Feds unveil COVID vaccine distribution plans amid HHS shakeup

COVID vaccine vials
COVID vaccine vials

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Among a flurry of new COVID-19 developments coming out of Washington, DC, today, the Trump Administration released new details about vaccine distribution, as federal officials testified before Congress, and the Department of Health and Human Services (HHS) announced that two of its embattled communications officers will be sidelined.

Meanwhile, the US Centers for Disease Control and Prevention (CDC) revealed more about the risk of severe disease in pregnant women and detailed a new tool to help schools make COVID-19 decisions.

Fast-moving developments in Washington

HHS and the Department of Defense (DoD) today released a pair of documents that outline administration steps to deliver vaccine, which the two groups developed with the CDC. In a statement, HHS said it provides an overview of the strategy and an interim playbook for state, tribal, territorial, and local public health departments.

HHS Secretary Alex Azar said as part of Operation Warp Speed, a massive effort to speed vaccine development, federal officials have been laying the groundwork for vaccine delivery. The agency said in August it signed a contract with McKesson, which also distributed vaccine during 2009 H1N1 flu pandemic.

In today's statement, CDC Director Robert Redfield, MD, said the CDC's Advisory Committee on Immunization Practices will play a vital role in deciding how initial limited doses will be allocated, looking at a goal of having more than 100 million doses by January. As part of a three-phase plan, the first doses would go to healthcare workers in high-risk settings, then to other essential workers and those at higher risk of severe disease, such as people age 65 and older.

HHS added that McKesson will use the CDC's guidance, with logistical support from the DOD, to ship products to vaccine administration sites.

In another development, the CDC's Redfield and two HHS officials today testified about COVID-19 response efforts at a Senate appropriations subcommittee hearing. Redfield told legislators that COVID vaccine probably won't be widely available until the spring or summer of 2021, NPR reported. He also said wearing a mask is still the most powerful tool against the virus that the nation has, and he raised eyebrows when he suggested that wearing a face mask might offer more protection than a vaccine.

President Donald Trump has hinted that a COVID-19 vaccine might be deployed ahead of the November election.

Redfield also rejected recent accusations yesterday by HHS spokesperson Michael Caputo that the CDC has a "resistance unit" that works against the Trump Administration, and he denied media reports late last week that said the agency's Morbidity and Mortality Weekly Report (MMWR) had been altered to align with President Trump's talking points, under pressure from Caputo.

Brett Giroir, MD, assistant secretary for health at HHS, told the committee that cases, hospitalizations, and deaths in the United States have declined since post-Memorial Day peaks, but it warned that progress could lose traction if people stop wearing masks and avoiding crowds.

The United States yesterday reported 39,617 new cases and 1,293 more deaths, raising its totals to 6,620,186 cases and 196,465 deaths, according to the Johns Hopkins online dashboard.

And in a breaking development that came on the heels of today's hearing, HHS today announced that Caputo will be on medical leave for the next 60 days and that Paul Alexander, an aide to Caputo who was reportedly part of efforts to control CDC's COVID-19 messaging, including that involving MMWR publications, will permanently leave the agency, the Washington Post reported.

Outcomes in hospitalized pregnant women

In June, the CDC warned that pregnant women with COVID-19 are at increased risk for critical care, and today it detailed clinical patterns and outcomes researchers saw in 598 pregnant women from 13 states who were hospitalized with the virus.

The authors, members of the CDC's COVID-NET Surveillance, described their findings today in an early online edition of MMWR.

Of those hospitalized, 55% were asymptomatic when they were admitted and 45% had symptoms. Of those who had symptoms, 16.2% were admitted to an intensive care unit (ICU), 8.5% needed mechanical ventilation, and 2 of 272 died. None of the serious outcomes involved asymptomatic pregnant women.

Preterm births occurred three times more often in symptomatic women, and the team found that 2.2% of moms lost their babies, occurring in both symptomatic and asymptomatic mothers.

The authors also note that the proportions of women hospitalized with COVID-19 were higher in Hispanic and black women when compared with the population in the surveillance areas.

In a separate MMWR study today, CDC researchers and their health system partners detailed the clinical course of 105 pregnant women with COVID-19 who were identified as part of Vaccine Safety Datalink surveillance of COVID-19 hospitalizations. They found that the incidence of pre-pregnancy obesity and gestational diabetes was higher in women who were hospitalized for their COVID-19 illness compared with those who were admitted for pregnancy-related reasons.

Of women admitted for COVID-19 reasons, 13 of 43 (30%) were admitted to the ICU, and 1 died. The authors said pregnancy counseling should cover preventive measures, especially for those who were obese before they got pregnant or who had gestational diabetes.

CDC unveils new tool for schools

Among several other developments, the CDC yesterday unveiled indicators to help schools make decisions about in-person learning amid changing local pandemic conditions.

The color-coded chart includes core and secondary indicators to help gauge the risk of COVID-19 spreading into and within schools, weaving in local metrics. In a press release, the CDC said, "The measures do not set strict cutoffs for individual schools and school systems; they should be used as guideposts for monitoring local conditions and adjusting teaching models as needed."

In other US COVID-19 developments:

  • A new analysis based on data on 50 million people from Epic Health Research and the Kaiser Family Foundation reveals that when compared to white patients, black, Hispanic, and Asian patients all had higher rates of COVID-19 infection, hospitalization, and death.

  • Eli Lilly announced today that its antibody treatment for COVID-19, called LYCoV555, cut the hospitalization rate by 72% compared to placebo. The company described the phase 2 trial findings, which haven't been peer reviewed, in a press release.

  • A survey from Kaiser Health News revealed that more than 20 states don't release or have incomplete data from rapid antigen testing, a factor that makes them less useful to state health officials. The tests are quicker than polymerase chain reaction tests but less accurate.

  • In a reversal, the Big 10 today announced that the college football season can resume the weekend of Oct 23 with strict medical protocols in place, which include daily antigen testing and enhanced cardiac screening. Each team must have a chief infection officer to collect data and make decisions about continuing practice and competition.

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