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Whenever a new drug goes into the first stages of clinical trial, there are certain groups of people that are excluded from the list of trial participants. Women and children are almost always on the list, as are people who are immunocompromised. Indeed, there are valid arguments for excluding vulnerable groups in the early stages of clinical trials. Many of those reasons have to do with concerns for participants' safety. That does not mean these groups of people can be simply forgotten, however, as was the case for the immunocompromised seeking a COVID-19 vaccine.
What happened? Check out this gallery to find out more.
Back in 2020, when pharmaceutical companies were in a race to develop a COVID-19 vaccine, they had to make a choice about who to include in clinical trials.
As is the case with many clinical trials, populations of immunocompromised people, including those living with HIV, were excluded from the list.
HIV, which attacks the body’s immune system and can develop into AIDS if left untreated, affects nearly 38 million people worldwide.
For a long time, experts have suspected that COVID-19 vaccines may not provide the same level of protection for HIV-positive people as they do for the general population.
And yet, there is a lack of reliable evidence on the topic, because HIV-positive people were almost completely excluded from the early phases of the clinical trials.
It is not uncommon for immunocompromised participants to be excluded from the initial rounds of vaccine trials. In many cases, they are excluded for safety reasons.
Indeed, while a drug is still in its early testing stages and scientists remain uncertain about its effect on humans, the chance that it may produce a harmful outcome is higher.
Giving the drug to people whose immune system is already compromised could put them at greater risk than someone who is otherwise healthy.
This is also part of the reason why pregnant women and children are usually excluded from the early rounds of clinical trials (other reasons include the risk of birth defects and the challenge of acquiring consent).
In cases where the development of a vaccine involves new technology, concerns about potential adverse effects are amplified.
This was the case for COVID-19 vaccines, some of which used mRNA technology that had never been used before in a licensed commercial product.
However, pharmaceutical companies may also choose to exclude immunocompromised people from their clinical trials to maintain the image of their vaccine’s efficacy.
Experts in the field have speculated that during the period where companies like Pfizer and Moderna were in competition to produce the most effective vaccine, they may have excluded certain groups from the trials to produce clean results.
When considered purely from a bottom-line perspective, this reason for not testing the vaccine on immunosuppressed people seems far less than ethical.
The main consequence of the pharmaceutical companies’ decision not to test their COVID-19 vaccines on HIV-positive people is that, still, we know very little about how the vaccine affects them.
This may have contributed to the way in which COVID-19 disproportionately affects the HIV-positive population.
Indeed, according to the BBC, people living with HIV are up to 70% more likely than the general population to be hospitalized from the disease.
On the other hand, the exclusion of HIV-positive participants from the trials may have made it more difficult to prevent the emergence of new variants.
For a person living with HIV, their immune system does not work properly, meaning that it cannot clear a virus such as COVID-19, and the virus is encouraged to mutate.
This process of so-called "prolonged infection" is what gives a virus the chance to mutate or reinvent itself and possibly transform into a "variant of concern."
The benefits of research that looks at how COVID-19 vaccines interact with the immune systems of HIV-positive people have been publicized since early in the pandemic.
As a result, several groups of protestors came out to demand that HIV-positive people be included in the clinical trials.
In July 2020, for example, several HIV activist groups and research organizations in the US protested the exclusion of HIV-positive participants from stages II and III of the Moderna vaccine trials.
They argued that if HIV-positive people are receiving treatment with antiretroviral therapy (ART) and their immune system functions in a comparatively normal way, they shouldn’t be excluded from the trials.
The protests were effective. Ultimately, Moderna did start to include people with well-controlled HIV in their trials. Pfizer quickly followed suit.
However, the number of HIV-positive participants included in the trials was so small that it was impossible to draw any meaningful conclusions from the results.
More recently, there have been calls for a dedicated, large-scale clinical trial that would look at exactly how HIV interacts with various COVID-19 vaccines.
One such study, which is currently under way, is the Ubuntu study. Sponsored by the US government, the aim of the study is to understand how the Moderna vaccine affects a group of 14,000 people across eight African nations, 90% of whom are living with HIV.
Sources: (BBC) (PRIM&R)
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Whenever a new drug goes into the first stages of clinical trial, there are certain groups of people that are excluded from the list of trial participants. Women and children are almost always on the list, as are people who are immunocompromised. Indeed, there are valid arguments for excluding vulnerable groups in the early stages of clinical trials. Many of those reasons have to do with concerns for participants' safety. That does not mean these groups of people can be simply forgotten, however, as was the case for the immunocompromised seeking a COVID-19 vaccine.
What happened? Check out this gallery to find out more.