COVID Vaccines: No Death Toll Threshold for Withdrawal From Market, Says Canadian Official Behind Vaccine Authorization

COVID Vaccines: No Death Toll Threshold for Withdrawal From Market, Says Canadian Official Behind Vaccine Authorization
Vials with Pfizer-BioNTech and Moderna coronavirus disease (COVID-19) vaccine labels are seen in this illustration picture taken March 19, 2021. Dado Ruvic//Reuters
Noé Chartier
Updated:

The Canadian official with final say on whether or not a vaccine gets approved in the country says there isn’t a threshold on the number of deaths that would cause the removal of a COVID-19 injections from circulation, court documents reveal.

This was the testimony of Dr. Celia Lourenco, director general of the Biologic and Radiopharmaceutical Drugs Directorate within Health Canada’s Health Products and Food Branch, while testifying on behalf of the government and its legal defence of the travel vaccine mandate.

“Is there a threshold of the number of deaths that you would need to see attributable to the COVID-19 vaccines before you would withdraw one from the market?” asked lawyer Keith Wilson during Lourenco’s cross-examination on June 6.

“No, there isn’t. There isn’t a threshold,” replied Lourenco. “A product could be removed from the market even on the basis of a single death.”

“It really depends on the circumstances; it depends on the condition in question that the product is being used for, or ... it could be removed from the market on the basis of more than one death.”

Lourenco was being cross-examined based on the affidavit she provided and which touches upon a range of issues, such as the authorization process for the COVID-19 vaccines and their adverse effects.

Lourenco testified that the authorization of the COVID-19 injections followed a very rare pathway for approval on the basis of an interim order issued by the federal government in September 2020.

She acknowledged that the available injections are still under phase three of their clinical trials, with Moderna expected to complete its trial in December 2022 and Pfizer in December 2023.

Four lawsuits are currently in federal court to challenge the vaccine mandate in travel. Cross-examination of each of the parties’ experts and witnesses took place in recent weeks.

The government is trying to have the lawsuits declared moot due to its suspension of the mandate on June 20. Ottawa said the mandates for travel and public service could be brought back depending on circumstances.

Deaths Data

Data from Health Canada (HC) says that up to and including June 24, there was a total of 355 reports of deaths following vaccination.

“Although these deaths occurred after being vaccinated with a COVID-19 vaccine, they are not necessarily related to the vaccine,” says the HC webpage titled “Reported side effects following COVID-19 vaccination in Canada.”

Of the 355 reports, “195 reports of deaths could not be assessed due to insufficient information; 110 reports of deaths are unlikely linked to a COVID-19 vaccine; 50 reports of death are still under investigation.”

“Certainly deaths are of really grave concern for us,” Lourenco said during cross-examination.

“If we can confirm that a product causes a death, that would be a very serious outcome and we would certainly look at that very seriously and consider whether the product should stay on the market or not.”

Blacklock’s Reporter reported on July 28 that so far eight vaccine death and injury claims have been paid out by the federal government. And of the 774 claims received by managers of the Vaccine Injury Support Program, 71 were rejected due to “incomplete information or ineligibility,” 8 were paid out, and 654 were being reviewed.

Health Canada’s webpage on reported side effects following COVID-19 vaccination in Canada notes 5,169 cases of adverse events of special interest up to and including June 24. This includes over 2,700 cases of side effects affecting the cardiovascular and circulatory systems, including cardiac arrest (47), cardiac failure (54), heart attack (124), myocarditis/pericarditis (1,097), and thrombosis (315).
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