Afterthought - Protecting pregnant patients going forward
As pregnancy care providers in Toronto and Peel, the two hardest-hit regions in Ontario by COVID-19, we have nervously watched how COVID-19 disproportionately affects our patient populations.
During waves one and two, we had a handful of patients’ contract COVID-19 during their pregnancy. They were anxious, not knowing what this would mean for them or their pregnancy. During this period, a retrospective cohort study from the United States showed pregnant women with COVID-19 had a higher risk of preterm birth, preeclampsia, and thrombotic events. A systematic review and meta-analysis, including international data, also showed an increased risk of preterm delivery and admission to the intensive care unit (ICU), maternal mortality, and admission to the neonatal unit for newborns. Shortly after, Canadian researchers showed that pregnant women with COVID-19 were at higher risk of requiring ICU admission, mechanical ventilation and preterm birth. We were not surprised by these findings, as family physicians who encourage our pregnant patients to get the flu vaccine annually, understanding they are at higher risk of morbidity and mortality. In fact, in most jurisdictions, pregnant individuals are prioritized at the onset of the flu season for this very reason.
In late December 2020 and early January 2021, with the first shipments of the vaccines arriving, it was an uphill battle to protect pregnant women and individuals. As with most drug and vaccine trials, pregnant individuals were excluded in Phase III clinical trials, so there was no data on the safety profile of the mRNA vaccines in our population. Healthcare providers advocated that despite this, pregnant individuals should have access to the vaccine and be allowed to make an informed choice about vaccination. Theoretically, we believed that the mRNA and viral vector vaccines would not be a risk to this population. Additionally, studies on rats and mice given the vaccine (AstraZeneca, Moderna, Pfizer, Janssen) while pregnant showed there were no effects on the pregnancy or babies.
After much advocacy, pregnant women and individuals were eligible to get the vaccine at the beginning of March 2021 but were not prioritized in the highest risk category. They had to wait their turn based on provincial rollout plans. In Ontario, they were included in the “at-risk category” originally. This meant the third leg of the multistage, phase two, which included the highest risk, then high risk, then at-risk conditions. Combined with this, there is a proportion of pregnant individuals hesitant to receive the vaccine. Understandably, there has been and continues to be, mixed messaging and confusion on the topic from the media and providers.
In the United States, a robust reporting system, the v-safe pregnancy registry and the Vaccine Adverse Events Reporting System allow us to have information about women who received the mRNA vaccines (Pfizer and Moderna) during pregnancy. Preliminary research findings from nearly 4000 pregnant women enrolled in the v-safe pregnancy registry did not show any obvious safety signals among pregnant women who received mRNA COVID-19 vaccines. To date, over 100,000 pregnant individuals have been vaccinated in the United States without safety concerns. In the United Kingdom, data on the safety of COVID-19 vaccines during pregnancy is collected through passive surveillance and also shows no sign of adverse events occurring more often than in the general population. Early studies also found that pregnant women who received the vaccine during their third trimester could pass protective antibodies to their baby through the placenta.
In early April 2021, wave three hit us and knocked us over. Despite emerging data from Israel in January showing that the variants of concern (VOC) caused pregnant women to have a higher incidence of serious illness than the general population, we were not prepared. With the VOC, the numbers of those acquiring COVID-19 increased exponentially locally. And so did the number of pregnant patients. We began to witness otherwise healthy pregnant women and individuals admitted to hospital and the ICU at alarming rates. They required ventilation, and their babies were forced into the world weeks and months before anticipated.
The alarm bells were ringing. Providers and medical societies nationally started advocating - pleading - that governments prioritize pregnant women and individuals for the vaccine. On April 15th, the SOGC called on Ontario specifically and all provinces “to immediately prioritize COVID-19 vaccination for pregnant women”. Five days later, on April 20th, the SOGC advised they “support the use of all available Covid-19 vaccines approved in Canada in any trimester of pregnancy and breastfeeding”. As of April 23rd, pregnant women and individuals in Ontario were finally included in the highest-risk category and are eligible for vaccination immediately. However, now we wait - impatiently - for increases to our vaccine supply so our patients can be vaccinated, particularly those living in high burden neighbourhoods, where the risk of acquiring COVID-19 is exceptionally high. In the meantime, we cross our fingers and hope the lockdown will avail us of a small pause and slow transmission of the virus.
As family physicians, who are often the first point of contact for patients, we urge you to stay informed and provide counselling to your patients based on the emerging data that is available and your patients’ context. As a society, let us not forget what we are experiencing today. As new pandemics emerge and new vaccines and treatment modalities develop, we have a moral and ethical responsibility not to allow our pregnant patients to be an afterthought ever again. Our present and future generations are depending on us.
Archna Gupta, MD, CCFP, MPH, PhD(c) is a family physician and a family medicine obstetrics provider at Brampton Civic Hospital and St Michael’s Hospital.
Tali Bogler, MD, CCFP, MScCH is a family physician and a family medicine obstetrics provider and chair of the family medicine obstetrics group at St. Michael’s Hospital.
