The Directorate-General of Health and Infarmed have stated that the AstraZeneca vaccine can continue to be administered and stressed that there is no evidence of a link with the thromboembolic cases registered in other countries.
"The DGS and INFARMED inform that, based on the data currently available and while the investigation is taking place, the information issued remains valid, and the vaccine will continue to be administered", says the statement.
In Portugal, they add, the Pharmacovigilance System has so far registered two cases of thromboembolic events after taking the AstraZeneca vaccine, "and they do not present the same clinical pattern as those under evaluation" by the Safety Committee, PRAC, of the Agency European Medicines Evaluation (EMA).
Irish health authorities recommended suspending administration of the AstraZeneca vaccine against covid-19 as a “precautionary measure” after reports of cases of blood clot formation in vaccinated people in Norway. The same decision had already been taken by other European countries.
In the joint statement, DGS and Infarmed recall that the cases reported in Norway, which led to Ireland's decision to suspend AstraZeneca's vaccine, “are being evaluated by the Safety Committee, PRAC, of the European Medicines Evaluation Agency (EMA), with a conclusion expected during the next week”.
The two Portuguese entities stress that "so far there is no evidence that vaccination could be at the origin of these events".
"The number of thromboembolic events reported in the vaccinated population in the European Union (about 5 million) and in the United Kingdom (about 11 million ) is still not higher than that seen in the general population", highlight the DGS and Infarmed.
The two entities guarantee that "this matter continues to be monitored by the national health authorities, through their participation in the assessment that takes place at European level, together with the European counterpart authorities, namely in meetings taking place next week".
The DGS and Infarmed warn that "health professionals who suspect adverse reactions after vaccination against covid-19 should immediately report these reactions in the National Pharmacovigilance System."
The Irish Vaccination Program Committee's recommendation to suspend administration of the AstraZeneca vaccine came after a report by the Norwegian Health Products Agency reported “four new serious cases of blood clots in adults” after receiving the vaccine from the Anglo-Swedish laboratory.
Norway, Denmark and Iceland announced a suspension of injections of AstraZeneca's covid-19 vaccine on Thursday last week, under the principle of “precaution” due to fears related to the formation of blood clots.
Bulgaria followed suit on Friday and Thailand delayed its campaign.
Earlier this week, Austria stopped administering a batch of AstraZeneca vaccines after the death of a 49-year-old nurse due to "serious clotting problems" a few days after being vaccinated.
In response, the pharmaceutical group said on Friday that its vaccine does not carry any "aggravated risk" of blood clot formation.
Based on "an analysis of safety data covering more than 10 million registered cases, we found no evidence of increased risk of pulmonary embolism or thrombosis", stresses the AstraZeneca laboratory in a statement, adding that, "in fact, numbers of this type [of medical problems] are much lower in those who are vaccinated compared to what would be expected in the general population”.
Also on Friday, the World Health Organization (WHO) stated that "there is no reason not to use" AstraZeneca's covid-19 vaccine, after its use was suspended in several European countries as a precautionary measure.
“Yes, we must continue to use the AstraZeneca vaccine. There is no reason not to use it,” spokeswoman Margaret Harris said at a press conference in Geneva.
The European Medicines Agency (EMA) said, however, that a causal relationship was "likely" in at least some of the "41 reports of possible anaphylaxis [serious allergic reaction] among some five million vaccinations in the UK ”.
The EMA advocates that severe allergies should be added to the vaccine's list of possible side effects, but that it remains safe.
