Vaccinating lactating mothers: What’s right, what’s wrong

While healthcare experts do support this development, there still seem to be a bit of suspicion around it

The Ministry of Health and Family Welfare (MoH&FW) recently accepted the recommendations made by the National Expert Group of Vaccine Administration for COVID-19 (NEGVAC) for vaccinating lactating mothers to protect them from COVID-19 using the two vaccines Covishield and COVAXIN that are currently being administered in India, even though such women were not a part of any clinical trials.

While healthcare experts do support this development, there still seem to be a bit of suspicion around it.

For instance, Bejon Misra, Founder, Patient Safety and Access, argued that a pre-vaccination screening of the vulnerable groups should be the primary step at the vaccination centres to understand their medical history and take preventive measures to avoid any side effects.

“Pre-vaccination screening at vaccination centres is must for people who are vulnerable – pregnant women, lactating mothers and those suffering from chronic diseases. Since the concept of public health care is missing in our system, there is a large population unaware of the fact that it might be risky to take a vaccine if they are already on medication for a disease. Therefore, it is essential to see their past medical history and understand if there could be any possible side effects post-vaccination,” he emphasised.

On the contrary, Dr Prasanna Bhat, a Delhi-based paediatrician, asserted that there is no harm in vaccinating lactating mothers for COVID-19; instead, it will help in developing antibodies against the disease, which is good for both – the mother as well as her child.

He also said, “It is important and safe to vaccinate lactating mothers as it will not only protect them, but they would secrete antibodies in the breast milk, which would be beneficial for babies.”

The same thought was shared by Dr Neeraj Lal, Group Senior Vice President, Medicover India and renowned virologist Dr Gagandeep Kang.

“Antibodies that transfer into the breastmilk may actually protect the child,” said Dr Lal.

Dr Kang also mentioned, “Vaccinating lactating mothers may protect the baby because the mother will make antibodies against the virus.”

Dr Sanish Davis, President, Indian Society for Clinical Research (ISCR), also agreed that getting breastfeeding women vaccinated is getting protection for two, i.e., when a breastfeeding mother who’s vaccinated for COVID-19, feeds her baby, the antibodies will be passed on to the infant as well, providing them some protection against the disease.

“There are no disadvantages for breastfeeding women getting vaccinated as compared to the general group,” he claimed.

Just like all of them, Dr JP Dadhich, Co-Chair – Global Council, International Baby Food Action Network (IBFAN), informed that several studies have reported presence of anti-SARS-CoV-2 antibodies in the breastmilk of COVID-19 positive mothers.

“Since, currently, COVID-19 vaccine is not recommended in children, antibodies against the disease in breastmilk may be a source of life-saving protection to the infants against this infection,” he suggested.

Backing the government’s guidelines, Dr Lal further said, “The government arrived at this decision after deliberation over the evidence from other countries. It has been reviewed by NEGVAC before the decision to allow lactating women access to any COVID vaccine that was finally made.”

But, no clinical trials….

Highlighting that none of the two vaccines have undergone a clinical trial, Dr Kang said, “The vaccines specifically made in India have not undergone any clinical trial on lactating women. Our system wants companies to develop vaccines, but if something goes wrong, where both the mother and the baby are affected, there are liability, insurance and compensation issues. So, it wants the treatment but doesn’t want the risk. Hence, when companies enroll for clinical trials, they rule out pregnant women. Now by doing this, we are doing the right thing in protecting women during the trial, but we are doing the wrong thing by not testing a product that is likely to help them.”

She also stressed that once trials are conducted in adults without any mishappening, it should be made mandatory for pregnant women too.

“After the trials are conducted in adults and there is nothing that happens, it should then be made mandatory to include some pregnant women. These are the kinds of discussion that people are having, but, right now, there is no regulation for that,” she added.

Further, according to Davis too, there are no specific clinical trials conducted in this group of population and it is not usual to do specific studies only in lactating women in vaccine development.

Non-live-virus vaccines cause no harm

Dr Bhat notified that both the vaccines are non-live-virus vaccines. “None of the vaccines – Covishield and COVAXIN – that are being administered in India, are live-virus vaccines. We know that spike protein is being used to make Covishield and COVAXIN is being made using time-tested age-old technologies of killed virus. Hence, the virus cannot cause any harm to the individual who gets the vaccine.”

Sharing a similar view, Dr Dadhich mentioned that both Covishield and COVAXIN are non-live vaccines, which are not expected to be significantly excreted into breastmilk or absorbed by the infant.

“So far, other non-live, inactivated vaccines (recombinant or killed organism) have not reported to cause adverse effects in infants via breastfeeding. In fact, non-live vaccines, like flu vaccine, are considered safe, and, therefore, routinely used in lactating women,” he pointed out.

Health experts do not expect safety issues with any product that is equivalent to an inactivated vaccine. In line with this, Dr Kang also said, “We don’t expect safety issues for either pregnant women or lactating women. Pregnant and lactating women were not included in the trials but after the vaccines have started to be used in different parts of the world, there are data on pregnant women who were vaccinated during pregnancy as well as on lactating women, where there has been no concern whatsoever.”

She also informed, “There is already data from the Pfizer and Moderna vaccines on 35,000 pregnant women who have received the vaccine, and unknown number of lactating women, but I can’t imagine that is less and there are no safety issues.”

The strive for data

To fight the pandemic, emergency use authorisation of vaccines/drugs is something that is required across the world and the authorities are doing the same.

Misra agreed that the current situation is dire and an emergency use authorisation of vaccines is the need of the hour and there is a limited data available. His only point of contention was that even that limited data is not available in the public domain. However, it is necessary to do so for achieving sustainable public health care.

“Even if the trials are conducted on a small scale, the data must be available in the public domain because transparency and accountability is needed for any action taken by the government and policy makers. Whatever data is collected, it should be shared with the scientific community at least, so that they can analyse it and make the required contribution in the process,” he lamented.

In spite of such a scenario, Dr Dadhich expressed hope that perhaps, in future, some data will be available regarding these trials.

“None of the clinical trials of the vaccine available so far (including Covishield and COVAXIN) have included pregnant and lactating women as study subjects. However, post-use data should be available in future as many countries have included lactating women in their vaccination programme,” he said.

Adding to it, Dr Davis said, “The UK Joint Committee on Vaccination and Immunisation (JCVI) advises that although “there is lack of safety data for these specific vaccinations in breastfeeding, there is no known risk in giving these vaccines to breastfeeding women. The American College of Obstetricians and Gynecologists (ACOG) recommends that COVID-19 vaccination also be offered to breastfeeding women, without the need to avoid vaccination or stop breastfeeding. The Federation of Obstetric and Gynaecological Societies of India (FOGSI) recommends vaccinating these women in line with the recommendations of international bodies.”

To understand the basis of the recommendations made by NEGVAC on the issue, Express Healthcare had also sent a query to one of the members of this group. However, no response was received on the same till the time of publishing this story.