New Brunswickers report more than 1,000 adverse reactions to COVID-19 vaccines

New Brunswickers have reported more than 1,000 adverse reactions after getting a COVID-19 vaccine, and more than a quarter of them were considered "serious," according to the Department of Health.

A total of more than two million vaccines have been administered in the province, putting the incidence of adverse reactions at roughly 0.06 per cent ot doses administered.

Spokesperson Adam Bowie did not provide any information about the nature of the reactions, but the Public Health Agency of Canada defines an adverse event as "any untoward medical occurrence which follows immunization." It isn't necessarily causally related to the vaccine.

The adverse event may be any:

• Unfavourable or unintended sign (for example: skin rash).
• Abnormal laboratory finding.
• Symptom.
• Disease.

An event is considered serious if it:

• Results in death.
• Is life-threatening, such as anaphylaxis, a severe allergic reaction.
• Requires in-patient hospitalization or prolongation of existing hospitalization.
• Results in persistent or significant disability/incapacity.
• Results in a congenital anomaly/birth defect.

Bowie did not provide a breakdown of reactions by type of vaccine or by ages, either.

Earlier this month, the Centers for Disease Control and Prevention (CDC) and the U.S. Food and Drug Administration (FDA) reported a possible link between ischemic strokes in people aged 65 and older and the Pfizer-BioNTech COVID-19 bivalent vaccine, which is designed to target the Omicron subvariants BA.4 and BA.5.

An ischemic stroke occurs when blood flow to the brain is interrupted or reduced by a blockage or clot. This prevents the brain tissue from getting the oxygen and nutrients it needs to survive.

"Although the totality of the data currently suggests that it is very unlikely that the signal in VSD [vaccine safety datalink] represents a true clinical risk, we believe it is important to share this information with the public," the U.S. health officials had said.

Monitoring the situation closely

New Brunswick Public Health, the Public Health Agency of Canada and Health Canada are all aware of the U.S. report, issued on Jan. 13, based on their vaccine adverse event reporting surveillance system, said Bowie.

"So far, these safety concerns have not been raised through other vaccine safety monitoring systems in the United States, or in other countries — including Canada," he said in an emailed statement.

"It should be noted the CDC did not recommend any changes to vaccination practices at this time, and that these adverse events have not yet been confirmed to have been caused by the vaccines administered.

If New Brunswick Public Health's recommendations regarding the safety or suitability of this vaccine were to change, that information would be communicated to the public.- Adam Bowie, Department of Health spokesperson

"Additional analysis and reviews must be completed to further explore the causes of these reactions and that data is used as part of the continuous monitoring of the safety of these vaccines."

Still, New Brunswick and federal health officials are "monitoring this situation closely," said Bowie.

"If New Brunswick Public Health's recommendations regarding the safety or suitability of this vaccine were to change, that information would be communicated to the public," he said.

'Less than five' strokes after bivalent reported in Canada

As of Jan. 1, more than seven million doses of mRNA bivalent vaccines have been administered in Canada, and the Public Health Agency of Canada and Health Canada say they've not observed any elevated risks or safety signals for thromboembolic or vascular events following the administration of these vaccines, noted Bowie.

"Less than five" reports of ischemic stroke following the administration of an mRNA bivalent vaccine have been submitted to the federal bodies to date, he said. Only one of these involved a Pfizer-BioNTech bivalent vaccine for a person aged 65 years or older.

In New Brunswick, 1,148 adverse events related to COVID-19 vaccines have been reported to the Department of Health, from the 2,028,684 total doses administered between Dec. 14, 2020, and Jan. 14, 2023, said Bowie.

"Of those, 313 events were labelled serious in nature," he said.

Benefits continue to outweigh risks

"Evidence indicates that the benefits of COVID-19 vaccines continue to outweigh the risks of the disease," the federal website states.

Across Canada, of the 96,432,067 COVID-19 vaccines administered to date, 53,611 adverse events have been reported. That's about six events in every 10,000 vaccinations administered..

Of those, 10,565 adverse events were considered serious in nature, an incidence of 0.01 per cent of all doses administered.

"Citizens should be aware that vaccine providers are legally required to report any adverse events in New Brunswick under the Public Health Act, and immunization data is regularly monitored to ensure that any unusual safety trends would be identified quickly," said Bowie.

Federal health officials also review data from provinces and territories across the country to identify any new or emerging trends, he said.