The WHO declared COVID-19 a pandemic on March 11, 2020. In response, a massive organizational, scientific, and economic effort has led to the availability of vaccines against the coronavirus. In India, three vaccines- Covishield, Covaxin, and Sputnik V received Emergency Use Authorization from the Drug Controller General of India. However, none of the clinical trials involved pregnant and lactating mothers. Breastfeeding and pregnant women were excluded from recent trials evaluating novel COVID-19 vaccines. ¹ In this current coronavirus disease 2019 (COVID-19) pandemic, vaccination remains a critical strategy to curbing infections and reducing disease severity. ² 

During the initial phase of vaccination, priority was given to healthcare workers and older people above 60 years. The vaccines were not recommended for individuals under 18 years, pregnant women, and lactating mothers due to a lack of safety data. However, the WHO and leading doctors recently recommended the use of vaccines in lactating mothers since the vaccines do not contain live replicating viruses and help develop antibodies against the disease, benefiting both the mother and the baby.

The American College of Obstetricians and Gynecologists (ACOG) recommended that the vaccine should be given to pregnant and lactating women based on their benefit and risk. ACOG also stated that mRNA-based vaccines pose a low risk to the fetus, as the mRNA is expected to degrade in circulation. ^{3, 4} The WHO and the Academy of Breastfeeding Medicine recommended that lactating women could continue to breastfeed even after vaccination, as it is unlikely for mRNA-based vaccines to be transmitted through breast milk. ^{5, 6} Lactating mothers could potentially infect the infant postnatally via droplet infection. ^{7, 8}

Despite approval from the government, there still seems to be some suspicion and hesitancy among lactating mothers regarding vaccination due to the lack of clinical trial data. Therefore, we are trying to analyze the willingness of COVID-19 vaccination among lactating mothers and collect details about adverse events that occurred after vaccination in lactating mothers.

A cross-sectional study was conducted from September 2021 to December 2021. Data were collected through a questionnaire method. The survey targeted lactating mothers attending the Paediatric Immunisation Outpatient Department (OP) in a Tertiary Care Hospital in Chengalpet, Tamil Nadu.

In this study we analysed the adverse effects following COVID-19 vaccination among lactating mothers, their babies and its impact on breast milk secretion. Our study includes major lactating women in the age group 18-25 yrs. This indicates a higher participation rate among younger lactating mothers. Interestingly, there were no participants in the 36-50 years age group. This absence suggests that lactating mothers in this age range were less prevalent in the population attending the Paediatric Immunisation Outpatient Department during the study period. Lactating mothers are more commonly seen in the reproductive age group of 18 -25 years. This age range typically corresponds to the period when women are most fertile and biologically prepared for childbirth and breastfeeding.

Overall, more than 60% of lactating women are willing to take vaccine in our study which is similar to the study done by Michael et al. ⁹ However various other studies showed the range (30%-80%). ^{10, 11} Differences are explained by different timing of study and differences in the incidence rate of COVID-19 cases. Many of them hesitate to take vaccine due to lack of safety data and clinical trials. Some mothers feared the risk of adverse reactions to the baby due to the effect of vaccination.

Based on our findings, educated working women have taken vaccine due the fear of high-risk exposure. Low /uneducated lactating mothers were hesitant to take vaccine due to the fear of side effects which is similar to other studies. 10, 11, 12, 13 According to our data, healthcare professionals make up the majority of those opting for vaccination. As frontline workers, they are at a high risk of COVID-19 transmission, which poses a significant threat to their babies.

Majority of them took Covishield Vaccine. This is explained by easy availability of COVISHIELD Vaccine. Majority of them not opted for COVAXIN and Sputnik due to limited stock during the study period.

Breastfeeding mothers after receiving COVID-19 vaccine experienced similar side effects as normal individuals. 14, 15, 6 Most common side effects were pain at Injection site, fever, headache and vomiting which are similar to side effects experienced by other common people.

In our study we did not find any impact on breastfeeding outcome or breast milk secretion. Previous studies reported impact on breast feeding and breast milk secretion. 1, 16 Impact was more among those who reported adverse effects such as pain, fever, headache, fatigue, chills.

Previous literature found that maternal illness and earlier breastfeeding cessation are associated. ¹⁶ This is explained by the fact that metabolic demand and insensible water loss are increased by maternal fever which reduces total body water available for milk production. 17 Vaccine adverse effects are much less in severity and duration compared to actual COVID-19 infection. COVID-19 infection is more severe and longer in duration which results in hospitalisation and produce negative impact on breastfeeding. ^{18, 19, 20}

In our study, no adverse effects were noticed in the child after COVID-19 vaccination of mothers. No significant Impact on breastfeeding mother, child and secretion of breastmilk. None of the breastfeeding mother reported negative impact on breastmilk secretion.

Based on our findings in our study vaccine did not produce major adverse effects on breastfeeding mother, child, and breastmilk secretion. Therefore, we recommend COVID-19 vaccine to breastfeeding mother without fear of affecting child and breastmilk Secretion. Our findings may help in guiding the clinician and breastfeeding mother about COVID-19 vaccine administration during lactation.

Limitations

It is a single tertiary centre study with limited sample size and time.

Ethics statement

The study was started only after getting written consent from the patient and approval from the Institute Human Ethical committee no: CARE IHEC-II/0030/21. The patients’ details were maintained confidentially and had not been disclosed.

Disclosure Statement

No financial conflicts of interest to disclose.

Funding Information

This research did not receive any specific grant from funding agencies in the public, commercial, or not for Profit Sectors.