Biden Says He’ll Release More Vaccine in Second-Dose Gamble

(Bloomberg) -- President-elect Joe Biden’s team says he’ll distribute more of the available doses of coronavirus vaccines, reversing the Trump administration’s practice of holding back the second shots needed to reach maximum potency.

The move, announced by Biden’s office Friday and supported by a group of Democratic governors, represents a gamble by the incoming administration that there will be enough vaccine available to ensure second shots after 21 days for the Pfizer Inc.-BioNTech SE vaccine, and 28 days for the Moderna Inc. shot.

The decision is a response to the sluggish vaccine rollout as Covid-19 cases and deaths have hit record levels in the U.S. Biden’s statement didn’t make clear how many shots he might still withhold. But TJ Ducklo, a Biden spokesman, said the president-elect plans to release added details next week.

“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,” Ducklo said in a written statement.

The Trump administration has withheld about half of allocated doses of the two vaccines authorized for emergency use in the U.S. The decision was a hedge against uncertainty in vaccine supply, made to ease concerns among Americans that they might not be able to complete the two-dose regimens shown in studies to be more than 90% effective.

Biden’s transition team, though, remains confident that manufacturers can meet the demand, and will use the Defense Production Act to force production of materials if necessary, according to a transition official who asked not to be identified. While Biden’s camp hasn’t said specifically how many of the withheld second doses they would send out immediately, the transition official said it’s expected to be nearly all of them.

Pfizer will work with the Biden administration on distribution challenges “so that as many Americans as possible have access to our vaccine as quickly as possible,” spokesman Eamonn Nolan said in an email. A representative from Moderna didn’t immediately respond to requests for comment.

Some patients who got the first doses of the Pfizer vaccine are already receiving their second shots.

Administering Shots

Some state health officials said on Thursday that getting a larger supply of vaccines would make it easier to efficiently administer the shots.

“I’ll have locations who are ready to administer a thousand or more shots a day, but if they can only get 150 or 200 shots a day, they can’t operate at full volume,” said Steven Stack, commissioner of the Kentucky Department for Public Health, on a call with reporters.

Kentucky has been getting about 53,000 doses a week of the Pfizer and Moderna shots and has been told to expect that same level for months ahead. Limited supply makes it harder to distribute widely, Stack said.

“There’s so little of it, that if you sprinkle it like pixie dust all over the state, if every site only got five doses a week, nobody ever knows when a site may or may not have vaccine,” he said.

Hard to Plan

Meanwhile, hospital officials said uncertainty over supply makes distribution difficult to plan.

Centura Health, a hospital system in Colorado and western Kansas, got almost 9,000 doses for first shots last week but just over 4,000 this week, said Shauna Gulley, chief clinical officer. “Really we’re limited as an organization by how fast our state receives supply from the federal government,” she said on Thursday.

Centura has administered more than 20,000 immunizations to date. By late January, the system could be doing more than that each week, if the supply is available, Gulley said.

Eric Dickson, chief executive officer of UMass Memorial Health Care in central Massachusetts, also expressed concern about the unpredictability of supply.

“It’s Thursday,” he said. “I don’t know how many I’m going to get this week.”

Dickson said UMass received fewer doses than it initially expected and has capacity to administer more. But he’s reserved some of the shots on hand to ensure the system can deliver second doses on time if new shipments don’t arrive.

“They’re holding second doses, I’m holding second doses, maybe the state’s holding second doses,” he said. “We’re a month in. We should be able to say, this is what you’re going to get and when, and now you can plan in terms of your capacity,” he said.

Dosing Risk

The Biden plan is contrary to current U.S. Food and Drug Administration recommendations that say vaccines shouldn’t be distributed without being sure a second dose is available, according to a spokesman for the Department of Health and Human Services.

“Second-dose management was always about ensuring supply chain availability,” HHS spokesman Michael Pratt said. “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.”

Operation Warp Speed is the Trump administration’s program to develop and distribute Covid-19 vaccines. Federal officials previously said they made the decision to withhold doses because without a second shot, there is a risk the first shot may not provide as strong or lasting protection against the virus.

“We don’t know how the behavior of the vaccine would be if we omit to give the second dose at three weeks or at four weeks after the first dose,” Moncef Slaoui, one of the officials leading the vaccine rollout, told CBS last month.

“As always, early in manufacturing, there may be challenges. Sometimes, vaccine doses can be delayed by a week or a few days or, God forbid, by three weeks. It would be inappropriate to partially immunize large numbers of people, and not complete their immunization,” he said.

FDA Chief

There has been wide debate in the public health community about whether to delay second doses of the Moderna and Pfizer shots in order to provide first doses to more Americans faster, in the hope the pandemic will be rapidly brought under control.

President Donald Trump’s FDA commissioner, Stephen Hahn, has publicly argued against such a strategy.

But Democratic governors echoed Biden’s plan in a letter to a pair of senior Trump administration officials, urging that the strategy be adopted even before Biden is inaugurated on Jan. 20.

“We demand that the federal government begin distributing these reserved doses to states immediately,” the governors wrote in a letter, dated Friday and obtained by Bloomberg News. It was sent to Health Secretary Alex Azar as well as General Gustave Perna, who has been leading the logistical rollout of the vaccine.

“Our states are ready to work around the clock to ramp up distribution, get more shots in arms, and save more American lives,” the governors said.

The letter was signed by New York Governor Andrew Cuomo, Michigan Governor Gretchen Whitmer, Illinois Governor J.B. Pritzker, California Governor Gavin Newsom, Kansas Governor Laura Kelly, Minnesota Governor Tim Walz, Washington Governor Jay Inslee and Wisconsin Governor Tony Evers.

©2021 Bloomberg L.P.