The Spanish Agency for Medicines and Health Products (Aemps) has published its seventh Pharmacovigilance Report on the vaccines developed against COVID-19 in our country. A document through which the main adverse events reported after the administration of the different sera are collected .
Until July 11, 2021, 47,780,916 doses of vaccines against COVID-19 have been administered in Spain, corresponding to a total of 28,128,536 people. 70% of the administered doses corresponded to Comirnaty , 18% to Vaxzevria (previously COVID-19 Vaccine AstraZeneca), 9% to Spikevax (previously COVID-19 Vaccine Moderna) and 3% to COVID-19 Vaccine Janssen , from according to the Vaccination Registry of the Ministry of Health.
Of the total number of people vaccinated, 53% are women . Regarding the distribution by age groups, 69% correspond to people between 18 and 65 years old, and 31% to people over 65 years old.
NOTIFICATION OF ADVERSE EVENTS
As of July 11, a total of 32,901 notifications of adverse events have been registered in the FEDRA database , which would correspond to 67 notifications for every 100,000 doses administered .
Of the 32,901 notifications of adverse events, 6,390 were considered serious , being understood as any adverse event that requires or prolongs hospitalization; results in a significant or persistent disability or congenital malformation; life-threatening or fatal, as well as any other condition deemed medically significant12. It should be taken into account that the notification of serious adverse events and their recording is a priority over those considered not serious.
It is very important to note that the data presented include the notifications received in Spain of adverse events that occurred after vaccination against COVID-19, and adverse reactions due to the vaccine cannot be considered until a causal relationship with its administration.
Of the notifications of adverse events considered serious received up to July 11, 254 had a fatal outcome .
PFIZER / BIONTECH, THE VACCINE WITH THE MOST REPORTED NOTIFICATIONS
If we break down the data provided by Aemps, we see that the COVID-19 vaccine developed by Pfizer and BioNTech is the one that accumulates the highest number of notifications of adverse events.
As of July 11, a total of 17,387 notifications of adverse events have been registered in the FEDRA database after receiving Comirnaty; the majority correspond to women (79%) and people between 18 and 65 years of age (83%). Of all the notifications registered, 3,361 were considered serious.
The 17,387 notifications include 46,001 descriptive terms of adverse events .
Regarding the rest of vaccines, Spikevax has registered 4,674 notifications of adverse events after inoculation (614 serious); Vaxzevria 10,058 (2,252 bass) and Janssen 720 (140 bass).
HOW IS VACCINES PHARMACOVIGILANCE PERFORMED?
The Spanish Pharmacovigilance System for Medicines for Human Use (SEFV-H), made up of the Autonomous Pharmacovigilance Centers and coordinated by Aemps, continuously assesses the suspected adverse reactions reported in Spain with all authorized medicines, including vaccines .
Vaccines are particular drugs and their pharmacovigilance as well. When millions of people are vaccinated, it is necessary to know any adverse event that occurs some time after vaccination and analyze, among other factors, if it occurs more frequently than is expected to occur in general in the population. For this reason, any adverse event associated temporarily after its administration is collected, without there being any suspicion that the vaccine may have originated it, since it may be medical problems that coincide in time or that are related to the act of vaccination itself.
In the event that the number of events collected after vaccination is higher than what we expect to occur in the population, a comprehensive and detailed evaluation is carried out with all the information available in the EU ; the notifications collected in Spain are part of the European evaluations.
Thus, the Aemps, a public and independent body, together with the rest of the EU agencies and the coordination of the European Medicines Agency (EMA), carries out a continuous evaluation of the data to detect non-adverse reactions. identified during clinical trials of vaccines against COVID-19. This is done in the European Pharmacovigilance Risk Assessment Committee (PRAC).