Why are pregnant women not included in COVID-19 trials?
Over the world, we are seeing some steady advancements take place in terms of vaccine development. With over seven promising candidates in phase II/III of trials, we might get to see a safe and effective vaccine launched in a few months from now.
Healthy adults, senior citizens and even kids are part of the focus group being tested on. Pregnant women are not.
While most companies are scouting for candidates from various profiles, pregnant women haven't been included yet. Traditionally, women in different stages of pregnancy, the ones who are currently feeding a child or the ones who are planning to conceive in a couple of years aren't considered ideal for a vaccine trial, citing "safety" reasons. Only a few clinical researches have been testing on pregnant women.
While safety is one of the reasons which keeps a woman of childbearing
age away from trials, some experts feel that it isn't the right thing to
do. Some also feel that excluding them from the vaccine trials can be
deterring, especially at a time like this. With strong studies which
support that COVID-19 could be just as consequential for pregnant women
and the unborn fetus, withholding trials for women could still make
COVID-19 dangerous for them.
Why are pregnant women not ideal for a vaccine trial?
While pregnancy vaccines are aimed at protecting the baby's health,
never has a vaccine been exclusively developed to protect pregnant women
from viral outbreaks like these.
Pregnancy makes a woman provide nourishment for the unborn baby, and
that often leads to compromised immunity and heightened infection risk.
More so, the vaccines which are usually being tested out make use of
experimental medicines which leave room for a person to experience
adverse side-effects. Scientists also say that the concept of 'altered'
immunity during pregnancy may also deliver different results in a trial.
However, it does not all mean good news. In past pandemics, the
absence of a definite vaccine for pregnant women exposed them to
life-threatening complications and health delays.
Another reason behind leaving pregnant women out is that vaccine
trials often involve high doses being volunteered to COVID patients,
sometimes, in additional rounds as well. When there's a growing baby
inside you, going over and above the safe doses could be potentially
harmful and even impact cell division, which is rapidly going on.
Vaccine makers also argue that there's a whole set of complications
and guidelines which need to be explained while administrating a vaccine
for pregnant women, who fall under the high-risk category for COVID and
hence, signal a delay. All of these, which are regarded as 'good
intentions' end up keeping a section of women away.
However, such a practice only impact a
women's general well-being, and the unborn fetus's as well. Some
experts also say that when it comes to COVID complications, delivering a
vaccine is much easier, and less damaging than treatment plans, since a
good medical strategy to root out COVID hasn't been developed yet.
Not only would an incomplete vaccine
trial make a COVID-19 vaccine subject to failure, but it would also be a
grave injustice to exclude pregnant women from COVID trials, impacting
them socially, mentally and economically too.
A right approach could be to let the
women take the decision for themselves. Just as non-pregnant women, men
and senior citizens are asked to sign an undertaking, letting pregnant
women know the risks beforehand will make them aware, and be prepared
for the consequences.
While fast-tracking a vaccine for
pregnant women isn't safe, in the long run, pharma groups could consult
with obstetricians, gynaecologists and other medicinal experts to devise
and test safe monitored doses for women.