Michael Mina, a “MD, PhD, Assistant Professor of Epidemiology and Immunology, Harvard T.H. Chan School of Public Health, Center for Communicable Disease Dynamics and Associate Medical Director of Microbiology, Brigham and Women’s Hospital, Harvard Medical School” has a piece out in Time magazine outlining how we can stop the coronavirus pandemic by Christmas without a lockdown or having to wait for vaccines.
In summary, we need at-home rapid antigen tests that are currently being held up by the FDA bureaucracy. From Time:
The antigen test technology exists and some companies overseas have already produced exactly what would work for this program. However, in the U.S., the FDA hasn’t figured out a way to authorize the at-home rapid antigen tests because the FDA is used to regulating medical devices, not public health screening tools. Thus, every test that is authorized, regardless of whether it is designed for medicine or public health, is authorized as a clinical medical device. Requiring public health tools to meet medical device specifications has caused company after company to delay their FDA submissions in a never ending attempt to meet the FDA’s guidelines—for example the need to separately qualify a rapid antigen test for symptomatic versus asymptomatic use.
And here’s Dr. Mina with a must-read thread on what needs to be done to get these at-home tests in use right now:
HERE IS THE PLAN TO GET US OUT OF THIS #COVID19 WAR
• NO lockdowns
• NO waiting for vaccines
• Reverses cases in weeksA true public health approach focused on the ppl
To end the public health *WAR* we are in.
RAPID At-Home COVID Testing for Allhttps://t.co/vQzaZeVmZv
— Michael Mina (@michaelmina_lab) November 18, 2020
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This Plan works WITH the people and meets them where they are.
It works WITH all the other public health approaches we are already taking – it does not replace them
It is bold and and ambitious – and addresses the fact that we are actually in a war with a virus…
2/
— Michael Mina (@michaelmina_lab) November 18, 2020
It is time the government STOPS the nonsence of treating this like scattered medical problems to be addressed medically
We MUST address the pandemic as a public health problem – with the RIGHT TOOLS – only then will the medical issues resolve
Not the other way around
3/
— Michael Mina (@michaelmina_lab) November 18, 2020
The tools we need are NOT those needed for sick people
Nor is the @US_FDA evaluatory pathway
We Need new thinking – a new paradigm – a new approach to a crisis causing public suffering, hardship, poverty, disease, and death
We Need to Readjust what we falsely believe works
4/
— Michael Mina (@michaelmina_lab) November 18, 2020
Our Leaders must rise to find the courage to buck the trends and be true leaders.
They must try new, bold ideas in the face of failure after failure
And the approaches must respond appropriately to where American's are today…
5/
— Michael Mina (@michaelmina_lab) November 18, 2020
It is not enough to tell people to stay home and don't go see their family for Thanksgiving
That's a failure of a response!!!
That's a poor attempt to do damage control for a failed response in every of the 50 states of these United States.
It's simply not good enough
6/
— Michael Mina (@michaelmina_lab) November 18, 2020
We MUST STOP FAILING
And we can't stop failing by doing the EXACT SAME THING OVER AND OVER FOR MONTHS
Trump did not help. No.
But states could have taken action earlier.
We can start now. Today.7/
— Michael Mina (@michaelmina_lab) November 18, 2020
States can start to use states powers and Say to the FDA – and the Federal Government – enough is ENOUGH!!!
We MUST ACCELERATE new approaches and we simply cannot just wait around to see what is FDA authorized next in hopes that it maybe possibly will be useful.
8/
— Michael Mina (@michaelmina_lab) November 18, 2020
If Congress won't provide $5B to produce 20M first in class rapid antigen tests every day for America, we need @elonmusk @Facebook @Apple @ATT @Verizon @amazon to start to build the tools we need so we can go home for the holidays!
And we need States to work with them!
9/
— Michael Mina (@michaelmina_lab) November 18, 2020
Simply put – we must change our approaches
The classical public health approaches haven't worked
The sputtering lockdowns won't work and will hurtWe need to treat this like an all out War. It is the greatest catastrophe in our country in decades
We must act like it!
10/10
— Michael Mina (@michaelmina_lab) November 18, 2020
Let’s get this done!
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