Moderna clinical trials will slow down its schedule to ensure participation of minorities, the elderly, and those with underlying conditions.
Moderna clinical trials are structured to register 30,000 individuals in the US to prove the safety and efficacy of its candidate coronavirus vaccine. As of Aug. 28, the drug manufacturer had enlisted 17,458, 24% of whom are from communities of color. The company presents updates on enrollment numbers every Friday afternoon.
Moderna shares were down more than 8% after the announcement, and had bounced back by early afternoon. The stock has increased by 211% since the start of the year.
Moderna clinical trials are prioritizing the enrollment of the elderly, communities of color and people with underlying health conditions since they are at greater risk from Covid-19. Meanwhile, public health experts place importance on the inclusion of diverse groups to make sure the vaccines are effective in every population and for establishing trust among all communities to take the vaccine if and when it becomes available.
“The Black community has been disproportionately impacted by the pandemic, and that’s not biological but rather due to socioeconomic inequities resulting from racism,” said Angela Rasmussen, a virologist at Columbia’s Mailman School of Public Health.
“It is particularly important to make sure that Black and Latinx participants are represented equitably in the trials and the vaccine shows protective efficacy in different populations of people," she added.
Moderna’s data revealed that two-thirds of those registered in the study are White, 20% are Hispanic or Latino and 7% are Black.
“We believe we could have one of the best vaccines,” Moderna CEO Stephane Bancel told CNBC. “We want to ensure we have data for all the people who could benefit and be protected.”
Moreover, Bancel explained that the company’s goal is for enrollment to reflect US Census Bureau numbers. In 2019, the Census Bureau revealed that 18.5% of people in the U.S. are Hispanic or Latino, and 13.4% are Black or African-American alone.
Quality trial
Bancel did not give any projection for when the study may be completely enrolled or produce data. When the trial started, he had told CNBC that there could be new data as early as October in “a really optimistic scenario; maybe November.”
He mentioned “a small delay to have a better quality trial is the right decision in the long run,” saying the company has told several clinical trial sites “they need to do better” in reaching minorities.
“I would rather we have higher diverse participants and take one extra week,” Bancel said. Diversity “matters more to us than speed.”
Moderna worked with White House health advisor Dr. Anthony Fauci’s NIAID early on in the pandemic to come up with its vaccine candidate, and has been granted almost $1 billion in government funding for development, on top of a purchase order for $1.53 billion for 100 million doses.
Moderna began its trial on July 27, the same day as pharmaceutical giant Pfizer.
Pfizer late-stage testing may produce results as early as October, according to the announcement of CEO Albert Bourla on Thursday.
There are already 23,000 volunteers for the Pfizer late-stage testing that started in late July, Bourla said during an interview with the International Federation of Pharmaceutical Manufacturers & Associations, a trade group. The CEO of the pharmaceutical company said they plan to enroll at least 30,000 participants.
