POLICY BRIEFING – WEEK IN REVIEW
Shifting sands of vaccine allocation and testing. Increased production and redistributions mean the vaccine may be coming to a pharmacy near you
The past few weeks have seen seismic changes in the approach to ending the covid-19 pandemic in the United States. President Biden announced a federal vaccination plan and an expansion of eligible individuals, as well as a proposed stimulus package to support a more robust response. Meanwhile, there was the unfortunate discovery that the federal reserve of vaccine doses had been depleted for weeks.
To bolster the new approach, one million doses of the currently-authorized vaccines will be distributed directly to pharmacies around the country next week, and state allocations will be increased by five hundred thousand doses per week until the goal of 10.5 million inoculations has been reached. Additionally, states have begun redistributing unused vaccines in a federal partnership between Walgreens, CVS and the US Centers for Disease Control and Prevention. The focus will be to vaccinate long-term care facility residents and staff. The exact number of doses needed to achieve this is unknown, as the choices and logistics around the change in the rollout will fall to officials in each state.
In the world of testing, the Biden administration also announced the expanded production of an over-the-counter rapid home test that automatically reports results back to a central system, which should improve the accuracy of tracing.
While this is a step forward, testing options for providers have moved backwards. Insurance reimbursement across the country for in-office testing is often less than the price of the supplies, which has led many facilities to resort to using "send-out" tests (i.e. using external laboratories such as Quest Diagnostics, and others). Ultimately, this results in a delay in results for days, which severely limits the public health benefits of testing in the first place. Various. 5 February 2021.
National mask requirement for public transit goes into effect tonight. CDC's previous guidance now a mandate
The US Centers for Disease Control and Prevention (CDC) has published a notice and order that activates a new mask requirement for domestic travelers. The action is set to take effect tonight, February 1st 2021, at 11:59pm.
The policy sets a minimum standard that all individuals using transportation–defined as any "conveyance" (ie. vehicle) directly operated by United States local, state, territorial, or tribal government authorities. Masks will also be required wear for any persons inside of transportation hubs defined as "any airport, bus terminal, marina, seaport or other port, subway station, terminal, ..., train station, U.S. port of entry, or any other location that provides transportation and is subject to the jurisdiction of the United States." People must wear a mask over their nose and mouth for the duration of travel or occupancy of a hub. States, localities, or tribal territories are exempt from the stipulations of the order, but only in cases where those jurisdictions have requirements that are at least as stringent.
The order empowers operators of the covered conveyances and hubs to require compliance to the policies, including only boarding those properly wearing a mask, instructing those that fail to comply that they are violating Federal law, monitoring those using the transportation services for compliance, disembarking any who refuse to comply, and providing adequate notice of this requirement. This new action is, in essence, a stricter version of a softer stance previously announced by the CDC in October, as we covered here in Brief19. At that time, the Trump administration effectively blocked the CDC's attempt to enact a mask mandate as extensive as this. Instead, guidance that had similar language as the forthcoming policy was published but was worded in ways that fell short of anything that could be construed as a true mandate outside of a few particular settings.
Additionally, the order makes exemptions for the following situations, as in the previous guidance: while eating, drinking, or taking medication; while communicating with someone who is hearing impaired where seeing the mouth is essential; while wearing an oxygen mask on an aircraft; if unconscious or otherwise incapacitated; when necessary to remove a mask during ascertainment of identity. Further exemptions include: children under age 2; a person with disability who cannot wear a mask as defined by the Americans with Disabilities Act; a person in whom wearing a mask would create a risk to workplace safety as defined by safety regulations or Federal guidelines.
These changes do not apply to personal, non-commercial transportation use, commercial motor vehicles in which the driver is the sole occupant, and those chartered or operated by the military that are otherwise in accordance with Department of Defense safety guidelines. While there are Federal penalties ascribed to the requirement, the CDC currently intends to rely on the honor system for compliance. The Centers for Disease Control and Prevention. 1 February 2021.
The White House has announced a new partnership with Ellume, an Australian maker of a home nasal-swab based coronavirus screening test, to expand distribution in the United States. The product was the first over-the-counter rapid home test to receive an Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA). Though approved in December, production restrictions limited the impact of the decision. Under this new deal, the US government would purchase 8.5 million tests and support the construction of a facility here in the US capable of producing nineteen million tests per month. This figure comes with the caveat that until building is complete, currently scheduled for July, only one hundred thousand kits will be available each month.
It is unclear how the initial batch of tests will be distributed. That said, the contract was awarded through the Department of Defense, and the press release announcing it stated that the tests will be used "in accordance with the National Strategy for the COVID-19 Response and Pandemic Preparedness policy established January 21, 2021."
A unique benefit of the Ellume test is that, while results are available in fifteen minutes, test users must download an app to view the findings. A copy of those results is automatically uploaded to a cloud-based database grouped by ZIP code, which stands to vastly improve reporting accuracy. On the other hand, the requirement of an app may be a barrier for some individual users, meaning that health literacy may yet again separate the haves from the have-nots. Various. 3 February 2021.