Maine Medicine Weekly Update
October 18, 2021

In This Issue
FDA Advisory Committee Recommends Moderna, J&J Boosters. What You Need to Know
More COVID Guidance & News
Maine CDC Memos: Planning Efforts for Moderna Booster and Pfizer Vaccine for 5-11-year-olds
Draft Study Shows Moderna & Pfizer May Be Better Boost for J&J Recipients
FDA Schedules Advisory Committee Meeting to Discuss COVID-19 Oral Treatment
Federal COVID Vaccine Mandate Rules Have Been Drafted
Maine Health System News
Central Maine Healthcare Services, Staffing, Vaccine Mandate, CEO Appointment
Clinical News
New Draft Recommendation Statement on Aspirin Use to Prevent Heart Disease and Stroke
Top JAMA, JAMA Network, and New England Journal of Medicine Articles
Physician Well Being
Using Electronic Health Records to Predict Physician Departure
Preventing Stimulant Misuse Among College-Aged Students
Upcoming Specialty Society Meetings
AAP EQIPP Course: Immunizations - Strategies for Success (for RURAL Health Providers)
SUPPORT for ME Training and Technical Assistance Initiative
SUPPORT For ME Training and Technical Assistance Initiative Webinars on November 3 & December 1
Maine Independent Clinical Information Service: MICIS presentations & Academic Detailing
Physician (BC/BE in Family Medicine) - Mt. Abram Regional Health Center, (Kingfield, Maine)
Physician (BC/BE in Family Medicine) - Bingham Area Health Center

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FDA Advisory Committee Recommends Moderna, J&J Boosters. What You Need to Know

A Food and Drug Administration (FDA) advisory committee voted unanimously in favor of a lower-dose Moderna COVID-19 vaccine booster on Thursday.

The recommendation from the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) was for a half booster of Moderna. Eligibility criteria was identical to eligibility criteria approved for Pfizer last month.

  •  Individuals 65 years of age or older
  • Individuals 18 to 64 years of age at high risk of severe COVID-19
  • Individuals 18 to 64 years of age who are put at a higher risk of severe COVID-19 due to their occupation

On Friday, the advisory committee voted unanimously on Friday to recommend a booster dose for the Johnson & Johnson COVID-19 vaccine.

Unlike the authorizations for boosters for the Pfizer-BioNTech and Moderna vaccines, no restrictions were put on the J&J booster. Johnson & Johnson representatives told the panel that a second dose given to persons 18 and older either two months or six months after the first shot increased antibody levels.

Despite the committee recommending approval, an FDA summary released earlier in the week highlighted a lack of high-quality data supporting giving a booster six months following the first dose.

The VRBPAC is scheduled to meet again October 26 to discuss arequest to amend Pfizer-BioNTech’s Emergency Use Authorization (EUA) for administration of their COVID-19 mRNA vaccine to children 5 through 11 years of age. Pfizer aims to give 5- to 11-year-olds one-third of the dose given to everyone 12 and older.

Next Steps

  • The recommendation will now be taken up by the FDA leaders.
  • The F.D.A.’s acting commissioner can then issue a final determination on whether to authorize the boosters and for whom
  • An advisory panel to the US CDC reviews the F.D.A.’s decision. The panel is scheduled to meet this week.
  • The C.D.C. Director can then issue formal guidance on whether boosters should be used and who should be eligible.
  • State health departments are not obligated, but generally follow the recommendations of the US C.D.C.

Additional meeting discussions and information

Despite the unanimous vote, many committee members still had concerns over the data they saw from Moderna and the Israel Health Ministry.

Following the Moderna booster vote on Thursday, the FDA advisory committee discussed whether everyone over 18 should receive a third COVID-19 vaccine dose but several committee members pushed back on suggestions that booster shots are needed for all people, concerned the emphasis on boosters may distract from reaching unvaccinated individuals.

“The effect of a booster is much less than vaccinating unvaccinated individuals — that means both here and abroad. If we want to get out of this thing, we’ve got to vaccinate the unvaccinated.” – Advisory Committee member, Eric Rubin, editor of the New England Journal of Medicine.

The FDA is holding off on approving the Moderna Covid-19 vaccine for teens to review more data about whether it could lead in rare cases to the heart condition myocarditis. Officials want to first determine whether there is an elevated risk, and it could take several weeks.

Click here for the latest COVID-19 Information from the FDA.

Materials for the October 26th meeting concerning Pfizer’s request to amend its EUA for persons 5 to 11 years of age will be available at the Vaccines and Related Biological Products Advisory Committee meetings main page.

The meeting will be broadcast via YouTube: https://www.youtube.com/watch?v=laaL0_xKmmA&feature=youtu.be

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