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The European Medicines Agency (EMA) considers that AstraZeneca's covid-19 vaccine should continue to be administered.

Given the recent notifications of thromboembolic events among people who had received this vaccine in Austria and Denmark, and which have led to the temporary suspension of the preventive administration of the vaccine, the EMA has issued a statement on Thursday in which it assures that "

there is

currently

no indication that vaccination caused these conditions

, which are not listed as side effects with this vaccine."

The EMA safety committee, the PRAC, emphasizes that "

the benefits of the vaccine continue to outweigh its risks

and the vaccine can continue to be administered while cases of thromboembolic events are being investigated."

In addition, from the EMA they emphasize that "

the number of thromboembolic events in vaccinated people is not greater than the number observed in the general population

. Until March 10, 2021, 30 cases of thromboembolic events had been reported among about 5 million people vaccinated with the AstraZeneca Covid-19 vaccine in the European Economic Area. "

This statement abounds in what has already been reported by the Spanish Agency for Medicines and Health Products (Aemps) which, through its web portal, indicates that "at this time,

there is no evidence that the vaccine was the cause of these events

" and that, "up to now, no relevant adverse event of the type that has been reported in Austria has been registered in Spain."

The Aemps explains that the Austrian authorities have reported that a 49-year-old person suffered multiple thrombosis 10 days after receiving the vaccine and died;

and that another 35-year-old had a pulmonary embolism after being vaccinated and is recovering.

They had both received the vaccine from the same batch, ABV5300

from the Covid-19 Vaccine AstraZeneca vaccine.

"Although it is considered unlikely, it is being investigated if there could be a quality problem with this lot. This lot has been distributed in 17 EU countries, including Spain. The date of distribution of the lot in Spain has been February 12 , having received and distributed 228,000 doses ", they add from Aemps.

Periodic reviews

Along with this, from the national agency they explain that all the reported events related to alterations in coagulation are reviewed monthly in the Committee for the European Risk Assessment of the European Medicines Agency (PRAC), which has initiated a "comprehensive review" of the cases reported with this vaccine.

"Coagulation alterations and, among them, thrombotic events,

have not been established as a possible adverse reaction of this vaccine

and do not appear as such in the technical data sheet of the drug", they point out.

In addition, they explain from the Aemps that the available data indicate that the thromboembolic events reported after the administration of the AstraZeneca vaccine

do not represent a greater number than those expected in the general population

.

So far 22 cases of this type of event have been reported in the EU in the context of three million vaccinated people.

"The preliminary evaluation does not indicate a relationship of the vaccine with the reported events," they emphasize.

Regarding this, the Aemps also recalls that

vaccination does not reduce health problems other than those caused by Covid-19

, so that during the vaccination campaign it is expected that serious adverse events will continue to occur, sometimes in close temporal association with administration of the vaccine: "In this sense, it is estimated that in Spain, in 2018, there were 11 hospital admissions for every 100,000 inhabitants aged 35 to 39 years due to pulmonary embolism. This figure increases to 82 cases per 100,000 people from 65 to 69 years and is higher in older people. The annual incidence of pulmonary embolism is estimated between 70 and 113 cases per 100,000 people of any age. "

For all this, the Aemps considers that

there are no reasons that justify the adoption of precautionary measures on this batch

, so that the vaccination plan planned for these units may be followed.

In addition, it states that any new relevant information on this matter will be communicated "immediately".

No physiopathogenic mechanism

For their part, AstraZeneca sources explain to this medium that so far, in all the safety analyzes carried out "

no physiopathogenic mechanism has been found as far as it is known that it may be related

to this type of thromboembolic events".

It is also not an effect that has been found in any clinical trial conducted with this vaccine.

The pharmaceutical company has reviewed the batch of vaccines associated with the first reported cases, and all the studies carried out in accordance with the regulatory agencies "

rule out that there is something that could justify the thromboembolic phenomena

."

They also emphasize that it is important not to create alarm among the population, "because

the risk of not vaccinating, with this or other vaccines, is much greater

than the possible risk of the vaccine."

The reviews of the safety and quality of vaccines continue, recall these sources, with additional analysis of possible adverse effects registered worldwide, in order to clear up any doubts about the safety of the vaccine.

From the pharmaceutical company they emphasize that the reported thrombotic events must be framed "in the context of a massive vaccination, in which a huge number of doses are administered in a very short period of time", so these episodes have a temporal relationship with the vaccination, and a causal relationship has not been shown.

The British company also recalls that in the latest Pharmacovigilance Report on Covid-19 Vaccines prepared by the Aemps on immunizations in Spain, and which was presented last Tuesday, no effect has been observed that was not already included in the technical sheet. .

According to this report,

there is even a lower frequency of these effects than expected, of 69 cases per 100,000 vaccinated

.

In other countries

Hours after Aemps made its position public, the case of another country that adopts similar measures to Austria has become known.

This is Denmark, which this Thursday, through its General Directorate of Health (SST), announced the

temporary suspension for 14 days of the AstraZeneca vaccine after registering "serious cases of thrombi"

in people who had received it.


One of the cases is related to a death, health authorities have explained in a statement, highlighting that it still cannot be concluded that there is a direct relationship between the vaccine and thrombi, according to EFE.

"We are in the largest and most important vaccination campaign in the history of Denmark, we need all the vaccines we can get. So it is not an easy decision to suspend one. But we must react carefully when there is evidence of possible serious effects," he said. noted the director of the SST, Søren Brostrøm.


Brostrøm stressed that this is a pause and that there is "good documentation" that the AstraZeneca vaccine

is "safe and effective", but that the Danish authorities are forced to react

to reports of possible effects "from Denmark and other countries. Europeans ".


The European Medicines Agency (EMA) has launched an investigation in this regard, according to the Danish Directorate General for Health, which has applied "a principle of prudence" and will carry out a new assessment in the penultimate week of March.

EFE also points out that

Estonia, Latvia, Lithuania and Luxembourg have also suspended the administration of the ABV5300 batch

of AstraZeneca's vaccine.

According to the criteria of The Trust Project

Know more

  • Science and Health

  • Coronavirus

  • Covid 19

  • Infectious diseases

  • Respiratory diseases

  • Vaccines

  • AstraZeneca

  • Pharmacology

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