Update: More Countries Limiting Use of AstraZeneca
Mar 15, 2021 16:59:38 GMT
elaine and valincal like this
Post by Deleted on Mar 15, 2021 16:59:38 GMT
Update #4 (see pg 5).
More countries limiting use of AZ vaccine on certain age groups.
What I'm more surprised to read about is the Forbes article stating that it has limited effectiveness on the South African variant. Hoping a larger study will be conducted to determine whether that's accurate.
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Update #3 (see pg 5).
Germany recommends those under 60’s not use AstraZeneca for their 2nd dose.
sleepingbooty also reported vaccine suspended in the Netherlands and France (under 55).
J&J discards 15M doses in US due to quality issues.
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Update #2:
Germany recommends those under 60’s not use AstraZeneca for their 2nd dose.
sleepingbooty also reported vaccine suspended in the Netherlands and France (under 55).
J&J discards 15M doses in US due to quality issues.
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Update #2:
Canada's National Advisory Committee on Immunization recommended Monday that the AstraZeneca Covid-19 vaccine should not be used in adults under age 55 while rare cases of serious blood clots following vaccination are being investigated, according to a release from the committee.
The rare cases of serious blood clots, known as vaccine-induced prothrombotic immune thrombocytopenia (VIPIT), have recently been reported in Europe following post-licensure use of the AstraZeneca vaccine, primarily in women under the age of 55.
According to the vaccine committee, the rate of this adverse event is still to be confirmed and information is being gathered to be more accurate.
"Following population-based analyses of VIPIT assessing risk of COVID-19 disease by age, and considering that alternate products are available (i.e., mRNA vaccines), from what is known at this time, there is substantial uncertainty about the benefit of providing AstraZeneca COVID-19 vaccine to adults under 55 years of age given that the potential risks associated with VIPIT, particularly at the lower estimated rates," committee officials said.
As a precautionary measure, while Health Canada carries out an updated risk versus benefit analysis based on emerging data, the committee is recommending that the vaccine not be offered to adults younger than 55 but will continue to reassess based on "rapidly evolving evidence."
According to the vaccine committee, the rate of this adverse event is still to be confirmed and information is being gathered to be more accurate.
"Following population-based analyses of VIPIT assessing risk of COVID-19 disease by age, and considering that alternate products are available (i.e., mRNA vaccines), from what is known at this time, there is substantial uncertainty about the benefit of providing AstraZeneca COVID-19 vaccine to adults under 55 years of age given that the potential risks associated with VIPIT, particularly at the lower estimated rates," committee officials said.
As a precautionary measure, while Health Canada carries out an updated risk versus benefit analysis based on emerging data, the committee is recommending that the vaccine not be offered to adults younger than 55 but will continue to reassess based on "rapidly evolving evidence."
The committee said because the AstraZeneca vaccine was expected to only make up a small proportion of the Covid-19 vaccines available for use in Canada, vaccinations "will not be significantly delayed."
CNN reached out to the drugmaker for comment but didn't get an immediate response.
CNN reached out to the drugmaker for comment but didn't get an immediate response.
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Update:
The European Union’s drug regulatory agency said Thursday that the AstraZeneca vaccine doesn’t increase the overall incidence of blood clots and that the benefits of using it outweigh the possible risks, paving the way for European countries to resume dispensing the shots.
Several European nations, including Germany, France, Italy and Spain, had suspended their use of the vaccine over the past week following reports of clots in a few dozen of the millions of people across the continent who have gotten the shot. The question was whether the vaccine had anything to do with those clots.
Italian Premier Mario Draghi welcomed the finding by a committee of the European Medicines Agency and immediately announced Italy would resume administering AztraZeneca’s vaccine as early as Friday.
Germany, France and others had said they would wait for the EMA’s determination before deciding whether to start using the vaccine again.
“The committee has come to a clear scientific conclusion,” said the head of the EMA, Emer Cooke. “This is a safe and effective vaccine.”
She added: “If it were me, I would be vaccinated tomorrow.”
However, she said the agency “still cannot rule out definitively a link” between certain rare types of blood clots and the vaccine. The EMA recommended adding a description of these cases to the vaccine leaflets so health workers and patients would be aware.
Clots that form in the arms, legs or elsewhere can break free and travel to the heart, brain or lungs, causing strokes, heart attacks or other deadly blockages. The EMA focused on very rare types of clots associated with low levels of platelets, which can lead to severe bleeding.
While many countries have continued to use the AstraZeneca vaccine, there are concerns the debate could seriously undermine confidence in the shot, which is key to efforts to immunize the world’s population, especially in poorer countries.
In Europe, where there is a choice of vaccines, the safety questions have complicated an already slow rollout across the 27-nation EU at a critical moment when infections are rising at an alarming rate again in many countries, in part because of mutant versions of the coronavirus.
Sabine Straus, the head of EMA’s safety committee, said experts found “no evidence of a quality or a batch issue” linked to any particular manufacturing site. She said the experts will continue to examine reports of rare blood clots and ensure that health care professionals and the public are kept informed.
Two rare types of blood clots -- one type appears in multiple blood vessels, the other in vessels that drain blood from the brain -- have been reported in at least 25 people, and at least nine deaths among them have been recorded, out of the 20 million who have received at least one dose of the AstraZeneca vaccine in Britain and the EU.
Most cases were in people under 55, and the majority were women, the EMA said.
But the EMA said the overall number of clotting events of various sorts reported after the rollout of the vaccination campaigns was lower than what would be expected in the general population.
The World Health Organization has said that there is no evidence to suggest the vaccine was to blame for the clots and that the benefits of immunization far outweigh the potentially small risk. The drugmaker likewise said it found no increased risk of clots.
Several European nations, including Germany, France, Italy and Spain, had suspended their use of the vaccine over the past week following reports of clots in a few dozen of the millions of people across the continent who have gotten the shot. The question was whether the vaccine had anything to do with those clots.
Italian Premier Mario Draghi welcomed the finding by a committee of the European Medicines Agency and immediately announced Italy would resume administering AztraZeneca’s vaccine as early as Friday.
Germany, France and others had said they would wait for the EMA’s determination before deciding whether to start using the vaccine again.
“The committee has come to a clear scientific conclusion,” said the head of the EMA, Emer Cooke. “This is a safe and effective vaccine.”
She added: “If it were me, I would be vaccinated tomorrow.”
However, she said the agency “still cannot rule out definitively a link” between certain rare types of blood clots and the vaccine. The EMA recommended adding a description of these cases to the vaccine leaflets so health workers and patients would be aware.
Clots that form in the arms, legs or elsewhere can break free and travel to the heart, brain or lungs, causing strokes, heart attacks or other deadly blockages. The EMA focused on very rare types of clots associated with low levels of platelets, which can lead to severe bleeding.
While many countries have continued to use the AstraZeneca vaccine, there are concerns the debate could seriously undermine confidence in the shot, which is key to efforts to immunize the world’s population, especially in poorer countries.
In Europe, where there is a choice of vaccines, the safety questions have complicated an already slow rollout across the 27-nation EU at a critical moment when infections are rising at an alarming rate again in many countries, in part because of mutant versions of the coronavirus.
Sabine Straus, the head of EMA’s safety committee, said experts found “no evidence of a quality or a batch issue” linked to any particular manufacturing site. She said the experts will continue to examine reports of rare blood clots and ensure that health care professionals and the public are kept informed.
Two rare types of blood clots -- one type appears in multiple blood vessels, the other in vessels that drain blood from the brain -- have been reported in at least 25 people, and at least nine deaths among them have been recorded, out of the 20 million who have received at least one dose of the AstraZeneca vaccine in Britain and the EU.
Most cases were in people under 55, and the majority were women, the EMA said.
But the EMA said the overall number of clotting events of various sorts reported after the rollout of the vaccination campaigns was lower than what would be expected in the general population.
The World Health Organization has said that there is no evidence to suggest the vaccine was to blame for the clots and that the benefits of immunization far outweigh the potentially small risk. The drugmaker likewise said it found no increased risk of clots.
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Mar 15, 2021:
Germany, France and Italy on Monday became the latest countries to suspend use of AstraZeneca’s COVID-19 vaccine over reports of dangerous blood clots in some recipients, though the company and European regulators have said there is no evidence the shot is to blame.
Germany's health minister said the decision was taken on the advice of the country's vaccine regulator, the Paul Ehrlich Institute, which called for further investigation into seven reported cases of clots in the brains of people who had been vaccinated.
“Today’s decision is a purely precautionary measure,” Jens Spahn said.
French President Emmanuel Macron said his country would likewise suspend shots at least until Tuesday afternoon, when the European Union's drug regulatory agency will weigh in on the vaccine. He said France hopes to resume using the formula soon.
Italy’s medicines regulator also announced a precautionary, temporary ban.
AstraZeneca said on its website that there have been 37 reports of blood clots out of more than 17 million people vaccinated in the 27-country European Union and Britain. The drugmaker said there is no evidence the vaccine carries an increased risk of clots.
In fact, it said the incidence of clots is much lower than would be expected to occur naturally in a general population of this size and is similar to that of other licensed COVID-19 vaccines.
The European Medicines Agency and the World Health Organization have also said that the data does not suggest the vaccine caused the clots and that people should continue to be immunized.
The AstraZeneca shot has become a key tool in European countries’ efforts to vaccinate their citizens against COVID-19. But Pfizer's and Moderna's vaccines are also used on the continent, and Johnson & Johnson's one-shot vaccine has been authorized but not yet delivered.
In the U.S., which relies on the Pfizer and Moderna vaccines, AstraZeneca is expected to apply any day now for authorization.
Blood clots can travel through the body and cause heart attacks, strokes and deadly blockages in the lungs. AstraZeneca reported 15 cases of deep vein thrombosis, or a type of clot that often develops in the legs, and 22 instances of pulmonary embolisms, or clots in the lungs.
Denmark last week became the first country to temporarily halt use of the AstraZeneca vaccine in recent days to investigate. It said one person developed clots and died 10 days after receiving at least one dose. The other countries include Ireland, Thailand, the Netherlands, Norway, Iceland, Congo and Bulgaria.
Germany's health minister said the decision was taken on the advice of the country's vaccine regulator, the Paul Ehrlich Institute, which called for further investigation into seven reported cases of clots in the brains of people who had been vaccinated.
“Today’s decision is a purely precautionary measure,” Jens Spahn said.
French President Emmanuel Macron said his country would likewise suspend shots at least until Tuesday afternoon, when the European Union's drug regulatory agency will weigh in on the vaccine. He said France hopes to resume using the formula soon.
Italy’s medicines regulator also announced a precautionary, temporary ban.
AstraZeneca said on its website that there have been 37 reports of blood clots out of more than 17 million people vaccinated in the 27-country European Union and Britain. The drugmaker said there is no evidence the vaccine carries an increased risk of clots.
In fact, it said the incidence of clots is much lower than would be expected to occur naturally in a general population of this size and is similar to that of other licensed COVID-19 vaccines.
The European Medicines Agency and the World Health Organization have also said that the data does not suggest the vaccine caused the clots and that people should continue to be immunized.
The AstraZeneca shot has become a key tool in European countries’ efforts to vaccinate their citizens against COVID-19. But Pfizer's and Moderna's vaccines are also used on the continent, and Johnson & Johnson's one-shot vaccine has been authorized but not yet delivered.
In the U.S., which relies on the Pfizer and Moderna vaccines, AstraZeneca is expected to apply any day now for authorization.
Blood clots can travel through the body and cause heart attacks, strokes and deadly blockages in the lungs. AstraZeneca reported 15 cases of deep vein thrombosis, or a type of clot that often develops in the legs, and 22 instances of pulmonary embolisms, or clots in the lungs.
Denmark last week became the first country to temporarily halt use of the AstraZeneca vaccine in recent days to investigate. It said one person developed clots and died 10 days after receiving at least one dose. The other countries include Ireland, Thailand, the Netherlands, Norway, Iceland, Congo and Bulgaria.