Trump administration reverses stance, will no longer hold back second shots of coronavirus vaccine

The changes are a sharp departure from the administration’s previous strategy, and they come just days after President-elect Joe Biden announced plans to release nearly all the vaccine supply. Biden is expected to provide a detailed blueprint on reinvigorating the rollout later this week.

The Trump administration has been holding back roughly half the vaccines to ensure sufficient supply for people to get a required second shot. But in draft remarks prepared for a scheduled call Tuesday afternoon with governors and obtained by The Washington Post, Health and Human Services Secretary Alex Azar disclosed the change in plans. The remarks were confirmed by a senior administration official who spoke on the condition of anonymity because they were not authorized to speak publicly.

Azar also will announce plans to expand the venues where people can get inoculated, including at community health centers, and offer technical assistance from the National Guard or Federal Emergency Management Agency for states seeking to set up mass vaccination sites as they expand populations prioritized for immunization, according to the remarks.

Administration officials will also recommend that the vaccines be made available to anyone 65 and over, and to adults who have a preexisting condition that puts them at greater risk for severe illness, sharply increasing the number of people who will be eligible for the shots, according to Axios and confirmed by the administration official.

The decisions to overhaul the vaccine distribution program were made in two meetings held by leadership of Operation Warp Speed, the administration’s efforts to develop and distribute vaccines and therapeutics, over the weekend as officials searched for ways to speed up a sluggish rollout, the official said.

The changes are expected to be announced Tuesday in a media call by Warp Speed, and in a call with the governors later in the day.

During the two Warp Speed meetings, which included officials from the White House and the Centers for Disease Control and Prevention, data showed that vaccine administration has been slowed because states and health-care providers are adhering too rigidly to guidance about priority groups while manufacturing has steadily increased, the official said. “States have to expand. It’s like boarding an airplane. Your group gets called, but you don’t wait for everyone before you announce the next group,” the official said.

Nearly 40 million doses are available to states now, the official said. The latest figures show that more than 25 million doses of the two authorized vaccines have been distributed, with nearly 9 million doses administered as of Monday at 9 a.m., according to the Centers for Disease Control and Prevention.

A second dose of the vaccine can be ensured by holding it in reserve or by “a dose coming off the manufacturing and quality control checks,” Azar’s prepared remarks said.

“To that end, over the next two weeks, the final doses we held in reserve will be shipped out based on orders. Going forward, each week, the doses available will be released to first cover the needed second doses and then cover additional first vaccinations.”

Azar’s remarks were prepared for a call that is scheduled to be led by Vice President Pence. The health secretary’s comments were widely circulated among HHS officials and shared with The Post.

The changes to be announced Tuesday appear to be similar to what Biden proposed last week. The Warp Speed plan is to release “a steady cadence for second shots and new additional first shots,” the official said. “If anything were to happen [with manufacturing,] you would cover the second doses first and pause any additional first ones.”

Azar is expected to acknowledge “bottlenecks” in the vaccination effort and said progress in getting shots into arms has been “highly uneven.”

He is set to reiterate the administration’s position that states do not need to rigidly adhere to vaccinating one priority group before moving to the next. “There is no reason that states need to complete, say, vaccinating all health-care providers before opening up vaccinations to older Americans or other especially vulnerable populations, while continuing to work to finish vaccinating those in the first stage.”

Last week, Azar had announced the federal government was accelerating a plan to distribute coronavirus vaccines through retail pharmacies. That program allows states to allocate vaccines directly to these pharmacies, and pharmacies can then administer the vaccine to certain groups. The pharmacies will handle scheduling appointments and reporting numbers of vaccinations, Azar said.

Officials are also “working to activate” federally qualified health centers that serve low-income and minority populations for vaccination. Some centers are already being used for the vaccination effort, Azar said.

While officials with the federal Warp Speed vaccine effort have always described the decision to reserve second doses as a temporary strategy, they had not said when they planned to alter it.

The administration has repeatedly defended its practice of holding back 50 percent of the vaccine supply, saying it is critical to ensure that everyone who gets a first shot is guaranteed a second one at the right time, even if manufacturing problems were to disrupt supply.

Both the Pfizer-BioNTech and Moderna vaccines — the only two coronavirus vaccines that have been cleared by the Food and Drug Administration — were shown in clinical trials this year to be highly effective when administered in a two-shot regimen. The second Pfizer shot is given after 21 days, and the second Moderna shot after 28 days.

But critics of withholding 50 percent of supply have said it is an overly conservative approach at a time when a raging pandemic is killing thousands of Americans a day. They have argued that it is imperative for the nation to vaccinate as many people as quickly as possible, saying it’s important to prevent a more transmissible variant of the virus, like the one that fueled a surge of infections in Britain, from gaining a foothold in the United States.

In addition, they have noted that the Pfizer and Moderna manufacturing processes have not had major hiccups. And many scientists have said that even if there is a slight delay — a few days, or a couple of weeks in someone getting a second dose — it wouldn’t be a major problem.

In this view, holding back available doses is wrong, as long as there is high confidence the vaccine production will continue uninterrupted.

But that view has its own skeptics, in part because many states and localities have not been able to use the vaccine they already have in a timely way.

“If I were confident we were efficiently using all the doses that are being distributed and that the supply was getting low, then I could understand releasing a lot more doses to meet demand,” said Stephen Ostroff, former acting commissioner of the FDA. He was reacting to the Biden plan and did not know about the new Trump plan.

“But we have lots of vaccines floating around the system and we don’t have the ability to get into people’s arms,” he said, saying the most needed step to speed up shots is to add vaccination sites and staff to administer the inoculations.

Others note that some parts of the country have unused supply, while others do not have enough. As states and localities move from vaccinating health-care workers and staff and residents of long-term care facilities to lower-priority groups in the next several weeks, public health officials predict that much more supply will be needed.