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The race to develop a vaccine -

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.

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Excluded groups -

As is the case with many clinical trials, populations of immunocompromised people, including those living with HIV, were excluded from the list.

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HIV -

HIV, which attacks the body’s immune system and can develop into AIDS if left untreated, affects nearly 38 million people worldwide.

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Doctors' suspicions -

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.

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Lack of evidence -

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.

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Standard practice -

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.

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Safety concerns -

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.

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Safety concerns -

Giving the drug to people whose immune system is already compromised could put them at greater risk than someone who is otherwise healthy.

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Other excluded groups -

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).

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When new technology is involved -

In cases where the development of a vaccine involves new technology, concerns about potential adverse effects are amplified.

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New mRNA technology -

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.

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Other reasons for exclusion -

However, pharmaceutical companies may also choose to exclude immunocompromised people from their clinical trials to maintain the image of their vaccine’s efficacy.

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Speculation -

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.

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Question of ethics -

When considered purely from a bottom-line perspective, this reason for not testing the vaccine on immunosuppressed people seems far less than ethical.

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Consequences -

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.

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COVID-19 in the HIV-positive population -

This may have contributed to the way in which COVID-19 disproportionately affects the HIV-positive population.

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Statistics -

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.

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Preventing the emergence of new variants -

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.

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More opportunity to mutate -

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.

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Prolonged infection -

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."

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Early concerns -

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.

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Protests -

As a result, several groups of protestors came out to demand that HIV-positive people be included in the clinical trials.

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Moderna 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.

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Line of argument -

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.

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Result -

The protests were effective. Ultimately, Moderna did start to include people with well-controlled HIV in their trials. Pfizer quickly followed suit.

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Limited impact -

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.

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Calls for further research -

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.

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The Ubuntu study -

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)

See also: The gender health gap—times medicine failed women

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