COVID-19 vaccine and pregnancy and breastfeeding! Effectiveness and safety! Should pregnant mothers take the vaccine?

 Coronavirus vaccine made us wait a long time. But now the vaccine is out for public use. But can everyone take it? The vaccine is indicated for children above 16 years of age and adults. But gradually, we are coming to know the people who cannot take the vaccine. Firstly, it was said that people with a history of serious allergic reactions to substances and food should avoid the vaccine. This became clear when 2 NHS workers with a history of severe allergies developed allergic symptoms after taking the vaccine. The symptoms were mild and brought under control with prompt detection and therapy. And now the question that has cropped up is about pregnant women in different trimesters and breastfeeding mothers! Can they take the vaccine?

MAURITIUS AND SUGARCANE PLANTATIONS-THE HISTORY-Read here

The clinical trials of the vaccine

When the company Pfizer-BioNTech did trials on humans of the vaccine, the recruits were adult healthy volunteers above the age of 16 years. No pregnant and lactating mothers were included in the clinical trial of the vaccine. Hence its efficacy in them could not be determined. But the company states that from the available data it is not certain whether the vaccine is safe for use in pregnant and breastfeeding mothers.

COVID-19 vaccine [Source: Al Jazeera]

Hence, in the UK considering the fact that the trial was conducted in pregnant and breastfeeding ladies, the regulators have put the exclusion clause of these women for the vaccination program. On the other hand, the USA regulators have played safe and pushed the responsibility of deciding to take the vaccine or not on the women themselves.  

Experts and their opinions

The data does not say much about giving or not giving the vaccine to pregnant women. Ruth Faden from John Hopkins University states:

"There were no data, period,"

Safety and efficacy data on the use of the vaccine in pregnant women is missing. The company said that they decided to not include pregnant and breastfeeding mothers in the trial because they were told to do so by the USA FDA. The reason was that the FDA wants the company to first do the Developmental and reproductive toxicity studies (Dart studies) before they try out the vaccine in pregnant and breastfeeding mothers.

Coronavirus vaccine [Source: NDTV]

Given the time constraints and urgency to have the vaccine early, these studies were not done and the company was concentrating to have the vaccine that could be administered for most of people.

Customary practice

Experts feel that this is not exceptional for COVID-19 vaccine but common with all types of vaccines. Ruth said:

"In non-pandemic times, if you are talking about a brand new vaccine, most reasonable people who are committed to advancing the interests of pregnant women and their offspring would still say we should not involve pregnant women" in early clinical trials. You can't put them in right from the beginning".

"In bioethics, pregnant women are described as a complex population. Nowhere else do you have two entities at one time, both of whom are objects of moral concern."

Dart studies [Source: Charles River Laboratories]

She added:

"And by and large, no one cares more about the well-being of the offspring than the pregnant woman. The first question you usually get is 'will this be safe for my baby?'"

Dart studies from the company will be available only by end of this year and hence pregnant women will have to wait until then for the vaccine.