COVID-19 Vaccine

Vaccine Temperature Monitoring: New Paper Temperature Logs Available

To ensure that the vaccine at your site is viable when administered to patients, consistent temperature monitoring is an important part of participating in the program. Our program requires sites to maintain active and passive monitoring. The passive monitoring is recorded by the Digital Date Logger (DDL) and reported to our program regularly. The active monitoring is recorded on the paper temperature logs.

Please download and review the updated documents below:
Fridge Temperature Log (Celsius)
Fridge Temperature Log (Fahrenheit)
Freezer Temperature Log (Celsius)
Freezer Temperature Log (Fahrenheit)

Please use the new logs and review the instructions to make sure you are documenting temperatures correctly.

Paper temperature logs are a requirement for the VFC, VFAAR, and COVID-19 programs and must be kept on file for at least 3 years.

New COVID Ordering Guidelines

Starting this week providers can now order COVID vaccine through PhilaVax any day of the week. A closed reconciliation and most recent temperatures are still required to be submitted with an order for approval.Partial orders through Monday.com will continue to be due Wednesdays by 5pm. Please reach out to vaxonthego@phila.gov with any questions regarding the new ordering guidelines.

COVID-19 Vaccine Updates

COVID-19 Vaccine Updates

The Year in Review

The public health emergency declaration for COVID-19 recently ended on May 11. In the past year, there have been major updates to COVID-19 vaccine recommendations. Here are the highlights:

May 5, 2022 – FDA Limits Use of Janssen COVID-19 Vaccine to Certain Individuals

Summary: The FDA limited the authorized use of the Janssen COVID-19 vaccine to adults for whom other authorized or approved COVID-19 vaccines are not accessible or clinically appropriate, and to adults who elect to receive the Janssen COVID-19 vaccine because they would otherwise not receive a COVID-19 vaccine.

July 13, 2022 – FDA Authorizes Emergency Use of Novavax COVID-19 Vaccine, Adjuvanted

Summary: The FDA issued an EUA for the Novavax COVID-19 vaccine, adjuvanted for the prevention of COVID-19 caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in adults.

April 18, 2023 – FDA Authorizes Changes to Simplify Use of Bivalent mRNA COVID-19 Vaccines

Summary: Current bivalent vaccines (original and omicron BA.4/BA.5 strains) have been authorized to be used for all doses administered to individuals 6 months of age and older, including for an additional dose or doses for certain populations. The monovalent Moderna and Pfizer-BioNTech COVID-19 vaccines are no longer authorized for use in the United States.

Eligibility

CDC recommends that people ages 6 months and older receive at least 1 bivalent mRNA COVID-19 vaccine.

Everyone aged 6 years and older should get 1 updated Pfizer-BioNTech or Moderna COVID-19 vaccine to be up to date.

View the COVID-19 vaccination guidance for people who are not moderately or severely immunocompromised.

View the COVID-19 vaccination guidance for people who are moderately or severely immunocompromised.

Insurance Coverage

For those with most types of private insurance, COVID-19 vaccines recommended by the Advisory Committee on Immunization Practices (ACIP) will be covered without co-pay when provided by an in-network provider.

For people with Medicare, COVID-19 vaccinations will continue to be covered under Medicare Part B without cost sharing. Medicare Advantage plans will also continue to cover COVID-19 vaccinations in-network without cost sharing.

For people who have Medicaid, COVID-19 vaccinations will continue to be covered without co-pay or cost sharing through September 30, 2024, and will generally cover ACIP-recommended vaccines for most beneficiaries thereafter.

Through the “Bridge” Program, people who are uninsured will continue to be able to access COVID-19 vaccine at no cost.

Interim Clinical Considerations for Use of COVID-19 Vaccine

CDC has updated the Interim Clinical Considerations for Use of COVID-19 Vaccines Currently Authorized in the United States to reflect the following changes in the mRNA COVID-19 vaccination schedule:

At the time of initial vaccination, depending on vaccine product, children ages 6 months–4 years are recommended to receive 2 or 3 bivalent mRNA vaccine doses; children age 5 years are recommended to receive 1 or 2 bivalent mRNA vaccine doses.
People ages 6 years and older who are unvaccinated or previously received only monovalent vaccine doses are recommended to receive 1 bivalent mRNA vaccine dose.
People ages 65 years and older may receive 1 additional bivalent mRNA vaccine dose.

Updated clinical guidance for individuals who are immunocompromised will be shared as soon as possible.

COVID-19 Bivalent mRNA Vaccine Authorized for Primary Use

CDC has taken steps to simplify COVID-19 vaccine recommendations and allow more flexibility for people at higher risk who want the option to receive an additional COVID-19 vaccine dose. COVID-19 monovalent vaccines are no longer authorized for use.

These changes include:

An additional updated (bivalent) vaccine dose for adults ages 65 years and older and additional doses for people who are immunocompromised.
- Individuals ages 6 years and older who have already received a bivalent mRNA vaccine booster do not need to take any action unless they are 65 years or older or immunocompromised.
CDC recommends that everyone ages 6 years and older receive a bivalent mRNA COVID-19 vaccine, regardless of whether they previously completed their primary series.
- For young children, multiple doses continue to be recommended and will vary by age, vaccine, and which vaccines were previously received.
Original monovalent COVID-19 vaccine is no longer authorized for use. Moving forward, bivalent mRNA vaccine is approved for the primary series.

What to do About Monovalent Waste

Monovalent vaccines in inventory and expired ancillary kits should be wasted. All wasted vaccine must be reported to PhilaVax, removed from your inventory, disposed of properly, and removed from Vaccine Finder. View the PDPH wastage guide.

The PDPH Immunization Program will share updated guidance next week when published by CDC.

Coming Soon: Discontinuation of All Monovalent COVID Vaccine Products

FDA is expected to put out a HARD STOP on all monovalent Moderna and Pfzier mRNA products either this Friday (4.14.2023) or Monday (4.17.2023). Though monovalent products are still active for ordering, all Moderna or Pfizer Monovalent orders submitting this week will be rejected. Sites will be contacted to see if they want to switch to a bivalent product to complete these orders.

Bivalent products will be approved for primary and booster doses. ACIP will also approve a new bivalent schedule for 65yrs+ and immunocompromised individuals. Please look out for this information soon.

Novavax 10 Dose Vials Unavailable to Order After 4/5/2023

April 5 will be the last date to order 10 dose vials of Novavax. These doses will be short-dated, with an expiration date of 4/30/23. After 4/30, please discard all Novavax doses.

To maintain a non-mRNA vaccine option on site, 5 dose vials of Novavax will be available to order starting the week of 4/10/23, with a minimum ordering quantity of 100 doses.

Updated COVID-19 Booster Eligibility for Children 6 Months – 4 Years

CDC expanded its recommendation to allow children ages 6 months through 4 years who previously completed the full 3-dose monovalent Pfizer COVID-19 primary vaccination series to now receive a booster dose of Pfizer’s updated bivalent COVID-19 vaccine. This update only applies to the children who have completed the Pfizer monovalent 3-dose primary series.

The vast majority of children in this age group have not received any doses of a COVID-19 vaccine and the update means all children in this age group are eligible to receive an updated vaccine, either through completion of their primary series or through a booster dose.

Minimum Ordering Quantity Reduction

The minimum order quantity for bivalent Moderna 6mo – 5yr old (NDC 80777-0283-99) vaccine is being reduced to 20 doses per order. As a reminder, one carton of this vaccine contains 20 doses in 10 two-dose vials.Because ancillary supplies are packed well in advance of demand, they will continue to be shipped in minimum quantities to support 100 administrations per kit with this product. If you have sufficient supplies to support administration of the doses you order, we recommend opting out of receiving ancillary kits when placing orders for Moderna bivalent pediatric vaccines.

COVID-19 Vaccination Schedule

The scheduling of COVID-19 vaccinations was discussed at a recent meeting of the CDC’s ACIP meeting, where efficacy, safety, and coverage were also reviewed. Although updates to the vaccination schedule were discussed, no changes were made. Providers are advised to continue using monovalent products for the primary series and encourage patients to receive the updated bivalent booster at least two months after completing the primary series.

PDPH recommends that providers continue to order monovalent vaccines to ensure community members can access vaccination. Please see the visual below for quick reference to the COVID-19 Vaccination schedule for individuals who are not moderately or severely immunocompromised.