OFFICIAL REPORTS ON PHARMACOVIGILANCE PROGRAMS - 20 September 2021

20/09/2021

Doses administered, spontaneous reports of suspected cases of AEFI, and fatal outcomes in Europe, based on the EudraVigilance database as of 2 September 2021

Source: https://www.ema.europa.eu/en/human-regulatory/overview/public-health-threats/coronavirus-disease-covid-19/treatments-vaccines/vaccines-covid-19/safety-covid-19-vaccines#latest-safety-information-section

 

BRAZIL

  • As of 1 August 2021, in Brazil (not including the State of São Paulo), 100,379,140 doses of COVID-19 vaccines had been administered – 49,893,631 of the AstraZeneca/FioCruz vaccine, 36,062,724 of the Sinovac/Butantan vaccine, 11,440,705 of the Pfizer-BioNTech vaccine, and 2,982,080 of the Janssen vaccine.[1]
  • During the first months of the vaccination campaign (from 18 January to 1 August 2021), 106,006 AEFI were reported, an incidence of 105/100,000 doses administered, with the AstraZeneca/FioCruz vaccine having the highest incidence of AEFI.
  • The following table shows the total number of AEFI and the number of serious AEFI, along with incidence per 100,000 doses administered, for each of the four vaccines:

 

[1] The Epidemiological Bulletin No. 78, of 6 September 2021, does not include doses administered in the State of São Paulo, since the State uses its own AEFI reporting system.

  • For the four vaccines administered, AEFI with the highest incidence were headache, myalgia, and pyrexia.
  • According to the System Organ Class (SOC), the reported occurrence of serious AEFI per 100,000 doses administered, by preferred term (PT), was as follows:

  • With regard to reports of serious events, by preferred term (PT), the following table shows incidence per 100,000 doses administered:

  • There were 7,944 reports of programmatic errors, as shown in the table below. Among these errors, 480 developed into adverse events, of which 25 resulted in serious events, including 9 deaths.

Source: MINISTÉRIO DA SAÚDE, Secretaria de Vigilância em Saúde. 78- BOLETIM EPIDEMIOLÓGICO ESPECIAL. Doença hair Novo Coronavírus – COVID-19. SE 34, 22/8 to 28/8/2021. https://www.gov.br/saude/ptbr/media/pdf/2021/setembro/14/boletim_epidemiologico_covid_78-1.pdf

 

CANADA

  • As of 10 September 2021, 37,610,913 doses of the Pfizer-BioNTech COVID-19 vaccine, 13,202,225 doses of the Moderna vaccine, and 2,784,910 doses of the AstraZeneca and Covishield vaccine (AstraZeneca vaccine manufactured by the Serum Institute of India) had been administered.
  • There were 15,326 individual reports of one or more adverse events (0.028% of doses administered). Of these, 4,195 reported events were considered serious (0.008% of doses administered).
  • A total of 40,929 AEFI were reported (15.326 involving one or more events). Most reported adverse events were non-serious, such as injection-site reactions, paresthesia, headache, pruritus, dyspnea, fatigue, nausea, etc.

An analysis of 716 of the 718 cases of myocarditis/pericarditis, with indication of the vaccine administered, is detailed below: