The European Union’s drug regulator said Wednesday that the
benefits of AstraZeneca’s COVID-19 vaccine outweigh its risks, but
that rare blood clotting events should be listed as a possible side
effect.
![image](/2021/04/lawp1.jpg")
The European Medicines Agency’s assessment comes after a panel
of experts reviewed reports of unusual blood clots occurring in
some vaccine recipients. Officials stressed these events are rare
and said that while they appear to be more common in women under
the age of 60, there is not enough available evidence to confirm
specific risk factors such as age, gender or previous medical
history.
![image](/2021/01/payne-alex.jpg")
They said it is important for health care providers and the
public to be aware of the signs and symptoms of these unusual
events — which include shortness of breath, persistent abdominal
pain and leg swelling — and that the vaccine’s product information
will be updated to list them as a possible adverse reaction. They
are still recommending its use and emphasized the vaccine has been
proven to prevent severe disease, hospitalizations and deaths.
“The risk of mortality from COVID is much greater than the risk
of mortality from these side effects,” said Emer Cooke, executive
director of the European Medicines Agency. ” I think it’s important
that we give the message that vaccines will help us in the fight
against COVID, and we need to continue to use these vaccines.”
In a statement, the agency said health care professionals and
vaccine recipients should be aware of the “possibility of very rare
cases of blood clots combined with low levels of blood platelets
occurring within 2 weeks of vaccination.”
The regulator’s Pharmacovigilance Risk Assessment Committee
noted that the recorded blood clots occurred in veins in the brain
and abdomen, and in arteries, combined with low levels of blood
platelets and “sometimes bleeding.”
As of Sunday, the European Union’s drug safety database had
recorded 169 cases of blood clots in the brain, also known as
cerebral venous sinus thrombosis, and 53 cases of those in the
abdomen, or splanchnic vein thrombosis, in the European Economic
Area and United Kingdom — where some 34 million people had received
the vaccine.
Dr. Sabine Straus, the chair of the committee, said there was a
“probable causal association” between the rare clots and the
vaccine. It is too soon for the European Medicines Agency to
identify a definite cause of the rare condition, conclusively
determine risk factors or recommend any specific measures to reduce
risk, officials said.
They noted that one plausible explanation for the combination of
blood clots and low blood platelets is an immune response
triggering a condition similar to one seen occasionally in patients
treated with the blood thinner heparin.
The agency said it will continue to monitor the cases and issue
new recommendations as necessary. It has also commissioned further
research by AstraZeneca.
“This case clearly demonstrates one of the challenges posed by
large-scale vaccination campaigns,” Cooke said. “When millions of
people receive these vaccines, very rare events can occur that were
not identified during the clinical trials.”
But it also demonstrates that the region’s pharmacovigilance
system works, she said, as the unusual events could be quickly
identified, analyzed and acted on.
The U.K.’s Medicines and Healthcare products Regulatory Agency
also put out additional findings on Wednesday drawing a “possible
link” between the AstraZeneca vaccine and extremely rare blood
clots.
It said the shot’s benefits continue to outweigh any risk but
advised “careful consideration” be given to individuals at higher
risk of specific types of blood clots due to a medical
condition.
It did not recommend age restrictions in the vaccine’s use, but
Britain’s Joint Committee on Vaccination and Immunisation said the
same day that it would be better, when possible, for adults under
the age of 30 with no underlying conditions to be offered an
alternative.
“We are not advising a stop to any vaccination for any
individual in any age group,” Wei Shen Lim, COVID-19 chair for that
committee, said at a briefing, according to Reuters. “We are
advising a preference for one vaccine over another vaccine for a
particular age group, really out of the utmost caution, rather than
because we have any serious safety concerns.”
Last month, reports emerged of dozens of blood clots occurring
after vaccination, several of them fatal. That prompted more than a
dozen countries, mostly in Europe, to suspend temporarily use of
the AstraZeneca vaccine, though the European Medicines Agency and
World Health Organization both continued to recommend its use.
Many of those countries resumed inoculations after a European
Medicines Agency investigation last month found that the vaccine’s
benefits far outweigh its risks, with officials pointing out the
number of “thromboembolic events” reported after vaccination was
actually lower than expected in the general population.
The regulator announced on March 18 that its preliminary
investigation had determined the vaccine to be safe and effective,
and said there is no increase in the overall risk of blood clots
associated with its use, even as some questions remained.
Several of the countries to resume AstraZeneca vaccinations have
done so with conditions; for example, French health authorities are
recommending it only for people ages 55 and older, Germany
suspended the “routine use” of the vaccine for people under 60 and
South Korea said Wednesday it will temporarily withhold the vaccine
from people under 60.
And on Tuesday, the University of Oxford announced it was
pausing a small trial in the U.K. that would test the vaccine on
individuals ages 6 to 17 as it waited for more data on the blood
clotting reports.
The AstraZeneca vaccine has been approved by many countries
across the world, and its affordability — at just $4 a dose — and
minimal handling requirements make it ideal for global use, as NPR
has reported.
The WHO in February approved the vaccine for emergency use to be
rolled out globally through COVAX, an international effort to help
low- and middle-income countries combat the pandemic. And the Biden
administration said last month it was finalizing plans to loan
millions of doses to Mexico and Canada.
It is not currently being used in the United States. The company
has said it will seek emergency use authorization from the U.S.
Food and Drug Administration, which would make it the fourth
coronavirus vaccine available in the country.
That process has also raised some questions after an independent
monitoring board said the company released data showing an
incomplete picture of its efficacy. AstraZeneca then published
results showing slightly diminished efficacy figures: 76% effective
against symptomatic COVID-19 and 100% effective against severe or
critical disease and hospitalization.
Dr. Anthony Fauci, the Biden administration’s chief medical
adviser, told Reuters earlier this month that the U.S. may not need
it to vaccinate the entire population.
“My general feeling is that given the contractual relationships
that we have with a number of companies, that we have enough
vaccine to fulfill all of our needs without invoking AstraZeneca,”
Fauci said.
Culled from https://www.npr.org/
The European Union’s drug regulator said Wednesday that the
benefits of AstraZeneca’s COVID-19 vaccine outweigh its risks, but
that rare blood clotting events should be listed as a possible side
effect.
The European Medicines Agency’s assessment comes after a panel
of experts reviewed reports of unusual blood clots occurring in
some vaccine recipients. Officials stressed these events are rare
and said that while they appear to be more common in women under
the age of 60, there is not enough available evidence to confirm
specific risk factors such as age, gender or previous medical
history.
They said it is important for health care providers and the
public to be aware of the signs and symptoms of these unusual
events — which include shortness of breath, persistent abdominal
pain and leg swelling — and that the vaccine’s product information
will be updated to list them as a possible adverse reaction. They
are still recommending its use and emphasized the vaccine has been
proven to prevent severe disease, hospitalizations and deaths.
“The risk of mortality from COVID is much greater than the risk
of mortality from these side effects,” said Emer Cooke, executive
director of the European Medicines Agency. ” I think it’s important
that we give the message that vaccines will help us in the fight
against COVID, and we need to continue to use these vaccines.”
In a statement, the agency said health care professionals and
vaccine recipients should be aware of the “possibility of very rare
cases of blood clots combined with low levels of blood platelets
occurring within 2 weeks of vaccination.”
The regulator’s Pharmacovigilance Risk Assessment Committee
noted that the recorded blood clots occurred in veins in the brain
and abdomen, and in arteries, combined with low levels of blood
platelets and “sometimes bleeding.”
As of Sunday, the European Union’s drug safety database had
recorded 169 cases of blood clots in the brain, also known as
cerebral venous sinus thrombosis, and 53 cases of those in the
abdomen, or splanchnic vein thrombosis, in the European Economic
Area and United Kingdom — where some 34 million people had received
the vaccine.
Dr. Sabine Straus, the chair of the committee, said there was a
“probable causal association” between the rare clots and the
vaccine. It is too soon for the European Medicines Agency to
identify a definite cause of the rare condition, conclusively
determine risk factors or recommend any specific measures to reduce
risk, officials said.
They noted that one plausible explanation for the combination of
blood clots and low blood platelets is an immune response
triggering a condition similar to one seen occasionally in patients
treated with the blood thinner heparin.
The agency said it will continue to monitor the cases and issue
new recommendations as necessary. It has also commissioned further
research by AstraZeneca.
“This case clearly demonstrates one of the challenges posed by
large-scale vaccination campaigns,” Cooke said. “When millions of
people receive these vaccines, very rare events can occur that were
not identified during the clinical trials.”
But it also demonstrates that the region’s pharmacovigilance
system works, she said, as the unusual events could be quickly
identified, analyzed and acted on.
The U.K.’s Medicines and Healthcare products Regulatory Agency
also put out additional findings on Wednesday drawing a “possible
link” between the AstraZeneca vaccine and extremely rare blood
clots.
It said the shot’s benefits continue to outweigh any risk but
advised “careful consideration” be given to individuals at higher
risk of specific types of blood clots due to a medical
condition.
It did not recommend age restrictions in the vaccine’s use, but
Britain’s Joint Committee on Vaccination and Immunisation said the
same day that it would be better, when possible, for adults under
the age of 30 with no underlying conditions to be offered an
alternative.
“We are not advising a stop to any vaccination for any
individual in any age group,” Wei Shen Lim, COVID-19 chair for that
committee, said at a briefing, according to Reuters. “We are
advising a preference for one vaccine over another vaccine for a
particular age group, really out of the utmost caution, rather than
because we have any serious safety concerns.”
Last month, reports emerged of dozens of blood clots occurring
after vaccination, several of them fatal. That prompted more than a
dozen countries, mostly in Europe, to suspend temporarily use of
the AstraZeneca vaccine, though the European Medicines Agency and
World Health Organization both continued to recommend its use.
Many of those countries resumed inoculations after a European
Medicines Agency investigation last month found that the vaccine’s
benefits far outweigh its risks, with officials pointing out the
number of “thromboembolic events” reported after vaccination was
actually lower than expected in the general population.
The regulator announced on March 18 that its preliminary
investigation had determined the vaccine to be safe and effective,
and said there is no increase in the overall risk of blood clots
associated with its use, even as some questions remained.
Several of the countries to resume AstraZeneca vaccinations have
done so with conditions; for example, French health authorities are
recommending it only for people ages 55 and older, Germany
suspended the “routine use” of the vaccine for people under 60 and
South Korea said Wednesday it will temporarily withhold the vaccine
from people under 60.
And on Tuesday, the University of Oxford announced it was
pausing a small trial in the U.K. that would test the vaccine on
individuals ages 6 to 17 as it waited for more data on the blood
clotting reports.
The AstraZeneca vaccine has been approved by many countries
across the world, and its affordability — at just $4 a dose — and
minimal handling requirements make it ideal for global use, as NPR
has reported.
The WHO in February approved the vaccine for emergency use to be
rolled out globally through COVAX, an international effort to help
low- and middle-income countries combat the pandemic. And the Biden
administration said last month it was finalizing plans to loan
millions of doses to Mexico and Canada.
It is not currently being used in the United States. The company
has said it will seek emergency use authorization from the U.S.
Food and Drug Administration, which would make it the fourth
coronavirus vaccine available in the country.
That process has also raised some questions after an independent
monitoring board said the company released data showing an
incomplete picture of its efficacy. AstraZeneca then published
results showing slightly diminished efficacy figures: 76% effective
against symptomatic COVID-19 and 100% effective against severe or
critical disease and hospitalization.
Dr. Anthony Fauci, the Biden administration’s chief medical
adviser, told Reuters earlier this month that the U.S. may not need
it to vaccinate the entire population.
“My general feeling is that given the contractual relationships
that we have with a number of companies, that we have enough
vaccine to fulfill all of our needs without invoking AstraZeneca,”
Fauci said.
Culled from https://www.npr.org/