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Washington, DC -- Representatives Jennifer Wexton, Don Beyer, and Gerry Connolly (all D-VA), sent a letter to the Acting Food and Drug Administration (FDA) Commissioner Woodcock requesting that the FDA look into ways to safely increase the vaccine supply via “pooling.” The practice of “pooling” consists of taking what's left over in a drug vial and combining it with what's left in another vial to create a full dose. Local clinicians have expressed frustrations over FDA’s policies that force them to throw out leftover doses in drug vials, rather than use them to get into the arms of patients. This letter comes in light of the high demand and lack of supply of the COVID-19 vaccine in Northern Virginia. In Fairfax County, the wait list for the vaccine exceeds 98,000, and in Loudoun County, the wait list exceeded 45,000 people in February. The letter also comes in the wake of an article from NBC News that describes how the supply of the Pfizer vaccine could be increased if clinicians are able to pool the vaccine. 

“It has been reported that there are significant amounts of leftover vaccine in almost every Pfizer-BioNTech drug vial, even after using the additional sixth doses in the vials,” the Representatives state in the letter. “With this leftover supply it could be possible for a hospital that typically administers 4,000 shots in a day to provide an additional 400 vaccine shots – a 10 percent increase in vaccine distribution capacity. Currently, however, clinicians are throwing away the extra doses in these vials due to FDA guidance that says ‘any further remaining product that does not constitute a full dose should not be pooled from multiple vials to create one.”

The Representatives seek answers on how the FDA came to the conclusion that remaining product from Pfizer-BioNTech and Moderna vials should not be pooled from multiple vials to create one full dose, if the FDA considered allowing clinicians to pool the COVID-19 vaccine when certain conditions are met, and if they have reviewed any data that shows this practice can be done safely.

The full letter can be found here and below.

March 10, 2021 

Janet Woodcock, M.D.  
Acting Commissioner 
U.S. Food and Drug Administration  
10903 New Hampshire Ave 
Silver Spring, MD 20993-0002 

Dear Acting Commissioner Woodcock: 

We would like to thank the Food and Drug Administration (FDA) for its strong commitment to making decisions based on data and science, which is of upmost importance during the COVID19 pandemic. We are also glad that, after vigorous review, FDA has approved the Johnson & Johnson vaccine and approximately four million doses were distributed throughout the United States last week. We write today regarding the FDA’s policies related to the pooling of the COVID-19 vaccine to help vaccine doses get into the arms of the American people. 

Northern Virginia is experiencing a high demand for the COVID-19 vaccine but lacks supply. Nearly half of all Virginians are eligible for the vaccine under Phase 1b. In Fairfax County the wait list for the vaccine exceeds 108,000 and in Loudoun County the wait list exceeded 45,000 people in February. The INOVA health system—a major vaccine source for Northern Virginians—has the infrastructure to administer thousands more doses but is unable to due to limited supply. 

It has been reported that there are significant amounts of leftover vaccine in almost every PfizerBioNTech drug vial, even after using the additional sixth doses in the vials. With this leftover supply it could be possible for a hospital that typically administers 4,000 shots in a day to provide an additional 400 vaccine shots – a 10 percent increase in vaccine distribution capacity.  Currently, however, clinicians are throwing away the extra doses in these vials due to FDA guidance that says, “any further remaining product that does not constitute a full dose should not be pooled from multiple vials to create one.”  

The FDA’s concerns about cross-contamination of vaccine doses due to a lack of preservatives in the Pfizer-BioNTech and Moderna vaccines is based on public health and patient safety. However, the FDA should continue to explore ways to increase vaccine supply without putting patients at risk, including safe ways to avoid vaccine waste by combining leftover doses from drug vials.  

• How did you come to the conclusion that remaining product from Pfizer-BioNTech and Moderna vials should not be pooled from multiple vials to create one full dose?
• Has the FDA considered allowing clinicians to pool the COVID-19 vaccine when the following conditions are met:
  • Combined doses are used within 6 hours of opening any vial to avoid cross contamination;
  • Vaccine doses are only combined from vials with the same lot number to allow clinicians to track the vaccine doses;
  • Allowing vaccine doses to be pooled and administered only at certain settings of care that FDA identifies has the capability to adhere to standards like those described above to ensure patient safety.
• Has FDA reviewed any data that shows this practice can be done safely? 

Sadly, we have reached a tragic milestone where over 500,000 Americans have died from COVID-19. We should be doing everything in our power to increase vaccine supply to help put an end to this pandemic and save lives. 

Thank you for all that you have done to help stop the spread of COVID-19 and the steps you have taken to ensure vaccine safety and efficacy. We look forward to your response.  

Sincerely,

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