New State Vaccine Guidance
New guidance for the State's COVID-19 Vaccination Program was issued on May 21st; click here to access it.
No Minimum Interval Between COVID-19 Vaccine and Other Vaccines
On May 14th, the Centers for Disease Control and Prevention (CDC) updated its Interim Clinical Considerations for Use of COVID-19 Vaccines Currently Authorized in the United States to recommend that “COVID-19 vaccines and other vaccines may now be administered without regard to timing. This includes simultaneous administration of COVID-19 vaccines and other vaccines on the same day, as well as coadministration within 14 days.”
Although COVID-19 vaccines were previously recommended to be administered a minimum of 14 days before or after other vaccines, that previous recommendation was out of an abundance of caution and not due to any known safety or immunogenicity concerns, and is no longer in effect. When deciding whether to co-administer another vaccine(s) with COVID-19 vaccines, providers should consider whether the patient is behind or at risk of becoming behind on recommended vaccines, their risk of vaccine-preventable disease (e.g., during an outbreak or occupational exposures), and the reactogenicity profile of the vaccines.
Updates to Pfizer-BioNTech COVID-19 Vaccine
On May 19th, the Food and Drug Administration (FDA) amended the Pfizer emergency use authorization (EUA) to allow undiluted, thawed Pfizer-BioNTech COVID-19 vaccine vials to be stored in the refrigerator at 2°C to 8°C (35°F to 46°F) for up to one month. Previously, thawed, undiluted vaccine vials could be stored in the refrigerator for up to five days. The updated storage and handling summary allowances for Pfizer are as follows:
- Ultra-cold (-80° to -60° C): May be stored in ultra-cold freezer until expiration or temporarily in the shipper with dry ice replenishment every five days for up to 30 days.
- Frozen (-25° to -15° C): May be stored in standard freezer for up to two weeks.
- Refrigerated (2° to 8° C): Undiluted for up to one month. Cannot be refrozen once thawed/refrigerated.
- Total storage time for Pfizer in freezer and refrigerator should not exceed 45 days (14 days frozen plus 31 days refrigerated). Beyond use dates for standard freezer/refrigeration must not exceed the labeled expiration date (i.e., not cumulative).
- Punctured vials: At refrigerated or room temperature for up to six hours.
In addition, the Pfizer COVID-19 vaccine will now have a new 450-dose ordering package (NDC 59267-1000-03), which will consist of three trays of 25 vials (150 doses) each and will ship ultra-frozen. Dry ice will NOT be sent in follow-up to the Pfizer 450-dose orders. Ancillary supply kit contents will be the same, with quantities adjusted for the smaller package. This new package size, combined with the updated storage requirements to allow the Pfizer vaccine to be stored refrigerated for one month, means that vaccination providers without ultra-cold storage may now be able to split one order to support both first dose and second dose administration. The 1,170-dose quantity of Pfizer vaccine will continue to be available as well and will still come with dry ice recharge 24 hours later if you have not opted out of dry ice shipments. Because only 35 percent of the U.S. Pfizer supply as of June 1st will be in the 450-dose package size, we encourage providers with ultra-cold storage to continue to order the full 1,170-dose package to enable those that do not have ultra-cold freezers for long-term storage to receive the smaller package size.
Johnson & Johnson Vaccine Supply
Members should be aware that as of May 19th, the majority of the U.S. supply of the Janssen (Johnson & Johnson) COVID-19 vaccine is due to expire by June 21st-23rd, according to Janssen’s expiration website.
Please reach out to your vaccination hub and/or your pharmacy providers if you are able to utilize this vaccine supply before its expiration.
Contact: Meg Everett, firstname.lastname@example.org, 518-929-9342