(Update: The Centre on Friday, 25 June, approved COVID-19 vaccination for pregnant women. "The vaccine is useful for the pregnant woman and it should be given," it said.

So far, only lactating women in India were recommended to take the vaccine.)

In the year 1977, a freak incident involving adverse reactions to Thalidomide, a sedative, led the US FDA to decide 'women of childbearing potential' should be excluded from vaccine trials because they were deemed to be too 'complex' and 'risky'.

16 years and numerous pushbacks later the US made it compulsory by law to include women in clinical research.

This was a major step in the history of women’s representation in medical research.

But fast-forward to a few decades later, and the vestiges of this attitude towards 'women with child-bearing potential' still have a hold on medical research.

And unfortunately, this hasn't changed with the COVID vaccine research.

A bias that is conversely keeping these 'vulnerable' groups from receiving vital protection.

When the vaccines were first rolled out globally in December, they came with an impossible choice for some, ‘take a vaccine that’s not been tested on pregnant people, or risk getting COVID.’

In India, this choice was made for them by the government.

But let's backtrack a bit.

Excluding pregnant and lactating women from the clinical trials of COVID vaccines stems from a long standing obstacle of systemic exclusion.

But the catch 22 here is that pregnant women are also extremely vulnerable to adverse COVID complications.

"The question then becomes, shouldn't they also be considered a priority population?" says Dr Anant Bhan, Adjunct Professor & Researcher in Bioethics at Mangaluru’s Yenepoya University.

This systemic exclusion is especially problematic considering a big portion of the healthcare workforce is made up of 'women of reproductive age'.

Speaking to FIT, Amar Jesani, Editor of the Indian Journal of Medical Ethics says, “Not including pregnant women in the clinical trials of COVID vaccines was ethically wrong as it was known that pregnant women do face a significant risk of infection."

This is exactly what's happening in India right now.

Health experts across the world including the World Health Organisation (WHO), the US FDA and CDC, and the Federation of Obstetric and Gynaecological Societies of India (FOGSI) , almost unanimously assert that it is safe for pregnant and lactating women to take the COVID vaccines.

The UK National Health Services (NHS) has also announced that they will be allowing pregnant women to get vaccinated.

However, despite these strong recommendations, the Ministry of Health and Family Welfare in India continues to list pregnant women and 'women who are not sure of their pregnancy' as contraindications to the vaccine stating that there is no data to prove its safety, as they have not been part of any of the clinical trials.

This would have been a sound decision (considering the limited safety data we do have comes from retrospective studies that apply to mRNA vaccines) if efforts were underway to generate said data in the country on an urgent basis. Why are a pregnant women still being shut out?

“For Covaxin the company hasn't released any paper in a journal or pre-print, so we do not know much about the vaccine except what has been released in press notes of the company,” says Amar Jesani.

In these, Covaxin clearly states that pregnant and lactating women should not be taking their vaccine.

Covishield on the other hand leaves it to the doctors to decide, giving no further information.

In fact,' not enough data' and, 'may take if the benefits outweigh the risks', are phrases one comes across often in COVID vaccine advisories across the board when it comes to pregnant women.

"They play it safe by just putting on their label that they have not evaluated the vaccines in pregnant women. You take this vaccine at your own risk," says Dr Gagandeep Kang.

In such a situation what would be required to ensure they get the vaccine? Is it more data? Or alternatively, are we going to go ahead with it without data because the benefits outweigh the potential risks?

With the COVID vaccines, experts have taken a middle route based on available data superimposed with past knowledge and a risk-benefit analysis considering the theoretical risks.

"And that’s the exact dilemma we are having. In the absence of data, we have been forced to find other ways to make the assessment. If we had the data we wouldn’t be arguing about it at all," adds Dr Bhan.

FOGSI, while acknowledging the lack of data, base their assessment on "basic science and animal studies" which have "not shown any teratogenic or adverse fetal or neonatal effects of the vaccine."

Speaking of retrospective studies, Dr Kang says, "Vaccines have been offered to pregnant women who are also healthcare workers in many countries. Over 35,000 women have been immunized in the US alone."

"There have been studies that have been done and published now, on pregnant women particularly with the mRNA vaccine," she adds.

In February, Pfizer became the first COVID vaccine to announce it was conducting clinical trials on pregnant women.

"You can’t even apply the data of one mRNA vaccine to another mRNA vaccine. The vaccine products are distinct even if they are on the same platform," says Dr Kang.

But, she adds that in certain situations, we may have to make judgment calls based on what we know and what the situation calls for.

By this Dr Kang is referring to the current COVID crisis that has gripped the country where leaving pregnant people vulnerable and unprotected could prove detrimental to them and their child.

Based on the recent risk-benefit analysis, Dr Bhan says, "the most sound thing to do is go with the recommendation of FOGSI, and to cover them for now."

Dr Kang agrees, saying, “All inactivated vaccines, including covaxin and covishield should be safe. I have no concern of a threat to the safety of pregnant women either."

But both Dr Bhan and Dr Kang add that extra steps such as close monitoring over a period of time will be needed to make up for the lack of safety data.

Dr Bhan says, "This (vaccinating pregnant and lactating people) will have to be followed up with stringent monitoring for any adverse reactions that may be linked to the vaccine."

Dr Kang, adds, “Another thing that regulators can do is ask for a pregnancy registry which is essential to ensure that, when pregnant women are given the vaccine, a record is maintained of what happens during the pregnancy, and after she delivers.”

In the meantime, meaningful steps must be taken to fill the gaps in safety and efficacy data.

At which point does "not enough data" stop being an acceptable answer to questions of neglected groups' safety?

"In vaccine response as well, the more data we have, the better we will be able to understand what's going on," says Dr Kang.

And the exclusion of pregnant women is only an extension of the lack of understanding of and consideration to women's physiologies in clinical research.

None of the covid vaccine trials, for instance, have taken sex as a variable, even though, due to genetic factors, women tend to be at a higher risk of developing autoimmune disorders.

Women have also been reporting worse side effects after getting the vaccine. The cause for which might have been more apparent if sex was a variable in the clinical trials.

There is also the issue of blood clots.

In the last few months, two COVID vaccines, AstraZeneca and Johnson & Johnson's Janssen have come under scrutiny for causing Thrombosis, a rare blood clotting issue.

Now, incidents of such blood clots from these vaccines are very rare occurrences. In fact, you're more likely to get blood clots from the COVID infection itself.

Subsequently, regulators would have been able to make a more informed call on the subgroups of people (if any) for whom the vaccine may be discouraged rather than throwing a wrench in the inoculation drives by pausing the concerned vaccines altogether.

Speaking specifically of the blood clots she says,"down the road, such a link may be established but at the moment the data is murky because of various factors and there is no evidence of any of the effects of the vaccine being predictable."

"Unless we have more granular data, we will never know," she adds.

Because Pregnant women are excluded in spite of being a high vulnerability group, it has led to multiple missed opportunities in the past to generate safety and efficacy data.

The global COVID pandemic has reinforced the repercussions of this oversight as well as presented us with the opportunity to rectify it by allowing pregnant women the choice of participating in trials.

Along with removing the roadblock to securing much-needed protection, clinical data would allow vulnerable groups to make a far more informed and confident choice, while also not having to take the vaccine without the safety net of clinical evidence provided to non-pregnant people.

This also includes trans women (and men) who have historically been underrepresented in clinical research and have over the decades grown to mistrust the medical industry that has treated them as afterthoughts with little consideration to the specific impact of the medicines and treatments on their bodies.

If we did have scientific data to back the claims of assurances, vaccine regulators and health authorities could then also tackle the problem of vaccine hesitancy among marginalised subgroups head-on, and encourage the uptake of their vaccines by providing confidence of their safety, instead of shifting the onus of their wellbeing entirely onto the consumer with an evasive, "it's your choice."