Pregnant women, especially those with comorbidities fall into the high-risk group for COVID-related complications. This article highlights the recent ACOG recommendations & Indian FOGSI's stand on COVID vaccines for pregnant and lactating women.

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COVID-19 risk of infection during pregnancy

Although the risk of serious illness is low in general, pregnant women are at a higher risk of severe illness from COVID-19 than non-pregnant women. Severe disease is described as one that involves hospitalisation, intensive care, or the use of a ventilator or other specialised breathing apparatus, or one that results in death. Additionally, pregnant women who have COVID-19 could be more likely to experience adverse pregnancy effects, such as preterm delivery, than pregnant women who do not have COVID-19.

Pregnant patients with comorbidities such as obesity and diabetes may face a much greater chance of serious disease than the general population. Pregnancy has been added to the list of factors associated with an elevated risk of serious COVID-19 illness by the CDC, based on growing data. There is a paucity of knowledge about the efficacy of COVID-19 vaccinations in pregnant women.

Experts agree that due to the way these vaccines operate in the body, they are unlikely to pose a danger to pregnant women. However, there is insufficient evidence on the efficacy of COVID-19 vaccinations in pregnant women at the moment.

1. Clinical trials examining the safety and efficacy of COVID-19 vaccines in pregnant women are either ongoing or scheduled. Additionally, vaccine makers are gathering and analysing evidence from women who got the vaccine and became pregnant after completed clinical trials.
2. No safety risks have been identified in pregnant animals or their offspring following vaccination with a Moderna, Pfizer-BioNTech, or J&J/Janssen COVID-19 vaccine prior to or during pregnancy. No such study in Covishield or Covaxin is reported to date.

The COVID-19 vaccines from Moderna and Pfizer-BioNTech are mRNA vaccines that do not carry the live virus that causes COVID-19 and therefore cannot infect anyone. Additionally, mRNA vaccines do not interfere with or alter a person's DNA because the mRNA does not reach the cell's nucleus, which is where our DNA is stored.

The J&J/Janssen COVID-19 vaccine is a viral vector vaccine, which means it delivers critical instructions to our cells from a modified version of another virus (the vector). Vaccines using the same viral vector have been administered to pregnant women during all three trimesters, including in a large-scale Ebola vaccine experiment. In these studies, vaccination was not associated with any adverse pregnancy-related effects, even those affecting the foetus.

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Breastfeeding mothers

Women who are breastfeeding were not included in clinical trials for the COVID-19 vaccinations that are officially approved for use in the United States under an emergency use authorisation. There are no reports on the following points since the vaccines have not been tested on lactating women:

1. COVID-19 vaccine safety of lactating women 
2. Vaccination effects on the breastfed infant 
3. Vaccination effects on milk output or excretion

COVID-19 vaccines are not considered to pose a danger to lactating women or their breastfeeding infants, based on how they function in the body. As a result, lactating women can get the COVID-19 vaccine. Breastfeeding mothers who have received COVID-19 mRNA vaccines contain antibodies in their breastmilk, according to recent studies, which may help shield their infants. More information is required to determine the level of protection that these antibodies will offer to the infant.

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ACOG recommendations

Anticipated adverse effects should be discussed with patients as part of the counselling process, and how they are a natural part of the body's response to the vaccination and the development of antibodies to protect against COVID-19 disease.

Women under the age of 50, including pregnant women, are eligible to receive any FDA-approved COVID-19 vaccine. They should, however, be cautious of the very unlikely risk of TTS (thrombosis with thrombocytopenia syndrome) following receipt of the Janssen COVID-19 vaccine and the availability of other FDA-approved COVID-19 vaccines (i.e., mRNA vaccines).

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International societies recommendations

COVID-19 vaccine guidance for pregnant and nursing women:

1. The FDA's emergency use permit for the Pfizer-BioNTech COVID-19 mRNA vaccine states: "If you are pregnant or breastfeeding, speak with your healthcare provider about your choices."
2. ACOG and SMFM recommend that all COVID-19 vaccines approved by the United States Food and Drug Administration (FDA) should not be withheld from pregnant women who want to obtain the vaccine.
3. A discussion between the patient and her clinical team can aid in making vaccine-related decisions.
4. According to the World Health Organisation (WHO), there is no need to think that particular hazards would overshadow the advantages of vaccination of pregnant people. Pregnant women that are at high risk of exposure to SARS-CoV-2 (for example, health care workers) or who have comorbidities (health conditions that increase the risk of death) can be vaccinated in consultation with their healthcare provider.

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Indian FOGSI stand

The Indian Federation of Obstetricians and Gynecologists has advised that obstetricians, gynaecologists, and women's healthcare professionals be permitted to prescribe COVID-19 vaccinations to pregnant and breastfeeding women with preparations to handle harmful incidents. However, they stated that individual practitioners cannot prescribe vaccination to pregnant and lactating women in India unless the Ministry of Health and Family Welfare, Government of India, changes its guidelines. FOGSI acknowledges that there is a dearth of data on the use of COVID-19 vaccines during pregnancy, especially those available in India.

"However, it is necessary to avoid more waves, and the vaccine is the most effective and long-term cure. Pregnant and lactating women should be included in this defence. The very concrete advantages of immunising pregnant and lactating women seem to overshadow any potential or distant risks," FOGSI stated.

The vaccine has not been proven to have any adverse prenatal or neonatal effects in fundamental research or animal experiments. These conclusions are focused on the ratio of the vaccine's possible advantages and risks to the disease in a particular geographic region. At the moment, it is believed that the possibility of contracting COVID-19 during breastfeeding and the resulting morbidity far outweighs the vaccine's potential risks.

FOGSI said,

“As things stand in our region, each person requires defence against the rapidly spreading COVID-19 infection. We are now experiencing the second surge. Lactating mothers can still be treated as eligible for the COVID vaccine, as there are no reported adverse effects on the breastfeeding neonate. Indeed, defensive antibodies are transmitted to the foetus, which can have a beneficial effect. Pregnant and lactating women should receive the vaccine using the same procedure and regimen as the general public."

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Disclaimer- The views and opinions expressed in this article are those of the author's and do not necessarily reflect the official policy or position of M3 India.

The author is a practising super specialist from New Delhi.