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On February 26, the U.S. Food and Drug Administration (FDA) announced it is allowing undiluted frozen vials of the Pfizer-BioNTech COVID-19 Vaccine to be transported and stored at conventional temperatures commonly found in pharmaceutical freezers for a period of up to two weeks. This reflects an alternative to the preferred storage of the undiluted vials in an ultra-low temperature freezer between -80ºC to -60ºC (-112ºF to -76ºF). The change will be reflected in updates to the Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers).
The FDA on February 27 authorized the emergency use of the adenovirus vector COVID-19 vaccine co-developed by Johnson & Johnson and Janssen. The Johnson & Johnson-Janssen vaccine is administered intramuscularly as a single dose. The product is initially stored frozen by the manufacturer and shipped at refrigerated temperatures of 2-8 degrees Celsius. The vaccine is estimated to remain stable for two years at minus-20 degrees Celsius, at least three months of which can be at a temperature of 2 to 8 degrees Celsius. In addition, unpunctured vials of the vaccine can be stored between 9 and 25 degrees Celsius for up to 12 hours. As required under the emergency use authorization (EUA), Johnson & Johnson-Janssen has released fact sheets for providers and for patients.
Here are other resources that may be helpful:
- New Guidance on Coverage for COVID-19 Testing (Feb. 26)
- MSDH: COVID-19 Vaccination Provider Resources and Enrollment
- MSDH: Reporting Adverse Events After COVID-19 Vaccination and Recommendations for Severe Allergic Reactions/Anaphylaxis
- CMS: Toolkit for Health Care Providers
- CMS: FAQs on Medicare Fee-for-Service Billing
- CMS: CPT/HCPCS billing codes for administration of the Pfizer and Moderna vaccines
- CDC: Standing Orders Template and Pre-Vaccination Screening Tool for Pfizer Vaccine
- CDC: Pre-Vaccination Checklist for COVID-19 Vaccines
MHA will continue to provide updates on vaccine distribution as they become available. Members with questions may contact Joyce Pearson at firstname.lastname@example.org.