Mixed messages hamstring US COVID-19 response

US officials continued to send mixed messages about the arrival of a COVID-19 vaccine and the benefits of masks, as vaccine developer Moderna today released a document that spells out how it's conducting phase 3 trials.

In other developments, US cases remained at steady but high levels, with 36,782 cases reported yesterday, according to the Johns Hopkins online tracker.

Patterns vary in different parts of the country, but a handful of states—Arkansas, Montana, North Dakota, West Virginia, Wisconsin, and Wyoming—set new records for weekly cases, according to a USA Today analysis. Others reported record death numbers, including Kansas, North Dakota, South Dakota, and Wyoming.

Trump, Redfield clash on vaccine, mask assessments

Yesterday at a Senate hearing, Centers for Disease Control and Prevention (CDC) Director Robert Redfield, MD, said a COVID-19 vaccine won't likely be widely available to the general public until the spring or summer of 2021 and that wearing a mask is the most powerful tool the nation has to curb the spread of the virus, perhaps even more powerful than a vaccine.

But just hours later at a media briefing, President Trump contradicted Redfield's assessment of the vaccine delivery timeline, saying that distribution could come as early as October of November, with as many as 100 million doses by the end of the year. When questioned by reporters, Trump said Redfield had incorrect information.

Also, Trump pushed back on Redfield's comments about the usefulness of masks. Afterward on Twitter, Redfield didn't pull back his statement but said COVID-19 vaccines are the key to people getting their lives back and that masks, hygiene, and distancing measures are the current best defense against the virus.

In another development related to masks, the Washington Post today reported that, based on e-mails, legal documents, and other items it obtained, the federal government scrapped a plan in April for the US Postal Service to distribute 650 million reusable face coverings, enough for 5 for every household. Unnamed administration officials said the White House abandoned the plan because it didn't want to cause concern or panic and instead sent the masks to critical infrastructure sectors, which included companies, health facilities, and faith-based organizations.

Many health experts have said masks are useful when combined with other measures, including hand hygiene, physical distancing, and efforts to detect and isolate those who are infected.

In other government developments:

  • Federal Reserve Chairman Jerome Powell yesterday pressed Congress and President Trump to make progress on a coronavirus relief package, warning that the lack of fiscal support could damage the US economy.

  • The number of Americans who applied for unemployment benefits dropped last week to 860,000.

  • The Department of Defense on Sep 14 announced on behalf of the Department of Health and Human Services that it has signed contracts with nine companies to restock the Strategic National Stockpile with 73 million disposable isolation gowns at a cost of $335 million, with delivery by January 2021.

Moderna spells out phase 3 trial protocols

Amid questions about how companies are conducting their late-stage clinical trials of COVID-19 vaccines, Moderna—one of the White House's Operation Warp Speed candidates—today released a 135-page explainer detailing how it is conducting its phase 3 trial. For example, it said the first analysis of data from the trial might not take place until late December. But in a media interview, the company's chief executive office said it should have enough data to know if the vaccine works by November.

Some experts on Twitter today praised Moderna's move. For example Eric Topol, MD, founder and director of the Scripps Research Translational Institute, said the Moderna document provided key information on stopping rules, interim analysis, and efficacy assumptions. "Every vaccine manufacturer in Phase 3 trials should follow suit. That's the transparency we need," Topol said.

Pfizer today released similar information on its phase 3 study protocols for its COVID-19 vaccine.

In other developments:

  • US producers are ramping up production of antigen tests for COVID-19, with a goal of producing 100 million per month by the end of the year, Reuters reported. Combining the production of earlier approved tests with those likely to be cleared in October would boost US testing capacity to 200 million per month by the year's end.

  • Visits to US offices remains down by 50% from February, according to data from a company that provides access-control systems, the Wall Street Journal noted.

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