Light at the End of the Pandemic Tunnel?

After the devastation of 2020 wrought by the COVID-19 pandemic, many of us are glad 2020 is behind us. The U.S. has suffered through hundreds of thousands of deaths caused by the virus, plus additional deaths resulting from the fallout of economic lockdowns: the potential for increased suicides,¹ domestic abuse, opioid overdoses,² deferred cancer treatment and other important healthcare services.

As with some of your families, our family has experienced COVID-19 up close and personal with my wife, stepdaughter and her boyfriend coming down with it just before Christmas Eve. While they were recovering, I shut down my office and quarantined from my family for two weeks. Certainly not a fun way to spend the holidays. I did not become infected, which was fortunate due to my age and an underlying medical condition putting me in a higher risk category for severe disease. Our household was visited by COVID-19 despite everyone following CDC recommendations of physical distancing, wearing masks, and frequent hand washing. I firmly believe that a COVID-19 vaccine is our best chance to get past this pandemic.

Operation Warp Speed cut red tape, supported COVID-19 vaccine research, and ordered millions of vaccine doses of the most promising candidates, giving pharmaceutical companies a guaranteed market for their potential vaccine. The FDA stepped up, slashed the red tape, and worked with the drug companies to make sure their studies were optimized for success. In addition, the development of the vaccines was done in parallel rather than series so that the various clinical phases were done concurrently while tens of millions of doses were being manufactured at the same time. The Operation delivered two vaccines in less than one year. This is by far a record for any vaccine approved by the FDA in history. Five years is usually estimated for a vaccine to go from the lab to approval. Even more encouraging is the 95% efficacy rate after two doses,³ which is far higher than the influenza vaccine and many others.

The FDA, a highly respected scientific organization not known for its speediness, went way beyond expectations giving emergency use authorization (EUA) to both mRNA vaccines within days of getting the phase III data from the companies. Even more impressive was that the vaccine was on its way to designated vaccination sites across the country within hours of the EUA.

As one would expect from this unprecedented effort, there have been glitches in the manufacturing process as well as in delivering the vaccines to where they are needed without unnecessary waste or spoilage. As of this writing on December 31, 2020, millions of doses have been administered to individuals across the U.S. in phase 1A. In Missouri, vaccine distribution priority for vaccination in phase 1A includes patient-facing healthcare workers, residents of long-term care facilities and their staff or about 500,000 Missourians. Phase 1B includes the three million Missouri residents older than 64, 18–64 with an underlying condition putting them at high risk of severe COVID-19 disease (obesity, diabetes, chronic kidney disease, COPD, hypertension, chronic heart disease), first responders and essential workers. Phase 2 includes other residents at increased risk such as the homeless and those who are incarcerated. Phase 3 includes all Missouri residents.

The rollout started with the Pfizer vaccine distributed to major hospitals (they have the necessary super-cold storage needed) around the state, which immediately started vaccinating all their staffs. Smaller hospitals started receiving the Moderna vaccine a few weeks later, especially in rural Missouri after CVS and Walgreens received the vaccine for the federal program to vaccinate long-term care facility residents and staff.

One group in phase 1A was conspicuous by its absence from the initial rollout—office-based, patient-facing physicians, and their staff. They take care of many elderly patients, often with underlying medical conditions. To provide a safe environment for these patients to be taken care of and kept out of overloaded hospitals, office-based practices are a key part of the healthcare system, especially during the pandemic. A few physicians in office-based practices were able to get vaccinated in a hospital where they see patients. Unfortunately, that still left many other physicians and, even more crucial, their patient-facing staffs unvaccinated. Independent practices were advised to sign up to be a vaccinator site. Becoming a vaccinator site for the Moderna vaccine requires a medical freezer and/or refrigerator, 24/7 temperature monitoring and recording, extensive record-keeping, and reporting to the ShowMeVax registry (https://showmevax.health.mo.gov/smv/login.aspx) and a minimum order of 100 doses. Since every dose must be accounted for, these requirements are practical only for the largest independent practices. What about the rest of us and our practices? It seemed to me as though office-based practices were not fully considered in the government’s carefully outlined and phased vaccination plans. Missouri is not alone, almost all other states seem to be in the same boat.

Your Missouri State Medical Association sprang into action and started working with the Missouri Department of Health and Senior Services (https://covidvaccine.mo.gov/), other healthcare organizations and even the National Guard to develop and execute a plan that would vaccinate office-based, patient-facing healthcare workers not affiliated with hospitals or healthcare systems during phase 1A as vaccine availability expands. Hopefully, by the time you read this, the plan will have been put into action with all independent practice patient-facing staff having been given the opportunity to get vaccinated. Hospitals have now started offering the vaccine to offices whose physicians are affiliated with them. The St. Louis County Department of Health has started offering the vaccine to unaffiliated office staff. I encourage you to advocate with your hospital and county health department to include your office staff as vaccine availability ramps up. As independent vaccinator sites are approved, they will be listed on https://covidvaccine.mo.gov/. Once the pharmacy chains have completed vaccinating staff and residents of long-term care facilities, they will start offering the vaccine to patient-facing health-care workers. You will be getting regular updates from MSMA (msma. org/covid) about when and how to get COVID-19 vaccination for your practices.

Missouri is expecting to receive about two million vaccine doses by February 2021 to be able to vaccinate phases 1A, 1B, and 2 individuals interested in getting a vaccine. The hope is that by April and May 2021 phase 3 individuals will get access to the vaccine. Support for getting a COVID-19 vaccine has dropped from 74% to 56% from April to December 2020⁴ and there are numerous reports of half or more of frontline healthcare workers (even in COVID-19 ICUs and nursing homes) refusing vaccinations. Such skepticism is quite disconcerting and perplexing to me. As the risk-benefit ratio of this vaccine is so overwhelmingly favorable, it is difficult to understand the opposition to it, especially by healthcare workers, who should know better. It has become clear that we must lead by example and get ourselves and our staff vaccinated when our turn comes. It is up to us to educate our patients and the public at large about the importance of getting as many people as possible vaccinated so that we can, as a society, get past this pandemic.

Operation Warp Speed has been a great public-private partnership as well as a “miracle” of science. It certainly gives many of us hope for a return to a semblance of “normal” with far less death and suffering in 2021 than what the world endured in 2020.