Safety of COVID-19 vaccine during pregnancy

For adults in general, the risk of severe COVID-19 disease is lower than in the elderly, except during and recently pregnant women at high risk. There is a desire to protect high-risk people, but clinical trials of the COVID-19 vaccine do not include pregnant people. There is also widespread disinformation that speculates that the COVID-19 vaccine is associated with infertility without providing evidence of the claim. What does scientific data say? What are the benefits and risks for pregnant people with respect to COVID-19 and vaccines, and do the benefits of vaccines outweigh the risks of infection?

Why were pregnant women excluded from the COVID-19 vaccine trial?

The US Food and Drug Administration (FDA) has officially banned the inclusion of “potentially childbirth” women in clinical studies that lasted from 1977 to 1993.¹ This was shortly after the medical community realized that taking it during pregnancy could cause serious birth defects, the most prominent example being thalidomide.

Since then, including pregnant women in clinical trials has become an ethically complex issue. Because no one wants to risk developing a birth defect. However, there are still medical conditions faced by pregnant people, and contrasting studies are needed to confirm that medications are safe and effective. With the life-saving COVID-19 vaccine available against life-threatening viruses, those wishing to become pregnant are forced to make complex decisions. Thankfully, we have some data to help you make that decision.

What can you tell from the data you have?

Pfizer-BioNTech, Moderna, Oxford-AstraZeneca Janssen’s vaccine is Developmental and reproductive toxicity (DART) studies..^{2,3,Four,Five} In these studies, rodents or rabbits are given high doses (several times higher than human equivalents) of vaccine to analyze what happens in animals and their offspring. The advantage here is that animals have a much shorter gestation period (weeks) than humans (months) and leave more offspring. That is, scientists have access to large numbers of samples for data collection. If there is a safety issue, it will be easier to find. To date, all DART studies conducted on the COVID-19 vaccine have had no effect on an animal’s fertility, fertility, or pregnancy outcome or birth defect.

The original clinical trial did not include pregnant people, but there are also safety data in humans. The US Centers for Disease Control and Prevention collects data on people who self-report as pregnant. v-safe after-vaccine health checker Surveillance system and recently reported findings of more than 35,000 pregnant women.⁶ Given the side effects after vaccination, pregnant people experienced the same symptoms as non-pregnant people. Surprisingly, pregnant women experienced these symptoms less often than non-pregnant women. The exceptions are pain and fatigue at the injection site. However, fatigue may be considered a side effect of the entire pregnancy.

The CDC also looked at the pregnancy outcomes of people vaccinated with COVID-19. The frequency of miscarriage, preterm birth, low birth weight, and birth defects is similar to that of pregnant women in general, so the mRNA vaccine appears to be safe for both mothers and babies.

The adenovirus vaccine platform (characterized by the Oxford AstraZeneca and Janssen vaccines) has been previously tested in pregnant people during clinical trials of the HIV and Ebola vaccines, raising significant safety concerns. There is none. ⁷ However, the increased risk should not be ignored, especially for women of childbearing age. Cerebral vein sinus thrombosis (CVST) + thrombocytopenia It was detected in recipients of the Oxford AstraZeneca and Janssen vaccines. This rare but serious complication is not associated with the mRNA vaccine (Pfizer–BioNTech or Moderna), so these vaccines may be an attractive option for women of childbearing age.

There is also evidence that antibodies produced by vaccinated mothers are transferred to the baby via both the placenta and breast milk after childbirth.^8,9 These antibodies provide temporary protection for newborns. Of course, community efforts to keep patient incidence low through vaccination and non-pharmaceutical interventions (such as masking) can also help protect unvaccinated newborns.

What is the risk of COVID-19 in pregnant women?

Compared to uninfected pregnant women, those infected with SARS-CoV-2 during pregnancy are five times more likely to be hospitalized in the ICU, six times more likely to be referred to high-risk monitoring, and pregnant women. The mortality rate is 22 times higher. Also, a royal incision is more likely than a vaginal delivery.^Ten Such discoveries are part of the reason. American College of Obstetrics and Gynecology (ACOG) shared its own recommendation to grant vaccines to pregnant people shortly after approval in December 2020.¹¹ Given the safety profile of vaccines during pregnancy to date, the benefits of vaccination appear to outweigh the risks, especially when compared to the risks associated with COVID-19 infection.

What about those who want to get pregnant or are breastfeeding?

There is widespread disinformation claiming that the COVID-19 vaccine is the cause of infertility, but millions of people have been vaccinated so far, but there is no data to support that claim. In fact, there are other reasons to suspect that COVID-19 infection may be the cause of infertility, rather than the COVID-19 vaccine. For example, high fever in men can reduce sperm production. It is not uncommon for COVID-19 disease to have a high fever for several days.

According to ACOG, “The unfounded claim to link the COVID-19 vaccine to infertility is scientifically provenWe strongly recommend vaccination for non-pregnant people, such as those who wish to become pregnant or breastfeeding.

What about the long-term effects of the vaccine?

Paul Offit Vaccine Education Center at Philadelphia Children’s Hospital. He recently Said Vaccine-related side effects, if any, always appear within the first two months of administration.He continues add to, “There is no long-term impact of one year. [or] Two years later, your child and you have problems that you didn’t notice at first. That was never the case. Since December 2020, more than 300 million COVID-19 vaccines have been administered in the United States alone. The two-month grace period is well overdone. If unexpected side effects occur, we would have seen it by this time – but we haven’t seen it yet. Perhaps the most important long-term effects of vaccination are due to hospitalization and illness. To avoid death. Isn’t that a goal anyway?

Ultimately, the risk of COVID-19 infection is greater than the risk of COVID-19 vaccination during pregnancy, pregnancy, or breastfeeding. However, this can still be an uneasy decision for many, so it’s okay to worry. Healthcare providers are a valuable source of information and can help you weigh the risks and benefits if you are uncertain.

References:

1. The policy is to include women in clinical trials. US Department of Health and Human Services. https://www.womenshealth.gov/30-achievements/04Updated April 1, 2019. Accessed on June 8, 2021.

2. Vaccine and Related Biological Products Advisory Board December 10, 2020 Meeting Briefing Document: Pfizer-BioNTech COVID-19 Vaccine. US Food and Drug Administration. https://www.fda.gov/media/144245/download.. Published December 10, 2020. Accessed on June 8, 2021.

3. Vaccine and Related Biopharmaceutical Advisory Board December 17, 2020 Meeting Briefing Document: Moderna COVID-19 Vaccine. US Food and Drug Administration. https://www.fda.gov/media/144434/download.. Published December 17, 2020. Accessed on June 8, 2021.

Four. Evaluation Report: COVID-19 Vaccine AstraZeneca. European Medicines Agency. https://www.ema.europa.eu/en/documents/assessment-report/vaxzevria-previously-covid-19-vaccine-astrazeneca-epar-public-assessment-report_en.pdf.. Published January 29, 2021. Accessed on June 8, 2021.

Five. Lack of effect on female fertility and prenatal and postnatal offspring development in rats using Bowman CJ, Bouressam M, Campion SN, and other mRNA-based COVID-19 vaccine BNT162b2. Toxicall to reproduce. 2021; 103: 28-35. Doi: 10.1016 / j.reprotox.2021.05.007..

6. Preliminary findings on the safety of the mRNA COVID-19 vaccine in Shimabukuro TT, Kim SY, Myers, TR, and others in pregnant women. New England Journal of Medicine. 2021. Online prior to printing. The last access date is June 8, 2021. doi: 10.1056 / NEJMoa2104983..

7. Tapia MD, Sow SO, Ndiaye BP, etc. Safety, responsiveness, and immunogenicity of the chimpanzee adenovirus vector Ebola vaccine in adults in Africa: randomized, observer-blind, placebo-controlled, phase II trial. Lancet infection. 2020; 20 (6): 707-718. Doi: 10.1016 / S1473-3099 (20) 30016-5..

8. 8. Gray KJ, Bordt EA, Atyeo C, etc. Coronavirus Disease 2019 Vaccine Response in Pregnant and Breastfeeding Women: Cohort Study. Am J Obstet and Gynecol. 2021. Doi: 10.1016 / j.ajog.2021.03.023.

9. Perl SH, Uzan-Yulzari A, Klainer H, etc. SARS-CoV-2 specific antibody in breast milk after COVID-19 vaccination of lactating women. JAMA. 2021; 325 (19): 2013-2014. Doi: 10.1001 / jama.2021.5782..

Ten. Villar J, Arif S, Gunier RB, etc. COVID-19 Pregnant and neonatal morbidity and mortality with or without COVID-19 infection: INTERCOVID multinational cohort study. JAMA Pediatrics. 2021. Doi: 10.1001 / jamapediatrics.2021.1050.

11. 11. Vaccination of pregnant and lactating patients with COVID-19. American College of Obstetrics and Gynecology. https://www.acog.org/clinical/clinical-guidance/practice-advisory/articles/2020/12/vaccinating-pregnant-and-lactating-patient-against-covid-19.. Updated April 28, 2021. Accessed on June 8, 2021.

About the author

Dr. Amber Schmidke is a science communicator and medical educator who worked at the Centers for Disease Control and Prevention and Mercer University School of Medicine.You can follow her work Here..