President-elect Joe Biden will seek to release nearly every available dose of the coronavirus vaccine when he takes office later this month, a move that signals a departure from the Trump administration and the FDA’s current stance of holding back half of the US vaccine supply in order to ensure that second doses are available. TJ Ducklo, a spokesman for Biden’s transition, said the President-elect thinks “we must accelerate distribution of the vaccine while continuing to ensure the Americans who need it most get it as soon as possible. He supports releasing available doses immediately.”
According to CNN, which first reported the story, a transition official said the Biden team believes that vaccine makers will be able to produce enough second doses in a timely manner while administering first doses to more Americans in the meantime. In addition, the report said Biden’s team plans to use the Defense Production Act to produce vaccine materials and other supplies in order to ensure there’s enough vaccine for both doses.
The US has so far issued emergency-use authorizations to Pfizer and BioNTech’s BNT162b2 as well as Moderna’s mRNA-1273, both of which consist of two doses that are given 21 days and 28 days apart, respectively. The contentious issue of adjusting COVID-19 vaccine regimens in an effort to stretch out supply is being looked in other countries as well, with the UK having already shifted to allow for wider gaps between the first and second doses. However, the FDA recently suggested it would be “premature” to make such changes because there is a lack of evidence about how they would affect the extent or duration of immunity.
Pressure from US states
The comment from Biden’s transition comes after a group of US governors wrote a letter to Health and Human Services Secretary Alex Azar and Operation Warp Speed chief operating officer Gustave Perna pressing the federal government to distribute “reserved doses” of the COVID-19 vaccine to states that need them. “Our states are ready to work around the clock to ramp up distribution, get more shots in arms, and save more American lives,” the letter states.
However, Michael Pratt, a spokesman for Operation Warp Speed, pushed back against the transition’s plan, noting it runs contrary to the FDA’s approved label. “Second-dose management was always about ensuring supply chain availability,” Pratt said, adding that “Operation Warp Speed monitors manufacturing closely, with the intent to transition from reserving as many second doses as manufacturing further stabilizes with a consistent flow of vaccines.”