U.S. plan to expand access to Covid-19 vaccine likely sets up new debacles

As health authorities across the country struggle to get Covid-19 vaccination programs up and running, outgoing Health and Human Services Secretary Alex Azar threw a new wrench into the works on Tuesday, telling states to expand priority access to tens of millions of additional people immediately.

But it will be several months before there is enough vaccine available to meet that kind of demand. The move all but ensures the current narrative around the vaccine rollout — it’s too slow — will shift, but not in a positive direction: The incoming Biden administration will likely face a groundswell of complaints about long lines, failed efforts to find vaccine supplies, and an inequitable distribution system as it tries to live up to its promise of seeing 100 million vaccine doses administered in the new president’s first 100 days in office.

Azar’s new instructions put 152 million people — about half of the adult population of the country — at the front of the vaccine line. But Operation Warp Speed, the U.S. effort to fast-track the development and distribution of vaccine, currently estimates it will take until the end of March before it has 200 million doses to distribute. Even if those doses can be manufactured and shipped seamlessly, that’s only enough for 100 million people, given that the currently authorized vaccines require two doses each.

Azar reported Tuesday that 38 million doses of vaccine have been made available to the states so far.

The new prioritization scheme pushes everyone 65 and older, as well as people 16 and older with one high-risk medical condition, to the front of the vaccine line, where they join health workers and nursing home residents and staff. (The Centers for Disease Control and Prevention’s list of health conditions that put people at high risk of severe Covid infection is here.)

If states follow Azar’s instructions, a 24-year-old smoker who works from home would have the same vaccine priority status as a frail 85-year-old — and would be ahead of non-smoking teachers, municipal bus drivers, meat packing plant employees, and other frontline essential workers whom the CDC had previously recommended should be vaccinated in Phase 1b.

States, lacking sufficient federal funding and coping with limited supplies, have struggled to complete the vaccination of people in Phase 1a, which includes health workers plus the residents and staff of long-term care facilities — a population of about 24 million people. Federal officials believe the efforts will get easier as more supply becomes available, but to date only about 9.3 million people have received their first dose of vaccine, according to the CDC.

The initial prioritization schedule was drawn up by the Advisory Committee on Immunization Practices, an expert panel that provided recommendations to the CDC. ACIP envisioned frontline essential workers and adults 75 and older being included in the second phase of the vaccine rollout. There are an estimated 49 million people in those two groups, a more manageable figure in a time of vaccine scarcity.

In upending the prioritization schedule, Azar has pushed to the front of the line people he wanted to see there in the first place. When the ACIP recommended health workers and nursing home residents for Phase 1a, he pressed for changing the first group to people 65 and older, STAT reported in November. But CDC Director Robert Redfield had already signed off on the recommendation.

The ACIP plan had its critics, too, with some experts questioning how workable it would be to require pharmacists or people working in a vaccine clinic to determine who qualified as a frontline essential worker.

“Who’s supposed to be the gatekeeper for that? I mean, you can’t go to Rite Aid and Walgreens and ask the pharmacist to be the gatekeeper, which is essentially what you’d have to do,” Peter Hotez, co-director of the Texas Children’s Center for Vaccine Development, said in an interview.

Hotez, who published an opinion piece in the Washington Post on Monday urging changes to the vaccination rollout, said the stages outlined by the ACIP were too complex and were slowing down the program. “So my view is to toss ’em at this point.”

Beth Bell, a global health professor at the University of Washington who chaired a working group that devised the ACIP’s recommendations, expressed dismay at Azar’s instruction to the states.

“We all want the most effective and efficient vaccination program. But I’m quite concerned this approach … is not the best way to get us there,” Bell said.

The outgoing HHS secretary blamed states for the slow pace of the rollout, saying some are hewing so closely to prioritization schedules that they are not using the doses they have been allotted. “Some states’ heavy-handed, micromanagement of this process has stood in the way of vaccines reaching a broader swath of the vulnerable population more quickly,” Azar said.

He also put states on warning that those that don’t rapidly use their doses will see their supplies diminished in the future. Vaccination allocation so far has been based strictly on a population basis; beginning in two weeks, states that rapidly use their doses will get a larger allocation.

But in two weeks’ time, Azar will not be the HHS secretary, meaning it’s unclear if the plan will hold.

If states follow Azar’s instructions, efforts to protect frontline essential workers — people who cannot work from home and whose work puts them at greater risk of contracting Covid — will tumble further back in the prioritization scheme.

“By opening things up … there would be some gains in efficiency, but there would be significant losses as it relates to equity, racial justice, and the ability to … prevent morbidity and mortality in a high-risk group,” said Kristen Ehresmann, director of infectious disease epidemiology, prevention, and control for the Minnesota Department of Health.

“You gain something and you lose some things,” she said. “And I think many of the things you lose are really important things.”

Saad Omer, director of Yale University’s Institute of Global Health, supported prioritizing adults over the age of 65. But Omer, who was on a National Academy of Medicine panel that recommended vaccine priority groups and who worked on a priority schedule for the World Health Organization, said changing the advice at this point will come at a cost. State and local public health authorities will have to junk some plans and draft others.

“There’s been whiplash at the state level,” said Omer, who noted these decisions should have been made months ago. “And all the community-based partners are thoroughly confused.”

Azar on Tuesday also announced that Operation Warp Speed will no longer hold back half of vaccine supplies, a move it took to ensure that when people need to get their booster dose, there was enough available to give them a second, matching vaccine in the timeframe required — 21 days for the vaccine developed by Pfizer and BioNTech, and 28 days for the one developed by Moderna. The incoming Biden administration previously said it planned to rescind the policy.

Tom Frieden, former director of the CDC, was among the people who criticized the original decision to hold back the second dose. “You need to flood the zone with the vaccine that’s available, anticipating that the manufacturers will not fail,” said Frieden, who is now president and CEO of the global health initiative Resolve to Save Lives.

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