Health Canada adds autoimmune disorder warning to AstraZeneca, J&J COVID-19 vaccines
Health Canada is updating the labels for the AstraZeneca and Johnson & Johnson COVID-19 vaccines to add immune thrombocytopenia (ITP), an autoimmune condition, as a potential side effect.
In a statement on Tuesday, the agency said very rare cases of ITP have been reported internationally after receiving the Vaxzevria (AstraZeneca) and Janssen (J&J) COVID-19 vaccines.
ITP is a disorder that can cause easy or excessive bruising and bleeding, which results from unusually low blood platelet levels.
Read more: Why rare blood clots could be a side effect of AstraZeneca COVID-19 vaccine
Such cases typically occur within 28 days after vaccination, the agency said. Deaths as a result of post-vaccination ITP have been reported outside of Canada. Some cases occurred in individuals who had a prior history of the disorder.
Both the AstraZeneca and J&J vaccines have been approved for use in Canada and are deemed safe and effective.
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The agency advised Canadians to seek immediate medical attention if any of the following symptoms occurred after receiving the AstraZeneca and J&J shots:
unexplained bleeding
unexplained bruising
small purplish spots beyond the site of vaccination
shortness of breath
chest pain
leg pain and/or swelling
persistent abdominal pain.
Health Canada said if an individual has a history of a thrombocytopenic disorder, such as immune thrombocytopenia, the risk of developing low platelet levels should be considered before administering the vaccine and platelet monitoring is recommended after vaccination.
Video: Booster shot recommended for AstraZeneca recipients
In its label update on Tuesday, the agency said there was also the rare risk of venous thromboembolism (VTE) – a type of blood clot that starts in the vein – following vaccination with the Johnson & Johnson vaccine.
More than 224,000 Canadians have received two doses of the AstraZeneca Vaxzevria COVID-19 vaccine and more than 9,000 have received the single-shot J&J vaccine.
In March, Health Canada added a warning about blood clots to the Oxford-AstraZeneca vaccine following several reports after immunization.
In June, the agency updated the label for the Oxford-AstraZeneca and Covishield COVID-19 vaccines to also add capillary leak syndrome as a potential side-effect.
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