Maine Medicine Weekly Update - December 16, 2020
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Maine COVID Vaccines: When, Who, Why...?
In this issue:
- The Whens, Whos, and Whys of Maine’s Vaccine Plan
- It All Hinges on Production & Delivery
- What about Moderna?
Whens, Whos, and Whys of Maine’s Vaccine Plan
FDA authorizing the new Pfizer-BioNTech COVID Vaccine for emergency use is
exciting news as potential light at the end of a long public health tunnel. The
Maine CDC team has been preparing for distribution and specific delivery
logistics for many weeks along with various statewide stakeholders, including
the Maine Medical Association.
Maine CDC public statements rightfully focused on maintaining critical health
care infrastructure such as hospital emergency departments (EDs), intensive
care units (ICUs), and inpatient COVID units, the main question we’ve been
fielding at MMA remains: how soon will it be widely available for non-hospital
employed physician practices fighting a different area of the front line?
wanted to outline for you what we have learned, through diligent research and
outreach on many fronts to those independent practices inquiring about the
state vaccination plan. For example, first and foremost, the limits on how many
doses will be received by the state will heavily influence any plan. Also, many
hospitals and large health systems are also at the mercy of simple math when it
comes to ensuring their critical and immediate pandemic care staff receiving a
vaccine. That math equation has a real effect on the possible time frame and
potential delay for independent physician practices and necessary staff to be
next up behind the ED, ICU, and COVID units, and other critical and essential
inpatient services not available elsewhere across Maine. There are a number of
reasons why outpatient physician practices, for example, whether hospital-based
or independent, whether rotating through hospital EDs or not, are not factored
in the first two weeks, and maybe three, of the current Maine CDC plan.
initial Phase 1a priority groups as recommended by US CDC and Maine CDC were
developed , “to preserve the critical care infrastructure for COVID patients.":
They are, as previously mentioned:
Hospital COVID units
what we understand, doses from the first deliveries to Maine may not enough to
first cover all on-site ICUs even at our largest hospitals. Even some smaller
hospitals within large health systems won’t receive any doses for their EDs or
staff treating COVID patients for the first two weeks, including the outpatient
practices affiliated with smaller hospitals that round daily on their own
system leaders are also hearing from their own outpatient clinics and
specialists concerned that they will be left out of initial allotments. In
fact, there are specialists throughout the state, who for example, rotate for
up to a week in hospital ICUs. Frequently, they are at the bedside for those
rotations. While they surely need to be vaccinated as quickly as supplies
become available, many are currently administering only to “full-time
unit-based” staff with the limited phase 1 doses available. It is only in week
3 that the ability to penetrate a broader range of clinicians and patient
facing staff, whether on-site at hospitals or otherwise.
to a statement by Dr. Shah in recent Portland Press Herald article , Maine
will receive just under 75,000 doses in the first three weeks and we have a
total of 75,000 health care workers according to Maine CDC numbers. A public
document released by Maine CDC shows just under 33,000 doses coming in the
first two weeks.
to what hospital systems are hearing from employed specialists, we have fielded
numerous feedback from independent physician members, both very large and very
small, both excited yet concerned about when doses may penetrate the outpatient
practice level. Many of you also cover specialist services at hospitals, both
large and small, and for high-risk patients.
further background, the first consideration for the state, and something being
strongly factored by Maine hospitals and systems is guidance from US CDC and
Maine CDC on allocating the very limited initial doses. It is not necessarily
to protect clinicians from at work exposure but to protect statewide COVID
inpatient, ICU, and ED infrastructure first and foremost from community/public
transmission under a theory that no one wants to see, that EDs themselves in a
worst case pandemic scenario can be backup for the outpatient offices hit by
the pandemic. That, and there is no clear backup staff for COVID units or ICUs
considering the specialized care provided.
will it be available in the community? Dr. Shah stated during his the
Wednesday, December 16, briefing that it may be months away for those at lower
risk for severe cases. MMA leadership sees it as promising that the time for a
vaccine to be available for health care workers and for residents of long term
care facilities is thus far being measured in weeks.
hope the information better lays out the process and numbers at least for
today. We at the MMA are strongly advocating to ensure inclusion in weeks three
and four for independent outpatient practices now that we have a better
understanding guardrails for the first few phases/weeks.
Hinges on Production & Delivery
informative StatNews article last week titled, The timeline for Covid-19 vaccine distribution keeps
slipping. Experts say it will change again, provides an experts view
on the one constant for mass vaccine dissemination: The schedule will always
constantly have to update the models as new production numbers came out,” said
Bruc Y. Lee, a professor at CUNY Graduate School of Public Health & Health
Policy, who developed computational models to guide the national response to
the H1N1 flu pandemic in 2009. “That just became accepted.”
article goes on:
Trump administration declared in May that 300 million vaccine doses would be
available by January 2021, with the first distributed in October of this year.
By October, that had shifted to 100 million doses by the end of the year,
according to Health and Human Services Secretary Alex Azar. Currently, the plan
is for 40 million doses to be distributed in December, though some in health
care are skeptical of even that prediction. Pharmaceutical and vaccine
production involves complex coordination, involving product development,
manufacturing, packaging, storage, distribution, and regulatory review, and
each stage can cause unexpected delays.
to the Washington Post, Pfizer last week told the Trump administration that it
cannot provide substantial additional doses of its vaccine until late June or
July, putting the nation’s aggressive vaccination schedule in jeopardy. Because
of delays in scaling up the raw material supply chain they were forced to cut
its end-of-year supply projections.
held hearings in 2009 criticizing Centers for Disease Control officials for
leading Americans to expect more H1N1 flu vaccine than would be ultimately
available. Media portrayed high-risk groups as left scrambling for needed
vaccines at the time. The H1N1 pandemic, although sadly resulting in
approximately 12,000 deaths nationally, pales in comparison to what we’re now
facing with cases, deaths, vaccine distribution and current demand.
there are potential supply chain issues. The StatNews piece has the quote,
“Once you make it and pack it, you just have to move it.” Any delivery company,
including FedEx and UPS face their own limitations. Two of which are the
current holiday season and winter storms—one of which is expected to pound the
northeast over the next 24 hours.
An FDA briefing
document released Tuesday revealed Moderna's COVID-19 vaccine
candidate, mRNA-1273, seemed to meet criteria for emergency use authorization
(EUA). The issue will now go before the FDA's Vaccines and Related Biological
Products Advisory Committee later this week and hopefully be quickly authorized
for emergency use authorization, similar to the Pfizer vaccine last week.
do not hesitate to reach out directly to MMA Director of Communications and
Government Affairs, Dan Morin by email or call/text at (207) 838-8613 with
questions, comments, or concerns, including if you are an independent physician
practice anxious to provide needed doses for you and your patient facing staff.
#besafe #maskup #distance #washhands #wegotyourback #MainePhyscians