Official reports on pharmacovigilance programs - 19 april 2021

CANADA
- As of 9 April 2021, 7,569,321 doses of Pfizer-BioNTech, Moderna, Covishield, and Oxford-AstraZeneca
COVID-19 vaccines had been administered.
- A total of 3,444 individual reports of one or more adverse events (0.045% of doses administered) were
received. Of these, 464 were considered serious events (0.006% of doses administered), with anaphylaxis
being the one most frequently reported.
- Of the total reports, there were 1,625 non-serious and 359 serious events associated with the Pfizer-
BioNTech vaccine. For the Moderna vaccine, 1,254 non-serious and 74 serious events were reported; for
Covishield, 99 non-serious and 26 serious events, and for Oxford-AstraZeneca, two non-serious events.
- A total of 10,111 adverse events following administration (AEFI) were reported, including 3,444 reports of
one or more events. The most frequently reported events were non-serious and mostly consistent of
injection-site reactions, parestesia, itching, hives, headache, hypoesthesia, and nausea. Only 60 cases of
anaphylaxis were reported.
- Most reported adverse events occurred in women (83.8% of the total) and in people between the ages of
18 and 49 (48.8% of the total), these being the groups prioritized for vaccination.
- A total of 31 reported cases of adverse events resulted in post-vaccination deaths. Following a medical
review, it was determined that 16 of these deaths were not linked to the administration of the COVID-19
vaccine. The other 15 are still being investigated.

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

UNITED STATES
- Nearly 189 million doses of vaccine were administered between 14 December 2020 and 19 April 2021.
- The Vaccine Adverse Event Reporting System (VAERS) received 3,486 (0.0016%) reports of deaths among
individuals vaccinated; tests failed to establish a link between these deaths and vaccination.
- Anaphylaxis following COVID-19 vaccination 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 effectively and immediately treatable.

Source: https://www.cdc.gov/coronavirus/2019-ncov/vaccines/different-vaccines/mrna.html

MEXICO
- As of 19 April 2021, 14,368,074 total doses of Pfizer-BioNTech, AstraZeneca, Sinovac, Sputnik V, and
CanSino vaccines had been administered.
- As of that date, 15,792 cases of AEFI (11 per 10,000 doses administered) had been reported, of which
13,619 were associated with the Pfizer-BioNTech vaccine, 1,154 with the AstraZeneca vaccine, 618 with
Sinovac, 255 with Sputnik V, and 138 with the CanSino vaccine.
- A total of 227 serious events were reported, representing 1.4% of total events reported. Of these serious
events, 109 occurred with the Pfizer-BioNTech vaccine, 49 with the AstraZeneca vaccine, 45 with Sinovac,
8 with Sputnik V, and 15 with the CanSino vaccine. Of these, 126 occurred in women and 101 in men; 68
cases remain hospitalized.

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

UPDATE ON THE SAFETY OF AUTHORIZED VACCINES: EUROPEAN MEDICINES AGENCY (EMA)
- Comirnaty: On 9 April, the Pharmacovigilance Risk Assessment Committee (PRAC), based on information
from clinical trials and vaccination campaigns, requested that the following adverse events should be added
to the product information: skin pruritus and rash, uncommon (1 in 100 people); and hives and
angioedema, rare (1 in 1,000 people).
- Vaxzevria (previously referred to as the Oxford-AstraZeneca COVID-19 vaccine): Regarding anaphylaxis and
other allergic reactions, PRAC requested more information for evaluation from the holder of the vaccine
authorization.
- With regard to thrombotic events related to the Vaxzevria vaccine, the Committee concluded that there was
a plausible causal relation between the vaccine and very rare cases of thrombosis in combination with
thrombocytopenia, sometimes accompanied by bleeding. Thrombotic events with thrombocytopenia include
venous thrombosis, which can also occur in unusual places such as veins of the cerebral venous sinus, and
the splenic venous system (involving one or more veins in the abdomen), as well as arterial thrombosis.
Although these events are very rare, the number of cases appears to be greater than the number in the
general population. Most of these cases occur within 14 days after vaccination and in women under the age
of 60. Some have resulted in death. Based on available data, no specific risk factors were identified.
- PRAC agreed that the following events should be updated in the Vaxzevria product information:
thrombocytopenia, as a new and common adverse event (less than 1 in 10 people), and thrombosis in
combination with thrombocytopenia, as a new and very rare adverse event (less than 1 in 10,000 people).
- PRAC requested more information from Vaxzevria's authorization holder on five suspected cases of capillary
extravasation syndrome (in which liquid leaks from smaller vessels, with a rapid drop in blood pressure
combined with tissue swelling) that were reported to EudraVigilance. To date, a causal association with
administration of the vaccine has not been established.
- PRAC continues to update Vaxzevria's risk management plan, in connection with the review by the
Committee for Medicinal Products and Human Use (CHMP) on clinical trial data, in order to determine
whether limb pain, abdominal pain, hives, and flu-like symptoms can occur as a result of this vaccine.
- Janssen: PRAC began an analysis of embolic and thrombotic events in a few serious and isolated cases of
thrombosis combined with thrombocytopenia, reported after administration of this vaccine. While these
events had previously been included for follow-up in the vaccine risk management plan, the Committee
requested a review by the authorization holder and is collecting more information for analysis. No causal
link has been established between this event and the vaccine.
- The reports conclude that no changes in the use of the Comirnaty, Vaxzevria, and Janssen vaccines are
recommended, and that they are effective in preventing COVID-19. As of 9 April, no new safety update for
the Moderna vaccine, following the latest update on March 25, was indicated.

Link: https://bit.ly/2QT8vBg