COVID-19 Vaccine Providers Newsletter 07.13.2022

**Beginning this week we will be reducing the COVID-19 Vaccine Updates to 2 times per month**

Significant Changes to Federal Guidance

(New) HHS 6/29/2022 Press Release: Biden-Harris Administration secures 105 million doses of Pfizer’s latest COVID-19 vaccine for fall vaccination campaign - The U.S. Department of Health and Human Services (HHS), in collaboration with the Department of Defense, announced an agreement to purchase 105 million doses of Pfizer’s COVID-19 vaccine for a fall vaccination campaign, with options for up to 300 million doses. The contract announcement follows a June 28, 2022 meeting of the U.S. Food and Drug Administration’s (FDA’s) Vaccines and Related Biological Products Advisory Committee meeting, which recommended the inclusion of an Omicron component for COVID-19 booster vaccines in the U.S.
(New) FDA 6/30/2022 Press Release: Coronavirus (COVID-19) Update: FDA Recommends Inclusion of Omicron BA.4/5 Component for COVID-19 Vaccine Booster Doses - On Tuesday, June 28, 2022, the U.S. Food and Drug Administration’s independent experts on the Vaccines and Related Biological Products Advisory Committee met publicly to discuss whether a change to the current vaccine strain composition of COVID-19 vaccines for booster doses is necessary for the 2022 fall and winter seasons. “Following the vote, and striving to use the best available scientific evidence, we have advised manufacturers seeking to update their COVID-19 vaccines that they should develop modified vaccines that add an Omicron BA.4/5 spike protein component to the current vaccine composition to create a two component (bivalent) booster vaccine, so that the modified vaccines can potentially be used starting in early to mid-fall 2022. As we expect this coming year to be a transitional period when this modified booster vaccine may be introduced, we have not advised manufacturers to change the vaccine for primary vaccination, since a primary series with the FDA-authorized and approved COVID-19 vaccines provides a base of protection against serious outcomes of COVID-19 caused by circulating strains of SARS-CoV-2.”

CDC

Statement 6/24/2022 - CDC Recommends Moderna COVID-19 Vaccine (Spikevax) for Children and Adolescents Ages 6 through 17 Years - CDC Director Rochelle P. Walensky, M.D., M.P.H., endorsed the CDC Advisory Committee on Immunization Practices’ (ACIP) recommendation that Moderna’s COVID-19 vaccine be used as an option for children ages 6 through 17 years, in addition to its already recommended use in children 6 months through 5 years and adults 18 years and older. This recommendation reinforces the use of Moderna’s COVID-19 vaccine as an important tool in the pandemic and provides another vaccine option for children and adolescents. The ACIP recommendation comes after a thorough review of the scientific evidence demonstrating safety and efficacy, and supports the use of the vaccine among those 6 through 17 years of age.

FDA:

Press release 7/6/2022 - FDA Authorizes Pharmacists to Prescribe Paxlovid with Certain Limitations - the U.S. Food and Drug Administration revised the Emergency Use Authorization (EUA) for Paxlovid (nirmatrelvir and ritonavir), to authorize state-licensed pharmacists to prescribe Paxlovid to eligible patients, with certain limitations to ensure appropriate patient assessment and prescribing of Paxlovid.“The FDA recognizes the important role pharmacists have played and continue to play in combatting this pandemic,” said Patrizia Cavazzoni, M.D., director for the FDA’s Center for Drug Evaluation and Research. “Since Paxlovid must be taken within five days after symptoms begin, authorizing state-licensed pharmacists to prescribe Paxlovid could expand access to timely treatment for some patients who are eligible to receive this drug for the treatment of COVID-19.”

How to Order Moderna Vaccine for children aged 6-11 years in VaXMaX

The recently released Moderna Blue Cap/Purple Label vial has been approved for primary series administration to children aged 6-11 years old AND as a booster for adults aged 18+ years. This vaccine is currently available for order in VaXMaX and appears in the system as Moderna - Booster Only.

For questions about VaxMaX and its functionality, please visit the VaxMaX Help website, which includes reference guides and tutorial videos.

Upcoming Events

CDC National Center for Immunization and Respiratory Diseases (NCIRD)

With COVID vaccines now available across the lifespan, meeting schedules have been streamlined. The changes are intended to balance consistent COVID-19 information sharing with summer schedules, and hopefully allow more flexibility for taking some much needed rest.

Beginning in July the meeting schedule will be:

First Wednesday of the month – Vaccine Finder/Vaccines.gov Office Hours. 3:30 – 4:00 ET
Second Wednesday of the month – Distribution Officer Hours. 3:30 – 4:00 ET
Third Wednesday of the month – All Awardee Call. 3:30 – 4:45 ET
Fourth Wednesday of the month – The Reader (formerly The Weekly Reader)

Please note: all calls will begin at 3:30 pm ET and meeting invitations will be updated shortly

We will still be available for answering questions or ad hoc calls. Please work with your Project Officer if you do have questions.

Pediatric Pfizer Training: https://www.pfizermedicalinformation.com/en-us/medical-updates

VDH External Web Updates

(Updated) For the resource When to End Isolation or Quarantine that was last updated on 6/15/2022, posted the translations for Spanish, Arabic, Chinese, Korean, Tagalog. These are available on multiple sites:
- VDH Resources and Support website (under Exposure or Illness)
- What to do if you were potentially exposed to coronavirus disease (COVID-19)? (under For More Information)
- Health Professionals website (under Print Resources)
- K-12 Education (under General Resources for Parents)
- Institutions of Higher Education website (under Resources for Students)
- Testing and Laboratory website (under Resources for Patients tab)
(Updated) Vaccination FAQs -
- Updated the availability of Moderna COVID-19 vaccines for children and adolescents 6 years through 17 years
- FDA recommendations for COVID-19 vaccine booster formulations for the fall
- information for children on the cusp of an age group for which a different Pfizer or Moderna formulation is recommended