Federal officials with ultimate authority to approve vaccines in Canada did not advise or consult on imposing or maintaining vaccine obligations during travel. Court documents reveal.
Dr. Celia Lorenco, director of the Department of Biopharmaceuticals and Radiopharmaceuticals in the Health Products and Foods Division of the Canadian Department of Health, provided this information in early June while being cross-examined as a government witness in support of the delegation. ..
Lorenco’s Directorate General is responsible for reviewing drugs such as vaccines, and she has the final say on their approval.
“So, I would like to clarify that everyone in the Government of Canada, and when I say” Government of Canada, “include the Prime Minister’s Office, the Ministry of Transport, and the Minister of Health. Shouldn’t the government establish its vaccine obligations for travel? Attorney Sam Presvelos has filed a legal objection to the mandate on behalf of applicants Carl Harrison and Sean Likert.
“That’s right,” Laurenko replied.
Presvelos also asked if government agencies had consulted with her about the ongoing requirements for mandatory vaccinations during travel since Lourenco approved the vaccine. SHe said it wasn’t.
The government may have been advised by other departments of Health Canada, such as the Public Health Agency of Canada (PHAC), but knowledge of Lourenco and her team. In and out Of the vaccine Offers Her authority to talk about the matter.
Lourenco said he was in contact with the PHAC about the efficacy and efficacy of the vaccine, but never discussed the need for the vaccine while traveling.
Other government officials were also cross-examined as part of the mandatory legal challenge process for travel vaccines.
The government is trying to declare a dispute in question in light of the suspension of mandates (except for international arrivals), but the applicant has fought a motion and hoped for a day in court. is.
many Lorenco’s The cross-examination revolved around vaccine performance issues and the approval process, which are discussed as “effectiveness” in clinical trials and “effectiveness” in the real environment.
Lourenco acknowledged that all current COVID-19 injections are still in Phase 3 of the clinical trial, with Moderna scheduled to complete the trial in December 2022 and Pfizer in December 2023.
However, she said they had completed a “reporting phase for regulatory approval.”
“Therefore, in order to obtain regulatory approval, it is necessary to complete the trial phase that can provide efficacy and safety data up to a median follow-up of 2 months for all participants in the clinical trial. did.”
To bring these new drugs to market, the government issued a rare provisional order in September 2020.
Prior to that, there was no alternative route for vaccines and other drugs to skip the stage, Lorenco said.
“Before the interim order … there was no other route … the normal route could be used to authorize a drug under the Food and Drug Act,” Lorenco said.
She added that this would be the case as long as she had been with Health Canada for 21 years, but also mentioned that she used the provisional order for the H1N1 influenza vaccine in 2009.
Despite not following the usual path, Lourenco said the review process was still robust.
“We did not change the requirements in terms of evidence criteria. The evidence and criteria for approval of the review to assess the safety of the vaccine have not changed,” she said.
“What we changed in the interim order was to make the review process more flexible, for example, to allow rolling transmissions, which would allow manufacturers to send the data to Health Canada when the data became available. You can now do something that can happen in the normal process. Then allow other tools such as contract terms that may be imposed on approval. “
Lourenco was asked many questions about the effectiveness and efficacy of the vaccine, as the government’s claim was that unvaccinated individuals should not sit next to vaccinated individuals in transit. I did.
“You can’t choose to endanger the people sitting beside you on the plane,” said Prime Minister Justin Trudeau. Said June 23 CBC defending mandate. The federal government suspended its mission on June 20.
“”Dr. Lorenco, do you agree that unvaccinated travelers bring health and safety? What are the risks to vaccinated travelers? Press Velos asked.
“… they pose some risk, but given that vaccinated travelers are vaccinated … they are protected by the vaccine, which reduces the risk,” Lourenco replies. I did.
On the protection issues offered by the COVID vaccine, Lourenco was presented with a chart produced by PHAC. protection.
The charts reportedly showed that two doses of mRNA injection probably provided 50 to 80 percent protection against symptomatic illness in the first month.
Beyond 12 weeks, “the majority of studies have shown that efficacy is less than 40% and is even lower. [over] Time to 20 percent or less’; correct? “Presvelos asked Lourenco about the chart.
“Yes, that’s right,” she said.
“So I take these numbers here, these efficacy numbers, if we observed this in the trial, is this not eligible for approval of this vaccine?” Press Velos says. rice field.
“No, no,” Laurenko replied.
Lourenco previously explained that in order for a vaccine to be approved, it must be more than 50% effective in preventing infection during clinical trials.
Given that vaccine performance declines dramatically over time, Lourenco now says that prevention of serious consequences justifies maintaining their approval.
“”MeAfter marketing, of course, we are still concerned about its effectiveness against infection, but if the vaccine weakens our defense against infection, what we are looking for is still protection against serious disease. How is it? If so, it supports our analysis in terms of benefits that continue to outweigh the risks of vaccines, “she said.
Still, Lorenco said there is no fixed number threshold for protection from serious illnesses such as infectious diseases.
“There is no corresponding number.”