The data are reported by Portugal to the European adverse reaction surveillance platform EudraVigilance, which it consulted. It reveals that, overall, at European level, 272 644 reports of suspected adverse reactions (adverse effects and clinical manifestations that may not necessarily have a causal relationship with the vaccine but that arose after immunization) have been reported to these three vaccines so far. , those that are mostly used in the EU since they were the first ones approved by the European Medicines Agency.
In the vaccination monitoring portal of the European Center for Disease Prevention and Control, it is possible to see how many vaccines were made for each brand in different countries. Crossing the information, the Pfizer vaccine now has more than 59 million doses administered in the EU and last week had 127 789 reported adverse reactions, between mild and severe, which means 2.1 reactions reported per thousand doses administered. Portugal, with 1.4 million doses of Pfizer vaccine administered, appears in this line.
The vaccine at Moderna, 5.2 million doses were administered and 11 545 reactions were reported at European level, which also gives an average of 2.1. In Portugal, about 128 thousand doses and 149 reactions were reported, below this threshold. In the case of the AstraZeneca vaccine, the difference becomes greater: at European level, 16 million doses have been administered and 133 310 adverse reactions are now reported, about 8.2 reactions per thousand doses administered – a number that has doubled since they sounded. the alerts surrounding thromboembolism cases associated with low platelets, which the EMA announced yesterday will be included in the group of rare adverse effects that may arise after the vaccine and that need to be monitored. And one of the appeals of the EMA, who stressed that at the moment there are no clear indications about previous risk factors that may be linked to these very rare adverse effects – as of April 4, 169 cases had been reported in this universe of 272 thousand adverse reactions to vaccines from covid-19, with an estimated one case report for every 100,000 people who get the AstraZeneca vaccine – it was precisely so that all people who experience unusual symptoms after the vaccine report them. And that in the case of the AstraZeneca vaccine, special attention should be paid to what may be symptoms of thrombosis: shortness of breath, cooling of limbs, severe headache that does not go away, hemorrhages and blood stains.
13 deaths without vaccine association
In Portugal, according to the latest information available on the Infarmed website still with reference to the end of March, it can be read that of the 3543 reactions reported at the time (Infarmed does not disclose the total number of reactions by type of vaccine, although these data are published later at European level), 1583 were classified as serious. A total of 13 deaths in the period after vaccination have already been reported in the country, most of them elderly, and the indicator indicates that in no case has a direct association with the vaccine been established.
The most common effects reported in Portugal, where there is no strong history of reporting adverse reactions, namely by patients, were muscle / joint pain, reaction at the injection site, headache, fever, asthenia / weakness / fatigue, nausea, lymphadenopathies (swollen lymph nodes), tremors, paraesthesias and general malaise.
Cases of thromboembolic events have been reported after the vaccine, but none of the cases that prompted the investigation by the authorities: cases of cerebral thrombosis of the venous sinuses and thrombosis of abdominal veins associated with a condition of low platelets identical to that manifested by some patients make an anticoagulant called heparin. Last week, Andreas Greinacher, the German doctor at the university hospital in Greifswald who discovered the link between a specific type of antibody that appears after vaccination in some people and that seems to lead to these pictures had already explained, in a press conference with European journalists, that the fact that there is this reaction in heparin did not cause this drug to leave the market. Even so, the concern that remains to be seen is whether there are risk factors or people with a greater predisposition to develop these conditions, which until now have been reported mostly in women under 60 years of age. At the EMA press conference, the head of the European agency’s safety committee, Sabine Strauss, stressed that “although the majority of cases have occurred in people under the age of 60 and women, as the vaccine has been administered in a different in different countries, the PRAC does not conclude that age or gender are a clear risk factor for these rare side effects ”.
For the European Medicines Agency, the benefits of the vaccine continue to outweigh the risks, but at yesterday’s conference it was clearer than in the previous one that the European body will not make recommendations on the use of vaccines and that it is up to the national vaccination commissions to evaluate how and to whom they recommend each vaccine depending on their vaccination plans, who has already been vaccinated, what vaccines they have available and the epidemiological situation. An early pass by calling for an emergency meeting of EU ministers convened by the Portuguese presidency, in this case by Health Minister Marta Temido, in an attempt to reach a concerted position, which has not happened in recent weeks. At the closing time of this edition, there were still no announced decisions on whether there will be common changes in European vaccination plans, but everything pointed as the most likely outcome that the ball would pass to the vaccination commissions. Last week, the national vaccination commission maintained the recommendation to use the Astra vaccine over the age of 18, without limitations, but now the matter should be considered again.
England chooses another vaccine for children under 30
In the United Kingdom, the medicine’s regulatory agency, which with Brexit is no longer linked to the European Medicines Agency although they collaborated in this investigation, yesterday proposed that an alternative vaccine be offered to those under 30, male, at this stage. or woman. The argument was precisely that of risks and benefits and the basis for an analysis by age group in three scenarios of covid-19 – low incidence, moderate and high – something that the EMA did not present yesterday, at least publicly. For every 100,000 people receiving the AstraZeneca vaccine, British experts estimate that 1.1 serious reactions are expected in the 20 to 29 age group, 0.8 from 30 to 39, 0.5 from 40 to 49, 0 , 4 from 50 to 59 and 0.2 from 60 to 69. If in all epidemic settings the benefits of the vaccine in preventing admission to intensive care if infected appears to be higher, only in the youngest, in a scenario of low incidence like what is currently experienced in England, the benefits can be comparable to the risks, hence the recommendation. Within 16 weeks, experts predict that, at a time when the incidence is around 6 cases per 10,000 inhabitants (60 cases per 100,000 inhabitants, identical to what is experienced in Portugal) in every 100,000 young people vaccinated, prevent every 16 weeks 0.8 admissions to the ICU, so the benefit is slightly less than the risk associated with the vaccine in this age group. The presentation, made available yesterday by the British Government, notes, however, that in a scenario of a high incidence of 20 cases of covid-19 per 10,000 inhabitants, 200 cases per 100,000 inhabitants, for every 100,000 young people vaccinated, the vaccine can prevent 6 , 9 intensive care hospitalizations every 16 weeks.
Vaccines vs adverse reactions
Pfizer / BiONTech (approved in the EU on 21.12.2020)
• Doses administered in the EU / EEA until April 7: 59 108 437
• Adverse reactions reported in the EU / EEA as of April 3: 127 789 // 2.1 reactions reported per thousand doses administered
• Doses administered in Portugal: 1 396 612
• Adverse reactions reported in Portugal: 2941 // 2.1 reactions per thousand doses administered
• Doses administered in the EU / EEA until April 7: 5 209 560
• Adverse reactions reported in the EU / EEA as of April 3: 11 545 // 2.1 reactions reported per thousand doses administered
• Doses administered in Portugal: 128 139
• Reactions reported in Portugal: 149 // 1.2 per thousand doses given
• Doses administered in the EU / EEA until 7 April: 16 114 868
• Adverse reactions reported in the EU / EEA as of April 3: 133 310 // 8.2 reactions reported per thousand doses administered
• Doses administered in Portugal: 388 709
• Reactions reported in Portugal: 535 // 1.4 per thousand doses doses given
Sources: EudraVigilance – European system for reporting adverse reactions and Vaccine
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