Six Reasons MaineHealth Implemented COVID-19 Vaccination as a Condition of Employment (CoE)

Why a COVID-19 Vaccine as a Condition of Employment (CoE)? (8/4/21)

1.????Vaccines protect others by preventing transmission to others, especially our patients and our care team members, as well as our families and the broader community. Vaccination helps us protect others who are unable to be vaccinated and/or cannot mount a protective immune response to the vaccines. Two main examples:

a.????Children under 12 years of age, who comprise about 15% of the population, are unable to be vaccinated and are now at high-risk of contracting COVID-19. There are reports of increases in pediatric hospitalizations due to COVID-19 in other parts of the country.

b.????Those who are immunosuppressed or are medically frail or are elderly may not mount sufficient immunity to COVID-19 from the vaccines.

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2.????COVID-19 vaccines are safe. Since the clinical trials started July, 2020, nearly 200 million people in the U.S. have been vaccinated, and about 350 million doses have been administered, under the most intense safety monitoring in U.S. history.

a.????The COVID-19 vaccines authorized by the U.S. by the FDA under an EUA (emergency use authorization) have similar safety profiles as those currently FDA-approved. In fact, the safety and efficacy thresholds for the COVID-19 vaccines’ EUA are essentially the same as for full licensure.

b.????To date, the safety monitoring systems have detected only two serious types of health problems after vaccination, both of which are very rare. These are: thrombosis with thrombocytopenia syndrome (a type of blood clot known as TTS) after vaccination with J&J vaccine among women <50 years old; and anaphylaxis (a serious allergic reaction), which is the reason for the 15-minute post vaccination wait. There is a possibility of myocarditis and pericarditis among adolescents and young adults after receiving the mRNA vaccine, though so far these have been mild cases that self-resolved.

c.????Long-term effects are highly unlikely. In the 200+ years of vaccines, none have shown a side effect that showed up after 6 weeks from the vaccine dose being administered. With a year of monitoring, no long-term side effects have been detected.

3.????Vaccines are effective:

a.????All COVID vaccines authorized in the U.S. demonstrate:

i.????Efficacy (65-95%) against symptomatic laboratory-confirmed COVID infection.

ii.????High efficacy (90%+) against severe COVID, e.g., hospitalization.

iii.????High efficacy (99%) against death.

b.????Transmission, even with Delta, is most highly associated with those who are unvaccinated. Data suggest higher breakthrough rates of non-severe infection with the Delta variant. Some who are fully vaccinated and infected with the Delta variant appear to have high enough viral loads that they can transmit it to others. This appears at this time to account for a small proportion of COVID transmission. However, given that transmission risk from the fully vaccinated appears higher with the Delta variant than previous strains, and given the increase in pandemic activity in Maine, we are also tightening our masking and distancing requirements.

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4.????COVID-19 has significant risk of transmission before and in the absence of symptoms. These risks are substantially higher among unvaccinated individuals.

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5.????Existing vaccine CoEs have proven effective.

a.????For instance, studies show that influenza vaccine rates among health care workers increase from 70% to 94% when vaccine becomes a CoE.

b.????MaineHealth has done well, with 84% vaccine rate overall, but we still have areas of low rates. For instance: as of July 21, Franklin is at 71%, NorDx at 77%; and our long term care facilities vary from 70-87%.

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6.????Making COVID-19 vaccine a condition of employment is aligned with our vision of working together so our communities are the healthiest in America, and is also aligned with our values of being patient-centered and setting standards of excellence.

Why a CoE Now?

·??????Current Surge: Because of the highly contagious Delta variant and significant numbers of unvaccinated people, COVID-19 cases, hospitalizations, and deaths are on the rise throughout the U.S. Vaccination is the primary strategy to put the pandemic behind us.

·??????Delta: Because of the increase contagiousness of the Delta variant, higher vaccination rates are necessary to reach herd immunity. Experts estimate vaccination rates will need to be >90%. Some of the reasons listed above are also time-sensitive because of the rise of the Delta variant.

Why not wait until FDA approval? The safety and efficacy thresholds for the EUA are essentially the same as for full approval. The main difference is the amount of time for monitoring clinical trial participants - a median of two months versus six months after the second dose. However, in the 200+ years of vaccines, no significant side effects have been detected from a vaccine more than six weeks after a dose.

Others are Implementing CoEs: Many other health systems are implementing COVID vaccine CoEs, including Millinocket Hospital, Northern Light Health, Mayo Clinics, the VA, Mass General-Brigham, Tufts, Dana Farber, Yale, Duke, UNC, Kaiser (250,000 employees), Texas Health, Baylor, Ascension (149 hospitals), Vanderbilt. Most of these are implementing their CoEs independently of FDA approval. State governments in ME and NH cannot mandate without lengthy rule-making. Additionally, many non-healthcare companies are implementing vaccine CoEs, including: Google, Facebook, Uber, Disney, Tyson, Walmart, and Washington Post.

Resources:

·??????CDC Safety of COVID Vaccines: Safety of COVID-19 Vaccines | CDC

·??????CDC Efficacy of COVID Vaccines: Science Brief: COVID-19 Vaccines and Vaccination (cdc.gov)

·??????Millinocket Hospital announcement with National Nurses Union statement: https://www.pressherald.com/2021/07/29/millinocket-hospital-is-first-in-maine-to-require-covid-vaccines-for-employees/?

·??????July 21 Statement of AHA in support of hospital CoE (no mention of needing full FDA approval): https://www.aha.org/public-comments/2021-07-21-aha-policy-statement-mandatory-covid-19-vaccination-health-care

·??????July 13 Statement of major infectious disease societies in support of COVID vaccine as a condition of employment (no mention of needing full approval) (includes effectiveness of CoEs for influenza vaccine): https://doi.org/10.1017/ice.2021.322

·??????July 26 Statement of 50+ health associations, including AMA, ANA, in favor of vaccine CoE (no mention of needing full approval):?https://www.ama-assn.org/press-center/press-releases/ama-support-covid-19-vaccine-mandates-health-care-workers

·??????July 26 VA CoE vaccines for patient-facing employees: https://www.va.gov/opa/pressrel/pressrelease.cfm?id=5696

·??????July 26 California mandate: https://www.gov.ca.gov/2021/07/26/california-implements-first-in-the-nation-measures-to-encourage-state-employees-and-health-care-workers-to-get-vaccinated/

·??????July 29 Federal employees and on-site contractors to be vaccinated or mask, distance, and be tested weekly: https://www.whitehouse.gov/briefing-room/statements-releases/2021/07/29/fact-sheet-president-biden-to-announce-new-actions-to-get-more-americans-vaccinated-and-slow-the-spread-of-the-delta-variant/

·??????List of health systems/hospitals implementing a CoE for COVID vaccine: https://www.beckershospitalreview.com/workforce/hospitals-health-systems-mandating-vaccines-for-workersjune17.html

Questions on this document: [email protected]

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