EXPLAINED: Why is Sweden waiting to restart AstraZeneca vaccinations?
While Germany, France, Italy and Spain all said they would restart giving the AstraZeneca vaccine after European Medicines Agency (EMA) declared the vaccine safe on Thursday, Sweden's Public Health Agency will not be ready to give a decision until Monday at the earliest. There are a few possible reasons for the delay.
At the press conference on Thursday evening, Sweden's Prime Minister Stefan Löfven said that what was most important was for the public to be fully confident that the safety risks had been properly evaluated.
"Everyone should feel that they are safe when they get their jab," he said.
At the press conference, the Public Health Agency's director, Johan Carlson, said that his agency needed time to digest the contents of the EMA's report.
"We must think about how this should be handled. Obviously, the sooner we are ready the better, but there's quite a lot that needs to be thought through," he said.
When The Local approached the Public Health Agency of Sweden for more detail on what further investigations justified waiting until Monday to give a decision, the agency said it could not reply until the decision had been made on Monday.
The delay has received some pushback from the opposition Moderate party.
"Finland and the UK never stopped AstraZeneca. France will start again this morning, but Sweden will wait until sometime next week (not Monday)," wrote Tom Hedrup, a Moderate on Stockholm's city council. "I guess it is too much to ask for the Public Health Agency work during the weekend in a pandemic."
Finland och UK stoppade aldrig AstraZeneca. Frankrike drar igång igen i morgon men Sverige ska avvakta tills någon gång nästa vecka (inte måndag). Jag antar att det är för mycket begärt att FHM arbetar under helgen i en pandemi. #svpol #08pol #coronavirussverige #coronasverige
— Tom Hedrup (@TomHedrup) March 18, 2021
The World Health Organization on Thursday renewed a call for countries to continue the use of AstraZeneca’s
Covid-19 vaccine, saying the "benefits far outweigh the risks".
But even countries which have decided to immediately restart the program are showing caution.
In Germany for example, doctors will be required to inform patients about the possible blood clotting risk before giving them their jabs, Germany's health minister Jens Spahn said on Friday.
READ ALSO:
- Swedish PM: 'People are getting lazy in following the Covid-19 recommendations'
- AstraZeneca vaccine ‘safe and effective’ against Covid-19, European Medicines Agency concludes
'Very rare'
In its report, the EMA said the AstraZeneca vaccine was a "safe and effective" tool in the battle against Covid-19 but its investigation could not rule out whether the jab had caused rare cases of blood clotting.
"A causal link with the vaccine is not proven," it said. "But is possible and deserves further analysis."
In its first response to the EMA report, the Swedish Medical Products Agency noted that even if a link between the vaccine and this side-effect was eventually proven, it remained extremely rare. Around 20 million people have received the AstraZeneca vaccine in the EU and the EEA, of whom only about 20 have suffered these complications.
"In very rare cases, the vaccine may be associated with the occurrence of coagulation disorders such as blood clots in combination with low platelet counts (thrombocytopenia), and sometimes bleeding," the agency wrote. "Causality has not been established, but neither can be written off. The investigation therefore continues."
Medical Products Agency 'supports using it'
Ulla Wändel Liminga, the Scientific Director for Pharmacovigilance at the Medical Products Agency, told The Local that the delay had nothing to do with the Public Health Agency awaiting her agency's judgement.
"At the Medical Products Agency, we agree with the EMA that the risk-benefit assessment benefit/risk balance for the vaccine currently remains positive, so we support using it," she said. "That's the conclusion of the EMA, that it should be on the market, and we support that. It's then up to the Public Health Agency to decide exactly how the vaccine is used."
She said that her agency was, however, helping the Public Health Agency to understand the implications of the EMA's report.
"We are, of course in contact with them and inform them on any details they would like to have. But as I’m aware right now, they have not said that they want to have exactly 'this' or 'that' before they can come to their decision."
Swedish cases
Skåne University Hospital in Lund has reported the first known death from a coagulation disorder suffered by someone who had received the AstraZeneca vaccine. According to SVT, has been reported to European authorities and forms part of the basis for the further investigations.
The patient, a 60-year-old female health worker with no previous health complaints, suffered severe blood clots and haemorrhages a week after receiving the vaccine. She died at the end of February.
"This is the first documented case of this combined picture of serious coagulation disorders," Sofia Bosdotter Enroth, from the Swedish Medical Products Agency, said at a press conference.
According to the agency, another Swedish case is also being investigated as having a suspected link to the vaccination.
As of Thursday, Sweden has given 1.25 million vaccinations in total (not all, but including those using the AstraZeneca vaccine).
The Norway connection
The Norwegian Institute of Public Health is also taking time to come to a decision and linked the delay to serious cases of blood clots reported in that country. In a press release after the EMA's ruling, it said it would decide "by the end of week 12", meaning it will take a further eight days.
"Due to the situation with several serious cases in Norway, we want to thoroughly review the situation before we come to a conclusion. This will take some time, and we will provide an update at the end of next week,” said Geir Bukholm, head of the institute's infection control division.
Two people in Norway have died of blood clotting and two remain hospitalised, with the doctors treating them concluding that their sickness had been caused by a "strong immune response" caused by the vaccine.
"We have found the cause. There is nothing but the vaccine that can explain the immune reaction that occurred,” Pål Andre Holme, professor and chief physician at Oslo University Hospital told the country's VG newspaper.
Norway sent its findings to the EMA on Thursday, but they were not included in the report, causing Norway to dissent from the report's conclusions.
"Norway believes that there is reasonable evidence to assume that there is a causal link, therefore we would have liked this new complication to be included in the list of side effects. When it did not happen, we dissented on the overall conclusions," Sigurd Hortemo at the Norwegian Medicines Agency told the VG newspaper.
READ ALSO:
- Norway to retain suspension of AstraZeneca vaccine until at least next week
- Norwegian experts conclude ‘strong immune response’ from AstraZeneca vaccine linked to blood clots
Narcolepsy and Swine flu
Sweden's state epidemiologist Anders Tegnell has long faced criticism for his role in the mass vaccination Sweden carried out to ward off the Swine Flu pandemic, after a rare side effect of the vaccine left as many as 440 young Swedes suffering from narcolepsy.
Given that 60 percent of the Swedish population received the vaccine, the highest take-up in the world, the side effect only affected a tiny proportion of those inoculated.
But Tegnell last November said that if he had known about the side effect, Sweden would have approached its campaign differently.
"Of course the decision would have been completely different if we had known about the side effects. But they were completely unknown, they were a surprise to everybody," he told AFP in an interview.
Comments
See Also
At the press conference on Thursday evening, Sweden's Prime Minister Stefan Löfven said that what was most important was for the public to be fully confident that the safety risks had been properly evaluated.
"Everyone should feel that they are safe when they get their jab," he said.
At the press conference, the Public Health Agency's director, Johan Carlson, said that his agency needed time to digest the contents of the EMA's report.
"We must think about how this should be handled. Obviously, the sooner we are ready the better, but there's quite a lot that needs to be thought through," he said.
When The Local approached the Public Health Agency of Sweden for more detail on what further investigations justified waiting until Monday to give a decision, the agency said it could not reply until the decision had been made on Monday.
The delay has received some pushback from the opposition Moderate party.
"Finland and the UK never stopped AstraZeneca. France will start again this morning, but Sweden will wait until sometime next week (not Monday)," wrote Tom Hedrup, a Moderate on Stockholm's city council. "I guess it is too much to ask for the Public Health Agency work during the weekend in a pandemic."
Finland och UK stoppade aldrig AstraZeneca. Frankrike drar igång igen i morgon men Sverige ska avvakta tills någon gång nästa vecka (inte måndag). Jag antar att det är för mycket begärt att FHM arbetar under helgen i en pandemi. #svpol #08pol #coronavirussverige #coronasverige
— Tom Hedrup (@TomHedrup) March 18, 2021
The World Health Organization on Thursday renewed a call for countries to continue the use of AstraZeneca’s
Covid-19 vaccine, saying the "benefits far outweigh the risks".
But even countries which have decided to immediately restart the program are showing caution.
In Germany for example, doctors will be required to inform patients about the possible blood clotting risk before giving them their jabs, Germany's health minister Jens Spahn said on Friday.
READ ALSO:
- Swedish PM: 'People are getting lazy in following the Covid-19 recommendations'
- AstraZeneca vaccine ‘safe and effective’ against Covid-19, European Medicines Agency concludes
'Very rare'
In its report, the EMA said the AstraZeneca vaccine was a "safe and effective" tool in the battle against Covid-19 but its investigation could not rule out whether the jab had caused rare cases of blood clotting.
"A causal link with the vaccine is not proven," it said. "But is possible and deserves further analysis."
In its first response to the EMA report, the Swedish Medical Products Agency noted that even if a link between the vaccine and this side-effect was eventually proven, it remained extremely rare. Around 20 million people have received the AstraZeneca vaccine in the EU and the EEA, of whom only about 20 have suffered these complications.
"In very rare cases, the vaccine may be associated with the occurrence of coagulation disorders such as blood clots in combination with low platelet counts (thrombocytopenia), and sometimes bleeding," the agency wrote. "Causality has not been established, but neither can be written off. The investigation therefore continues."
Medical Products Agency 'supports using it'
Ulla Wändel Liminga, the Scientific Director for Pharmacovigilance at the Medical Products Agency, told The Local that the delay had nothing to do with the Public Health Agency awaiting her agency's judgement.
"At the Medical Products Agency, we agree with the EMA that the risk-benefit assessment benefit/risk balance for the vaccine currently remains positive, so we support using it," she said. "That's the conclusion of the EMA, that it should be on the market, and we support that. It's then up to the Public Health Agency to decide exactly how the vaccine is used."
She said that her agency was, however, helping the Public Health Agency to understand the implications of the EMA's report.
"We are, of course in contact with them and inform them on any details they would like to have. But as I’m aware right now, they have not said that they want to have exactly 'this' or 'that' before they can come to their decision."
Swedish cases
Skåne University Hospital in Lund has reported the first known death from a coagulation disorder suffered by someone who had received the AstraZeneca vaccine. According to SVT, has been reported to European authorities and forms part of the basis for the further investigations.
The patient, a 60-year-old female health worker with no previous health complaints, suffered severe blood clots and haemorrhages a week after receiving the vaccine. She died at the end of February.
"This is the first documented case of this combined picture of serious coagulation disorders," Sofia Bosdotter Enroth, from the Swedish Medical Products Agency, said at a press conference.
According to the agency, another Swedish case is also being investigated as having a suspected link to the vaccination.
As of Thursday, Sweden has given 1.25 million vaccinations in total (not all, but including those using the AstraZeneca vaccine).
The Norway connection
The Norwegian Institute of Public Health is also taking time to come to a decision and linked the delay to serious cases of blood clots reported in that country. In a press release after the EMA's ruling, it said it would decide "by the end of week 12", meaning it will take a further eight days.
"Due to the situation with several serious cases in Norway, we want to thoroughly review the situation before we come to a conclusion. This will take some time, and we will provide an update at the end of next week,” said Geir Bukholm, head of the institute's infection control division.
Two people in Norway have died of blood clotting and two remain hospitalised, with the doctors treating them concluding that their sickness had been caused by a "strong immune response" caused by the vaccine.
"We have found the cause. There is nothing but the vaccine that can explain the immune reaction that occurred,” Pål Andre Holme, professor and chief physician at Oslo University Hospital told the country's VG newspaper.
Norway sent its findings to the EMA on Thursday, but they were not included in the report, causing Norway to dissent from the report's conclusions.
"Norway believes that there is reasonable evidence to assume that there is a causal link, therefore we would have liked this new complication to be included in the list of side effects. When it did not happen, we dissented on the overall conclusions," Sigurd Hortemo at the Norwegian Medicines Agency told the VG newspaper.
READ ALSO:
- Norway to retain suspension of AstraZeneca vaccine until at least next week
- Norwegian experts conclude ‘strong immune response’ from AstraZeneca vaccine linked to blood clots
Narcolepsy and Swine flu
Sweden's state epidemiologist Anders Tegnell has long faced criticism for his role in the mass vaccination Sweden carried out to ward off the Swine Flu pandemic, after a rare side effect of the vaccine left as many as 440 young Swedes suffering from narcolepsy.
Given that 60 percent of the Swedish population received the vaccine, the highest take-up in the world, the side effect only affected a tiny proportion of those inoculated.
But Tegnell last November said that if he had known about the side effect, Sweden would have approached its campaign differently.
"Of course the decision would have been completely different if we had known about the side effects. But they were completely unknown, they were a surprise to everybody," he told AFP in an interview.
Join the conversation in our comments section below. Share your own views and experience and if you have a question or suggestion for our journalists then email us at [email protected].
Please keep comments civil, constructive and on topic – and make sure to read our terms of use before getting involved.
Please log in here to leave a comment.