Emer Cooke, Director of the EMA, said that she had set up a group of experts to investigate each case of complications.
"We remain firmly convinced that the benefits of AstraZeneca's vaccine in preventing Covid-19, with its associated risk of hospitalisation and death, outweigh the risk of these side effects," she said.
"There is no evidence that the vaccine is responsible for these side effects," Cooke said, pointing out that the 30 or so cases of thrombosis reported in Europe in recent days appear to be proportionally similar to the clotting problems seen in the placebo group (i.e. those who did not receive AstraZeneca) during the vaccine's clinical trials.
Explaining that the EMA will be holding a number of meetings dedicated to this vaccine in the coming hours, Emer Cooke announced that the European Agency would be issuing its conclusions this Thursday, "in complete transparency".
The director of the body concluded her speech by asking people who have received the AstraZeneca vaccine "who think they may have side effects to report them to their doctor".
A total of 14 European countries have now suspended use of the vaccine from the Anglo-Swedish company, including Sweden.
READ ALSO Which European countries have suspended use of the AstraZeneca vaccine?
Earlier on Monday, firefighters in the southern département of Buches-du-Rhône announced they would pause the staff vaccination programme after one firefighter was hospitalised with cardiac symptoms after receiving the vaccine.
Last week, French Health Minister Olivier Véran said that the benefits of the vaccine still outweighed the risks, saying that in Europe around 5 million people have received the AstraZeneca jab and there had been just 30 reports of blood clots, well within the normal range of reports within the general population.
AstraZeneca is only licensed for use on under 74-year-olds in France and has so far been administered only by GPs, while vaccine centres have used Pfizer and Moderna vaccines.
French pharmacies are scheduled to begin vaccinating this week, and have already received large numbers of AstraZeneca doses.
Anyone who has an appointment at a vaccine centre in the coming days should go as normal, since vaccine centres use the Pfizer and Moderna vaccine, but GP appointments on Wednesday and Thursday will likely be affected by the AstraZeneca suspension.
The World Health Organisation, the EMA and experts have stressed that no causal link has been established between the vaccine and blood clotting and insisted that the vaccine is safe.
On March 11th the European Medicines Agency (EMA) told AFP that information available so far indicated the risk of blood clots in those vaccinated against Covid-19 was “no higher than that seen in the general population.”
It also said that European countries could keep using the AstraZeneca vaccine while the issue was investigated, concluding that “the vaccine’s benefits continue to outweigh its risks”.
Stephen Evans, a professor of pharmacoepidemiology at the London School of Hygiene and Tropical Medicine said: “The risk and benefit balance is still very much in favour of the vaccine.”
Referrring to the suspensions he said: “This is a super-cautious approach based on some isolated reports in Europe.”
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