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AstraZeneca, the Ema verdict: "Effective vaccine, benefits outweigh the risks"
March 31, 2021 The benefits of Vaxzevria (Astrazeneca), Comirnaty (Pfizer) and Moderna vaccines in preventing Covid-19 disease "continue to outweigh the risks and there are no recommendations that change the conditions of use" in all three cases.
This is the conclusion that emerges from the new
updates on the safety of vaccines for Covid-19
, published by the European Medicines Agency (Ema).
The assessments are carried out by the EMA Safety Committee (Prac) and are based on new emerging safety data around the world made available after the authorization of the sera.
For AstraZeneca, this is the first monthly report and the possibility of "a severe allergic reaction which will be included in the product information as a known side effect" has been included.
In particular, the cases of suspected anaphylaxis reported to EudraVigilance were 41 out of 5 million vaccinated in the UK, "the frequency of such events cannot yet be estimated", but "will continue to be monitored".
In the product information, in light of the episodes of the past few weeks that have led some countries to temporarily stop administrations as a precaution, "a warning on very rare specific blood clot events has been included".
In this regard, Ema specifies that "further investigations are underway on the possible causal relationships with the vaccine" and recommends vaccinated people "to seek immediate medical attention if thrombus or bleeding occurs".
As for Pfizer and Moderna, this is the third monthly report and "the data are consistent with the current safety profile of these vaccines".
For Pfizer, the evaluation identified extensive swelling of the vaccinated limb as a new side effect, but which resolves spontaneously within a couple of days.
While the frequency of diarrhea and vomiting, recently identified side effects, has now been estimated as very common (more than 1 in 10 vaccinees) and common (1 in 100 cases), therefore "the product information will be updated accordingly".
Finally, for all three vaccines used in the EU, "a specific assessment has been initiated for immune thrombocytopenia or low blood platelet levels as a suspected side effect" even if "a causal association has not been established at this stage. with vaccination ".