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.
“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.
Pfizer-BioNTech’s initial clinical trial for pregnant women, announced publicly in February 2021, encountered recruitment problems.
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.”
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.”
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,” he told The Epoch Times, 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 told The Epoch Times 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.
“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.
‘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.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.”
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.
“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.
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.
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.
