Maine Medicine Weekly Update - 12/16/2020  (Plain Text Version)

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In this issue:
•  Maine COVID Vaccines: When, Who, Why...?


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?

The Whens, Whos, and Whys of Maine’s Vaccine Plan 

The US 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. 

With 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? 

We 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. 

The 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

•            Non-COVID ICUs

•            EDs

From 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 patients.

Health 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.

According 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.

Similar 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.  

For 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.

When 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.

We 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.

It All Hinges on Production & Delivery

A very 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 change.

“We’d 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.”

The article goes on:

“The 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.

According 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.

Congress 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.

Then 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.

What About Moderna?

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.

Please 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