Pharmacists Can Use Extra Doses Found in Pfizer COVID-19 Vaccine Vials to Expand Supply

Officials with the FDA have affirmed that pharmacists administering the Pfizer/BioNTech coronavirus disease 2019 (COVID-19) vaccine can use leftover doses in vials containing multiple doses, which may boost the US supply by up to 40%, according to reporting by Politico.¹

There have been recent reports of hospital pharmacists discarding 1 in 6 doses of the Pfizer vaccine over labeling confusion. Without clear direction from the pharmaceutical company, extra doses were thrown away based on rules set by the FDA last week. Now, the FDA has advised 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 recent statement.²

As 2020 comes to a close, the government, pharmaceutical companies, and the health care system have raced to distribute a COVID-19 vaccine to Americans. Operation Warp Speed and Health and Human Services (HHS) have secured 40 million doses of the authorized vaccine. Although the extra vaccine could add up to millions of more doses, HHS Secretary Alex Azar, MD, remains optimistic about also ramping up production of the Pfizer vaccine by tens of millions of additional doses by the spring rather than the summer, as previously planned.³

“We are working with [Pfizer] to provide them whatever assistance, now that they have identified some of the production challenges,” Azar said in a briefing.

The variation in leftover doses is a result of different types of needles being used to administer the vaccine, according to Pfizer in a statement.³

However, the agency cautioned that leftover vaccine from different vials amounting to less than a full dose should not be administered due to the risk of cross contamination.

Andy Slavitt, former acting administrator of the Centers for Medicare and Medicaid Services, told Politico that the discovery “is more clever pharmacists than something missed by Pfizer.”¹

The Pfizer-BioNTech COVID-19 vaccine requires 2 doses (30 µg, 0.3 ml each) 3 weeks apart. The first vaccinations were administered on Monday to health care workers and the elderly, with the next delivery expected on December 21. Officials said that the earliest the general public can expect to be vaccinated is April 2021.⁴

References

1. Owermohle S. FDA says Pfizer vaccine vials hold extra doses, expanding supply. Politico; December 16, 2020. Accessed December 17, 2020. https://www.politico.com/news/2020/12/16/pfizer-vaccine-extra-doses-447117.

2. FDA says extra doses from vials of Pfizer’s COVID-19 vaccine can be used. Reuters; December 16, 2020. Accessed December 17, 2020. https://www.reuters.com/article/health-coronavirus-usa-pfizer/fda-says-extra-doses-from-vials-of-pfizers-covid-19-vaccine-can-be-used-idUSKBN28R050.

3. Nirappil F. FDA says Pfizer coronavirus vaccine contains extra doses, expanding nation’s supply. Washington Post. December 16, 2020. Accessed December 17, 2020. https://www.washingtonpost.com/health/pfizer-vaccine-doses-us/2020/12/16/9d63848c-3fc1-11eb-8bc0-ae155bee4aff_story.html.

4. Interim clinical considerations for use of Pfizer-BioNTech COVID-19 Vaccine. CDC; December 14, 2020. Accessed December 17, 2020. https://www.cdc.gov/vaccines/covid-19/info-by-product/pfizer/clinical-considerations.html.