Biotech firm Moderna said Thursday that it had successfully recruited ethnic minorities, older people and those with underlying health issues for its Covid-19 vaccines trial, after it pushed to enrol groups most vulnerable to the virus.
Moderna said it had now signed up all 30,000 participants for the phase-3 trial, and more than 25,000 of them had already received a second dose of the vaccine, four weeks after the first.
The firm said it was working “to develop a vaccine for everyone, including communities that have historically been under-represented in clinical research and are disproportionately impacted by Covid-19.”
More than 7,000 people taking part in the trial are over 65, and more than 5,000 under 65 have high-risk diseases such as diabetes, severe obesity and cardiac disease.
The firm said more than 11,000 are “from communities of color, representing 37 percent of the study population and similar to the diversity of the US at large” — 6,000 are Hispanic or Latino, and more than 3,000 are African-American.
Massachusetts-based Moderna is one of the few companies to have launched a large-scale clinical trial less than 10 months after the genetic sequencing of the novel coronavirus was established.
Some Chinese, Russian and other Western projects are also in advanced tests, including US firm Pfizer.
Moderna hopes to have sufficient results by the end of November and to then file an emergency authorization request with the US Food and Drug Administration (FDA).
The company has already said it was aiming to file for authorization soon after November 25, with Pfizer at the third week of November.
The US government says it will distribute the first doses immediately after authorization free of charge.
Health Secretary Alex Azar said Wednesday there would be enough doses to vaccinate the “most vulnerable” Americans before the end of the year, then the elderly and health workers in January, and all Americans by early April.
In the trials, half of the volunteers receive a placebo, and the other half get the vaccine.
Initial FDA guidance stipulated that if the number of participants in the vaccinated group naturally contracting the virus and falling ill with Covid-19 was at least 50 percent lower than in the placebo group, the vaccine would be declared effective.
But on Thursday, a National Institutes of Health official said during a meeting of the FDA’s advisory committee on vaccines that they would require a 60 percent efficacy for emergency use.
It’s a thought-provoking prescription for reflection and learning, and you don’t have to be an artist or a clinician to enjoy it.
Every Monday, the project sends subscribers an email that includes a piece of art work and a short essay that delves into challenging themes that connect the art to medicine. The essays are reflective and wide-ranging, covering uncertainty, death, suffering, salvation and more. Each is accompanied by a list of sources so that readers can learn more.
One recent newsletter included a reflection on permanence and the participation of AIDS patients in their own care tied to “Strange Fruit,” an installation by artist Zoe Leonard that was exhibited at the Philadelphia Museum of Art in 1998. Another featured Henri Rousseau’s “Woman Walking in an Exotic Forest” and tied it to questions of colonialism and diversity in medicine.
In a reflection on Horace Pippin’s 1940 painting “Supper Time,” the team reflects on cultural bias. Pippin, a Black artist who used his work to reflect on racism and slavery, regularly had his work branded as “primitive” and “tribal” by art critics. The essay connects the art world’s disquieting reception to Pippin’s work to clinicians’ implicit biases and the use of terms like “noncompliant” or “unmotivated” to describe patients.
“We’re trying to weave an interesting multidisciplinary lens of clinical medicine and anthropology and social justice,” Lyndsay Hoy, assistant professor of clinical anesthesiology and critical care at Penn Medicine and the co-creator of the project, told the Daily Penn.
Sign up to receive the weekly email yourself — or just tool around the intriguing list of themes the consortium has already explored — at rxmuseum.org.