UPDATED PLEASE REVIEW—Extra Doses in mRNA COVID-19 Vaccine Vials

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Good Afternoon Immunization Partners,

The extra doses being reported in the vials has raised several questions. Here is the guidance we have received thus far.

For Moderna COVID-19 Vaccine, updated guidance as of January 8, 2021, the dose can be accepted if it is indeed a full dose obtained. It is crucial that providers only use an 11^th dose if it is truly a FULL dose obtained, and that they DO NOT use multiple vials to create a full dose. Here is CDC’s guidance:

• In some cases, providers may be able to obtain an 11^th dose from a Moderna vaccine vial, and this may be used if it is truly a full dose. Whether an 11^th dose is obtainable depends, in part, on the type of syringes and needles used to withdraw doses from the vials. Because the vaccine does not contain preservative, it is critical to note that if the amount of vaccine remaining in the vial cannot provide a full dose, discard the vial and content. Do not pool excess vaccine from multiple vials to create one dose.
• The URL for this information is: https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/moderna-covid-19-vaccine-frequently-asked-questions
• Note that CDC does not recommend repeating a dose in the situation you describe. No additional doses beyond the two-dose primary series are recommended at this time. Therefore, an 11^thdose from a Moderna COVID-19 vaccine vial does not need to be repeated.  

  For the Pfizer Bio-NTech COVID-19 Vaccine here is the guidance we have received:

• At this time, given the public health emergency, FDA is advising that it is acceptable to use every full dose obtainable (the sixth, or possibly even a seventh) from each vial, pending resolution of the issue. However, since these are preservative free vials, it is critical to note that any further remaining liquid that does not constitute a full dose should not be pooled from multiple vials to create one.
• The URL for this information is: https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/pfizer-biontech-covid-19-vaccine-frequently-asked-questions

As we receive more guidance regarding administering extra does, we will share it with you. We have a tip sheet on MCIR Inventory Adjustment for possible “Extra” COVID-19 Pfizer or Moderna Vaccine Doses. That adjustment tip sheet is: https://www.mcir.org/wp-content/uploads/2021/01/ExtraPfizerDoseTipSheet-1.4.2021.pdf

Additional information can be found at: https://www.cdc.gov/vaccines/covid-19/info-by-product/clinical-considerations.html.

Another concern that may arise when giving an extra dose is that you may not have enough vaccine records or other supplies within your ancillary supply kit. We have attached a copy of the Vaccination Record Card for you to make copies, as necessary. Also, CDC is continuing to review the ancillary supply kits and working to see about additional supplies being sent. In a recent CDC call it was reported that the ancillary kits will be updated to accommodate for the additional doses. As we hear more about the ancillary kits, we will share it.

Again, the information above is what our guidance is at this time and as more details are shared, we will announce it.

Thank You,

-The Immunization Nurse Education Team,
Andrea, Heidi, Maria, and Terri