Official reports on pharmacovigilance programs - 5 mayo 2021
05/05/2021
CANADA
- As of 23 April 2021, 11,526,938 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 4,128 individual reports of one or more adverse events (0.036% of doses administered) were received. Of these, 617 were considered serious events (0.005% of doses administered), with anaphylaxis being the most frequently reported.
- Of total reports, 1,928 non-serious events and 445 serious events were associated with the PfizerBioNTech vaccine. For the Moderna vaccine, 1,385 non-serious and 87 serious events were reported; for Covishield, 167 non-serious events and 46 serious events; and for AstraZeneca, 29 non-serious events and 32 serious events.
- A total of 12,140 adverse events following immunization (AEFI) were reported––equivalent to 0.1% of doses administered (4,128 with one or more events). The most frequently reported adverse events were injection-site reactions, parestesia, itching, hives, headache, hypoesthesia, and nausea. There were 60 reported cases of anaphylaxis.
- As of 23 April, there were six reports of thrombosis with thrombocytopenia syndrome following vaccination with Covishield/AstraZeneca.
- Most of the adverse events were reported in women (85%) and in people between the ages of 18 and 49 (47%), which are the groups prioritized for vaccination.
- A total of 40 reported adverse events resulted in deaths. Following medical review, it was determined that 21 of these deaths were not linked to administration of the COVID-19 vaccine.
The other 19 cases are still under investigation.
- On 5 May, Health Canada authorized the use of the Pfizer-BioNTech vaccine in children between the ages of 12 and 15.
Sources:
https://health-infobase.canada.ca/covid-19/vaccine-safety/
COSTA RICA
- As of 20 April 2021, the Epidemiological Sub-Surveillance Directorate, of the Costa Rican Social Security Fund, recorded a total of 698,327 people vaccinated against COVID-19 with the PfizerBioNTech vaccine.
- From 24 December 2020 to 18 April 2021, 3,164 AEFI were reported.
- From 11 April to 16 April, 216 AEFI were analyzed, of which 76% were in women and 35% were in people between the ages of 30 and 39. All of the AEFI analyzed during this period were classified as non-serious, with 95% of events categorized as mild, and the remaining 5% as moderate. Of the total, 23% of reported events involved pain at the vaccination site, 10% involved fever, and 10% headache.
Source: Reports of adverse events following immunization (AEFI) associated with the Pfizer-BioNTech COVID-19 vaccine between 11 April and 16 April 2021. Directorate for the Regulation of Healthcare Products of Interest.
National Pharmacovigilance Center. Costa Rica Ministry of Health.
UNITED STATES
- Nearly 245 million doses of vaccines were administered between 14 December 2020 and 3 May 2021.
- The Vaccine Adverse Event Reporting System (VAERS) received 4,178 (0.0017%) reports of deaths among vaccinated individuals; tests failed to reveal a link between the deaths and vaccination.
- Anaphylaxis following vaccination against COVID-19 remains very rare, with approximately two to five cases per million people vaccinated in the United States. When this occurs, it is around 30 minutes after vaccination, and is immediately and effectively treatable.
- Johnson & Johnson's COVID-19 Janssen Vaccine: Since 23 April, the U.S. Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) have recommended that the use of Johnson & Johnson's COVID-19 vaccine should be continued. However, women under the age of 50, in particular, should be informed that there is a very low risk of blood clots, accompanied by low platelet levels, after administration of this vaccine.
Source: https://cdc.gov/coronavirus/2019-ncov/vaccines/safety/adverse-events.html
FRANCE
- As of 22 April 2021, 18,749,000 doses of COVID-19 vaccines (Comirnaty, Moderna, and Vaxzevria) had been administered, with reports of 29,752 cases of AEFI (0.16% of doses administered), of which 25% were serious and 75% non-serious.
- Regarding the Comirnaty vaccine (Pfizer-BioNTech): 13,660,000 doses have been administered since the start of the vaccination program, with 16,030 reports of adverse events (25% serious and 75% non-serious). Of total adverse events, 73% were reported in women and 27% in men.
Most of the adverse events associated with this vaccine were expected and were non-serious.
- To date, five cases of myocarditis have been identified after administration of the Comirnaty vaccine. However, based on the available data, there is no evidence to conclude that there is a causal link between the event and the vaccine. These effects do not call into question the benefit/risk ratio of the vaccine; however, they could constitute a possible vaccine safety signal and are continuing to be tracked.
- For The Moderna COVID-19 vaccine, with 1,483,000 doses administered as of 22 April, 1,283 adverse events (23% serious and 77% non-serious) had been reported. Of total adverse events reported, 75% were in women and 25% were in men. Most cases of adverse events with this vaccine involved delayed local non-serious reactions.
- Regarding the AstraZeneca COVID-19 vaccine: 3,605,000 doses have been administered, with 12,439 adverse events reported (25% serious and 75% non-serious). Of total adverse events reported, 71% were in women and 29% were in men.
- Most of these cases involved flu-like symptoms, often intense (such as high fever, body aches, and headaches). In France, use of this vaccine is restricted to people over 55 years of age.
- A new case of thrombosis of atypical location (total 28 cases, including 8 deaths), was analyzed.
MEXICO
- As of 30 April 2021, 17,718,806 doses of Pfizer-BioNTech, AstraZeneca, Sinovac, Sputnik V, and CanSino vaccines had been administered.
- A total of 17,027 cases of AEFI (0.1% of doses administered) had been reported as of that date, of which 14,183 were associated with the Pfizer-BioNTech vaccine, 1,591 with the AstraZeneca vaccine, 711 with Sinovac, 268 with Sputnik V, and 333 with the CanSino vaccine.
- A total of 280 serious events were reported, representing 1.6% of reported events. Of these serious events, 133 occurred with the Pfizer-BioNTech vaccine, 65 with the AstraZeneca vaccine, 51 with Sinovac, 9 with Sputnik V, and 20 with the CanSino vaccine. Among these, 156 occurred in women and 124 in men; 89 cases remain hospitalized.
Source: https://www.gob.mx/salud/acciones-y-programas/versiones-estenograficas-conferencia-de-prensa
UNITED KINGDOM
- As of 21 April 2021, an estimated 18 million doses of the Pfizer-BioNTech vaccine and 26.4 million doses of the Oxford-AstraZeneca vaccine had been administered in the United Kingdom. No information is available on the number of Moderna vaccine doses administered.
- As of the above date, there were 52,130 Yellow Card reports for the Pfizer-BioNTech vaccine, 153,098 for the Oxford-AstraZeneca vaccine, 228 for the Moderna vaccine, and 541 for which the vaccine was not specified. For the first two vaccines, the reporting rate was approximately three to six cards per 1,000 doses administered (0.3% to 0.6%). To be clear, Yellow Card data cannot be used to reach conclusions on adverse event rates, or to compare the safety profile of vaccines, since more information is required.
- For all of the vaccines, the vast majority of reports were related to injection-site reactions (arm pain) or to general symptoms such as headaches, chills, fatigue, nausea, fever, weakness, muscle pain, tachycardia, or flu-like symptoms. These events usually occur shortly after vaccination, and are not associated with more-serious or longer-lasting events.
- Regarding anaphylaxis (severe allergic reaction) events, the Medicines and Healthcare Products Regulatory Agency (MHRA) received 275 spontaneous reports for the Pfizer-BioNTech vaccine.
- For the AstraZeneca vaccine, 562 spontaneous reports of adverse events involving anaphylaxis or anaphylactic reactions have been reported. Although these events are very rare, a product information update has been issued, stating that cases of anaphylaxis have been reported for the vaccine.
- With regard to Bell's palsy (facial paralysis) events, the MHRA continues to review reports and compare these against the number of cases that would occur randomly in the unvaccinated population (baseline rate). The number of cases reported to date is similar to the baseline rate.
- In terms of thromboembolic events with thrombocytopenia, the MHRA received 209 Yellow Card reports following administration of the AstraZeneca vaccine (120 in women and 89 in men), with 41 deaths, a mortality rate of 19%.
- Of more than 20 million doses of the AstraZeneca vaccine administered, four cases of capillary filtration syndrome (a condition in which blood filters from small blood vessels to the body) have been reported. Current evidence does not suggest a causal link between this syndrome and the vaccine.