Publication: Wednesday March 10, 2021 09:31
The Ministry of Health, through the Spanish Agency for Medicines and Health Products (AEMPS), has updated its information on COVID-19 vaccines in Spain. And, contrary to what was stated in previous reports (this is the third), the entity includes new symptoms in one of the vaccines, from the Pfizer company.
This is stated in the COVID-19 pharmacovigilance document released this week, which concludes that the American antidote can also cause nausea and vomiting. However, he also insists on the fact that these side effects do not always come from the injection: “The reporting of adverse events is not a systematic collection of data, and they are not necessarily related to events. vaccination, ”writes the entity.
However, while these data cannot be used to measure how often side effects occur, they do allow us to see how people responded to injections. And, in this sense, the new one points to Pfizer: “The benefit / risk ratio of this vaccine is not changed. But the evaluation identifies diarrhea and vomiting as new side effects that may appear after administration of Comirnaty, although the frequency with which they occur is unknown. “
In this way, these two effects are added to those that AMPS had already identified, such as pyrexia (fever), anaphylaxis (a type of allergic reaction), malaise, nausea or chills, although they conclude that “it is not necessary for the moment to update the technical data sheet and the leaflet of this vaccine, which already contains information on its clinical management”.
The report also measured the deaths of people who received the Pfizer vaccine and, once again, confirms its safety: “Most have occurred in patients with various treatments and underlying diseases whose progression explains the result, without be able to establish a relationship with the vaccine. These data do not identify any new aspect of the safety of this vaccine, ”they say.
On the other hand, as the document shows, the side effects that result from the injection of Moderna are very similar to those of Pfizer, also in terms of percentages: while the former accounts for 42% of people injected with fever, in second, the figure reaches 39%.
Regarding the first, despite the fact that data has been collected (unlike what happened with AstraZeneca), from Health they conclude that its balance “is not changed”. A total of 430 cases of adverse events were reported, corresponding to 332 reports per 100,000 doses administered.
Along with this, AEMPS also studied the effects of the latest vaccine approved in Spain, the Anglo-Swedish injection jointly developed between AstraZeneca and Oxford. However, concerning the update of the report, the ministry acknowledges that “given its recent authorization, the evaluation of the first monthly safety report is not yet available”.
Although this does not mean that from the first studies it was possible to make a compilation of the most common side effects. And, with regard to the rest of the antidotes, the big difference is that the AstraZeneca vaccine was able to generate fever in up to 82% of cases; that is to say more than double of the previous ones. Of course, the sample is much lower, with just 84 notifications.