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Health Canada- Covid Vaccination Is Safe But…

May 14, 2024 The Silo Leave a comment

COVID Vaccination Is ‘Safe’ but Remains Clinically Untested for Pregnant Women: Health Canada

Nearly four years after the launch of the massive COVID-19 vaccination campaign, which included mandates and passports, the safety of the products for pregnant women remains mostly untested clinically.

Health Canada answered a series of questions from Tory MP Colin Carrie in April about the issue.

“What specific research data supported the claims that … this product may be safely administered at any stage of pregnancy?” asked Mr. Carrie in an Inquiry of Ministry.

“Please note that the vaccine manufacturers did not seek an indication for use in pregnant and lactating women and the Product Monographs included statements about the uncertainty regarding safety and efficacy in pregnancy and lactation,” answered Health Canada, which is responsible for authorizing vaccines in Canada.

The product monographs for the widely administered COVID-19 shots from Pfizer-BioNTech and Moderna, which describe the properties, claims, indications, and conditions of use for the drug, state the unavailability of data regarding use during pregnancy.

“No data are available yet regarding the use of COMIRNATY Omicron XBB.1.5 during pregnancy,” said Pfizer-BioNTech’s monographs, both for its updated Omicron injection and its original one.

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“The safety and efficacy of SPIKEVAX XBB.1.5 in pregnant women have not yet been established,” similarly say Moderna’s monographs for its updated Omicron shots and its legacy product.

Pfizer-BioNTech’s initial clinical trial for pregnant women, announced publicly in February 2021, encountered recruitment problems.

A Pfizer Canada representative told a member of the National Advisory Committee for Immunization (NACI) in April 2022 that the trial had been stopped due to slow enrolment, according to internal emails seen by The Epoch Times.

Jelena Vojicic, vaccines medical lead at Pfizer Canada, also said “it became unreasonable/inappropriate to randomize pregnant women to placebo given the amount of observational evidence that the vaccine is safe and effective, coupled with increasing number of technical committees supporting immunization of pregnant women.”

Despite hurdles, Pfizer-BionTech submitted results for a small clinical trial with 348 participants in July 2023, according to the U.S. government website ClinicalTrials.gov.

Moderna’s observational pregnancy outcome study was terminated in the fall of 2023 due to low enrolment, with ClinicalTrials.gov noting 20 enrolled participants.

Neither Pfizer nor Moderna responded to a request for comment.

While confirming there is little to no clinical trial data, Health Canada said vaccination for pregnant women was recommended based on evidence of safety and effectiveness growing from “real-world use.”

“Analysis of the data show that mRNA COVID-19 vaccines are safe for people who are pregnant or breastfeeding.”

Dr. Bernard Massie, a virologist and former National Research Council acting director general of the Human Health Therapeutic Research Center, raised doubts about the reliability of data obtained outside clinical trials, calling them “very incomplete and often biased.”

“We won’t find what we’re not looking for,” noting that real-world passive surveillance of side effects can be underrepresented by a factor of 10 and up to a 100 for lax systems.

‘Off-Label’

While Health Canada authorizes vaccines, the regulator said that NACI is responsible for formulating recommendations for public use.

“This means that NACI may provide recommendations that are broader or narrower than the conditions of use approved by Health Canada, often referred to as ‘off-label’ recommendations,” said spokesperson Anna Maddison, adding such a practice by NACI is ”not uncommon.” Ms. Maddison also noted the COVID-19 vaccines are not contraindicated in pregnant or lactating women.

At the beginning of the vaccine rollout, NACI said in December 2020 that pregnant or breastfeeding mothers “should not” in most circumstances be offered the vaccine “until further evidence is available.”

The recommendation was changed in January 2021 to “may be offered” following a risk assessment.

By May 2021, NACI had updated its recommendation for pregnant women that they “should be offered” COVID-19 mRNA shots.

To back its recommendation, NACI cited a U.S. government study of 35,000 pregnant women using data from December 2020 to February 2021.

“Preliminary findings did not show obvious safety signals among pregnant persons who received mRNA Covid-19 vaccines,” said the study. It noted, however, that “more longitudinal follow-up, including follow-up of large numbers of women vaccinated earlier in pregnancy, is necessary to inform maternal, pregnancy, and infant outcomes.”

Dr. Massie questioned whether the study by government scientists was interested in finding issues with vaccination and pregnancy given that the government was promoting mass vaccination.

After the results of the study were published on April 21, 2021 in the New England Journal of Medicine, other government advisory bodies recommended COVID-19 vaccination in pregnant women.

Quebec’s government announced vaccination would be offered to pregnant women on April 27 of that year, citing a recommendation from its immunization committee which “analyzed the evolution of scientific data and recommendations in different countries.”

B.C.’s government recommendation came on May 4, 2021. “All Health Canada-approved vaccines are safe and effective, and I encourage everyone to register and receive their vaccine as soon as they are eligible. Today, this includes people who are pregnant,” said Dr. Bonnie Henry, B.C.’s provincial health officer.

‘Not’ Advertising

Dr. Philip Oldfield, who has more than three decades of experience specializing in the bioanalysis of protein/nucleic acid therapeutics and regulatory affairs, raised questions about the product monographs for vaccines saying effects on pregnancy were not tested while government bodies encourage pregnant women to be vaccinated.

He also points to passive surveillance data on vaccine adverse events collected in the United States showing over 2,000 miscarriages following COVID-19 vaccination. While this data doesn’t prove causality, it is considered largely underreported.

Dr. Oldfield said Health Canada encouraging pregnant women to get vaccinated for COVID-19 could contradict “both the law with respect to false and misleading advertisements of a drug, and contradicts the safety data found on both the Moderna and Pfizer monographs.”

The Epoch Times asked Health Canada if it is allowed by law to make recommendations about the use of products for certain populations for which the products’ monographs do not indicate safety information. The Foods and Drugs Act states that “No person shall label, package, treat, process, sell or advertise any drug in a manner that is false, misleading or deceptive or is likely to create an erroneous impression regarding its character, value, quantity, composition, merit or safety.”

Health Canada spokesperson Anna Madison responded that “public health messages from a government authority that promote vaccination would not qualify as advertising of a health product.”

Despite different bodies’ recommendations for pregnant woman, NACI noted in a summer 2022 report that “uptake of COVID-19 vaccine has been lower among pregnant people compared to non-pregnant people in Canada.”

“Preliminary unpublished evidence in Ontario indicates that primary series vaccine coverage among pregnant people (71 percent) was 16 percentage points lower than in the general female population of reproductive age in Ontario by the end of 2021.”

Animal Studies

Outside of emerging real-word evidence, regulators and advisory bodies have also cited studies conducted on animals to determine the safety for pregnant women and their babies.

“Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryo/fetal development, parturition, or post-natal development, and human randomized clinical trials were not submitted for regulatory evaluation,” said Health Canada in responding to MP Carrie.

The NACI also cited a study conducted on rats with Pfizer’s mRNA vaccine to back its recommendation, saying no issues were encountered.

A Moderna nonclinical overview submitted to the U.S. government and obtained by legal advocacy group Judicial Watch through a lawsuit indicates the presence of “statistically significant increases” in rat offsprings with “wavy ribs and 1 or more rib nodules.”

“There were no other indicators of mRNA-1273-related developmental toxicity observed, including delayed ossification; therefore, these common skeletal variations were not considered adverse,” concluded the manufacturer.

Both Dr. Oldfield and Dr. Massie said the animal studies conducted are not proper to assess risk in humans. “Using an inappropriate species in the Developmental and Reproductive Toxicity (DART) studies would never pick up the toxic effects due to the spike protein,” said Dr. Oldfield. “The animal studies were performed using an inappropriate species (rat) which unlike humans, their ACE receptors does not bind to the vaccine generated spike protein.”

Breastfeeding

MP Carrie also raised the issue of breastfeeding in his request for information to the government, asking what specific research data there is to say that “modRNA vaccine, and consequently the spike protein, do not excrete into breast milk.”

Health Canada responded that the product monographs for authorized COVID-19 vaccines “include a statement that it is unknown whether the COVID-19 vaccine is excreted in human milk.”

“A risk to newborns/infants cannot be excluded,” it adds.

Studies have found mRNA from COVID shots does end up in breast milk, with a recent one published in the medical journal Lancet in September.

In response to previous questions, Health Canada told Mr. Carrie last year that “mRNA-encoded spike protein is only expressed transiently and at the injection site and the liver, then declines over time.”

Authors of the study published in the Lancet noted their “findings demonstrate that the COVID-19 vaccine mRNA is not confined to the injection site but spreads systemically and is packaged into [breast extracellular vesicles].”

The scientists said that since only “trace quantities” are present and a “clear translational activity is absent, we believe breastfeeding post-vaccination is safe, especially 48 h after vaccination.” They specified that since the minimum mRNA dose to elicit an immune reaction in young infants is unknown, breastfeeding mothers should consult with a health-care provider to discuss risks and benefits in the first two days after vaccination. For the Silo, Noé Chartier/Epoch Times.

Politics

Deadly Virus Flew From Canada To China On Commercial Flight

April 20, 2024 The Silo 2 Comments

Minister Says He Was Taken Aback After Learning Deadly Viruses Were Shipped From Winnipeg Lab to Wuhan

Report first published via friends at The Epoch Times

After learning that samples of deadly Ebola and Nipah viruses had been sent from Canada’s top-security lab in Winnipeg to China, Public Safety Minister Dominic LeBlanc said his reaction was similar to that of an MP who expressed incredulity upon learning of the move.

“I’m really concerned about the March 2019 incident where [Winnipeg lab scientists Xiangguo Qiu and Keding Cheng] were implicated in a shipment of live Ebola in Hanipah [Nipah] viruses on a commercial Air Canada flight. How the hell did that happen?” NDP MP Charlie Angus asked during a House of Commons Canada-China committee meeting on April 15.

In response, Mr. LeBlanc said, “When I saw that report, and publicly, I had the same reaction as you.”

A partly redacted national memo sent by the prime minister’s national security advisor to Prime Minister Justin Trudeau on June 29, 2017.

The minister deferred Mr. Angus’ question to the Public Health Agency of Canada, saying, “I don’t have any [information], but I had the same reaction as you, Mr. Angus.”

Mr. LeBlanc, who became minister of public safety in July 2023, was previously minister of intergovernmental affairs starting in July 2018.

The National Microbiology Laboratory (NML) in Winnipeg shipped 15 different strains of Nipah and Ebola viruses to the Wuhan Institute of Virology (WIV) in China on March 31, 2019. The package was sent from Winnipeg to Toronto and then on to Beijing via a commercial Air Canada flight.

Timeline: What Declassified Documents Reveal About the Fired Winnipeg Lab Scientists

Ms. Qiu and Mr. Cheng

The request to the NML management for the shipment of the viruses was facilitated by Ms. Qiu. The shipment was eventually approved by the NML management.

Ms. Qiu and Mr. Cheng, a married couple, were escorted out of the NML in July 2019 while under RCMP investigation. The couple were fired from their positions on Jan. 20, 2021, for having undisclosed ties to Chinese regime entities.

In 2021, in response to MPs’ questions about why the NML shipped virus samples to the Wuhan lab, laboratory management said the shipment followed all proper protocols and was in response to a letter from the Chinese lab indicating that they were to be used to understand their pathophysiology—the nature of infection—and the development of antivirals.

Declassified intelligence documents show that Ms. Qiu also sent antibodies and other materials to China without prior approval.

Shipments included antibodies for the China National Institute for Food and Drug Control, as well as small amounts sent to laboratories in the United Kingdom and the United States for testing.

The documents show that Ms. Qiu discussed the shipment of Ebola and Nipah with WIV employees in July 2018, and initially suggested that a formal agreement is not necessary as “no one owns the IP.” She also expressed “hope there is another way around” rather than issuing a formal agreement.

The documents also show that Ms. Qiu signed on to a project at WIV involving research on Ebola, and that some of the virus strains that were shipped from NML were meant for this project. Ms. Qiu had asked that the project remain a secret to her Canadian management as WIV was in the process of requesting the transfer of the virus strains from NML, the documents say.

Researchers work in the National Microbiology Laboratory in Winnipeg, Man., where the ZMapp antibody “cocktail” was created to fight Ebola. PHOTO BY HANDOUT

The Wuhan lab has been involved in synthetic biology research on the deadly Nipah virus, according to testimony from a U.S. scientist. Synthetic biology involves creating or redesigning biological entities and systems.

“The Nipah virus is a smaller virus than SARS2 [the virus causing COVID-19] and is much less transmissible,” Dr. Steven Quay, a Seattle-based physician-scientist, told a U.S. Senate subcommittee hearing on Aug. 3, 2022. “But it is one of the deadliest viruses, with a greater than 60 percent lethality” and 60 times deadlier than SARS2, he said. “This is the most dangerous research I have ever encountered.”

Chinese Talent Recruitment

During the April 15 House committee meeting, Mr. LeBlanc acknowledged revelations from the declassified documents that Ms. Qiu was involved in China’s Thousand Talents Program. The program was recognized by U.S. authorities as China’s efforts to “incentivize its members to steal foreign technologies needed to advance China’s national, military, and economic goals.”

It is clear that “elements from a Chinese-sponsored recruitment program were involved” at the Winnipeg lab, Mr. LeBlanc said. “It is well known that such programs are one way that China seeks to incentivize academics to participate in activities that exploit advancements in Canadian technologies.”

China is using the programs “to improve its military and intelligence capabilities, as well as the economic competitiveness all at the expense of Canada’s national interest,” the minister said.

He declined to address concerns raised by Conservative MP Michael Cooper regarding the delay in removing Ms. Qiu from the NML, saying it should be addressed to the health minister whose department is in charge of the Public Health Agency of Canada, which in turn oversees the NML.

Although concerns about the two were first raised in 2018, they weren’t fired until three years later. For The Silo, Andrew Chen. Omid Ghoreishi and Noé Chartier contributed to this report

Supplemental– Bio-warfare experts question why Canada was sending lethal viruses to China.

Supplemental- Canada sent untested ebola vaccine to World Health Organization.

Politics

Former Canada Finance Minister’s Thank-You Letter to WEF Suggests More Collaboration Than Disclosed

March 14, 2024 The Silo Leave a comment

Former Finance Minister’s Thank-You Letter to WEF Suggests More Collaboration Than Disclosed — A press photographer works next to the logo of the World Economic Forum (WEF) at the opening of their annual meeting in Davos on Jan. 15, 2024. (Fabrice Coffrini/AFP via Getty Images)

By our friends at Epoch Times/ Noé Chartier

Close interactions between Canadian cabinet ministers and the World Economic Forum are well-documented, but a newly revealed letter suggests forum staff may have been doing more work with the federal government than previously disclosed.

In an undated letter to a WEF official, former Finance Minister Bill Morneau praised the organization and its collaboration to achieve “common” objectives.

“I would also like to take this opportunity to express my sincere appreciation to the WEF staff, for the support provided to the Government of Canada,” wrote Mr. Morneau in the letter obtained through the access-to-information regime.

Neither the WEF nor the Canadian government typically advertise what support the forum provides. The finance department has not replied to a request for information about the date of the letter and details of how WEF staff helped the government.

The letter was addressed to Philipp Rösler, a former German politician who served as a WEF manager and head of its Centre for Regional Strategies.

The federal government is known to have been involved in at least two WEF policy initiatives: the Known Traveller Digital Identification (KTDI) project and the Agile Nations network.

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KTDI was a pilot project between Canada, the Netherlands, and private sector interests to develop a system of digital credentials for airplane travel between countries. Agile Nations is a group of countries working to streamline regulations to usher in the WEF-promoted “Fourth Industrial Revolution” that includes gene editing and artificial intelligence.

KTDI began in 2018, and Canada signed onto Agile Nations in November 2020, a few months after Mr. Morneau resigned during the WeCharity scandal. Both projects were worked on while Mr. Morneau was finance minister from 2015 to 2020.

Since both these projects fell outside of Mr. Morneau’s portfolio as finance minister, it seems to suggest that his letter of appreciation to the WEF was referring to other joint collaborations.

Canada's then-minister of Finance Bill Morneau speaks to the Canadian Club of Canada in Toronto, on March 6, 2020. (Cole Burston/The Canadian Press) — Canada’s then-minister of Finance Bill Morneau speaks to the Canadian Club of Canada in Toronto, on March 6, 2020. (Cole Burston/The Canadian Press)

The WEF’s mission statement says it is dedicated to “improving the state of the world.” It gathers leaders in the fields of politics, business, and activism to promote progressive policies on issues like climate change and making capitalism more “inclusive.” As is routine with the organization, it did not respond to requests for comment.

Critics of the WEF, which gathers world elites to shape global policies, often disagree with its progressive agenda and warn about its influence on countries.

“No staff, no ministers, no MPs in my caucus will be involved whatsoever in that organization,” Conservative Party Leader Pierre Poilievre said in January.

He added that officials who attend the forum’s annual meeting in Davos are “high flying, high tax, high carbon hypocrites” who travel in private jets while telling average citizens not to “heat their homes or drive their pickup trucks.”

Alberta Premier Danielle Smith has also criticized the WEF, saying in 2022 she finds it “distasteful when billionaires brag about how much control they have over political leaders, as the head of that organization has.”

Ms. Smith was likely referring to comments made by WEF founder and chairman Klaus Schwab in 2017, when he said said he was “very proud” to “penetrate the cabinets” of world governments, including that of Prime Minister Justin Trudeau.

“I know that half of his cabinet or even more than half of his cabinet are actually Young Global Leaders of the World Economic Forum,” Mr. Schwab told an audience at Harvard University.

WEF founder Klaus Schwab delivers a speech during the "Crystal Award" ceremony at the World Economic Forum annual meeting in Davos, on Jan. 16, 2023. (Fabrice Coffrini/AFP via Getty Images) — WEF founder Klaus Schwab delivers a speech during the “Crystal Award” ceremony at the World Economic Forum annual meeting in Davos, on Jan. 16, 2023. (Fabrice Coffrini/AFP via Getty Images)

Davos Links

Mr. Morneau’s letter to the WEF comes from internal Finance Department records and is the only document in the release package that pertains to Mr. Morneau. It consists mostly of praise for the organization.

“As a Steward of Economic Growth and Social Inclusion, I have had the privilege of observing first-hand and benefiting from the WEF’s important contributions to foster public and private collaboration towards developing concrete solutions for strong, broad-based economic growth,” he wrote, adding that WEF analysis of different topics such as “structural reform priorities” was “helpful to develop substantive policy measures.”

He wrote that “as we enter another ambitious year for the WEF, I look forward to a continued fruitful collaboration to pursue our common objective of achieving stronger, sustainable and more inclusive growth.”

Other department records relate to current Finance Minister Chrystia Freeland and her involvement with the WEF. She is a board member of the forum and also an alumnus of the Young Global Leaders program that Mr. Schwab referenced.

Mr. Morneau, who resigned as minister in 2020, is listed on the WEF website as an “agenda contributor“ and a ”digital member.” He was a regular participant at the group’s annual meetings in Davos, Switzerland, while he was in office.

During those years, the Finance Department’s media relations office wasn’t shy about advertising ministerial trips to Davos.

“Canada’s strong presence at the Forum underscores the importance of this meeting for shaping the international agenda and advancing economic opportunities for Canadians,” read a January 2020 press release from the department announcing Mr. Morneau’s trip.

The Finance Department has not returned inquiries in recent years pertaining to Ms. Freeland’s involvement with the WEF, nor has it issued press releases referencing her involvement.

Some have questioned whether Ms. Freeland’s role as deputy prime minister and finance minister as well as a forum board member constitutes a conflict of interest. The Office of the Conflict of Interest and Ethics Commissioner said in its 2022 annual report it received more than 1,000 requests in a two-month period from members of the public to investigate the participation of MPs and ministers in the WEF.

The office said the requests “did not provide sufficient information to warrant an investigation.” Ms. Freeland’s leadership position with the WEF has been declared to the office and has therefore been cleared.

Featured image: Original paintings by R. Delaney.