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The
European Medicines Agency (EMA)
concluded on Wednesday that the development of very rare thromboembolisms will be included as a side effect of the
AstraZeneca
vaccine
due to the existence of a possible link with the cases reported after
vaccination
, but maintained a positive opinion on your benefit against Covid-19.
Although four weeks of research have failed to define specific risk factors that explain the development of
unusual
blood clots
in people who received the
AstraZeneca
vaccine
, the
EMA
does see that there is a "strong association" of these "adverse events" and that they are a "sign that there is a probable causal relationship" between the drug and
very rare thromboembolisms
.
If it is not age, gender, or a previous medical history that poses a risk of developing
thromboembolism
, what could be the cause of these clots?
"A plausible explanation for these rare events is that they are an
immune response
that leads to a condition similar to that sometimes seen in patients treated with heparin, which is called
heparin-induced
thrombocytopenia
(HIT)," he explained in a conference. Telematics Press
Emer Cooke
, the Executive Director of the EMA.
Cooke noted that the
safety committee (PRAC)
"has confirmed that the benefit of the
AstraZeneca
vaccine
in preventing
Covid-19
outweighs the risk of
side effects
" and recalled that this is "a very serious disease with high rates of hospitalization and death, and every day it causes thousands of deaths throughout the
European Union (EU)
. "
In addition,
AstraZeneca
"has been shown to be highly effective in preventing a serious illness and its hospitalizations, it is saving lives" and vaccination is "extremely important to help us in the fight against
Covid-19
, so we have to use the vaccines that we have. to protect us against the devastating effects "of the
coronavirus
.
Sabine Strauss, head of the PRAC, added that the risk of mortality due to blood clotting is still "much lower" than the possibility of dying from the effects of
Covid-19
, which makes it necessary to continue using
AstraZeneca
in vaccination campaigns in the EU, where some countries decided to paralyze the use of this drug in people under 60 years of age, pending the conclusions published today by the EMA.
As there is no defined risk factor, the EMA emphasizes that it is "important that both vaccinated people and health professionals are aware of the possibility of developing very rare cases of blood clotting combined with
low levels of platelets
in blood within two weeks after vaccination. "
Go to the doctor "without delay"
So far, most of the reported cases have occurred in
women under 60 years of age within 15 days of vaccination
, but the EMA does not consider being a young woman a risk factor because these events have also occurred in men. and in older than that age group.
The PRAC reviewed in depth a total of 62 cases of
cerebral venous thrombosis (CVST)
and 24 cases of
splanchnic vein thrombosis
, notified to the EMA until March 22, of which 18 were fatal.
The EMA has highlighted the importance of resorting to specialized medical treatment "without delay" when recognizing
signs of blood clots
, which can be reflected in the following
seven symptoms
:
Difficulty breathing
Chest pain
Swelling in the leg
Persistent abdominal pain
Blurry vision
Severe headaches
Petechiae
(small spots of blood under the skin) beyond the injection site
In addition to
AstraZeneca
(or
Vaxzevria
), authorized at the end of January, the EMA has given the green light to the
Pfizer / BioNtech
,
Moderna
and
Janssen
vaccines
, and has an ongoing review process open for three other
Covid-19
vaccines
-
Novavax
,
Curevac
and
Sputnik V
- although none have yet a set timetable for receiving a European license.
As part of the ongoing evaluation, the EMA has confirmed that it will carry out "a good clinical practice inspection" in Russia on the way in which
Sputnik V
trials were conducted on volunteers
to determine whether proper procedures were followed to scientific and ethical level, given the concern that international standards were not met.
Russia has indicated that military and state employees have participated in trials of the vaccine, developed in a state laboratory and funded by the
Russian Direct Investment Fund
(RDIF), a sovereign Kremlin fund, which noted that there were no pressure on the people who took part in the trials.
According to the criteria of The Trust Project
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