President-elect Joe Biden is reportedly planning to ditch the current Trump administration policy of withholding half of all available COVID-19 doses to ensure that the requisite second doses are available, according to a report by CNN.
Instead, the incoming administration plans to release the full available supply to states and jurisdictions.
“The President-elect believes 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 and believes the government should stop holding back vaccine supply so we can get more shots in Americans’ arms now,” TJ Ducklo, a spokesman for Biden’s transition, told CNN. “He will share additional details next week on how his administration will begin releasing available doses when he assumes office on January 20th.”
The policy news comes amid heated debate on vaccine release strategies and criticism of the federal and state rollouts so far. It also comes as the pandemic continues to break new records in cases, hospitalizations, and deaths. Over 266,000 people tested positive for COVID-19 Thursday, and a new grim record of more than 4,000 people died.
Today, a group of governors sent a letter to Health and Human Services Secretary Alex Azar and General Gustave Perna, chief operating officer of Operation Warp Speed, urging them to release the reserved vaccine doses.
“According to publicly reported information, the federal government currently has upwards of 50% of currently produced vaccines held back by the administration for reasons unknown,” the governors wrote. “While some of these life-saving vaccines are sitting in Pfizer freezers, our nation is losing 2,661 Americans each day, according to the latest seven-day average.” (The seven-day average of daily deaths is 2,758 as of the time of publication.)
The governors argued that the manufacturing pipeline for vaccine doses is “robust, safe, and capable of protecting a majority of the America public in the coming year.” They urged the officials to release the rest of the vaccines now, writing: “General Perna, as you have stated before, ‘a vaccine sitting on a shelf is not effective.’ We couldn’t agree with you more.”
The letter was signed by Gov. Gretchen Whitmer (Mich.), Gov. Gavin Newson (Calif.), Gov. Laura Kelly (Kans.), Gov. J.B. Pritzker (Ill.), Gov. Tim Walz (Minn.), Gov. Andrew Cuomo (N.Y.), Gov. Tony Evers (Wisc.) and Gov. Jay Inslee (Wa.).
In a brief modeling study published this week in the Annals of Internal Medicine, researchers estimated that nixing the strategy to withholding 50 percent of vaccines could indeed increase the speed of two-dose vaccination. They found that if officials instead withheld 10 percent of the supply for second doses during the first three weeks of vaccination, 90 percent during each of the next three weeks, and 50 percent thereafter, they could avert between 23 percent and 29 percent of COVID-19 cases in a hypothetical pool of 24 million people.
Meanwhile, other public health researchers have publicly debated more straightforward ideas for stretching out the vaccine supplies available to vaccinate as many people as possible. Ideas introduced include having people delay their second vaccine dose, cutting vaccine doses in half, or even mixing and matching vaccines in a two-dose regimen.
In a Washington Post op-ed published January 3, Robert Wachter, chair of the department of medicine at the University of California at San Francisco, and Ashish Jha, dean of the Brown University School of Public Health, argued for delaying second doses. “[A]s Mike Tyson famously said, ‘Everybody has a plan until they’ve been punched in the mouth.’ When it comes to COVID-19, we’re being punched in the mouth over and over again. It’s time to change the plan; namely, we should give people a single vaccination now and defer their second shot until more doses of vaccine become available.”
But other experts and federal officials have pushed back, saying there’s no evidence that a single dose will protect against the pandemic coronavirus. Moreover, some fear that a single dose could create weak immune responses that would give the virus more chances to mutate to avoid immune responses altogether.
In a statement earlier this week, two top officials at the US Food and Drug Administration tried to quash the debate, saying that without more data, vaccine doses and scheduling will stay as they are.
What is the problem?
“We have been following the discussions and news reports about reducing the number of doses, extending the length of time between doses, changing the dose (half-dose), or mixing and matching vaccines in order to immunize more people against COVID-19,” FDA Commissioner Dr. Stephen Hahn and Dr. Peter Marks, the FDA’s top vaccine regulator, said in the statement. “These are all reasonable questions to consider and evaluate in clinical trials. However, at this time, suggesting changes to the FDA-authorized dosing or schedules of these vaccines is premature and not rooted solidly in the available evidence. Without appropriate data supporting such changes in vaccine administration, we run a significant risk of placing public health at risk, undermining the historic vaccination efforts to protect the population from COVID-19.”
Federal officials have also questioned the call for more supplies to be distributed at all. They argue that the slow vaccination campaign so far is not due to a limited number of doses reaching states but hurdles getting those distributed doses into people’s arms.
“Operation Warp Speed is continuing to ensure second doses are available to vaccine administration sites, at appropriate intervals, as directed by jurisdiction leaders,” an HHS spokesperson told CNN. “We would be delighted to learn that jurisdictions have actually administered many more doses than they are presently reporting. We are encouraging jurisdictions to expand their priority groups as needed to ensure no vaccine is sitting on the shelf after having been delivered to the jurisdiction-directed locations.”
In an interview with the Washington Post this week, top infectious disease expert Anthony Fauci echoed that position while pushing back on the ideas to stretch vaccine doses, saying, “Right now, I don’t think there’s a need to do that at this point because you’ve got to ask yourself: What is the problem? And our problem is efficiently getting doses we already have into people.”