OB/GYN Docs in U.S. Want COVID-19 Vaccines Tested on Pregnant Women

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Originally published on www.thevaccinereaction.org

OB/GYN Docs in U.S. Want COVID-19 Vaccines Tested on Pregnant Women

A U.S. Centers for Disease Control and Prevention (CDC) report1 on pregnancy and SARS-CoV-2 infection released on June 26 suggested that pregnant women may be at increased risk for COVID-19 complications. The report was followed by a statement issued by the American College of Obstetricians and Gynecologists (ACOG)2 urging that pregnant and lactating women be included in COVID-19 vaccine and therapeutics trials and that pregnant women be among the first to get the vaccine after it is licensed.

Pregnant Women Report Fewer COVID-19 Symptoms

The CDC reported that the government's COVID-19 surveillance program has received reports of 326,335 women of reproductive age (15-44 years) who had positive rest results for SARS-CoV-2, the virus that causes COVID-19. Data on pregnancy status was available for 29 percent of the women, and among these, 9 percent were pregnant.

Symptomatic pregnant and non-pregnant women reported similar frequencies of cough and shortness of breath during COVID-19 infections. However, pregnant women less frequently reported headache, muscle aches, fever, chills, and diarrhea.3

Chronic Conditions Reported During COVID-19 Infections May Be Pregnancy Related

Chronic lung disease, diabetes mellitus, and cardiovascular disease were reported among pregnant women at roughly twice the rate of those who were not pregnant. However, data was not available to distinguish whether chronic conditions were present before or were uniquely associated with pregnancy (e.g. gestational diabetes or hypertensive disorders of pregnancy).4

More Pregnant Women Admitted to Hospital and ICU for COVID-19 But Death Rates Identical Between Pregnant and Non-Pregnant Women

Approximately one third (31.5 percent) of pregnant women were hospitalized compared with 5.6 percent of non-pregnant women. However data were not available to distinguish hospitalization of women for COVID-19 related circumstances from hospital admission for pregnancy-related treatment or procedures, including birthing.

After adjusting for age, presence of underlying conditions and race/ethnicity, pregnant women were 1.5 times more likely to be admitted to the intensive care unit (ICU) and receive mechanical ventilation during COVID-19 infections. Risk of death for the pregnant and non-pregnant women was identical (0.2 percent).5

The CDC data indicates that Hispanic and black women may be disproportionately more likely to suffer complications from SARS-CoV-2 infection during pregnancy, which reflects an overall increased risk for COVID-19 complications in Hispanic and black populations in the U.S.6

Limitations of CDC study on COVID-19 in Pregnant Women

CDC officials acknowledged at least four limitations to their report, which include missing data, insufficient time for accurate outcomes, lack of data on trimester of pregnancy at the time of infection and whether the hospitalization was related to pregnancy conditions rather than for COVID-19 illness, and no data on pregnancy or birth outcomes such as pregnancy loss or preterm birth.7

COVID-19 Pregnancy Registries Seek Answers

ACOG represents more than 60,000 physician obstetricians/gynecologists in the U.S.8 In response to the CDC report, the ACOG released a statement advising member physicians of the increased risk to pregnant women of COVID-19 infections. ACOG urged its members to encourage pregnant patients testing positive for COVID-19 to enroll in a COVID-19 registry to help gather more data measuring the impact of COVID-19 on pregnancy and pregnancy outcomes.9

In April, UCLA Health and the University of San Francisco launched a nationwide registry called PRIORITY (Pregnancy CoRonavIrus Outcomes RegIsTrY) to study how COVID-19 impacts pregnant women and their newborns. Researchers will collect data throughout pregnancy, then track the new mothers and babies for up to one year.

"The issue is we don't have data in pregnancy. A lot of this data is extrapolated from other SARS infection, MERS, and non-pregnant individuals," says Yalda Afshar, MD, assistant professor in the Division of Maternal Fetal Medicine at UCLA Health.10

In May, the PRIORITY study launched the Reproductive Health Equity and Birth Justice Core to focus on the impact of COVID-19 on Black, Indigenous, and People of Color communities.11 Other COVID-19 pregnancy registries include COVI-Preg, a global collaboration between 198 antenatal clinics from 23 countries,12 the International Registry of Coronavirus Exposure in Pregnancy (IRCEP), and Coronavirus Health Outcomes in Pregnancy and Neonates (CHOPAN) in Australia.

ACOG Says Pregnant Women, Breastfeeding Moms Should Be Test Subjects in COVID-19 Vaccine Trials and Be Among the First to Get Vaccinated

In its June 24 statement, the ACOG also stated:

In light of this new information from the CDC regarding the risk to pregnant patients, it is even more concerning that pregnant and lactating patients have been excluded from clinical trials for a coronavirus vaccine. The new information from the CDC highlights the importance of pregnant patients being prioritized for a coronavirus vaccine once it becomes available. ACOG again urges the federal government to use its resources to ensure the safe inclusion of pregnant and lactating patients, including patients of color, in trials for vaccines and therapeutics to ensure that all populations are included in the search for ways to prevent and treat COVID-19.13

Questions About Safety of Vaccination During Pregnancy

The time-honored rule of avoiding any potential toxic exposure that might interfere with the normal development of the fetus was suspended and replaced by the CDC in 2006 with an assumption that vaccination during pregnancy was safe after the CDC strengthened recommendations that all pregnant women, healthy or not, should get influenza vaccine during in any trimester. This CDC recommendation was followed up in 2011 with another new one directing obstetricians and gynecologists to administer a pertussis containing Tdap (tetanus, diphtheria and pertussis) shot to all pregnant women during every pregnancy.14 15

Influenza and Tdap vaccines were formerly categorized by the U.S. Food and Drug Administration (FDA) as Pregnancy Category B and C biologicals because it is not known whether they are genotoxic and can cause fetal harm or can affect maternal fertility and reproduction.16 Influenza and pertussis containing Tdap vaccines were not tested in or licensed for use in pregnant women prior to the CDC's recommendation for their use by all pregnant women, and their use has been considered "off label" during pregnancy.17

The text of one vaccine manufacturer's prescribing information for the use of Tdap vaccine in pregnant women highlights a critical lack of knowledge about the potential negative biological effects of pertussis containing Tdap vaccine on the pregnant woman and her fetus, which appears to be common for vaccines administered to pregnant women:

Animal reproduction studies have not been conducted with Adacel vaccine. It is also not known whether Adacel vaccine can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity." In addition, the following language is common in most vaccine manufacturer prescribing information inserts: "Adacel vaccine has not been evaluated for carcinogenic, mutagenic potential or impairment of fertility.18

About 35 Percent of Women in U.S. Get Vaccinated During Pregnancy

Barbara Loe Fisher, cofounder and president of the National Vaccine Information Center (NVIC) states, "The rush to vaccinate pregnant women and reach into the womb to try to passively vaccinate the developing fetus is a clear case of policy preceding science."19

A 2019 report by the CDC found that 35 percent of women received both influenza and pertussis containing Tdap vaccines during pregnancy. Anne Schuchat, MD, principal deputy director of the CDC states that for any woman wary of getting vaccinated, "it's been proven repeatedly that these vaccinations are safe for pregnant women and their developing babies."20

Civil Liability Waiver Encourages Pharmaceutical Companies to Test Experimental Vaccines on Pregnant Women

The 21st Century Cures Act passed by Congress and signed into law in 2016 amended the National Childhood Vaccine Injury Act of 1986 to give vaccine manufacturers a product liability shield so they can't be sued in civil court when there is evidence that a federally FDA licensed vaccine (or vaccines) recommended by the CDC for pregnant women injured or caused the death of a woman or an infant born alive who was injured in the womb by a vaccine administered to the infant's mother.

The fact that commercial pharmaceutical companies producing vaccine products are no longer legally liable for harm caused to pregnant women or their infants during gestation if they are born alive, becomes even more significant as COVID-19 vaccines using experimental mRNA and DNA technology are being fast tracked to market.21 As pointed out in a 2017 review of ethical issues involved in vaccine research on pregnant women:

"As a fetus or infant cannot consent to participation in research, a critical issue is how much risk is acceptable to impose upon the fetus or the infant. For research with the potential of direct medical benefit to the woman or fetus, risk proportionate to the potential benefit is acceptable. For research that does not involve the prospect of direct medical benefit, risk to the fetus must be no more than minimal. However, the definitions of minimal risk in the context of pregnancy are unclear."

Big Gaps in Vaccine Safety Research and Knowledge Concerning for Pregnant Women

In a response to the FDA's 2018 proposed guidance for scientific and ethical consideration for inclusion of pregnant women in clinical trials, Barbara Loe Fisher and Theresa Wrangham on behalf of the National Vaccine Information Center submitted a public comment and noted the "lack of basic understanding of the biological mechanisms and high risk factors for vaccine injury and death in individuals who are not pregnant hampers the ability to design ethical research into the biological effects of vaccination in pregnant women. The lack of published biological mechanism studies and well-designed prospective case controlled studies that assess immune and brain function and genetic integrity before and after adults or children are vaccinated is of great concern to those being directed to receive all federally recommended vaccines. That justifiable concern is magnified when it comes to the potential adverse effects of vaccination on pregnant women and their unborn infants developing in the womb."22

Fisher observed that, "This maternal vaccination policy is a violation of the precautionary principle to "first, do no harm," and warned "it is of grave concern to women having babies in America."23


1 U.S. Centers for Disease Control and Prevention (CDC). Characteristics of Women of Reproductive Age with Laboratory-Confirmed SARS-CoV-2 Infection by Pregnancy Status--United States, January 22-June 7, 2020Morbidity and Mortality Weekly Report June 26, 2020.
2 American College of Obstetricians and Gynecologists. ACOG Statement on COVID-19 and Pregnancy. June 24, 2020.
3 CDC. Characteristics of Women of Reproductive Age with Laboratory-Confirmed SARS-CoV-2 Infection by Pregnancy Status--United States, January 22-June 7, 2020 Morbidity and Mortality Weekly Report June 26, 2020.
4 Ibid.
5 Ibid.
6 CDC. COVID-19 in Racial and Ethnic Minority Groups. June 25, 2020.
7 See Footnote 3.
8 American College of Obstetricians and Gynecologists. About Us. 2020.
9 See Footnote 2.
10 WBBJ Eyewitness News. Researchers seek COVID-19 effects on pregnancy. Apr. 20, 2020.
11 University of California - San Francisco. PRIORITY Study Reproductive Health Equity & Birth Justice Core.
12 Advances in Surgery. COVI-Preg, a structured data collection tool available to any facility accessing pregnant patients for SARS-CoV-2 infection. Apr.28, 2020.
13 See Footnote 2.
14 Fisher BL. Vaccination During Pregnancy: Is It Safe? NVIC Newsletter Nov. 9, 2013.
15 CDC. Vaccines During and After Pregnancy. Dec. 16, 2019.
16 Fisher BL. FDA Prepares to Fast Track New Vaccines Targeting Pregnant Women. National Vaccine Information Center Nov. 17, 2015.
17 See Footnote 14.
18 Fisher BL, Wrangam TK. Written Comment on 83 FR 15161, Docket No. FDA-2018-D-1201 - "Pregnant Women: Scientific and Ethical Considerations for Inclusion in Clinical Trials; Draft Guidance; Availability National Vaccine Information Center June 8, 2018.
19 See Footnote 14.
20 Preidt R. Only a Third of Pregnant Women Get Needed VaccinesWebMD Oct 8, 2019.
21 Fisher BL. COVID-19 Meltdown and Pharma's Big Money Win: DNA and mRNA Vaccines: Flying Blind Into Uncharted TerritoryNVIC Newsletter Apr. 1, 2020.
22 See Footnote 18.
23 See Footnote 16.

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