A Resource Guide for Women

The following is a summary of epidemiologic studies for women with concerns about fertility, vaccines, and pregnancy. This information is not intended to replace guidance from a healthcare provider.

Has COVID-19 affected women differently than men?

Over the course of the entire pandemic, women comprise 52.2% of cases and 45.7% of deaths. Women are more likely to seek medical care than men, which could account for the higher case identification in women. We also know nearly 70% of healthcare workers are women, and healthcare workers are high risk for getting COVID-19. The higher death rate in men may be attributed to prevalence of multiple comorbid conditions (higher than in women) and delays in seeking treatment. Overall, there is no strong evidence in support of women being more likely to get COVID-19 than men.

Does COVID-19 affect fertility?

There is no evidence to date to indicate COVID-19 affects fertility.

Interestingly, there is very limited evidence COVID-19 can affect male fertility by impacting sperm quality. The study producing this result was small and additional study is needed.

What should I know if I want to get pregnant?

Women contemplating pregnancy are strongly encouraged to be vaccinated because of increased risk for serious illness while pregnant. According to The American College of Obstetrics and Gynecology (ACOG), it is not necessary to delay pregnancy after completing both doses of the vaccine.

How does COVID-19 affect pregnant women?

Multiple studies show pregnant women are at increased risk for developing serious COVID-19 illness including hospitalization, intensive care, use of a ventilator, and even death, compared to non-pregnancy women. Other factors can affect a pregnant woman’s risk such as having underlying medical conditions or being advanced maternal age.

How does COVID-19 vaccination affect pregnant women?

As it stands now, CDC recommends pregnant women talk with their healthcare provider about vaccination. The American College of Obstetricians and Gynecologists (ACOG) states the vaccine should not be withheld from pregnant women. The risk of complications, serious illness or death from COVID-19 infection is higher in pregnant women compared to non-pregnant women.

What we know now…

Women in large clinical trials became pregnant during and after receiving vaccination. There were no substantial adverse outcomes experienced by those participants.

Unfounded claims linking COVID-19 vaccines to fertility have been scientifically disproven. 

CDC recently released V-safe data which are self-reported vaccine information with supplemental interview information. This is the distribution of those data from 275 women who were pregnant when vaccinated.

maternity graphic.png

Another study was published on 4/23:

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Preliminary Findings of mRNA Covid-19 Vaccine Safety in Pregnant Persons | NEJM

What we will know in the next few months…

Clinical trials specific to pregnant women are underway. The results of those trials will be published and reviewed by all federal regulatory agencies before recommendations for use are changed.

It is important to reiterate decisions regarding pregnancy and vaccination should be discussed with a healthcare provider. Side effects and allergies are just some of the medical complexities to consider with a healthcare provider when making the decision to vaccinate.

What are my risks when getting the Janssen (J&J) vaccine?

Approximately 7.9 million people have received the Janssen vaccine in the US. There are 15 cases of Thrombosis with Thrombocytopenia (blood clot development) reported among those recipients at a rate of 1.9 cases per million people. While cases are occurring in women primarily between 18-50 years of age, cases may also happen in men.

By comparison, serious effects from the rotavirus vaccine occur at 16-69 cases per million; immune thrombocytopenia with MMR at 26, Guillain-Barre Syndrome is 3.4, anaphylaxis in any non-COVID-19 vaccine is 1.2 per million.

Another comparison – the rate of Thrombotic stroke for women taking oral contraceptives is 151-156 per million.

This vaccine presents unique benefits as it is a single dose which may help reduce disparities among hard-to-reach populations and those adverse to receiving multiple doses. It is expected FDA will allow vaccination with Janssen to resume.

Concerns regarding this or any vaccine should be directed to your local health agency or healthcare provider.

What are my risks when getting the Pfizer or Moderna vaccines?

Minimal. Anaphylaxis associated with either vaccine is approximately three per million doses. Published clinical trial information is located here –

·       Pfizer Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine | NEJM

·       Moderna Efficacy and Safety of the mRNA-1273 SARS-CoV-2 Vaccine | NEJM

If I vaccinate, will breastfeeding protect my baby? Can I pass COVID-19 to my baby through breastfeeding?

YES! The human body is so amazing. Antibodies to infections found in mothers are naturally passed to babies through breastfeeding. There are now several studies demonstrating the same happens when a mother had COVID-19 infection or is vaccinated. It is not known how long a baby is protected.

Conversely, there is no evidence COVID-19 is passed from mother to baby through breastfeeding.

How long will the vaccine provide protection?

Protection is estimated at six months and may require a booster according to vaccine manufacturers. Booster doses may be needed to protect against new variants of COVID-19.

What are the long-term effects of getting COVID-19?

Several studies determined the prevalence of lingering neurologic or psychologic effects of COVID-19 in 30-35% of people infected with COVID-19 at six months or more.

References

Fertility

Female health workers drive global health (who.int)

Comparison of COVID-19 infections among healthcare workers and non-healthcare workers (plos.org)

CDC COVID Data Tracker

COVID-19 infection may reduce fertility in men - Scimex

ASRM, ACOG and SMFM Issue Joint Statement: Medical Experts Continue to Assert that COVID Vaccines Do Not Impact Fertility | ASRM

Risk of getting COVID-19

Update: Characteristics of Symptomatic Women of Reproductive Age with Laboratory-Confirmed SARS-CoV-2 Infection by Pregnancy Status — United States, January 22–October 3, 2020 | MMWR (cdc.gov)

Birth and Infant Outcomes Following Laboratory-Confirmed SARS-CoV-2 Infection in Pregnancy — SET-NET, 16 Jurisdictions, March 29–October 14, 2020 | MMWR (cdc.gov)

Risk factors for illness severity among pregnant women with confirmed SARS-CoV-2 infection – Surveillance for Emerging Threats to Mothers and Babies Network, 20 state, local, and territorial health departments, March 29, 2020 -January 8, 2021 | medRxiv

Vaccine safety in pregnancy

Preliminary Findings of mRNA Covid-19 Vaccine Safety in Pregnant Persons | NEJM

Neonatal outcomes appear to be similar among women vaccinated during pregnancy compared to pre-pandemic. Additional studies are needed as this was conducted using VSAFE self-reported and telephonic data.

COVID-19 vaccine response in pregnant and lactating women: a cohort study | medRxiv 

Breastfeeding

SARS-CoV-2–Specific Antibodies in Breast Milk After COVID-19 Vaccination of Breastfeeding Women | Breastfeeding | JAMA

Antibodies found in breast milk of these women showed strong neutralizing effects, suggesting a potential protective effect against infection in the infant.

No Evidence of Infectious SARS-CoV-2 in Human Milk: Analysis of a Cohort of 110 Lactating Women

SARS-CoV-2 RNA can be found infrequently in the breastmilk of women with recent infection, but we found no evidence that breastmilk contains infectious virus or that breastfeeding represents a risk factor for transmission of infection to infants. Limitation: Small sample size

Efficient Maternal to Neonatal transfer of SARS-CoV-2 and BNT162b2 antibodies

Antenatal BNT162b2 mRNA vaccination induces a robust maternal humoral response that effectively transfers to the fetus, supporting the role of vaccination during pregnancy.

The vaccine-elicited immunoglobulin profile in milk after COVID-19 mRNA-based vaccination is IgG-dominant and lacks secretory antibodies

Antibodies (Abs) elicited in breast milk >14 days post mRNA vaccination are IgG-dominant, with only 6 of 10 post-vaccine samples positive for IgA. In post-SARS-COV-2 infection milk antibody response, Spike-specific IgA is dominant and highly correlated with secretory Abs, which are resistant to enzymatic degradation in mucosae.

Long COVID

6-month neurological and psychiatric outcomes in 236 379 survivors of COVID-19: a retrospective cohort study using electronic health records

Characterizing long COVID more than 6 months after acute infection in adults; prospective longitudinal cohort study, England

 

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The Janssen/Johnson & Johnson COVID-19 Vaccine

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Breakthrough Disease