COVID-19 BULLETIN BOARD

++ Disclaimer: This page is strictly for educational purposes, is updated periodically, and may not be reflective of the ever-changing pandemic. It does not reflect any of the views/opinions of HPhA. HPhA does not endorse or have any specific affiliations with the groups and/or organizations. ++ 


Interim Clinical Considerations for Use of COVID-19 Vaccines Currently Authorized n the United States (posted 5/1/2023)

COVID-19 Public Health Emergency ends May 11, 2023. (posted 4/20/2023)

Interim Recommendations from the Advisory Committee on Immunization Practices for the Use of Bivalent Booster Doses of COVID-19 Vaccines — United States (posted 11/11/2022)

TRC COVID-19 Resource Hub

Interim Clinical Considerations and COVID-19 Immunization Schedule

Administration Error Revaccination Guidance

Updated vaccination numbers by state: Tracking the covid vaccine: Doses, people vaccinated by state - Washington Post 

COVID-19 Vaccine Tracker Updates by the New York Times

Status of COVID-19 in Hawaii and Metrics

Hawaii COVID-19 Vaccine Distribution Data and Distribution Plan

HI-EMA COVID Resource Map 

Vaccine Finder

 

Hawaii-specific Legislation: (ongoing)

Topic Brief Description Last Updated
Prep Act

Pharmacist Administering Vaccines to Minors Between the Age of 3 – 18

Pharmacist, pharmacy intern or pharmacy technician Administering Seasonal Influenza Vaccines to Adults

Declaration is specifically for the purpose of providing immunity from liability, and is different from, and not
dependent on, other emergency declarations.

 9/2021
Vaccine Eligibility
Hawaii opened up COVID-19 vaccine eligibility to 16 years and older on April 19, 2021.
Click here to register for a vaccine.
4/2021
COVID-19 Allocation
Organizations to sign up here for essential frontline workers in phase 1b.
Note: Do not sign up if you are an individual employee.
 2/2021
Ready Reserve Corps
Interested in public service but not able to commit full time? Ready Reserve Corps may be for you!
The DOH is directing anyone interested in public service to sign up with the Hawaii Medical Ready Reserve Corps.
 1/2021
COVID-19 Vaccine Distribution is underway

If your pharmacy, both on Oahu and the neighbor islands, haven't heard from the DOH by Friday, January 8th, please also complete the survey to be contacted by the DOH. https://hawaiicovid19.com/vaccine/  or click link here: Survey of Independent Practice Sites for COVID-19 Vaccination Program (office.com)

For members of the general public and clinicians who have questions, please call the DOH COVID-19 line at 808-586-8332.

1/2021

State released draft plan Click here

11/2020

Free PPE for Small Businesses and Non-profits Starting August, 26, 2020, the Hawaii Emergency Management Agency (HI-EMA) has opened an opportunity for non-profit organizations and small businesses to obtain PPE equipment free of charge. To qualify, businesses must have fewer than 100 employees (pre-COVID). There is no restriction of size of non-profits.

9/2020-11/15/2020

Pharmacists administering COVID-19 tests Pharmacists and pharmacy interns, under the direct supervision of a pharmacist, to administer COVID-19 tests as long as they are following all appropriate guidelines. Employers should refer to DHHS 20-02 for further guidance regarding staff education/training.  8/2020

 

 

National Legislation: (ongoing)

Topic Brief Description Last Updated
COVID-19 vaccine reimbursement

NCPA has prepared information for pharmacies claiming reimbursement for administering COVID-19 vaccines during the public health emergency. Click here for more information.

4/2021
Joint CDC and FDA Statement on Johnson and Johnson COVID-19 Vaccine

UPDATE: ACIP recommendations for the J&J vaccine - overall benefit outweighs risk

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Johnson and Johnson COVID-19 Vaccine Health Alert

  • On 4/13/2021, the CDC and FDA issued a statement to pause further use of the Johnson and Johnson COVID-19 vaccine after reviewing data involving six cases, out of nearly 7 million doses so far in the US, were reported of cerebral venous sinus thrombosis in women between the ages of 18 and 48 with symptoms occurring 6 to 13 days after vaccination. These blood clots are extremely rare.
  • The CDC is recommending monitoring for signs and symptoms of a clot for those who received the J&J vaccine. However, the risk of developing a clot is very low for those who received a dose within 3 weeks. There have been no matching reports for the Pfizer or Moderna vaccines. 
  • On 4/14/2021, the ACIP held a public meeting which can be watched here. They will reconvene in the next 2 weeks to review any additional data. Click here for the FDA/CDC Joint Media Call.
  • Dr. Fauci's video about the J&J vaccine pause.
  • Additional information about the safety of COVID-19 vaccines can be found here.
  • ACOG Guidance

4/2021
FDA Update

Two revisions made to the Moderna COVID-19 Vaccine

  • Number of doses per vial increased to 15 (from 10)
  • Storage changes: Expiration increased from 12 hours to 24 hours under proper storage; expiration increased from 6 hours to 12 hours for punctured vials.
4/2021
CMS Update

CMS released updates to the Coverage and Reimbursement of COVID-19 vaccines, vaccine administration, and cost sharing

3/2021
Provider Resource

Enroll as a COVID-19 Vaccination Provider

3/2021
3rd COVID-19 vaccine FDA EUA

Janssen COVID-19 Vaccine (adenovirus vector)

EUA Fact Sheet for Providers

EUA Fact Sheet for Recipients and Caregivers

Adverse events

Preparation and Storage

ACIP recommendations

Understanding and Explaining Viral Vector COVID-19 Vaccines

In APhA's February 26th weekly open forum, John Grabenstein, RPh, PhD, FAPhA covers key attributes of the Janssen COVID-19 vaccine. 

2/2021
COVID-19 mRNA vaccine updates

1) The CBC updated clinical considerations for the COVID-19 mRNA vaccines in the United States included: 

  • Recommendations on interval between first and second dose
  • Recommendations on interchangeability of vaccine productions
  • Updates on vaccination in person with a history of COVID-19, dermal fillers, and vaccine excipients.

2) The FDA updated the Pfizer-BioNTech EUA labeling with guidance regarding withdrawal of doses from vaccine vials. Low dead-volume syringes and/or needles should be used to consistently withdraw 6 full doses. Do not combine remaining volumes from multiple vials.

3) APhA's Know the Facts on Minimizing COVID-19 Vaccine Dose Variability

4) USP's COVID-19 Vaccine Handling: Operational Considerations for Healthcare Practitioners, includes guidance on pre-drawing vaccine doses and storing within syringes. 

5) FDA allows more flexible storage and transportation for Pfizer COVID-19 vaccine

2/2021
Federal Student Loans
Biden signs federal student loan forbearance through September 2021!
Click here.
1/2021
National Strategy for the COVID-19 Response and Preparedness
Click here for PDF.
1/2021
FDA Statement on Following the Authorized Dosing Schedules for COVID-19 Vaccines | FDA
Reducing the vaccine dose violates the EUA and impacts liability of the administrator/facility. FDA issued a strong statement stating to only follow the dosing in the EUA.
1/2021
Clinician Resources

APhA At-A-Glance: COVID-19 Vaccine here*Note: In the table, the ACIP interim recommendations for use were switched. Correction: Pfizer-BioNTech for persons > 16 years of age and Moderna for persons > 18 years of age for prevention of COVID-19. 

The CDC ACIP Interim Recommendation for Use of COVID-19 VaccinesPfizer-BioNTech and Moderna COVID-19 Vaccines.

EUA Fact Sheet for Healthcare Providers: Pfizer-BioNTech and Moderna

EUA Fact Sheet for Recipients and Caregivers: Pfizer-BioNTech and Moderna

12/2020
FDA issues EUA for COVID-19 Vaccines

Pfizer's COVID-19 Vaccine - FDA approves EUA 

Moderna's COVID-19 Vaccine - FDA approves EUA

Safety and Efficacy of the BNT162b2 mRNA COVID-19 Vaccine. Click here to read the clinical trial published in the NEJM on 12/10/2020. 

Safety and Efficacy of the mRNA-1273 SARS-CoV-2 Vaccine.  Click here to read the clinical trial published in the NEJM on 12/30/2020.

12/2020
FDA  issues EUA for monoclonal antibodies for treatment of COVID-19
  • EUA issued for casirivimab and imdevimab to be administered for mild to moderate COVID-19 in adults and pediatric patients < 12 years old weighing at least 40 kg with positive results of direct SARS-COV-2 viral testing and who are at high risk for progressing to severe COVID-19. This includes those who are 65+ years of age or who have certain chronic medical conditions. Click here for press release.
  • EUA issued for baricitinib (Olumiant), in combination with remdesivir (Veklury) for the treatment of suspected or laboratory confirmed COVID-19 in hospitalized adults and pediatric patients > 2 years of age requiring supplemental oxygen, invasive mechanical ventilation, or ECMO. Baricitinib is not authorized or approved as a stand alone treatment for COVID-19. Click here for more info.
  • EUA issued for bamlanivimab for the treatment of mild to moderate COVID-19 in adult and pediatric patients < 12 years old and weighing at least 40 kg, and who are at high risk for progressing to severe COVID-19 and/or hospitalizations. This includes those who are > 65 years old or who have chronic medical conditions. Click here.
  • FDA approved the first treatment for COVID-19: remdesivir (Veklury) for use in adult and pediatric patients < 12 years old and weighing at least 40 kg for the treatment of COVID-19 requiring hospitalization. Veklury should only be administered in a hospital or in a healthcare setting capable of providing acute care comparable to inpatient hospital care. Click here.
11/2020
Amazon Prescription Delivery

Amazon is entering the pharmacy business with a new offering called Amazon Pharmacy, allowing customers in the United States to order prescription medications for home delivery, including free delivery for Amazon Prime members.

Amazon currently does not have licensure to access pharmacy services in Hawaii, but it is expected in the future. 

11/2020
Increased Access to Future COVID-19 Vaccines

Independent pharmacies and regional chains will also be part of the federal pharmacy program, further increasing access to the COVID-19 vaccine across the country. 

11/2020
COVID-19 vaccine-specific CPT codes

AMA published an update to the CPT-code set that includes new vaccine-specific codes to report immunizations for the novel coronavirus (SARS-COV-2). 

11/2020
Forth COVID-19 Interim Final Rule

Press Release Summary (issued 10/28/2020)

  • CMS removes administrative barriers to eliminate potential delays to patient access to a lifesaving vaccine. 
  • Any FDA or EUA COVID-19 vaccine will be covered.
  • The COVID-19 vaccine will be free for patients and providers. Providers will be paid an establishment fee for administration for Medicare patients, and a "reasonable" administration fee is suggested for Medicaid and commercial plans. 
  • If a patient is enrolled in a Medicare Advantage (MA) plan, the COVID-19 vaccine provider should bill Medicare Part B. 
  • Additional information on how to fill for uninsured patients through HRSA will be forthcoming.
  • Pharmacies providing COVID-19 vaccine to Medicare patients must be an enrolled Medicare provider or as mass immunizer with Medicare. Enrollment link
  • Toolkit for state Medicaid, providers, and others
  • Nursing Home Resource
  • CMS COVID-19 Office Hours Calls (twice a month on Tuesdays from 5-6PM EST or 12-1PM HST). Information here.
11/2020
Operation Warp Speed

What's Operation Warp Speed. Click here to learn more.

10/2020
Expanded Access to COVID-19 Vaccines & Tests

HHS issued guidance-PDF under the PREP Act authorizing qualified pharmacy technicians and State-authorized pharmacy interns to administer childhood vaccines, COVID-19 vaccines when made available, and COVID-19 tests, all subject to several requirements. 

10/2020
Well-Child Test tools provided by APHA, NASPA, NCPA

Well-Child Visit Brochure

Template Referral Form Well-Child Visit

Well-Child Checkup Letter

9/2020
Administration Action to Expand Access to Vaccines

Guidance for Licensed Pharmacists and Pharmacy Interns Regarding COVID-19 Vaccines and Immunity under the PREP Act

9/2020
COVID-19 Vaccine Allocation Discussion

**TIME SENSITIVE**

Public Listening Session 9/2/2020 - visit the website to register!

Written Comment Period for Discussion Draft - 9/1/2020 - 9/4/2020

9/2020-9/4/2020
Adovate for Provider Status

Take Action! Contact Congress today! 

9/2020
CARES ACT 2020

On Aug. 8, 2020, President Trump directed the Secretary to continue to suspend loan payments, stop collections, and waive interest on ED-held student loans until Dec. 31, 2020.

8/2020
Access to Childhood Vaccines

HHS expanded access to childhood vaccinations during the COVID-19 pandemic. After appropriate training, the pharmacist and pharmacy intern, under direct supervision of a pharmacist, is authorized to order and administer vaccines to ages 3-18 years old. Further requirements is explained in the amendment.

8/2020
Midyear Clinical Meeting and Exhibition

ASHP announced Midyear Clinical Meeting and Exhibition will transition to a virtual platform on December 6-10, 2020. Visit their website for more information.

8/2020
COVID-19 Vaccine Guidance Authorization for Licensed Pharmacists to Order and Administer COVID-19 Vaccines under the PREP Act 6/2020
COVID-19 Testing Form Pharmacies will need a CLIA Waiver to participate in testing. Fill out a form and mail it in to your state.  4/2020
HEROES Act of 2020 

Pharmacists and pharmacy technicians added to HEROES Act 

H.R.6800 - Emergency supplemental appropriations for the fiscal year ending September 30, 2020.

4/2020

 

 

CE Opportunities:

TRC COVID-19 Resource Hub - FREE

 

Resources:

Hawaii Board of Pharmacy Website - for updates on online applications, examination status/closures, contains material for MPJE

Hawai‘i DOH Website

City of Honolulu Website

CDC Website 

WHO Website 

ASHP Website 

HMSA Website

UW Medicine COVID-19 Resource Site

Johns Hopkins Interactive Map

VaccineFinder

MedFinder

Clinical trials

COVID-19 Vaccine Development

 


If you have any questions/concerns or would like to submit additions to this page, please contact us at [email protected].