Women can’t be excluded from vaccine trials

Insights

08 Mar 2021
woman writing

Women’s voices, women’s approach and women’s thinking should be visible in every level of our society. Too often they’re not and the results are frustrating.

In the early clinical trials of Covid-19 vaccines, pregnant and breastfeeding women were left out of testing for no good reason. We weren't using live attenuated vaccines (a weakened form of the virus) so there weren’t likely to be any significant safety concerns in the trials. Because pregnant or breastfeeding women weren’t able to participate with full informed consent, it led to insufficient clinical data.

Results from countries like America and Israel now show it’s highly likely to be a very safe vaccine for pregnant women, but it’s disappointing the clinical trials didn't do the same and we aren’t learning from the past.

In 2014, the Ebola virus tore through Guinea, Liberia, and Sierra Leone and in two years killed 11,310 people. Nobody recognised that a large percentage of the frontline healthcare staff who were putting their lives on the line were pregnant and breastfeeding women. There was a lack of women in positions of authority who were able to stand up and say, “Look at the issues, haven't you noticed this is going to be a problem?”.

The first Ebola vaccines also excluded pregnant and breastfeeding women in their clinical trials, so these women weren’t offered the vaccine. This is wrong for women. It isn’t enough to exclude pregnant women on the grounds of safety when it may be unfounded. We need to address this issue much earlier on.

A bit of history for all of us is really important because once diseases are out of sight, they can be out of mind. In Europe, the 18th century was crippled by smallpox. Most of the population was exposed to the disease and around 30 percent of people died. Heartbreakingly, women were used to losing their children to diseases like measles, diphtheria and other common childhood diseases.

My mother once said to me: “When you were born, we wanted you to be healthy.” That sounds so simple, but when children are born nowadays, we want them to be Olympic runners and child prodigies. It's very hard for us to understand the extraordinary progress vaccines have made for the world. We’ve still got the visual imagery of polio, of kids in callipers and rows of polio patients locked in iron lungs. We do not see the crippling effects of these diseases as frequently today because of vaccines.

What keeps me up at night are the stories from my anaesthetist colleagues who are on the frontline of Covid-19, the people with severe complications from the virus, the people who can’t access health care services and the stories of children who are dying because healthcare services are falling apart.

I don't think any of us in New Zealand can really - heart and soul - imagine what it's like out there for many people in other countries at the moment. This disease is devastating but it could have been a lot worse for us in New Zealand.

In less than a year, the world has produced vaccines that are highly effective with an excellent safety profile. That’s extraordinary and a game changer.

Traditionally it takes many years to get a vaccine out to market and that has been getting faster over the last few years. The kickback of course, is some people say, “It’s way too fast, you must have cheated, or you must have skipped jumping through some hoops”. Well, actually we didn’t. We were able to develop vaccines so quickly because the Chinese released the genome of the disease, so the world understood it very early on, and then there was enormous international attention for very good reason.

Because there were so many Covid cases and people willing to participate in trials, the large clinical trials were able to be performed last year in months when it used to take significantly longer.

The world took a big risk and built large manufacturing plants even before they knew if the vaccines would work. They stood to lose a lot of money if the vaccines fell over. Fortunately, with good science and modern technology, the majority of the first vaccines coming off the block are looking highly effective, so the manufacturing plants were ready to go.

The final step that removed a lot of roadblocks was the licensure authorisation process, which reviewed the data as it was coming through rather than waiting months for a dossier to be put together and then reviewed. Those processes were all run in parallel, but they did not remove any of the important safety steps along the way.

I've been involved in vaccines and immunisation programmes for well over 20 years. It was absolutely incredible to look at both the safety and the effectiveness data of the vaccines New Zealand has pre-purchased, particularly the Pfizer BioNTech vaccine. It has worked amazingly well in its clinical trials and now also out there in widespread use with well over 100 million doses delivered. Now we are able to start protecting our population with confidence in the data. If you give the vaccine to 100 people, 90 to 95 percent of people - when they are later exposed to the virus - will not get sick.

Obviously, it's not a magic bullet and we can't get carried away. We don't yet know how effective it will be against spread. Can we ease up on our border protections? We just don't know yet. How long the protection will last is also unknown at this point.

Covid-19 is a smart little virus, it likes travelling and it will continue to travel. New Zealand cannot just build a large wall and exist away from the rest of the world. We will have to open up our borders because the virus is going to be with us long-term, but we will manage it. 

There is so much that is unjust about this pandemic and vaccine nationalism is rampant around the world. Countries with great healthcare systems are protecting their own and grabbing vaccines. It shouldn’t be those with the loudest voice who get serviced first.

Every well-resourced country should right now be saying from a moral point of view, they can share their vaccines because we know there will be good supplies. There’s also an economic argument. New Zealand needs to help the world really get on top of this pandemic as fast as possible and as a high-income country we have a lot to gain from global collaboration on vaccine access. So, take whatever argument you like, New Zealand should be thinking internationally, not nationally.

Vaccination programmes show how quickly equity gaps can spiral out of control. Last year with the arrival of Covid-19, particularly during lockdown, we saw a 5 percent drop-off in the timely delivery to infants in our routine childhood immunisations, particularly with tamariki Māori. New Zealand health services have put in a lot of effort since then, and most of that has been picked up.

New Zealand has good health services, but many countries overseas aren’t in the same position. They are seeing dramatic drop-offs in their infant immunisation programs and I can predict with my hand on my heart, and it’s breaking my heart, that we will see a lot of measles returning. We will see children dying from infectious diseases, because Covid-19 is disrupting services.

UNICEF and the World Health Organization work very closely together to support the systematic approach to effective communication and delivery of vaccines. I think a lot of people have taken UNICEF for granted – they’re a quiet hero. They’re doing an extraordinary job as part of the COVAX facility which will provide two billion vaccine doses to people in 190 countries this year.

Covid-19 is a disease for the whole community; children need this vaccine as well and we can’t lose sight of them. Although the vaccines are currently only available for 16 years and up, clinical trials including children are underway and we will see data in the next few months around the effectiveness and safety of the data.

Women play such a key role in supporting children to get vaccinated, but in many countries young girls still have lower immunisation coverage than boys and miss out on vital healthcare services. In 2021, we must continue to protect the rights of girls and women.

I'm proud to say as a medical scientist that women in New Zealand are well-supported and there is greater equality now than in 1911, the first International Women’s Day. Yet there is no excuse for leaving women out of clinical vaccine trials and denying them their right to be vaccinated.

We need women’s voices in strategy, planning and policy discussions. After all, the success of Covid-19 vaccines depends on a worldwide solution and women need to be at the heart of it.

This article is the result of a conversation between the University of Auckland's Nikki Turner and Shelley Knowles, Communications Manager UNICEF NZ. To find out more about UNICEF's work visit unicef.org.nz.