Introduction

From 16^th January 2021, India launched the Covid-19 vaccination programme to protect health workers and frontline workers. Later, from 1st March 2021 vaccination drive was extended to people above 60 years of age and of 45 years of age with specific co-morbidities. From 1st April 2021 people of more than 45 years of age without co-morbidities were also included in the programme. Two vaccines are currently being used in India, Covishield, a recombinant vaccine based on viral vector technology and Covaxin, whole virion inactivated corona virus vaccine. As on 13^th May 2021, more than 177 Million doses using above-mentioned vaccines have been administered. To provide protection to the younger population of the country, India opened up vaccination against the Covid-19 infection for the 18-45 years age group from 1^st May 2021.

However, lactating women have been kept out of the vaccination programme as they were not a part of any Covid-19 vaccine trial and therefore, safety data for use of the vaccine in these groups are not available. It is important  to note that a sizeable population comes under the category of pregnant and lactating women in India where 25 million child births occur every year.

There are several unanswered questions. is it prudent to deprive lactating women protection through vaccination from this dreaded infection simply because they were not included in the clinical trials? Has the same criteria of exclusion in clinical trials been used while allowing vaccination in other recipients? What do the published scientific data say about it? What are the recommendations by global agencies, different Government agencies and professional organizations on vaccinating the lactating women? This article explores available information on some of these issues.

What scientific information is available on use of COVID-19 vaccine in lactating women?

Vaccines currently available in India are non-live vaccines. It is not expected that they will be significantly excreted into breastmilk or absorbed by the infant. No non-live, inactivated vaccine (recombinant or killed organism) has ever been reported to cause adverse effects in infants via breastfeeding. (See) There is no reason to assume that a vaccine is harmful, and exclusion should rely on clinical evidence rather than assumption. In fact, non-live vaccines, like Flu vaccine, are considered safe and therefore used in lactating women. (See)

There are several published reports, mainly from the USA, about use of mRNA vaccines in pregnant and lactating women, some of which are mentioned below. Instead of any harmful effect to the breastfeeding infants, they have documented the presence of protective antibodies against SARS CoV-2 in the breastmilk. See the list below.

What are the global/national recommendations?

Several professional organizations and governmental health authorities across the globe have recommended providing  COVID-19 vaccines to breastfeeding women as potential benefits of maternal vaccination during lactation to her own health and that of her infant outweigh any theoretical risks. Some of these organisations are listed below:

World Health Organization:

WHO does not suggest avoiding the vaccine in lactating women. It says, “It is not yet clear whether COVID-19 vaccines can be excreted through breastfeeding. To determine the best course of action, the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for immunization against COVID-19. WHO does not recommend discontinuing breastfeeding after vaccination.” (See)

The US Centers for Disease Control and Prevention (CDC):

CDC recommends giving COVID-19 vaccine to lactating women. It says, “Based on how these vaccines work in the body, COVID-19 vaccines are thought not to be a risk to lactating people or their breastfeeding babies. Therefore, lactating people can receive a COVID-19 vaccine. Recent reports have shown that breastfeeding people who have received COVID-19 mRNA vaccines have antibodies in their breastmilk, which could help protect their babies. More data are needed to determine what protection these antibodies may provide to the baby.” (See)

Joint Committee on Vaccination and Immunisation (JCVI), the Department of Health and Social Care, Government of UK: 

The JCVI has issued an advice on priority groups for COVID-19 vaccination, which states, “There is no known risk associated with giving non-live vaccines whilst breastfeeding. JCVI advises that breastfeeding women may be offered vaccination with the Pfizer-BioNTech or AstraZeneca COVID-19 vaccines.” (See)

The Department of Health, Australian Government:

Australian Government’s COVID-19 vaccination decision guide for women who are pregnant, breastfeeding or planning pregnancy recommends, “If you are breastfeeding you can receive Comirnaty or COVID-19 Vaccine AstraZeneca at any time. You do not need to stop breastfeeding before or after vaccination.” (See)

Ministry of Health, New Zealand Government:

New Zealand Government recommends vaccination against COVID-19 in breastfeeding women. Its guideline on ‘COVID-19 – Who can get a vaccine’ states,“As with all vaccines on the New Zealand Immunisation Schedule, there are no safety concerns about giving the Pfizer vaccine to women who are breastfeeding. When you’re vaccinated, this can also provide some protection against COVID-19 for your baby through your breastmilk.” (See)

American Academy of Pediatrics (AAP):

AAP states, “the COVID-19 vaccine should be available to teens who are pregnant or breastfeeding and who meet the criteria set by the Advisory Committee on Immunization Practices as a priority group.” (See)

The American College of Obstetricians and Gynecologists (ACOG):

ACOG supports vaccinating lactating women against the COVID-19 infection. Its statement says, “ACOG recommends COVID-19 vaccines be offered to lactating individuals. While lactating individuals were not included in most clinical trials, COVID-19 vaccines should not be withheld from lactating individuals who otherwise meet criteria for vaccination. Theoretical concerns regarding the safety of vaccinating lactating individuals do not outweigh the potential benefits of receiving the vaccine. There is no need to avoid initiation or discontinue breastfeeding in patients who receive a COVID-19 vaccine.” (See)

International Federation of Gynecology and Obstetrics (FIGO):

FIGO supports offering COVID-19 vaccination to pregnant and breastfeeding women. It says, “Breastfeeding confers many health benefits to mother and newborn. COVID-19 vaccines are believed to pose minimal to no potential risk to the newborn through breastmilk. Based on previously administered vaccines, there is the potential for direct neonatal benefit if the vaccine-stimulated immunoglobulin A prove to pass through breastmilk. For breastfeeding women, therefore, the COVID-19 vaccine can be offered if the mother meets the criteria based on prioritisation groups, such as a breastfeeding health care provider.” (See)

Royal College of Obstetricians and Gynecologists (RCOG):

RCOG, in the Q&As on the COVID-19 vaccines, pregnancy and breastfeeding, states, “Although there is lack of safety data for these specific vaccinations in breastfeeding, there is no plausible mechanism by which any vaccine ingredient could pass to your baby through breast milk. You should therefore not stop breastfeeding in order to be vaccinated against COVID-19.” (See)

The Infectious Disease Committee of the Society of Obstetricians and Gynaecologists of Canada (SOGC):

SOGC supports use of COVID-19 vaccines in lactating mothers. Its’ statement on COVID-19 vaccination in pregnancy states, “The SOGC supports the use of all available COVID-19 vaccines approved in Canada in any trimester of pregnancy and during breastfeeding in accordance with regional eligibility.” (See)

The Italian scientific societies: Position statement of six Italian scientific societies:

These societies, namely, the Italian Society of Neonatology (SIN), the Italian Society of Pediatrics (SIP), the Italian Society of Perinatal Medicine (SIMP), the Italian Society of Obstetrics and Gynecology (SIGO), the Italian Association of Hospital Obstetricians-Gynecologists (AOGOI) and the Italian Society of Infectious and Tropical Diseases (SIMIT) have issued a position statement. The statement says, “Currently, knowledge regarding the administration of COVID-19 vaccine to the breastfeeding mother is limited. Nevertheless, as health benefits of breastfeeding are well demonstrated and since biological plausibility suggests that the health risk for the nursed infant is unlikely, Italian scientific societies conclude that COVID-19 vaccination is compatible with breastfeeding.” The statement also recommends inclusion of pregnant and lactating women in future vaccination trials. (See)

Have the same criteria of exclusion in clinical trials been used while allowing vaccination in other recipients?

Clinical trial protocol of Covishield reveals that subjects with any confirmed or suspected condition with impaired/altered function of immune system were excluded from the Phase 2/3 clinical trial of the vaccine.

Clinical trial protocol of Covaxin informs that several groups of people were excluded from the phase 3 trial of the vaccine e.g.

However, the list of 20 specified co-morbidities for determination of eligibility of citizens in age group of 45 to 59 years in India includes several of these categories of people who were excluded from the clinical trial. These are, Moderate or Severe Valvular Heart Disease, Congenital heart disease with severe PAH or Idiopathic PAH, Significant Left ventricular systolic dysfunction (LVEF <40%), Kidney/ Liver/ Hematopoietic stem cell transplant: Recipient/On wait-list, Current prolonged use of oral corticosteroids/ immunosuppressant medications, Decompensated cirrhosis, Primary Immunodeficiency Diseases/ HIV infection, Lymphoma/ Leukaemia/ Myeloma, Diagnosis of any solid cancer on or after 1st July 2020 OR currently on any cancer therapy. Inclusion of persons with above-mentioned co-morbidities among the vaccine recipient groups in spite of their exclusion from the phase 2/3 clinical trials of vaccines is a welcome step. This is a pragmatic approach. A similar approach can be taken in case of lactating women.

Conclusions

Breastfeeding is considered the first vaccine of the infant. In India, where the median duration of breastfeeding is 29.6 months (NFHS-4), it remains the primary source of nutrition to the infants and young children. Breastfeeding is also important to prevent morbidity and mortality during the neonatal period, infancy and childhood and in lactating mothers later on in life. According to one estimate, in India alone, it can prevent hundred thousand childhood deaths each year. For these very facts, protection, promotion and support to breastfeeding have been major components of the Government of India’s initiatives like MAA programme, LaQshya programme, establishing Lactation Management Centres in Public Health Facilities; and Poshan Abhiyan.

With 25 Million women giving birth each year in India, mostly in the age of 18 – 45 years, many of which are part of country’s COVID response (health care providers, security personnel, transport workers, teaching personnel, community level health and nutrition care workers etc.), it will be prudent to provide them protection from COVID-19 with vaccination.

PS: There are some media reports (13th May 2021) stating that National Technical Advisory Group on Immunisation (NTAGI) has recommended provision of COVID-19 vaccination of lactating women. It is a welcome development which should be institutionalised with utmost urgency.