Leaders of the Moderna vaccine trial acknowledged one of the most important aspects of the effort will be to enroll diverse participants, including African Americans, Latinos and native Americans, as well as the elderly and disabled, all populations which disproportionately suffer from Covid-19.
However, finding diverse participants will be challenging. African American, Latino and Native American people may be less likely to enroll in the trial, because of mistrust of government science based on a history of abuse. The elderly and disabled may be less likely to enroll because of fear of the virus.
“We really are going to depend on that sense of volunteerism,” said NIH director Dr Francis Collins. “We’re going to be tracking this every week to see what the distribution [of diversity] looks like in the trial to make sure we’re achieving that kind of diversity.”
Dr Anthony Fauci said results of the trial were most likely going to begin being released in November, but would not rule out the possibility of an “October surprise”. Such a surprise would be proof of a safe and effective vaccine in the midst of the most highly anticipated presidential election in generations.
At 6:45am in Savannah, Georgia, the first American participant in a large experimental Covid-19 vaccine trial received a shot in the arm, the National Institutes of Health announced.
Researchers at Moderna, Inc. and the US National Institute of Allergy and Infectious Diseases (a branch of the NIH) hope to enroll 30,000 people for the final phase of safety and efficacy testing for the vaccine, including 15,000 people by the end of this week.
The trial will take place across 89 sites across America, with the potential for sites in South Africa and Brazil. The activated American sites will be focused in places with current Covid-19 outbreaks.
NIAID director Dr Anthony Fauci described the initiation of the Phase 3 trial as historic, and one of the fastest vaccine developments ever.
“We’re beginning a Phase 3 trial that is very quick – it certainly is the world’s record – when one thinks from the time of the sequence to a Phase 3 trial,” Fauci said.
He added: “There is no compromise at all in safety or scientific integrity.”
Downtown Portland saw fresh clashes early on Monday morning, between anti-racism protesters and federal officers using teargas, flash-bangs and crowd control munitions.
For a 60th night in succession, protesters gathered to mark the killing of George Floyd by demanding action against police brutality. A peaceful demonstration of about 1,000 people began on Sunday evening, the crowd chanting “Black Lives Matter”, at a steel fence erected around the federal courthouse after two earlier barriers were torn down.
The US agents, drawn mainly from border patrol, were dispatched to Portland by Donald Trump ostensibly to protect the courthouse. Far from quelling unrest, Trump’s actions have also lit a fuse under demonstrations in other cities. Protesters reconvened in Seattle on Sunday night in support of fellow demonstrators in Portland.
The Seattle gathering remained peaceful. The previous night, protesters had clashed with local police officers, with rocks and bottles thrown according to the authorities.
The clashes in Portland broke out shortly after midnight, according to the Oregonian newspaper. The federal forces turned out lights illuminating the courthouse and over loudspeakers ordered protesters to disperse on the grounds that they were holding an unlawful assembly.
Confrontations erupted after the US agents began to clear the area. According to the Associated Press, the officers deployed several rounds of what appeared to be teargas, flash-bangs and pepper balls. Protesters responded by igniting fireworks and beaming lights on to the courthouse, with some scaling the fence.
Fauci says vaccine is possible by October but more likely by November
Director of the National Institute of Allergy and Infectious Diseases, Dr Anthony Fauci, refused to rule out the possibility of “October surprise” news of an effective vaccine in a call with the media.
Such news could come in the midst of the most highly anticipated election season in generations. The NIH started a large Phase 3 trial for a Covid-19 vaccine today.
Fauci said an October approval “is certainly conceivable, if we have a real blast of a rash of infection in those sites in which we do have active enrollment, that you might get an answer earlier than November. I doubt that, but we’re leaving an open mind that that might be possible.”
He added: “Likely November, but it is possible it could be earlier.”
Updated
at 10.56am EDT