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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

    Know more

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