EXCLUSIVE – Official Authorizing COVID Vaccines In Canada Was Not Consulted On Mandate

Court documents show that the federal official who has final authority to approve vaccines in Canada was not consulted on whether or not it should be imposed on travel.

Dr. Celia Lourenco was the director general of Radiopharmaceutical Drugs Directorate within the Health Products and Food Branch of Health Canada. She provided the information while she was being cross-examined by the government as a witness to support the mandate.

Lourenco is responsible for reviewing vaccines, and has final authority to approve them.

“To be precise, no one from Canada–and I mean the Prime Minister’s Office, Ministry of Transport and minister of Health–ever consulted you about whether the government should mandate vaccine travel.” asked Sam Presvelos who represented applicants Shaun Rickard and Karl Harrison in their legal challenge to the mandate.

“That is correct,” Lourenco replied.

Presvelos asked Lourenco whether any department of government had consulted her about the requirement to travel with the vaccines since Lourenco authorized them. S he stated that it was not the case.

It is possible the government received advice from other sectors of Health Canada, such the Public Health Agency of Canada (PHAC), but Lourenco and her team’s knowledge of the ins and outs of the vaccines provides her authority to speak on the matter.

Lourenco stated that she regularly communicates with PHAC about the effectiveness and efficacy of vaccines but never mentioned the need for a vaccine when traveling.

Also, other government officials were cross-examined in the context of legal challenges to travel vaccine mandate.

The government wants to declare this issue moot since the mandate was temporarily suspended (barring international arrivings), but the applicants oppose the motion and demand their time in court.

Clinical Trials

Much of Lourenco’s cross-examination revolved around the issue of vaccine performance, discussed as “efficacy” in clinical trials and “effectiveness” in a real-world setting, and around the approval process.

Lourenco acknowledged that the current COVID-19 injections are all still under phase three of their clinical trials, with Moderna expected to complete its trial in December 2022 and Pfizer in December 2023.

She stated, however that they had completed the “reporting-out phase” for regulatory approval .”

“They needed regulatory approval to finish the phase of trial. They were then able to give data about safety and efficacy up to two months after all participants completed the clinical trial .”

.

In order to bring these new drugs to market, the government issued a rare interim order in September 2020.

Before that there weren’t any other routes to get vaccines or drugs skip stages. Lourenco stated.

” There was no other route than the interim one… we used the regular path to authorise a drug in accordance with the Food and Drugs Act,” Lourenco stated.

She added this has been the case for as long as she’s been with Health Canada, 21 years, yet she did mention the use of interim orders for the H1N1 flu vaccine in 2009.

Lourenco stated that the review process had not been conducted in the traditional way.

” We did not alter the criteria for the evidence standard. She stated that the criteria and evidence for authorizing review to assess the safety of vaccines have not been changed.

” What we did was modify the interim order to give more flexibility to the review process. We allowed rolling submissions, which allow manufacturers to submit data to Health Canada as soon as it becomes available. This is something that cannot happen during the regular process. It also allows for additional tools, such terms and conditions, that could be applied to the authorization .”

Effectiveness

Lourenco received many questions regarding vaccine effectiveness and efficacy. The government argued that people who are not vaccinated should not travel with others.

“You cannot choose to put at risk the people sitting beside you on an airplane,” Prime Minister Justin Trudeau told CBC on June 23 in defending the mandate. The federal government had suspended the mandate on June 20.

“Dr. Lourenco. Do you think unvaccinated travelers pose a risk to health and safety ?” Presvelos asked.

” I would respond by saying, “They pose some risk but since vaccinated travelers are vaccinated, their risk is decreased because they are protected from the vaccine.” Lourenco agreed.

Lourenco received charts from PHAC regarding the waning protection to address the question of COVID vaccinations’ protection.

The chart reportedly showed that two doses, presumably of mRNA injections, offered a 50 to 80 percent protection against symptomatic disease in the first month.

Beyond 12 weeks, the “‘vast majority of studies show effectiveness below 40 percent with a further decline [over] time to 20 percent or less’; correct?” Presvelos asked Lourenco about the charts.

“Yes that’s right,” she stated.

“I take it that these figures, these effectiveness numbers, wouldn’t be eligible for authorisation of this vaccine, if we hadn’t observed this during the trial? said Presvelos.

“It wouldn’t, no,” said Lourenco.

Lourenco had previously explained that for vaccines to be authorized, they must demonstrate an efficacy superior to 50 percent in preventing infections during clinical trials.

Given the dramatic decline in vaccine performance, Lourenco believes that the prevention and treatment of serious consequences is the reason for their continued authorization.

“I n After-market, we are still concerned about the effectiveness of vaccination against infections. However, if vaccines show a decline in protection, we ask if it is still protecting against serious diseases. She said that if the vaccine does work, it supports our analysis of whether the benefits continue to outweigh any potential risks.

But Lourenco stated that there’s no set threshold for protection from severe diseases like infection.

” There is no .”

with a similar number.

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