The Department of Veterans Affairs on Thursday reversed its plans to discard additional doses of the coronavirus vaccine from Pfizer vials that arrived overfilled.
The department's initial guidance was issued despite the Food and Drug Administration approving use of all full doses available in each vial during the public health emergency, an internal memo shows. VA issued new guidance Thursday authorizing the use of additional full doses of the vaccine when they are present.
"After receiving additional input from FDA and other governmental agencies, VHA has made the decision to rescind the initial guidance on this topic and proceed with using the extra doses of Pfizer vaccine in the vials when the extra doses are present," VA Press Secretary Christina Noel told Connecting Vets.
Pfizer COVID-19 vaccine vials that recently shipped may be overfilled beyond the standard five doses per bottle. In some cases, it may be a negligible amount, but in others, it may be enough for several extra doses of the limited vaccine, company and federal officials said this week.
But VA officials initially didn't want medical staff to administer more than the five doses per vial, and any additional doses were planned to be "discarded," according to a memo obtained by Connecting Vets, which was sent to Veterans Health Administration pharmacy chiefs and others at the department Thursday morning. VA officials initially argued using the extra doses could jeopardize future allocations of the vaccine before changing course Thursday evening.
"The national COVID planning team has made the decision that only five doses of product should be withdrawn from each vial until the time in which VA is able to solicit more information from FDA, CDC and Pfizer," Jennifer Martin, deputy chief consultant of formulary management for VA Pharmacy Benefits Management Services, wrote in the first memo.
The Food and Drug Administration on Wednesday said it was aware some vials of the Pfizer vaccine may contain extra product, and was working with the company to determine the best path forward. Overfilling is not unusual in medicine to ensure full, accurate doses, but since some of the Pfizer vials may contain enough for additional full doses beyond the standard five, the FDA specifically advised all doses were acceptable to be used in the meantime, though separate vials should not be combined.
"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," the FDA said in a tweet on Wednesday. "However, since the vials are preservative-free, it is critical to note that any further remaining product that does not constitute a full dose should not be pooled from multiple vials to create one."
Dr. Peter Marks, director of the FDA Center for Biologics Evaluation and Research, said in an email that "it is acceptable to use every full dose obtainable (the sixth or possibly even the seventh) from each vial, pending our administrative solution to this issue" and once again warned against mixing liquid from multiple vials.
VA cited three main reasons for its initial decision to discard additional vaccine doses, "despite the information that has come from the FDA:"
- The CDC is requiring strict inventory monitoring for the vaccine, and drawing extra doses could make the data "questionable" since there is no current way to confirm which vials were overfilled and which were not. "Sending what appears to be inaccurate data to CDC may jeopardize VA's ability to get additional allocations (of the vaccine) in the future," the memo reads.
- There is a risk that some VA sites may try to combine overfill from multiple vials of the vaccine. Mixing those could be an "injection risk" for patients since the vials don't contain preservatives. FDA specifically warned against this.
- The vaccine requires a two-dose series, and the allocation sent to VA for the second dose is based on the total number of doses sent in the first round -- five doses per vial. If VA is able to get extra doses from some vials and not others, there's no guarantee a second allocation of the vaccine will also be overfilled and have enough extra doses to go around, leaving some patients unprotected, according to the memo.
VA said it planned to wait for additional information from the FDA, Pfizer and the Centers for Disease Control and Prevention before it will determine "whether or not it makes sense to change this policy in the future," the initial memo reads. "Until that time, sites should only be using five doses per vial." But after Connecting Vets' story published, VA released new guidance calling for the use of additional doses when available.
VA does not plan to track how many doses it's discarding in its pharmacy benefits tracking system, according to the initial memo.
"Any overfill that is discarded does not have to be tracked as waste per the PBM tracker," the memo said.
So far, it's unclear how many extra full doses may be included in the initial shipments of the Pfizer vaccine.
A spokesman for Senate Veterans Affairs Committee Chairman Jerry Moran, R-Kansas, told Connecting Vets Thursday afternoon that the senator "expects VA leaders to coordinate with CDC and FDA leaders on how to use the extra doses in an effective way."
Sen. Kyrsten Sinema, D-Arizona, said "wasting vaccine doses is outrageous" in a statement on social media Thursday.
"The Department of Veterans Affairs must follow FDA guidance and use all vaccine doses available to save lives," Sinema said.
The initial guidance followed the leader of the Veterans Health Administration, Dr. Richard Stone, telling Congress last week that initial shipments of the vaccine wouldn't be enough for the millions of Veterans and hundreds of thousands of VA staff who will need or want it.
As the largest healthcare system in the United States and America's backup healthcare system in times of crisis, VA hospitals were among the first to receive and administer doses of the vaccine, and VA, the second-largest federal agency, is likely receiving more shipments of the vaccine than many other major health systems.
VA's public-facing COVID-19 data tracking tool has also been offline for maintenance for six days. The last time the data was updated, VA had reached a record-high number of active cases and patient and staff deaths were spiking at the department.
{jcomments on}