Maine Medicine Weekly Update - Maine Medicine Weekly Update
October 31, 2021
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One Step Closer to COVID Vaccines for Kids; FDA Authorizes Vaccine for Children Ages 5-11

The Food and Drug Administration on Friday, October 29th authorized the Pfizer COVID-19 vaccine for children ages 5-11, one of the final steps in making vaccines available to children under 12.

The Pfizer-BioNTech COVID-19 Vaccine for children 5 through 11 years of age is administered as a two-dose primary series, 3 weeks apart, but is a lower dose (10 micrograms) than that used for individuals 12 years of age and older (30 micrograms).

What’s Next?

The US Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) is scheduled to meet this week (Nov. 2 & 3) to discuss further clinical recommendations and how the vaccine should be used. If the panel gives favorable recommendations and CDC Director Rochelle Walensky accepts them, vaccinations can begin pending state guidance.

The Maine CDC has released guidance regarding the availability of Pediatric Pfizer. The Maine Immunization Program (MIP) will make the Pfizer COVID-19 vaccine for 5- 11-year-olds available for enrolled MIP Providers to order through ImmPact.

The Food and Drug Administration on Friday, October 29th authorized the Pfizer COVID-19 vaccine for children ages 5-11, one of the final steps in making vaccines available to children under 12.

The Pfizer-BioNTech COVID-19 Vaccine for children 5 through 11 years of age is administered as a two-dose primary series, 3 weeks apart, but is a lower dose (10 micrograms) than that used for individuals 12 years of age and older (30 micrograms).

What’s Next?

The US Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) is scheduled to meet this week (Nov. 2 & 3) to discuss further clinical recommendations and how the vaccine should be used. If the panel gives favorable recommendations and CDC Director Rochelle Walensky accepts them, vaccinations can begin pending state guidance.

The Maine CDC has released guidance regarding the availability of Pediatric Pfizer. The Maine Immunization Program (MIP) will make the Pfizer COVID-19 vaccine for 5- 11-year-olds available for enrolled MIP Providers to order through ImmPact.

Important Note: Although the vaccine is available to order now, it cannot be administered until it has received final approval by the US CDC.

  • The ordering minimum will be 300 doses initially, but Maine CDC anticipates that a minimum of 100 doses will be available to order in late October. Packaging consists of 10-dose vials in cartons of 10 vials
  • The Maine Immunization Program will be working with all school districts to assist with orderingpediatric Pfizer vaccine and coordinating clinics.
  • Please be advised if you are a Federally Qualified Health Center or Rural Health Center, you will need to order the vaccine through ImmPact since this presentation will not be available through HRSA

·      The 5-11 year old population in Maine is ~79,000. Supply is not expected to be an issue.

Maine State survey data show that only ~30-35% of parents will want the vaccine for their kids immediately upon approval. The MMA has throughout the pandemic and will continue to advocate for physicians as a trusted source of medical advice and care for patients and families, and that participation in the vaccination process is imperative to keep Mainers healthy and safe.

ACIP Meeting Information and Resources:

Draft Agenda for November 2nd and 3rd

November 2nd—COVID-19 Vaccines (10:00 a.m. start)

November 3rd—Hepatitis Vaccines, Immunization Schedules, Orthopoxviruses Vaccines, Ebola Vaccine

 

Webcast Link to Watch Meetings

Background:

Read the FDA Press Release to learn more.

Pfizer/BioNTech submitted its clinical trial data to the FDA for emergency use authorization. The trials show the vaccine is 91 percent effective in preventing symptomatic disease for children ages 5 to 11 and was well-tolerated, with few side effects.

FDA briefing documents on the Pfizer-BioNTech COVID-19 vaccine, released before the FDA advisory panel meeting, indicated an immune response and that is was safe and effective in young children.

The White House recently unveiled its plans to vaccinate children between the ages of 5 and 11 years old, pending authorization by the Food and Drug Administration in the coming weeks. The distribution plan will rely on pediatricians, community health centers, schools, and pharmacies to put parents and children at ease, rather than the mass vaccination sites used in the initial rollout for adults.

Identify to Protect: Recognizing the Signs of Child Maltreatment

As providers entrusted with the care of children, we all strive to protect the most vulnerable patients from child abuse.

In this high-yield presentation, you will be given the tools to recognize signs and symptoms that may be concerning for abuse and provided with guidance for evaluating children with suspected abuse and making effective reports to child protective services. These actions can be truly lifesaving interventions.

 

As providers entrusted with the care of children, we all strive to protect the most vulnerable patients from child abuse.

In this high-yield presentation from mid-October, attendees were given the tools to recognize signs and symptoms that may be concerning for abuse and provided with guidance for evaluating children with suspected abuse and making effective reports to child protective services. These actions can be truly lifesaving interventions.

See the recording and slides through the following link:

https://www.maineaap.org/education/identify-to-protect-recognizing-the-signs-of-child-maltreatment

 

US FDA & CDC Officially Expand Eligibility Recommendations For COVID-19 Booster Shots

The FDA, on October 20th, amended the emergency use authorizations (EUA) for COVID-19 vaccines to allow for the use of a single booster dose for COVID-19 vaccines in eligible populations. A day later, the CDC endorsed the CDC Advisory Committee on Immunization Practices’ (ACIP) recommendation for a booster shot of COVID-19 vaccines in certain populations.

For individuals who received a Pfizer-BioNTech or Moderna COVID-19 vaccine, the following groups are eligible for a booster shot at 6 months or more after their initial series:

  • 65 years and older
  • Age 18+ who live in long-term care settings
  • Age 18+ who have underlying medical conditions
  • Age 18+ who work or live in high-risk settings

For the nearly 15 million people who got the Johnson & Johnson COVID-19 vaccine, booster shots are also recommended for those who are 18 and older and who were vaccinated two or more months ago.

The FDA, on October 20th, amended the emergency use authorizations (EUA) for COVID-19 vaccines to allow for the use of a single booster dose for COVID-19 vaccines in eligible populations. A day later, the CDC endorsed the CDC Advisory Committee on Immunization Practices’ (ACIP) recommendation for a booster shot of COVID-19 vaccines in certain populations.

For individuals who received a Pfizer-BioNTech or Moderna COVID-19 vaccine, the following groups are eligible for a booster shot at 6 months or more after their initial series:

  • 65 years and older
  • Age 18+ who live in long-term care settings
  • Age 18+ who have underlying medical conditions
  • Age 18+ who work or live in high-risk settings

For the nearly 15 million people who got the Johnson & Johnson COVID-19 vaccine, booster shots are also recommended for those who are 18 and older and who were vaccinated two or more months ago.

Maine CDC guidance and FAQs on expansion of eligibility for COVID-19 Booster Shots – October 22, 2021

According to the US CDC, “available data right now show that all three of the COVID-19 vaccines approved or authorized in the United States continue to be highly effective in reducing risk of severe disease, hospitalization, and death, even against the widely circulating Delta variant.”

FDA Action on Booster Doses – October 20, 2021

CDC Expands Eligibility for COVID-19 Booster Shots – October 21, 2021

The US Centers for Disease Control and Prevention (CDC) conducted a Clinician Outreach and Communication Activity (COCA) call on October 26th.

Posted materials from the October 26, 2021, FDA Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting. Click this link for meeting video.

Updated Fact Sheets:

 

Moderna COVID-19 Vaccine Booster Dose Webinar & Ordering Reminders

The Maine Immunization Program has distributed a memo announcing that Moderna will be hosting a webinar for vaccination providers to learn more about the Moderna COVID-19 Vaccine booster dose.

The Maine Immunization Program has distributed a memo announcing that Moderna will be hosting a webinar for vaccination providers to learn more about the Moderna COVID-19 Vaccine booster dose.

Note: There will be no continuing education offered for this webinar.

Please register at the links below for one of the available sessions.

Webinar: Important updates on the mRNA-1273 50 µg Booster Dose

• Thursday, November 4th at 3pm ET – Register here for Nov 4

• Thursday, November 11th at 12pm ET – Register here for Nov 11

Moderna COVID-19 Vaccine Dose Reminders

As you place your future Moderna orders in ImmPact, we would like to remind providers of a few important points. Please keep in mind the following:

  • Upcoming orders of Moderna vaccine can be used for both 1st and 2nd doses.
  • Please do not set doses aside to be used only as 2nd doses.
  • When ordering, please take into consideration that the vaccine dosage for the booster dose (0.25 mL) is different than the dosage for the primary series (0.5 mL).
  • For example, if you are ordering 140 doses intended to be used for booster administration, you will get 280 doses out of it.

If you have any questions, please call the Maine Immunization Program at 207-287-3746.

 

Further Clarification to The Moderna Guidance That Was Previously Sent to Providers

The volume of the Moderna booster dose is 0.25 mL (half the volume of the primary dose). Both 0.5 mL primary doses and 0.25 mL booster doses can be drawn from the same vial. The Moderna COVID-19 vaccine is supplied in two multiple-dose vial presentations:

            A multiple-dose vial containing 5.5 mL (i.e., Moderna 10-dose)

            A multiple-dose vial containing 7.5 mL (i.e., Moderna 14-dose)

The volume of the Moderna booster dose is 0.25 mL (half the volume of the primary dose). Both 0.5 mL primary doses and 0.25 mL booster doses can be drawn from the same vial. The Moderna COVID-19 vaccine is supplied in two multiple-dose vial presentations:

            A multiple-dose vial containing 5.5 mL (i.e., Moderna 10-dose)

            A multiple-dose vial containing 7.5 mL (i.e., Moderna 14-dose)

When extracting only booster doses or a combination of primary series and booster doses, the maximum number of doses that may be extracted from either vial presentation should not exceed 20 doses; the Moderna COVID-19 vaccine vial stopper should not be punctured more than 20 times. Once punctured, multidose vials of the Moderna vaccine must be used within 12 hours.

Despite the volume of the booster dose being 0.25 mL, providers should still report a full dose as administered in ImmPact. At this time ImmPact pulls a full dose from inventory even if your EMR sends a partial dose. We are working on a fix for this issue. Until we have installed the fix you will need to modify your inventory quantities and add doses. Use the reasonVial Did Not Contain All Doses.

Upcoming Training Sessions for Pfizer COVID-19 Vaccines

Pfizer Vaccines U.S. Medical Affairs will be hosting Immunization Site Training Sessions for All Providers on the Storage, Handling, & Administration for Current & Potential New Formulations of the COVID-19 vaccine (with their partner BioNTech).

These sessions will be updated to reflect new information and changes that evolve. Such updates will be identified at the start of each session and further explained during each presentation.

Pfizer Vaccines U.S. Medical Affairs will be hosting Immunization Site Training Sessions for All Providers on the Storage, Handling, & Administration for Current & Potential New Formulations of the COVID-19 vaccine (with their partner BioNTech).

These sessions will be updated to reflect new information and changes that evolve. Such updates will be identified at the start of each session and further explained during each presentation.

Please click on the links below to join the sessions at the designated times.

Attendee link – November 1 – 5 PM ET; Password: g9ZmgHaip32

Attendee link – November 2 – 5 PM ET; Password: sJDZQERp325

Attendee link – November 3 – 12 PM ET; Password: 82qdN3PppPp

Attendee link – November 4 – 12 PM ET; Password: Y4ZkXdh2bz7

Attendee link – November 5 – 12 PM ET; Password: rJSpNPts332

New Standing Orders for Moderna, Janssen, & Pfizer with Booster Language Dose Information

Most Moderna and Janssen vaccine preparation, administration, storage, and handling materials have been updated.

Most Moderna and Janssen vaccine preparation, administration, storage, and handling materials have been updated.

An updated Quick Reference Guide is also available.

All materials for the three COVID-19 vaccinations are located here.

 

An updated Clinical Considerations Summary is available here.

 

Immunocompromised Americans who had a 3rd COVID-19 shot can now get a 4th

Most fully-vaccinated immunocompromised people in the US can now get a fourth COVID-19 shot after their third under new guidance from the Centers for Disease Control and Prevention (CDC).

  • The fourth dose can be any FDA-authorized shot, given six months after the third.
  • People that got J&J's vaccine have different guidance — they shouldn't get more than two doses.

Most fully-vaccinated immunocompromised people in the US can now get a fourth COVID-19 shot after their third under new guidance from the Centers for Disease Control and Prevention (CDC).

  • The fourth dose can be any FDA-authorized shot, given six months after the third.
  • People that got J&J's vaccine have different guidance — they shouldn't get more than two doses.

 

COVID-19 Monoclonal Antibody Therapies in Maine

Maine DHHS would like to encourage clinicians to consider the use of COVID-19 monoclonal antibody (mAb) therapies (i.e. REGEN-COV, bamlanivimab/etesevimab, and sotrovimab) for individuals at high risk for developing severe disease.   Because national mAb supplies are constrained, Maine DHHS has currently prioritized use of mAbs for treatment of individuals diagnosed with COVID-19 over the routine use for post-exposure prophylaxis, though use for post-exposure prophylaxis is encouraged specifically in the setting of high-risk congregate settings such as Long-Term Care facilities and correctional facilities.

Maine DHHS would like to encourage clinicians to consider the use of COVID-19 monoclonal antibody (mAb) therapies (i.e. REGEN-COV, bamlanivimab/etesevimab, and sotrovimab) for individuals at high risk for developing severe disease.   Because national mAb supplies are constrained, Maine DHHS has currently prioritized use of mAbs for treatment of individuals diagnosed with COVID-19 over the routine use for post-exposure prophylaxis, though use for post-exposure prophylaxis is encouraged specifically in the setting of high-risk congregate settings such as Long-Term Care facilities and correctional facilities.

Why now? 

Maine continues to experience a statewide surge in COVID-19 cases related to spread of the Delta variant, resulting in continued high rates of hospitalization and Intensive Care Unit (ICU) utilization.  Appropriate and timely use of COVID-19 mAb therapies for individuals at risk for progressing to severe disease can help decrease the number of individuals who develop severe COVID-19 and can also help to decrease the pressure on Maine’s hospital and ICU treatment capacity. 

Where to send patients?

There currently are several sites in Maine that offer mAb treatment, including many hospitals, free-standing infusion centers, urgent care centers, and some primary care practices.  Providers should refer patients who qualify for mAb therapy to a facility in their area that offers mAb therapy as soon as possible following diagnosis (see list of Maine mAb treatment sites).  Additionally, providers and patients can search for mAb treatment site in their area by checking the online infusion center locator from the National Infusion Center of America (NICA) at https://covid.infusioncenter.org. 

More info:

Please see the attached Provider Info Sheet for more information.  Maine DHHS will also be offering more information on COVID-19 mAb therapies (as well as COVID-19 vaccines) during an extended version of the monthly “COVID-19 Clinical Info Session” on Tues, Nov 9 (7:30A-8:30A):

>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>> 

Join Nov 9 (7:30AM) Zoom mtg: https://zoom.us/j/6218434986?pwd=dEJoNEVRSkVSN2dwZlJ5WEl3WjJsZz09

Meeting ID: 621 843 4986

Passcode: 338847

One tap mobile: +13017158592,,6218434986#,,,,,,0#,,338847#

>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>> 

Maine DHHS appreciates your help to consider this important treatment option when appropriate for your patients. 

US CDC Adds Certain Mental Health Conditions to List of High-Risk Individuals Eligible for Booster Shots

Having mood disorders, including depression, and schizophrenia spectrum disorders can make you more likely to get severely ill from COVID-19.

The determination allows people with the diagnoses to be eligible for COVID-19 booster shots.

A recent analysis found a link between mood disorders and risk of severe and fatal COVID-19.

Having mood disorders, including depression, and schizophrenia spectrum disorders can make you more likely to get severely ill from COVID-19.

The determination allows people with the diagnoses to be eligible for COVID-19 booster shots.

A recent analysis found a link between mood disorders and risk of severe and fatal COVID-19.

Get more information:

US CDC COVID-19 Resources: People with Certain Medical Conditions

NIMH - Shareable Resources on Coping with COVID-19 (nih.gov)

NIMH - Depression (nih.gov)

Mood Disorders - MentalHealth.gov

US Surgeon General Vivek Murthy on Vaccinating Kids, Mix and Match Boosters, Other Top Concerns

US Surgeon General Dr. Vivek Murthy, Co-chair of President Biden’s White House COVID Task Force appeared on a recent podcast to explain the latest approval for mixing vaccine brands for booster shots. He also addresses White House plans to roll out COVID vaccine support for the nation’s 5-11-year-olds pending FDA approval, examines the growing crisis of unmet mental health needs, addiction, and overdose in the wake of the pandemic, and discusses an initiative he’s creating to address burnout in the health care profession.

US Surgeon General Dr. Vivek Murthy, Co-chair of President Biden’s White House COVID Task Force appeared on a recent podcast to explain the latest approval for mixing vaccine brands for booster shots. He also addresses White House plans to roll out COVID vaccine support for the nation’s 5-11-year-olds pending FDA approval, examines the growing crisis of unmet mental health needs, addiction, and overdose in the wake of the pandemic, and discusses an initiative he’s creating to address burnout in the health care profession.

The Conversations on Health Care podcast with General Murthy can be heard here.

 

US Supreme Court Lets Maine Health Care Vaccine Mandate Stand

The United States Supreme Court left intact a vaccine requirement for Maine health care workers stand this week, rebuffing another legal challenge targeting COVID-19 vaccination mandates. The denial by Justice Stephen Breyer, who handles emergency requests from Maine.