Lack of Diversity Threatens to Undermine COVID-19 Vaccine Trials

Experts are warning that the current two leading contenders for an effective coronavirus vaccine might have their efforts undermined by the fact that there is a lack of diversity among the trial participants.

The US biotechnology company Moderna, reported promising results from their first phase of vaccine trials. Also last month, the University of Oxford from UK also reported that its coronavirus vaccine under development elicited a “strong immune response” in people involved in an initial trial.

These two vaccine candidates right now are leading the race between more than 140 vaccines in development for coronavirus. However, the problem right now is the overwhelming whiteness of their subjects.

The Oxford trial in which there were more than 1,000 healthy adult subjects, 91% were white, and only 5% were Asian and less than 1% were black. On the other hand, in the Moderna trial  where there were 45 adult participants, 40 of them were white and just two were black.

Now that both trials are moving to next phases, where there would be nearly 30,000 volunteers in each trial, it is important that more people of color are included as these populations are disproportionately hospitalized and killed by the virus.  It is important to note that Oxford University will be holding a phase three trial in India while Moderna will be conducting the trial in US.

According to Oluwadamilola Fayanju, a surgeon and researcher at Duke University it is disappointing as “they are countries where there are known huge disparities along racial lines”.

“Diversity is important to ensure pockets of people don’t have adverse side-effects. People of color disproportionately have co-morbidities such as hypertension and diabetes and you need to know how these things interact with any vaccine”, she added.

Previous research has concluded that people from different ethnicities react differently to medications, drugs, and vaccines.

Despite widespread efforts by the governments, the drug and vaccine trials end up being white dominated.

African Americans make up only 5% of clinical trials, whereas they have a less than half overall population share in the US. Hispanics on the other hand make up around 18% of the American population but just 1% of trial participants.

Source: Trailfacts

It is “essential” that vaccine trials involve appropriate numbers of black and Latino people to help curb a disease that has surged through minority communities, according to Marjorie Speers, executive director of Clinical Research Pathways, a charity that promotes ethical research.

Fauci ‘Satisfied’ with Enrollment in Moderna Covid-19 Vaccine Trial

Dr. Anthony Fauci, United States’ leading infectious disease expert said that he is satisfied with the enrollment in the first week of the first US Phase 3 clinical trial of the Moderna Covid-19 vaccine.

Moderna on July 31 announced through an email that the company randomly assigned 1,290 subjects to get either the vaccine or a dummy shot as of that date. The phase 3 trial began on Monday, July 27. The company plans to enroll 30,000 people at its 89 sites.

“We hope within a period of a few months, a couple of months, that we’ll be able to enroll hopefully by the end of the summer so that we can start getting some results,” said Fauci, the director of the National Institute of Allergy and Infectious Diseases.

He also announced that the results might start coming in as early as October or December. Right now, the pace of enrolment is too slow and if this pace was to continue the study won’t be able to recruit enough subjects till late fall or early winter.

However, Fauci said that he was confident that the enrollment will pick up pace as the study will continue. He explained that right now very few sites were up and working and enrollment will surge when more sites open up.

More than 310,000 people have registered with the COVID-19 Prevention Network to take part in clinical trials for a vaccine or monoclonal antibody treatment for coronavirus. The group is aiming to register “millions” of people, according to Dr. Jim Kublin, executive director of operations for the network.

President Trump in a tweet said that he was optimistic that a vaccine would be ready around election day on November 3.

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