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MaineHealth to require COVID-19 vaccine for all staff starting Oct. 1 as FDA considers full approval

Dora-Anne Mills M.D., chief health improvement officer of MaineHealth, told NEWS CENTER Maine that MaineHealth will not wait for full FDA approval of the vaccines.

PORTLAND, Maine — MaineHealth, northern New England’s largest health system and Maine’s largest private employer, announced in a release Tuesday that it will require COVID-19 vaccination for all employees, with very few exceptions.

All employees will be required to be fully vaccinated by Oct. 1. 

Dora-Anne Mills M.D., chief health improvement officer of MaineHealth, told NEWS CENTER Maine that MaineHealth will not wait for full approval of the vaccines by the U.S. Food and Drug Administration (FDA). Mills said MaineHealth is very confident in the safety and efficacy of the vaccines, which thus far have received emergency use authorization from the FDA.

This comes one day after Northern Light Health announced that staff will be required to be vaccinated against COVID-19, but not until the vaccines are fully approved by the FDA.

"The FDA full approval really was not a consideration of ours. The vast majority of health systems around the country that we looked into that are mandating vaccines for their employees actually have picked a date, usually six to eight weeks later from the announcement and they're not tying it to FDA approval," Mills said. "And the reason why that makes sense is that the safety and efficacy thresholds for the emergency use authorization for FDA are essentially the same as for full approval."

In May, Pfizer and BioNTech submitted a biologics license application with the clinical data from its Phase 3 trial of the vaccine. The companies also submitted an application with the FDA in May for full approval of the vaccine for children ages 12 through 15.

The FDA granted priority review for their two-dose mRNA vaccine for individuals 16 and older, shortening the approval process from 10 months to only six.

Moderna and Johnson & Johnson have not yet initiated submissions to the FDA to get full approval, although both companies say they plan to soon. 

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As of late July, MaineHealth spokesperson Matt Wickenheiser said 83.8% of all MaineHealth care team members were fully vaccinated.

Wickenheiser said in Tuesday's release that the health system will consider bona fide medical and religious exemptions under the vaccination policy.

Wickenheiser said the policy is part of a public health effort to limit the spread of the virus, especially in light of the growing threat of the delta variant of coronavirus.

“The vaccines are very effective, and are preventing hospitalizations and health complications with COVID-19. In addition, the vaccines are proven safe – we have a full year of data from the clinical trials and almost 200 million Americans have received a COVID-19 vaccination,” Mills said. “To be consistent with our values and to protect our colleagues, families, patients and communities, we believe it is paramount that all care team members be vaccinated.”

“Our care team members have worked extremely hard and have sacrificed much in the fight against COVID-19, and we thank them profoundly,” she continued. “As we ask all our care team members to be vaccinated, I’d ask all Mainers to please, please get your COVID-19 vaccination. It will protect you, your family and your community.”

In Tuesday's release, MaineHealth said having broad vaccination is especially necessary to protect those who are vulnerable, including unvaccinated children and the immunocompromised. It is for this very reason this many health care and long-term care organizations already require vaccinations for COVID-19, along with influenza, pertussis, and chickenpox, according to MaineHealth.