Moderna’s coronavirus vaccine trial is fully enrolled, with people of color making up more than one-third of the 30,000 participants, the drugmaker announced Thursday, as government scientists said they must build trust with communities of color and other Americans who will be expected to roll up their sleeves in the coming months.
The Cambridge, Massachusetts, biotechnology company said about one-fifth of its phase 3 enrollment is Hispanic and 10% is Black, filling gaps after concerns the trial wasn’t attracting enough people of color.
It is important to ensure that any COVID-19 vaccine works well in a variety of populations. People of color have been hit particularly hard by COVID-19, likely because of underlying health inequities or their inordinate representation in higher-risk jobs that leave them exposed to the virus.
Roughly one-quarter of participants in the Moderna trial are over age 65, a group that is especially vulnerable to the disease, the company said.
The completion of enrollment does not mean Moderna is just getting started. More than 25,000 participants have received the second dose of the investigational vaccine.
Moderna is one of four drugmakers steeped in phase 3 trials of a COVID-19 vaccine that could help the U.S. bring the coronavirus to manageable levels. Federal officials on Thursday said maintaining trust in the vaccine-approval process will be vital to their success.
“You can have a fantastic vaccine and if no one takes it, it’s not going to do much to end this pandemic. And there is a good deal of work to be done in this area. We know a good portion of the U.S. public is skeptical of these vaccines and not jumping to take them once approved, at least at present,” Hilary D. Marston, medical officer and policy adviser for pandemic preparedness at the National Institutes of Health.
A Kaiser Family Foundation poll this month showed half of Black Americans say they would shun a COVID-19 vaccine, even if scientists deem it safe and it is available for free to anyone who wants it. By contrast, two-thirds of Whites and 60% of Hispanic adults said they would definitely or probably get vaccinated.
Dr. Marston said the government is making sure trials are carried out safely and is working with community leaders in minority communities. Officials are pushing drugmakers to be as transparent as possible and disclose their trial protocols or enrollment data, as Moderna did on Thursday.
Dr. Marston spoke during an advisory committee discussion hosted by the Food and Drug Administration. The session sought to put a scientific stamp on an approval process that has been tainted by politics in the run-up to Election Day.
Marion F. Gruber, director of the FDA’s Office of Vaccines Research and Review, said to earn emergency approval, a vaccine must have potential benefits that outweigh risks. Recipients must be told the shots are investigational and they have the right to refuse it.
She also said the approval process can be expedited but “cannot and must not be rushed.”
President Trump hasn’t been shy about seeking an approved vaccine by Election Day. He has grumbled at times about the FDA’s timelines.
FDA Commissioner Stephen Hahn recently demanded extra safety data from drugmakers in late-stage clinical trials, a move that made it all but impossible for drugmakers to seek approval by Nov. 3.
The president did see progress Thursday on therapeutics for the viral disease. Remdesivir became the first and only FDA-approved treatment for COVID-19.
The drug from Gilead Sciences had been shown to improve recovery times and has been widely available in hospitals for months under emergency-use provisions.
“It is incredible to be in the position today, less than one year since the earliest case reports of the disease now known as COVID-19, of having an FDA-approved treatment in the U.S. that is available for all appropriate patients in need,” said Gilead Chairman and CEO Daniel O’Day.
On the vaccine side, the academics and scientists who convened on Thursday didn’t try to judge each company’s candidate — no drugmaker has sought approval. Rather, the discussion focused on the government plan to vet safety and efficacy data and distribute the vaccines.
Federal officials on Thursday did point to six front-runners, however. Besides the Moderna candidate, there is a fellow messenger RNA vaccine from Pfizer/BioNTech. Also, there are adenovirus-vector versions from Johnson & Johnson and AstraZeneca and recombinant-protein technologies from Sanofi/GSK and Novavax.
Government officials said there may be a situation in which people hold out for what they consider to be a better product in the pipeline, such as a one-dose vaccine instead of a two-dose one. They say people shouldn’t delay.
“We’re working hard within our own strategy to help people understand that vaccination is one of the key tools that we have to start to get our lives back on track — and the things we like to do,” said Janell Routh, a medical officer at the Centers for Disease Control and Prevention. “I do think we’re going to lean forward into the promotion of vaccines that are available.”
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