ANDRÉ KOSTERS/LUSA

Infarmed: AstraZeneca benefits outweigh risks 

Portugal’s National Medicines Authority (Infarmed) issued a statement on Friday saying that the AstraZeneca vaccine’s benefits outweigh the risks.

The statement came after the European Medicines Agency (EMA) said the vaccine was safe and effective but that the vaccine’s summary of product characteristics and package leaflet would be updated with information on cases of disseminated intravascular coagulation (DIC) and cerebral venous sinus thrombosis (CVST).

“Although these are very rare occurrences, the [EMA safety] committee recommended that the summary of product characteristics and the information leaflet for this vaccine be updated to include more information on these risks, along with the distribution of a communication to health professionals to alert them to the remote possibility of the occurrence of alterations in the coagulation ”of the blood of vaccinees, the statement reads.

The EMA and Infarmed said health professionals should be aware of the possibility of the occurrence of “cases of thromboembolism, namely disseminated intravascular coagulation or cerebral venous sinus thrombosis”, in vaccinated people, especially in the seven to 14 days after vaccination and particularly in women under 55 years of age.

Also, healthcare professionals should tell vaccinated people to seek immediate medical help if they experience symptoms of thromboembolism and especially signs of thrombocytopenia and brain blood clots, such as bruising or easy bleeding and persistent or severe headache, especially during the first few days after vaccination.

Infarmed warns that they should see a doctor immediately if they experience one of the following symptoms after vaccination: shortness of breath, chest or stomach pain, swelling or cold in the arms or legs, severe headache or if it worsens or blurred vision, persistent bleeding and multiple and small bruises, reddish or purplish spots or bloody vesicles under the skin.

The Infarmed statement highlights that the EMA safety committee concluded that the vaccine’s benefits in preventing Covid-19 hospitalization and death outweigh these risks.

“The events observed are very rare – seven cases of disseminated intravascular coagulation and 18 cases of thrombosis of the cerebral venous sinuses – compared to the number of vaccinates of around 20 million in the United Kingdom and the European Economic Area, until 16 March, not having been any relationship with the vaccine has been proven,” the document also states.

The World Health Organization recently pointed out: “The available data do not suggest any overall increase in clotting conditions such as deep venous thrombosis or pulmonary embolism following administration of COVID-19 vaccines. Reported rates of thromboembolic events after COVID-19 vaccines are in line with the expected number of diagnoses of these conditions. Both conditions occur naturally and are not uncommon. They also occur as a result of COVID-19.  The observed rates have been fewer than expected for such events.”

The Portuguese health authorities decided on Monday to resume the administration of AstraZeneca vaccines, three days after the announcement of a temporary suspension due to reports in several countries of blood clots in vaccinated people.

In Portugal, over 16,000 people died from over 816,000 confirmed cases of infection, according to recent figures from the Directorate-General for Health.