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Drugs and Lactation Database (LactMed) [Internet]. Bethesda (MD): National Library of Medicine (US); 2006-.

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Drugs and Lactation Database (LactMed) [Internet].

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COVID-19 vaccines

Last Revision: November 15, 2021.

Estimated reading time: 15 minutes

Drug Levels and Effects

Summary of Use during Lactation

No evidence suggests that women receiving a vaccine against SARS-CoV-2, the virus that causes COVID-19, is harmful to either the nursing mother or the breastfed infant. Antibodies appear in the milk after maternal vaccination, which neutralize the SARS-CoV-2 virus and likely protect the infant against COVID-19 infection[1,2] Professional organizations and governmental health authorities have recommended that COVID-19 vaccines be offered to those who are breastfeeding because the potential benefits of maternal vaccination during lactation outweigh any theoretical risks, including mothers with diabetes mellitus.[3-14] Nursing mothers experienced minimal disruption of breastfeeding after vaccination and noticed no serious adverse effects in their infants.[15-19]

Several vaccines for COVID-19, have been developed. The first vaccines available in the US (by Pfizer-BioNTech [Comirnaty] and Moderna) are messenger RNA (mRNA) vaccines. Another mRNA vaccine is available in Europe (CureVac). Other vaccines (by Janssen-Johnson & Johnson, Astra-Zeneca, Sputnik-V, and CanSino) are made using human and primate adenovirus vectors. A third type of vaccine available outside of the US is an inactivated whole-virus SARS-CoV-2 vaccine (by Bharat Biotech, Sinopharm and Sinovac). None of the vaccines are live vaccines and none of them are expected to be appreciably excreted into breastmilk or absorbed by the infant. No non-live vaccine has previously been reported to cause infant adverse effects via breastfeeding.[20] Studies with mRNA vaccines indicate that little to no mRNA is detectable in milk.[21,22] Mothers who receive an mRNA vaccine have marked increases in milk antibodies against SARS CoV-2 that potentially protect breastfed infants from infection. Milk antibody levels are slower to develop after the first dose of an mRNA vaccine in lactating women, but increase after the second dose.[23] Milk antibody levels after the vaccine are higher than after a COVID-19 infection. Occasionally women report a change in the color of their breastmilk to blue or blue-green. Some mild infant effects reported after mRNA COVID-19 vaccines may not necessarily be attributed directly to the vaccine. Some infants have anti-SARS-CoV-2 IgG in their saliva after breastfeeding, but IgG is not found in their serum.

Holder pasteurization of milk from women who had previously had COVID-19 resulted in a marked decrease in SARS-CoV-2 spike neutralizing capacity, even though the total levels of SIgA in milk were reduced to a much lesser extent.[24] The effect of pasteurization on milk antibodies after immunization has not been studied.

Drug Levels

mRNA vaccines are genetically engineered messenger RNA strands that encode for a portion of the SARS-CoV-2 S spike or “S” protein and are encapsulated within lipid nanoparticles. These nanoparticles are microscopic spherical-shaped mixtures of specialized fats, cholesterol, and polyethylene glycol that protect and deliver the mRNA strands to the recipient’s cells after injection. Once inside the vaccine recipient’s cells, mRNA is released, and its genetic code translated into viral S proteins. mRNA does not enter the cell nucleus or alter the cell’s DNA. Those proteins are processed into peptides that are displayed on the cell surface, which then stimulates the antiviral immune response.[25] There is no plausible mechanism for intact, complete, functional viral S proteins to be distributed into the milk from the maternal circulation after immunization. Testing of the milk of mothers who received either the Pfizer-BioNTech or Moderna vaccine found no mRNA in their milk.

mRNA has an estimated half-life of 8 to 10 hours and does not enter the breastmilk.[21,22,26] The tiny amount of polyethylene glycol-2000 in Pfizer-BioNTech vaccine is not found in breastmilk or absorbed orally, so breastmilk PEG exposure from maternal immunization is not a concern.[27] Neither of the currently available mRNA vaccines contains a preservative or adjuvant.

Adenovirus vaccines. These vaccines are made from adenoviruses vectors that have been genetically engineered so they cannot reproduce in the human body. They are also engineered to contain DNA sequences for the S protein. Once inside the vaccine recipient’s cells, the DNA is transcribed to mRNA, which is then translated into viral S protein just like the mRNA vaccines. The adenovirus vaccines do not require a lipid nanoparticle carrier, and thus contain fewer unique ingredients for the breastfed infant to be potentially exposed to compared to the mRNA vaccines. The Janssen-Johnson & Johnson vaccine contains the solubilizer polysorbate 80, a common food additive, in small amounts that are not expected to be harmful to a breastfed infant.

Whole-virus inactivated vaccines. These vaccines are conventional, killed whole-virus particles prepared in a manner that has been used for decades for various vaccines that are safe for breastfeeding.[20,26] The SARS-CoV-2 virus is grown in a cellular medium and then completely denatured so it is not infectious. When injected, the body creates an immune response against the S protein that is capable of neutralizing the virus if infection occurs.

Maternal Levels. Thirty-one healthcare workers who were lactating were given one of the mRNA vaccines (15 Moderna and 16 Pfizer-BioNTech) for routine immunization. Maternal blood and milk samples were taken at the time of the first dose, at the time of the second dose and 2 to 6 weeks after the second dose, although not all subjects donated samples at all times. The median time postpartum was 7.3 months (IQR 3.8 to 10.8 months). Maternal serum antibody titers were equivalent to those of non-breastfeeding women and higher than those of women who previously had COVID-19. Breastmilk anti-spike IgA, IgG and IgM all increased, with IgA and IgG increases being the most robust. Most of the increase in IgA and IgM antibodies occurred after the first dose, but IgG further increased after the second dose, in parallel with increases in maternal serum IgG.[28]

Five subjects who received the Pfizer-BioNTech vaccine donated a total of 29 milk samples, beginning before the first vaccine dose and weekly thereafter. Milk samples were assessed for SARS-CoV-2 RNA by polymerase chain reaction and anti-spike IgG 67 and IgA. All pre-vaccine samples were negative for SARS-CoV-2 RNA. Anti-spike IgG and IgA levels were elevated relative to pre-vaccine baseline at all time points. Anti-spike protein IgG remained sustained at a significant elevation beginning at 20 days after the first dose through the final milk sample. Levels of anti-spike protein IgA were elevated from baseline starting 2 weeks after first dose through the final sample; however, a possible gradual decline in anti-spike IgA in milk occurred over time following the second dose. Results suggest an immune benefit to the nursing infant for at least 80 days.[29]

In a prospective cohort study, 84 breastfeeding healthcare workers in Israel were immunized with 2 doses of the Pfizer-BioNTech vaccine 21 days apart. Breastmilk samples were collected before the first dose and then weekly for 6 weeks beginning 2 weeks after the first dose. Mothers were an average of 10.3 months postpartum and provided 504 breastmilk samples. Breastmilk IgA antibodies increased rapidly, with 62% testing positive 2 weeks after the first dose and 86% on week after the second dose. At 6 weeks after the first dose, 66% tested positive. Breastmilk IgG antibodies were low until week 4 when 92% tested positive and at weeks 5 and 6, 97% of samples were positive for anti-SARS-CoV2 antibodies.[30]

A study of lactating women who received either the Pfizer-BioNTech (n = 11) of Moderna (n = 5) mRNA vaccines found that binding and neutralizing antibodies were observed in breastmilk. Breastmilk IgA and IgG titers were greater after the vaccines than after natural infections.[31]

Twenty six nursing mothers who received either 1 (n = 6) or 2 (n = 20) doses of the Pfizer-BioNTech vaccine donated milk samples before and on 7 days after the first and second dose of the vaccine. SARS-CoV-2 specific IgA began increasing between days 5 to 7 after the first dose, tripled by day 15, and declined thereafter to about half of the baseline. After the second dose, SARS-CoV-2 specific IgA increased by 2.3 times within a week compared to the level prior to the second dose. The peak level after the second dose was 1.3 times higher than the peak level after the first dose. Seven days after the second dose, SARS-CoV-2 specific IgA levels gradually declined, decreasing by 33% until the end of sample collection 15 days after the second dose.[32]

Twenty nursing mothers received 2 doses of an inactivated virus vaccine (CoronaVac, Sinovac). Four of them had previously had COVID-19. Ten mothers presented specific IgA antibody levels above the seroconversion value at week 7 (21 days after the second dose). Among the ten mothers who donated a sample four months after the first dose, five still had specific IgA levels above the seroconversion value at that time.[33]

Mothers who received either the Pfizer-BioNTech (n = 5) or Moderna (n = 2) mRNA vaccine had no detectable mRNA in their breastmilk between 4 and 48 hours after vaccination.[21]

Thirty-two mothers who received the Pfizer-BioNTech vaccine donated milk samples at 4 times during and after the vaccine schedule. Levels of IgA, IgG and IgM against SARS-CoV-2 were measured in milk. The highest concentrations of IgA and IgG antibodies in milk were observed on day 29 (7 days after the second dose) with a decrease on day 43. IgM antibodies against SARS-CoV-2 were not detected in any samples.[34]

Seven nursing mothers who received either the Pfizer-BioNTech (n = 4) or Moderna (n = 3) mRNA vaccine had breastmilk antibody levels measured before receiving the vaccine and at 11 timepoints after the first dose. Levels of SARS-CoV-2 specific IgG and IgA antibodies in human milk were markedly elevated beginning approximately 7 days after the initial vaccine dose, predominantly with an IgG response.[35]

Ten nursing mothers received the Pfizer-BioNTech vaccine. Milk and serum samples were collected 20 days after the first dose and 7 seven days after the second dose. Two women has low, but detectable anti-SARS-CoV-2 spike protein antibodies in milk before the first dose. After the first dose, all women had detectable anti-S antibodies in their milk. Milk antibody (presumably IgG) levels increased markedly after the second dose.[36]

Breastmilk samples were obtained from 61 women vaccinated postpartum with the Pfizer-BioNTech vaccine. All breastmilk samples were positive for IgG antibodies against SARS-CoV-2. Eighteen of 47 milk samples (38.3%) were found to neutralize SARS-CoV-2 infectivity. SARS-CoV-2 secretory IgA was detected in 15% of the breastmilk samples.[37]

Breastmilk samples were obtained from 33 lactating women vaccinated postpartum with the Pfizer-BioNTech vaccine at about 2 weeks after the first dose and 2 and 4 weeks after the second dose. Breastmilk andi-SARS-CoV-2 IgG appeared at 2 weeks after the first dose, peaked at 2 weeks after the second dose and remained about the same at 4 weeks after the second dose.[38]

Twenty-two lactating healthcare workers who received either the Pfizer-BioNTech or Moderna mRNA vaccine donated milk samples before vaccination, and after the first and second doses. Anti-SARS-CoV-2 IgA antibodies in milk increased after the first dose and further after the second dose of the vaccine; 85% had a 2 SD or greater increase after the second dose compared to prevaccination levels, which was comparable to that seen after natural infection. IgG anti-SARS-CoV-2 levels likewise increased after each vaccination such that all patients tested (n = 10) had levels after the second dose. Milk antibody levels were similar between the two vaccines.[39]

Fourteen lactating healthcare workers who received 2 doses of the BioNTech vaccine 3 weeks apart donated milk samples at 5 time points. Levels of both IgA and IgG anti-SARS-CoV-2 antibodies increased over time after vaccination, with the highest levels 3 to 7 days after the second dose, decreasing somewhat at 4 to 6 weeks after the second dose. Levels were similar to levels of a comparison group of women (n = 6) who had recovered from COVID-19 and were considerably higher than levels in milk from healthy, uninfected individuals (n = 9). Only 4 of 40 milk samples contained negligible amounts of mRNA from the vaccine.[22]

Nursing mothers (n = 98) who received an mRNA vaccine against SARS-CoV-2 (92 Pfizer-BioNTech and 6 Moderna) donated blood and milk samples on day 14 after their second injection. Twenty-found nursing mothers who had not had COVID-19 nor vaccination served as a control group. All samples were analyzed for IgG antibodies against nucleocapsid protein as well as IgG and IgM antibodies against the spike 1 protein receptor-binding domain (RBD). Milk was also tested for IgA, IgM, and IgG antibodies against SARS-CoV-2. Anti-SARS-CoV-2 RBD-S1 IgG level in the HM from the vaccinated participants was lower than in maternal serum, but it was found in the milk of all vaccinated mothers and it was greater than levels in the milk from the control group. Anti-SARS-CoV-2 S1 IgA was found in 89% of milk samples, but anti-SARS-CoV-2 S1 IgM was not detected in milk. Mothers who had lactated for 24 months or longer had more than double the concentration of anti-SARS-CoV-2 RBD-S1 IgG in their milk than mothers who had breastfed for less than 24 months.[40]

A study compared milk antibody levels 30 days after the second doses of the Pfizer-BioNTech (n = 70) and Moderna (n = 20) vaccines and 30 days after a single dose of the Astra-Zeneca (n = 20) vaccine. Both IgA and IgG levels in milk were 2 to 5 times higher after two doses of the mRNA vaccines than after the single dose of the Astra-Zeneca vaccine. Differences were even greater for IgG antibodies specifically against the spike protein.[41]

One hundred eighty nursing mothers in the US who received two doses of an mRNA vaccine completed a questionnaire for 7 days after each dose of vaccine. More subjects reported adverse effects after the Moderna vaccine than the Pfizer-BioNTech, especially after the second dose. Milk supply decreased in a small number of women, but it was most prevalent after the second dose of the Moderna vaccine. Between 4% and 8% of mothers noted a change in milk color after a dose of vaccine, usually to a blue-green color.[16]

Fourteen lactating healthcare workers in Portugal who were vaccinated with the Pfizer-BioNTech vaccine donated milk samples an average of 9.5 and 10 days after their first and second dose of the vaccine, respectively. IgA was found in 35.7% of milk samples after the first dose, but only 21.4% after the second dose. IgG was present in 7.1% of samples after the first dose and 42.9% of samples after the second dose. No IgM response was observed after either dose.[42]

A study in Israel on 64 women vaccinated the Pfizer-BioNTech vaccine during pregnancy and 11 women who had COVID-19 disease during pregnancy were studied postpartum. All breastmilk samples were positive for SARS CoV-2 IgG. A positive correlation was found between maternal serum levels of SARS Cov-2 IgG and breast milk levels.[43]

A prospective cohort study followed 10 lactating healthcare providers who received their first dose of the Pfizer-BioNTech vaccine approximately 5 months postpartum (mean 154 days, range 68−382) and the second dose 21 days later. Maternal serum and milk samples taken 7 and 14 days after the first and second doses found that spike- and RBD-specific IgA and IgG responses in milk closely followed the maternal serum responses, with a peak at 7 days after a dose. IgA was predominant at all time points, but the proportion of IgG increased after the second dose. Neutralization capacity for milk against the spike and RBD proteins was observed in all samples.[1]

In a study of milk antibodies following vaccination with an mRNA vaccine (18 Moderna, 12 Pfizer-BioNTech), IgA antibodies increased after the first injection, but not after the second, whereas IgG increased steadily thought the 90-day observation time. Microneutralization activity increased throughout time and both IgA and non-IgA (IgG-containing) fractions of human milk exhibited microneutralization activity against SARS-CoV-2 at 90 days post-vaccination.[2]

Infant Levels. Sixty-one women vaccinated postpartum with the Pfizer-BioNTech vaccine. SARS-CoV-2 IgG was detected in the oral mucosa of 3 of 5 breastfed infants. None of 21 infants who had serum samples taken had anti-SARS-CoV-2 IgG detected.[37]

A study published as a preprint reported 8 breastfed infants of mothers who received an mRNA vaccine against SARS-CoV-2 at ages between 61 days and 1 year of age. No anti-SARS-CoV-2 IgG or sIgA antibodies were detected in the serum of any of the infants.[27]

Effects in Breastfed Infants

In a prospective cohort study, 84 breastfeeding healthcare workers in Israel were immunized with 2 doses of the Pfizer-BioNTech vaccine 21 days apart. Mothers were an average of 10.3 months postpartum and 42% were exclusively breastfeeding. No infants experienced a serious adverse reaction. Four infants developed a fever after maternal vaccination, but appeared to have upper respiratory tract infections.[30]

No adverse effects were noted in 18 breastfed infants whose mothers were vaccinated with the Pfizer-BioNTech vaccine.[44]

In a cohort study of 180 women who received an mRNA vaccination (71% Pfizer, 29% Moderna) against SARS-CoV-2, some mothers reported side effects in their infants following vaccination. The most common events following the second dose were irritability (10.3% and 10.4% for Pfizer and Moderna, respectively), poor sleep (7.8% and 8.3% for Pfizer and Moderna, respectively), and significantly more drowsiness in children whose mothers received Moderna than Pfizer (6.4% and 0%, respectively).[16] It is not known if these side effects were caused by the vaccine directly.

Twenty nursing mothers received 2 doses of an inactivated virus vaccine (CoronaVac, Sinovac). None of their breastfed infants had any adverse effects reported.[33]

An on-line survey of 4455 nursing mothers who received either the Pfizer-BioNTech or Moderna vaccine found that 7.1% of mothers reported an adverse effect in their breastfed infant. The most frequent symptoms were increased sleepiness and increased fussiness, both at about 3% of infants, with the frequency greater after the second dose. Less frequently reported side effects included fever, rash, diarrhea, vomiting, changes in feeding frequency, and other miscellaneous symptoms. All were numerically, but not statistically more frequent after the second dose.[15]

A study published as a preprint found that among the breastfed infants of 50 women who receive an mRNA vaccine against COVID-19 during pregnancy or lactation, none had any serious adverse effects. A few reports of minor sleep changes and gastrointestinal symptoms were reported after the first dose of vaccine, but 88% of women reported no infant side effects. None of the infants had any reported symptoms after the second dose.[27]

Fourteen lactating healthcare workers who received 2 doses of the BioNTech vaccine 3 weeks. All of their infants were born full term and healthy. Twelve of the 14 infants were breastfed within 72 hours after their mothers were vaccinated. None of these 12 developed any adverse reactions (fever, rash, vomiting, diarrhea, cough or rhinorrhea) up to 28 days after ingestion of post-vaccination human milk.[22]

A prospective study was performed in 88 lactating healthcare workers in Singapore given the Pfizer-BioNTech vaccine for COVID-19. No adverse events (fever, rash, cough, behavioral change, vomiting, or diarrhea) were reported by mothers among infants who were breastfed after maternal vaccination.[17]

Effects on Lactation and Breastmilk

In a cohort study of 180 women who received an mRNA vaccination (71% Pfizer, 29% Moderna) against SARS-CoV-2, some women reported a temporary reduction in milk supply. The percentages of women who reported a decrease in milk supply after the Pfizer vaccine was 7.3% and 8% after the first and second doses, respectively. The percentages of women who reported a decrease in milk supply after the Moderna vaccine was 8% and 23.4% after the first and second doses, respectively. The difference between the two vaccines was statistically significant after the second dose. In all cases, the milk supply returned to normal within 3 days. A few women reported an increase in milk supply after each dose. Five women reported a change in milk color to blue-green after a dose of vaccine.[16]

In an on-line survey of 4455 nursing mothers who received either the Pfizer-BioNTech or Moderna vaccine, 3.9% reported an increase in milk production and 6% reported a decrease in milk production. The remainder of mothers reported no change in milk production.[15]

A prospective study was performed in 88 lactating healthcare workers in Singapore given the Pfizer-BioNTech vaccine for COVID-19. No participant reported a change in milk supply. One reported a transient bluish-green tinge to her milk color after her first vaccine dose but not after her second dose.[17]

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Substance Identification

Substance Name

COVID-19 vaccines

Drug Class

Breast Feeding

Lactation

Vaccines

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