The objective of this recommendation is production of an evidence-based document to guide the pediatricians to give advice to breastfeeding mothers regarding the safety of COVID-19 vaccines in lactating women.

Formulation of key question was done under the chairmanship of President of the Indian Academy of Pediatrics (IAP). It was followed by review of literature regarding efficacy and safety of COVID-19 vaccines in breastfeeding women. The recommendations of other international and national professional bodies were also deliberated in detail. The available data was discussed in the Advisory Committee on Vaccines and Immunization Practices (ACVIP) focused WhatsApp group. Opinion of all members was taken and the final document was prepared after the consensus and was approved by all members of the ACVIP (authors of the guidelines).

The theoretical risk of COVID-19 vaccination in breastfeeding mothers and the potential harm to the infant is unknown. However, it is to be noted that none of the vaccines available for the COVID-19 contains live virus. There is no plausible biological mechanism to explain how an inactivated vaccine, given to the mother, would cause harm to a breastfed baby [5].

The COVID-19 vaccines presently available in India, i.e., Covishield and Covaxin are classified as inactivated (non-live) vaccines. Theoretically, administration of these vaccines to breastfeeding women should not render any harm to the breastfed infant. While the safety of adenovirus vectors in pregnancy and lactation is not established, wild adenoviral infections are present worldwide and have not been associated with teratogenic effects in the fetus or newborns [6]. With the exception of small pox and yellow fever vaccines no other vaccine is contraindicated during breast feeding [7].

Breast milk is a rich source of antibodies for the infant. Milk produced by infected mothers is a source of anti-SARS-CoV-2 IgA and IgG and neutralizes SARS-CoV-2 activity [8].

Studies have shown that maternal vaccination with the mRNA vaccine results in high titers of RBD-IgG binding antibodies and neutralizing antibodies as measured by the pseudovirus neutralizing tests (NT50), in maternal serum. High titers of RBD–IgG binding antibodies, neutralizing antibodies as measured by the NT50 and robust T-cell responses, as measured by ELISPOT and intra-cellular cytokine staining, have been demonstrated in the breast milk of mothers vaccinated with the mRNA vaccines [9]. In another study, involving six lactating women who received two doses of SARS-CoV-2 vaccine, significantly elevated levels of SARS-CoV-2 specific IgG and IgA antibodies in breast milk was observed, beginning at Day 7 after the initial vaccine dose, with an IgG-dominant response [10]. These SARS-CoV-2 specific immunoglobulins and products of the T-cell responses in breast milk may be protective for infants.

There is a paucity of data on immunological parameters in breastmilk following the administration of the AstraZeneca COVID-19 vaccine in lactating women. Thus, merely the absence of data should not exclude lactating women from getting the benefits of COVID-19 vaccination.

Many international and national recommending bodies have now recommended administration of COVID-19 vaccines in breastfeeding women (Table I).

While some have recommended the COVID-19 vaccines in breastfeeding women who are in the priority groups, after fully informing them about the benefits and risks of vaccination, some authorities have recommended the vaccine for all breastfeeding women. All have emphasized that breast feeding should be continued after vaccination.

Contributors: All authors were part of the IAP ACVIP team that formulated these guidelines. PG, BJP, GVB, and SGK: conceived the Guidelines, prepared the agenda, and executed adminis-tratively. PG and SGK: led the discussions and all the members actively participated. SGK, SKD, SV, HKP, AS reviewed the literature on national and international guidelines, SGK, SM, SKA, SS, SK reviewed the literature on safety of COVID vaccines in breast feeding women, S, KC, SK reviewed the literature on immunological parameters in breast milk. SGK, SKD wrote the first draft. The first draft was peer reviewed by PG, SBS. PG, BJK, PG, GVB, RK provided intellectual inputs and overall guidance at every step. PG, BJP, GVB provided the administrative support from the Indian Academy of Pediatrics and coordinated between the team and executive board members of the Academy. The final document was drafted by SGK and SKD; and edited by PG and SBS. All authors approved the final recommendations of the guidelines.

Funding: None; Competing interests: None stated.

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