Official reports on pharmacovigilance programs - June 2 2021

02/06/2021

CANADA

  • As of 21 May 2021, 20,328,984 doses of COVID-19 vaccines of Pfizer-BioNTech, Moderna, AstraZeneca, and Covishield (AstraZeneca manufactured by the Serum Institute of India) had been administered.
  • A total of 5,989 individual reports of one or more adverse events (0.029% of doses administered) were received. Of these, 1,126 were considered serious events (0.006% of doses administered), with anaphylaxis being the most frequently reported.
  • Of total reports, the Pfizer-BioNTech vaccine accounted for 2,570 non-serious events and 736 serious events. For the Moderna vaccine, there were 1,782 reports of non-serious events and 133 of serious events; for the Covishield/AstraZeneca vaccine, there were 503 reports of nonserious events and 214 of serious events.
  • A total of 16,582 AEFI were reported (including 5,989 reports of one or more events), of which the majority were for non-serious adverse events, such as injection-site reactions, paresthesia, pruritus, hives, headache, hypoesthesia, and nausea. A total of 69 cases of anaphylaxis were reported (59 for the Pfizer-BioNTech vaccine and 10 for the Moderna vaccine).
  • As of 21 May, 54% of vaccine doses administered were to women and 46% to men. The majority of adverse events reported were among women (82% of total doses administered).
  • As of the same date, there were 33 reports of thrombosis with thrombocytopenia syndrome (TTS) following vaccination with Covishield/AstraZeneca. Symptoms occurred between 3 and 30 days after vaccination; 13 were in women (ages 40 to 72), 19 were in men (ages 34 to 73), and in one case the sex of the person was not identified.
  • A total of 76 reported cases of adverse events resulted in post-vaccination deaths. Following a medical review, it was determined that 25 of these deaths were not linked to administration of the COVID-19 vaccine, while 42 are under investigation; four were potentially attributable to vaccination (TTS cases), and the cause of death in five cases could not be determined due to insufficient information.

Source: https://health-infobase.canada.ca/covid-19/vaccine-safety/     

SPAIN  

  • As of 25 April 2021, a total of 14,290,507 doses of COVID-19 vaccines had been administered to

10,425,631 individuals. The Comirnaty vaccine accounted for 70% of doses administered, Vaxzevria (formerly the AstraZeneca COVID-19 vaccine) for 24%, and Moderna for 6%, while less than one percent were for the Janssen vaccine.

  • As of the same date, 17,297 AEFI had been reported. The most frequently reported events were fever, pain at the injection site, headache, dizziness, myalgia, and arthralgia.
  • Of total adverse events reported, 3,171 were considered serious, of which 1,734 were associated with the Comirnaty vaccine, 237 with the Moderna vaccine, and 1,186 with the Vaxzevria vaccine.
  • With regard to the thrombosis with thrombocytopenia syndrome (TTS), as of 25 April, 11 probable or confirmed cases had been reported. Most of these were in unusual locations (cerebral venous sinus thrombosis and mesenteric thrombosis); three of the patients subsequently died. With these data, the estimated notification rate is five cases per million doses of vaccine administered, ranging from 13 cases per million doses in people ages 30 to 39, to one case per million doses in people age 60 and above.

Source: https://www.aemps.gob.es/laAEMPS/docs/informe-farmacovigilancia-mayo-2021.pdf?x74586    

ITALY

  • From 27 December 2020 to 26 April 2021, a total of 18,148,394 doses of COVID-19 vaccines had been administered – 70.9% of Comirnaty, 22% of Vaxzevria, 7% of Moderna, and 0.1% of the Janssen vaccine.
  • A total of 56,110 adverse events were reported, equivalent to 309 per 100,000 doses administered; of these, the majority (75%) were associated with the Comirnaty vaccine, followed by Vaxzevria (22%) and Moderna (3%). No AEFI were reported for the Janssen vaccine.
  • Serious events accounted for 8.6% of all adverse events reported, with 27 serious events per 100,000 doses administered (24 per 100,000 doses administered for the Comirnaty vaccine; 18 for the Moderna vaccine, and 39 for the Vaxzevria vaccine).
  • A total of 223 events resulting in death were reported, of which 141 occurred after the first dose and 59 after the second dose; for 23 of these events, the reports contained insufficient data to conduct an evaluation. An assessment determined that in 56% of these deaths there was no correlation with vaccination; in 39%, a possible correlation was undetermined; and 3% were deemed unclassifiable. Only three reports (2% of total deaths) were correlated with the administration of the first dose of Vaxzevria vaccine; these involved TTS cases.

Source: https://www.aifa.gov.it/documents/20142/1315190/Rapporto_sorveglianza_vaccini_COVID-19_4_EN.pdf
  

MEXICO  

  • As of 29 May 2021, 29,861,331 doses of the Pfizer-BioNTech, AstraZeneca, CanSino, Sinovac, and Sputnik V vaccines had been administered.
  • A total of 19,984 cases of adverse events following immunization (AEFI) were reported (0.07% of doses administered), of which 15,625 were associated with the Pfizer-BioNTech vaccine, 1,925 with the AstraZeneca vaccine, 1,007 with Sinovac, 359 with Sputnik V, and 1,049 with the CanSino vaccine.
  • There were 401 reports of serious events, representing 2.0% of total events reported. Of these serious events, 174 occurred with the Pfizer-BioNTech vaccine, 88 with the AstraZeneca vaccine, 73 with Sinovac, 17 with Sputnik V, and 46 with the CanSino vaccine; 225 occurred in women and 176 in men.

Source: https://www.gob.mx/salud/acciones-y-programas/versiones-estenograficas-conferencia-deprensa  

 

UNITED KINGDOM

  • As of 19 May 2021, in the United Kingdom, an estimated 12.7 million first doses of the PfizerBioNTech vaccine, 24.2 million first doses of the Oxford/AstraZeneca vaccine, and 0.3 million doses of the Moderna vaccine had been administered, while approximately 10.5 second doses of the Pfizer-BioNTech vaccine and 10.7 million second doses of the Oxford/AstraZeneca vaccine had been administered.
  • As of the same date, there were 61,553 yellow cards reports for the Pfizer-BioNTech vaccine, 182,751 for the Oxford/AstraZeneca vaccine, and 1,972 for the Moderna vaccine, while 694 did not specify the vaccine manufacturer. For the first two vaccines, the reporting rate was approximately 3 to 7 cards per 1,000 doses administered. To be clear, yellow card data cannot be used to draw any conclusions on the rate of adverse events, or to compare the safety profile of different vaccines, since more information is needed to do so.  
  • For all vaccines, the vast majority of reports were related to injection-site reactions (arm pain) or to general symptoms such as headache, chills, fatigue, nausea, fever, weakness, muscle pain, tachycardia, or flu-like symptoms. These events usually occur close to the time of vaccination and are not associated with more-serious or longer-lasting events.
  • The UK Medicines and Healthcare Products Regulatory Agency (MHRA) received 317 spontaneous reports of anaphylaxis (severe allergic reactions) associated with the PfizerBioNTech vaccine.
  • There were 674 spontaneous reports of adverse events involving anaphylaxis or anaphylactic reactions for the AstraZeneca vaccine. Although these events are very rare, the product information has been updated to reflect the fact that cases of anaphylaxis have been reported after administration of the vaccine.
  • Regarding events involving Bell's palsy (facial palsy), the MHRA continues to review reports of facial paralysis and to compare them against cases that would be expected to occur randomly in the general population (baseline rate). The number of cases reported, to date, is similar to the baseline rate, and there is no indication that this will increase with vaccination. These events continue to be monitored.
  • With regard to thromboembolic events with thrombocytopenia, the MHRA received 332 yellow card reports following vaccination with the AstraZeneca vaccine (180 in women and 151 in men), with 58 deaths, a case fatality rate of 17%. There were 17 reported cases of deaths following administration of the second dose of the vaccine. The event has a reporting frequency of 13.0 per million doses administered, with the incidence in young adults appearing to be higher than in the older age group. However, based on ongoing data, the Agency continues to recommend that, for the majority of the population, the benefits of the vaccine outweigh the risks.
  • There have been seven reported cases of capillary leak syndrome (a condition in which blood leaks from small blood vessels to the body) associated with the AstraZeneca vaccine, out of more than 34 million doses of the vaccine administered. Current evidence does not indicate a causal relationship between this syndrome and the vaccine.

Yellow cards are a mechanism by which anyone can voluntarily report suspected adverse reactions or side effects associated with the vaccine. It should be emphasized that a yellow card report does not necessarily mean that the vaccine caused the reaction or the event. 

 

Link: https://www.gov.uk/government/publications/coronavirus-covid-19-vaccine-adverse-reactions/coronavirus-vaccine-summary-of-yellow-cardreporting   

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