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TUESDAY, December 06, 2022
Trump administration reverses stance, will no longer hold back second shots of coronavirus vaccine

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

WEDNESDAY, January 13, 2021

WASHINGTON - The Trump administration announced sweeping changes to its vaccination rollout on Tuesday, including making all of the coronavirus vaccine supply immediately available, urging states to provide shots to anyone 65 and older and warning that states with lagging inoculations will lose some of their shots to speedier places.

The steps, part of an effort to accelerate a delayed and disjointed rollout, depart from the administration's original strategy, and 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, including likely calling for inoculations of everyone 65 and older and expanding the number of venues where shots are administered, according to two people familiar with the deliberations who spoke on the condition of anonymity because they were not authorized to discuss them.

But it is not clear how, or even if, the outgoing administration's plan to change state allotments of vaccines will play out. Health and Human Services Secretary Alex Azar told reporters in a briefing that in two weeks, the government would begin "redirecting" shots to states based on the size of their 65-and-older population and the pace of their vaccinations. States doing a poor job of getting shots into arms could see their allotments shifted to those performing better, he said, noting that about 10 states might be affected.The current allocation system is based on a state's population.

Federal officials have complained the data on state immunization efforts is incomplete and that states vary significantly in how many of the shots given to people are reported within the required three days.

"This new system gives states a strong incentive to ensure that all vaccinations are being promptly reported, which they're currently not," Azar said. "And it gives states a strong incentive to ensure that doses are going to work protecting people rather than sitting on shelves or in freezers."

But Azar, a Trump cabinet secretary, will be gone in a little over a week, and it is unclear whether the Biden camp endorses the idea. The president-elect's transition team declined to comment on it. Other federal health officials expressed concern the changes would cause confusion, and questioned how they could be enforced, said one health official who spoke on the condition of anonymity to share internal discussions.

State health officials, meanwhile, denounced the plan as punitive.

"It is too early to begin to judge how well states are administering this, and a punitive approach isn't going to help us reach our goal of vaccinating the entire population as safely and quickly as possible," said Michael Fraser, who heads the Association of State and Territorial Health Officials.

Since the mass vaccination effort began last month,the Trump administration has held back roughly half the vaccines to ensure sufficient supply for people to get a required second shot.Under the new policy, the expectation is that people will still get their second doses about a month later, as planned. Azar and other Operation Warp Speed officials, who oversee vaccine distribution, said concerns about possible hiccups in manufacturing and distribution have been allayed by the steady ramp-up.

Over the next two weeks, Azar said, doses held in reserve will be shipped out based on states' orders. Beyond that, he said, the available doses will be released first to cover second doses and then to provide additional first vaccinations.

Ohio Gov. Mike DeWine, a Republican, called the move to release all available doses a "welcome change." "More details will be coming," he said at a briefing Tuesday. "It is in fact very good news."

Other supporters said that while releasing more vaccines could mean some people might face a small delay in getting a second shot, the risk of delayed inoculations is much greater as the pandemic claims thousands of lives daily and as a new, more contagious variant of the virus first identified in Britain spreads through the United States.

Critics, however, worry that an unforeseen and extended delay of the booster shot could undermine the efficacy of the vaccines.

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.

The administration's call to states to broaden access to those 65 and older and those under 64 with high-risk medical conditions sharply increases the potential number of people seeking shots to about 184 million, intensifying demand on already stressed sign-up systems.

Under the original CDC recommendations, about 74 million people are in the first priority groups for vaccination: health-care workers; staff and residents of long-term care facilities; front-line essential workers; and adults 75 and older.

Neither Azar, nor other Warp Speed leaders, addressed how expanding the priority age groups would affect access to vaccine for front-line essential workers, from grocery store clerks to bus drivers, who had been in the next group prioritized for vaccination in many state plans. Azar noted that some states, such as Florida and Texas, already are vaccinating those 65 and older, and called it a faster way to protect many of the most vulnerable.

But Jason Schwartz, an assistant professor of health policy at the Yale School of Public Health, said on Twitter that the change could usher in "a free-for-all."

"This seems like chaos," he added. "Effectively telling 100 million+ people that they are eligible for vaccines now, while knowing that most will have to wait for several months actually get it" will cause rampant frustration.

Others noted that the priorityrecommendations from a Centers for Disease Control and Prevention advisory committee were a compromise between the desire to shield front-line essential workers who are disproportionately people of color and most likely to catch and transmit the virus because they cannot work from home, and to protect older people who are most prone to serious complications and death.

The change in the vaccination plans was discussed with governors in a meeting Tuesday afternoon chaired by Vice President Pence. Azar told the group the United States was on track to hit 1 million vaccinations a day within seven to 10 days, according to a Washington state readout.

The decisions to overhaul the vaccine distribution program were made this weekend in two meetings held by the leadership of Operation Warp Speed, as officials searched for ways to speed up a sluggish rollout, according to the senior administration official.

Some of the changes closely mirror options under consideration by Biden's covid-19 response team, which is preparing the president-elect to lay out his own pandemic plan later this week. The Biden team was also looking at ways of broadening access for adults 65 and older, and getting states a clearer forecast of future vaccine supply, according to two people familiar with the deliberations who spoke on the condition of anonymity because they were not authorized to discuss the specifics.

Several state health officials and immunization managers complained Tuesday that they got no advance notice of the changes.

"I don't think making allocations more complicated and unpredictable does anything to improve efficiency, or help states get vaccine to where it needs to go," said Claire Hannan, executive director of the Association of Immunization Managers, whose members direct immunization programs throughout the country.

Fraser, the head of the state health officials group, added, "The root problem is a supply issue. When will we have 184 million x 2 vaccines?"

But Azar blamed the slow rollout on states that have been overly rigid in adhering to the priority list, attempting to inoculate everyone in one group before moving to the next. "There was never a reason that states needed to complete vaccinating all health-care providers before opening vaccinations to older Americans and other vulnerable populations," he said.

He likened it to boarding an airplane. "Imagine if you fined gate agents for boarding people out of order - you'd be standing at the gate for hours."

Nearly 40 million doses are available to states now, Azar said. The latest figures show that more than 27 million doses of the two authorized vaccines have been distributed, with more than 9 million doses administered as of Tuesday at 9 a.m., according to the Centers for Disease Control and Prevention.

Last week, he had announced the federal government was accelerating a plan to distribute vaccines through retail pharmacies, which will handle scheduling appointments and reporting vaccinations. He said officials are also planning to use federally qualified health centers that serve low-income and minority populations.

An expansion of vaccination venues is part of Biden's plan as well. The president-elect said last week that he wants to "establish thousands of federally run and federally supported community vaccination centers of various sizes across the country located in high school gyms or NFL football stadiums."

Biden said the effort will include mobile clinics in rural areas remote from pharmacies, as well as a storefront vaccination programs in pharmacies and other commercial spaces. But he cautioned "that will cost money," saying that the Trump administration and Congress have not yet devoted enough effort to the unprecedented mass vacation campaign.