ALSO IN THIS ISSUE
FDA requires serial testing rules on antigen test labeling
Disease surveillance matters even without a pandemic
New and Noteworthy
The White House pandemic preparedness plan is here - with both promise and problems
Last week the White House released an update to its 2018 National Biodefense Strategy and Implementation Plan. The update has a bit of a pedigree: It is largely consistent with last March’s bipartisan PREVENT Pandemics Act (PPA), itself developed as a result of a June 2020 Senate white paper, Preparing for the Next Pandemic, that characterized the collapse of 20 years of preparedness in the face of COVID.
The original white paper set five clear priorities:
Tests, treatments, and vaccines
Disease surveillance
Stockpiles, distribution, and surge capacity
Increased state/local public health capabilities
Clear assignment of responsibility, aka “Who is on the flagpole?”
During the height of the pandemic, for priorities 1 and 2, the singular hero was diagnostic testing. Immediate global access to NGS (next generation sequencing) of the viral genome enabled tests for transmission monitoring and patient diagnosis, as well as global variant surveillance and the development of exceptionally effective vaccines, all in record time. In spite of slow decision-making, brute force spending achieved priority number 3.
But priorities 4 and 5 were our Achilles heels: Our lines of authority were never clear, and we had little basic project management. The problem was then compounded by public resistance (which was predictable, but not predicted).
Commentary: So what should we do? We know the answer on the scientific front: We need comprehensive genomic and variant monitoring of the eight WHO pandemic-potential diseases with known animal reservoirs (SARS, influenza, Lassa and Rift Valley fevers, Ebola/Marburg, Crimea/Congo hemorrhagic fever, Nipah and Zika virus), and we need ongoing surveillance for the emergence of novel zoonotic spillover diseases against which humans have weak or absent pre-existing immunity. The threat of this second group in particular is growing, as human development closes in on previously isolated animal reservoirs, and global climate change forces animals to migrate beyond traditional geographic ranges.
As we approach COVID’s third anniversary, it is absolutely essential we learn the lessons to be prepared for the next pandemic. Unfortunately, this is likely to turn out to be a lot harder than it should be. The US public health infrastructure is underfunded and highly fragmented across city, state, and federal agencies, with no consensus on who should do what. The WH plan defines 65 necessary actions assigned across 28 federal agencies (plus an uncounted number of state, local, tribal, and territorial entities). The CDC might be assumed to be the natural leader in these efforts, but no - that agency leads in just five areas. It shares leadership in eight more (with up to five other groups); it has a supporting role in 29 and no role at all in the remaining 23.
Had this 53-page plan been released before the COVID epidemic, it would have seemed laughably beyond reach: lab tests in 30 days; rapid tests in 90 days; vaccines in 100 days. And yet all of these objectives were achieved for COVID in 2020 (although approvals took longer).
While we’re pleased to see that the administration has written up an organized plan that would enable us to face the next pandemic in a proactive rather than reactive way, we can’t help but think that - at least in the current political climate - the whole endeavor is largely aspirational. Unless Congress provides the funds to put it into practice, there’s no way that this plan (or the PREVENT Act) can adequately prepare us for the next COVID. Ignorance is bliss until it isn’t.
FDA: Antigen tests must be used in series this way. Period.
Yesterday, the FDA issued a revision letter requiring the labeling of all antigen tests under EUA to indicate that the tests are to be used in series - and in specific ways. If the test has EUA for use in symptomatic folks, labeling must specify that the tests are to be used “at least twice over three days, with at least 48 hours between tests.” Tests with EUA for use in asymptomatic people now must indicate that they’re to be used “at least three times over five days, with at least 48 hours between tests.”
The FDA made these recommendations to the general public back in August - now they’ve decided to put them in writing. Along with this update, the agency has also rescinded the requirement that antigen test manufacturers send them data related to serial testing. Clearly, for the currently available tests, they consider the matter closed.
Food for Thought
Disease surveillance: It’s not just for pandemics
For those of us who didn’t live and breathe diagnostic testing before the pandemic, the last two years have been a crash course in disease surveillance. We’ve learned how it works, what it requires, who does it relatively well in a crisis (UK, Israel, South Korea), and who does it poorly (US).
This fall is teaching us another lesson: There’s no reason that disease surveillance should be used only in a ginormous crisis like a global pandemic. If we can use it then, why can’t we use it to monitor the behavior of diseases like RSV and flu, which are currently wreaking havoc among American kids?
As we know, the same mitigation measures that work against COVID (air cleaning, masking) will work against those viruses, too. If we knew that respiratory viruses were on the rise in our area, that could trigger an increase in mitigation by our schools (and other congregate settings).
Commentary: There’s a lot of talk in the K-12 sphere about decreasing absenteeism as much as possible - if we’re serious about this goal, disease monitoring and mitigation are tools we should be using. It isn’t just COVID that keeps kids sick in bed instead of in school.
So what stands in our way? Only the usual: Lack of funding, lack of requirements, lack of coordination, lack of will. Our hope - as always - is that instead of trying so hard to get “back to normal,” this country will realize that a better normal is possible - and that it lies ahead of us, not behind us.
Quick Hits
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