Vaccinate all pregnant women. Real-world medical experience indicates COVID-vaccination extreme urgency
- “Pregnancy has been excluded from past pandemic research,” say experts who study immunology history.
- “Pregnant women are excluded from COVID-19 vaccines,” says a May 2020 report in the US National Library of Medicine.
- Among 621,370 trials in the World Health Organization International Clinical Trials Registry, 927 (0.15%) were COVID-19 related. Of those, the majority (52%) explicitly excluded pregnancy or failed to address pregnancy at all (46%) and only 16 (1.7%) were pregnancy specific according to a study published by the USA National Institutes of Health
“If trials data were available,” say frontline clinicians interviewed, “it would confirm what we know and hesitancy among pregnant women would vanish. As we look at nearly 2 years of experience, the real-world data is extremely compelling to vaccinate those pregnant, recently pregnant or trying to become pregnant or who might become pregnant in the future.”
Pharmaceutical corporations should take note that RINJ Women recently raised a serious concern to the media that pregnant women were excluded from the clinical trials conducted prior to approval of the currently available vaccines and treatments.
A preliminary evaluation of available data indicates that exclusion of pregnant women is a characteristic of almost all non-obstetric clinical trials.
“Our challenge is that we need to prevent SARS2 infection well before the third trimester. At that point the impact of the infection is highly likely to be severe, in fact the prospect is terrifying our medical practitioners, especially those who have experienced the searing pain of having an infant to care for without a mother, or losing both the mother and the baby,” explains Michele Francis who manages three clinics and one hospital in the Amazon Basin of Venezuela.
“I have actually gone with colleagues to the homes of women to vaccinate them and give them a supply of respirator masks for them and their family, immediately upon learning the good news of their pregnancy,” explained nurse practitioner Michele Francis.
“We do a home inspection and make suggestions for enhanced hygiene as well as listing items we are able to donate for that purpose. Also we verify that all family members know the plan for getting the patient to the hospital at any sign of complications like, but not limited to fever or breathing difficulty. And we admit pregnant women whom we feel we need to monitor because of indications of pregnancy complications,” she added.
“That’s how we are looking at this crisis, because having a pregnant patient in our hospital with COVID-19 in the latter part of the pregnancy is more than just a challenge, especially where there are comorbid chronic health scenarios like diabetes and hypertensive heart disease, it’s our worst possible scenario,” she emphasized.
This finding of Ms. Francis and her colleagues in the field concurs with a new, 2 November 2021, report in The Lancet medical journal.
“Pregnant women are vulnerable to COVID-19, with increased risk of more severe illness and pregnancy complications, particularly if infected during the third trimester. Based on prior experience with vaccines in pregnancy, and with no hypothesised mechanisms for fetal harm, similar efficacy and side-effects to the non-pregnant population were anticipated with vaccination against SARS-CoV-2 in pregnancy. Current, albeit limited, data support this; no major safety signals were observed in animal reproductive toxicology studies or with post-marketing surveillance. However, until recently, there was little consensus regarding routine vaccination in pregnancy, and vaccine hesitancy in pregnant women remains high.” Citing: Lancet—COVID-19 vaccination in pregnancy—number needed to vaccinate to avoid harm
“We have a strong trust relationship with our communities hence since we have had supplies of the British, Russian and Chinese vaccines, all women have been getting vaccinated and pregnant women have led. We have stressed vaccination in our obstetric classes and child birth seminars. Because of this, we don’t have significant experience with pregnant women contracting the COVID-19 disease, but among the unvaccinated, the worst impact is in the third trimester and it is a fight to keep them and their babies alive,” Ms. Francis added.
Pregnant? Get Vaccinated
Delta Variant, comorbid chronic illness, and being unvaccinated stack the deck against the pregnant patient. These circumstances lead to a bad outcome.
“If you are pregnant, see your doctor to get vaccinated and learn how to properly wear a comfortable respirator mask. Maintain strict hand washing routines and home hygiene, and literally stay away from all people outside your immediate, trusted, COVID-19-mitigation-compliant family,” is the consensus of many doctors and nurses FPMag queried for this article.
According to the Mayo Clinic, “The overall risk of COVID-19 to pregnant women is low. However, women who are pregnant or were recently pregnant are at increased risk for severe illness with COVID-19. Severe illness means that you might need to be hospitalized, have intensive care or be placed on a ventilator to help with breathing. Pregnant women with COVID-19 are also more likely to deliver a baby before the start of the 37th week of pregnancy (premature birth) and might be at increased risk for problems such as pregnancy loss.”
“In addition,” according to the Mayo Clinic’s research, “pregnant women who are Black or Hispanic appear to be disproportionately affected by infection with the COVID-19 virus. Pregnant women who have underlying medical conditions, such as diabetes, also might be at even higher risk of severe illness due to COVID-19.
“Some research suggests that pregnant women with COVID-19 are also more likely to have a premature birth and caesarean delivery, and their babies are more likely to be admitted to a neonatal unit.” Citing “Pregnancy and COVID-19: What are the risks?“
Dr. Nassima al Amouri, supervising birthing clinics in the Middle East, says there is a vaccine hesitancy problem in much of the Middle East except Syria where strong trust relationships built over the years between her clinics’ staffs and shelters with communities have led to high vaccination rates, especially among pregnant women.
“I look at the Chinese vaccine because it relies on historic technology, using inactivated virus particles to deliver the genomics of the virus to the immune system, like many of our long-used vaccines that are very successful. My instincts tell me to rely on that experience. That experience indicates that pregnant women do not have any different experience getting vaccinated than does the general population and that has been true for the past 80 years or more according to the textbooks on immunology,” said Dr. Nassima al Amouri.
“These new technology vaccines are considerably better in their efficacy and like all vaccines, have few incidents of undesirable vaccination outcomes. Nevertheless I want to see pregnant women included in future clinical trials. We also need to see more studies of real world data. Pharmaceutical companies must prove their vaccine and other pharmacological solutions to disease are safe and effective for pregnant women. That’s the future of the human race we are talking about,” Dr. Nassima al Amouri stressed.
“And that should be passed along with emphasis to pharmaceutical companies which have been excluding pregnant women in clinical trials,” the doctor added.
One study indicates approximately 1.7% of current COVID-19 research is pregnancy related and the majority of trials either explicitly exclude or fail to address pregnancy. Only three interventional trials worldwide involved pregnant women. The knowledge gap concerning the safety and efficacy of interventions for COVID-19 created by the exclusion of pregnant women may ultimately harm them. While “ethical” concerns about fetal exposure are often cited, it is in fact unethical to habitually exclude pregnant women from research. (Read the study in PDF form from here: s-0040-1712103)
Even before the onset of the COVID-19 Pandemic, practitioners were urging for pregnant women being included in non-obstetric clinical trials.
“The moral imperative to approve pregnant women’s participation in randomized clinical trials for pregnancy and newborn complications,” is a study report dating back to September 2019.
Doctors and nurses on the front line are learning more than the scientists in the labs, and they say, “vaccinate all women who are pregnant or plan to become pregnant, immediately”. Why, because mortal outcomes of known cases of COVID-19-infected pregnant persons are high.
“In a multinational cohort study of 2130 pregnant women in 18 countries, women with COVID-19 diagnosis were at increased risk of a composite maternal morbidity and mortality index. Newborns of women with COVID-19 diagnosis had significantly higher severe neonatal morbidity index and severe perinatal morbidity and mortality index compared with newborns of women without COVID-19 diagnosis,” citing ‘Maternal and Neonatal Morbidity and Mortality Among Pregnant Women With and Without COVID-19 Infection’ original investigation.
According to the US CDC:
Updated Oct. 19, 2021 (Check the source for updated data.)
- “Pregnant and recently pregnant people are more likely to get severely ill with COVID-19 compared with non-pregnant people.
- “Getting a COVID-19 vaccine can protect you from severe illness from COVID-19.
- “COVID-19 vaccination is recommended for all people 12 years and older, including people who are pregnant, breastfeeding, trying to get pregnant now, or might become pregnant in the future.
- “Evidence about the safety and effectiveness of COVID-19 vaccination during pregnancy has been growing. These data suggest that the benefits of receiving a COVID-19 vaccine outweigh any known or potential risks of vaccination during pregnancy.
- “There is currently no evidence that any vaccines, including COVID-19 vaccines, cause fertility problems in women or men.” Citing: CDC—COVID-19 Vaccines While Pregnant or Breastfeeding