The Trump administration on Tuesday released updated guidelines intended to speed states' distribution of authorized Covid-19 vaccines by recommending that states immediately expand who's eligible for vaccinations and broadening where Americans can receive the vaccines.
Just released: The U.S. Covid-19 vaccination scenario planning guide
America's coronavirus vaccine rollout off to a slow start
The administration issued the new guidelines in response to criticism over America's lagging vaccine rollout—and just a few days after President-elect Joe Biden's transition team announced similar plans to ramp up vaccine distribution once Biden takes office. CDC data shows that, as of Tuesday morning, the federal government had distributed about 27.7 million doses of the Covid-19 vaccines currently authorized for use in the United States, but just about 9.3 million Americans had received their first dose of the two-dose Covid-19 vaccines. In recent days, public health experts, state officials, and federal lawmakers have called on the Trump administration to issue more guidance on how states should distribute the vaccines to help speed up the rollout.
Trump admin releases updated guidance intended to accelerate vaccinations
On Tuesday, HHS Secretary Alex Azar and officials from Operation Warp Speed, the Trump administration's Covid-19 vaccine initiative, announced new guidelines intended to accelerate vaccinations by expanding both the number of Americans who are eligible to receive the vaccines and the locations at which Americans can be vaccinated.
Previously, CDC guidelines recommended that states first prioritize inoculating health care workers as well as residents and staff in long-term care facilities. The guidelines suggested that, once that first priority group was vaccinated, states then should move on to vaccinating certain essential workers and people ages 75 and older.
But the new guidelines announced Tuesday recommend that, in addition to health care personnel and long-term care residents, states should immediately open vaccine eligibility to all Americans ages 65 and older, as well as Americans with health conditions that put them at higher risk of developing a severe case of Covid-19 or dying from the disease.
The new guidelines also seek to expand the nation's capacity to administer Covid-19 vaccines by authorizing more community health centers and pharmacies to begin doing so.
In accordance with the new guidelines, Azar said the federal government will start distributing additional vaccine doses to states based on the size of their populations ages 65 and older and their pace of vaccinations so far. "If you are not using vaccines that you have the right to, then we should be rebalancing to states that are using that vaccine," he said.
Further, Azar said the federal government will move to distribute all of the available vaccine doses it currently has—which marks a reversal from the Trump administration's previous distribution plan. So far, the Trump administration only has released doses of the vaccines that were intended to serve as patients' first shot in the two-dose vaccine regimens.
"This next phase reflects the urgency of the situation," Azar said, adding, "Every vaccine dose sitting in a warehouse rather than going into an arm could mean one more death that could have been avoided."
The upsides—and potential downsides—of expanding vaccine eligibility, distributing all doses
According to Becker's Hospital Review, the new guidelines are similar to the plans recently announced by Biden's transition team. States don't have to follow the new guidelines, but some already have taken measures to speed up their vaccine rollouts. For instance, as of Monday at least 16 states had either started allowing or announced that they would soon allow older Americans who didn't fall under CDC's original first-priority group to get vaccinated against Covid-19. In Florida, Georgia, and Texas, for example, adults ages 65 and older already were eligible for vaccinations. Texas also already offers Covid-19 vaccines to individuals with chronic health conditions.
Opening eligibility to all Americans ages 65 and older and Americans with high-risk health conditions nationwide would mean an additional 128 million people would qualify to receive a Covid-19 vaccine—which could significantly accelerate the country's vaccination efforts.
But experts have warned there also could be downsides to expanding eligibility and ramping up distribution too soon.
For example, as the New York Times reports, instead of the federal government reserving enough doses to supply Americans' second shots of the vaccine, second doses now will "be provided by new waves of manufacturing." However, "vaccine manufacturing has not ramped up as rapidly as many experts had hoped," according to CNN, and experts therefore are concerned that it could be months before there's enough vaccine supply to meet increased demand.
According to STAT News, Operation Warp Speed officials have estimated that the federal government will have 200 million doses of authorized Covid-19 vaccines to distribute by the end of March. Because the two vaccines currently authorized for use in the United States each require patients to get two separate doses of the vaccines a few weeks apart, that supply is enough to fully vaccinate 100 million Americans.
As such, it's not guaranteed that there will be enough vaccine doses available to provide patients with their second shots if the country's current allotment of doses is depleted from administering patients' first shots. FDA officials recently emphasized the importance of administering two doses of the vaccines at the manufacturers' recommended intervals, but CDC in guidance updated Monday now states that although Americans should receive their second doses "as close to the recommended 3-week or 1-month interval as possible," there's "no maximum interval between the first and second doses for either vaccine." Public health experts and vaccine manufacturers have pushed back on that guidance, however, noting that there's no data to support stretching Covid-19 vaccine doses beyond the periods recommended by manufacturers, the Times reports.
For their part, federal officials said they are confident the country will have enough vaccine supply to meet increased demand. According to the Associated Press, Vice President Pence during a call with governors on Tuesday said, "This is not a supply issue at this moment in time."
Federal officials also said Americans in need of their second dose of a Covid-19 vaccine should be given priority, the AP reports.
But even if vaccine supply isn't an issue, experts have noted that distributing the vaccines among a larger share of the country's population will be far from easy—and it could result in some inequities.
In Florida, Texas, and some other states, for instance, officials have struggled to keep up with expanded demand for Covid-19 vaccines among older adults—with a number of their vaccination sites having to turn people away after running out of supplies.
Marcus Plescia, CMO of the Association of State and Territorial Health Officials (ASTHO) said, "We are focused on speed but you have to focus on safety too. … That means having the staff to monitor people for allergic reactions after they get vaccinated, and also having enough space at the distribution sites for social distancing. The last thing you want is for someone to get Covid when they're waiting in line to get the vaccine."
According to Politico, some state officials also expressed concerns about having enough freezer space needed to safely store an influx in vaccine doses.
"That adds another planning task and wrinkle in our system," Kristen Ehresmann—director of infectious disease epidemiology, prevention, and control for the Minnesota Department of Health—said.
Further, some public health experts expressed concerns that the eligibility expansions don't prioritize certain essential workers who may be at higher risk of contracting the novel coronavirus than many Americans ages 65 and older. As the Times reports, "While the elderly have died of the virus at the highest rates, essential workers have borne the greatest risk of infection, and the category includes many poor people and people of color, who have suffered disproportionately high rates of infection and death."
Ehresmann said, "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."
Overall, Plescia said, "A lot of [ASTHO] members are feeling like this is just beginning to move too fast. … What we're going to get to is a first-come, first-served approach to vaccine distribution, and that's just not going to be equitable."
America grapples with persistently high rates of new coronavirus cases, hospitalizations, and deaths
The vaccine distribution changes come as America continues to see persistently high rates of new coronavirus cases, hospitalizations, and deaths.
According to data compiled by the Times, U.S. officials as of Wednesday morning had reported a total of about 22.9 million cases of the novel coronavirus since America's epidemic began—up from about 22.6 million cases reported as of Tuesday morning.
According to the Times, the United States' average daily number of newly reported coronavirus cases over the past week was 249,961—which is up by 37% when compared with the average from two weeks ago.
As of Wednesday morning, data from the Times showed that the rates of newly reported coronavirus cases were "staying high" in Puerto Rico; Washington, D.C.; and every state except Hawaii. According to the Times, those territories and states have had a daily average of at least 15 newly reported cases per 100,000 people over the past week.
Hawaii has had comparatively low case rates, but it was seeing those rates "going up" as of Wednesday morning, according to the Times. In Guam and the U.S. Virgin Islands, meanwhile, rates of newly reported coronavirus cases were "staying low" as of Wednesday morning, the Times' data showed.
U.S. hospitalizations for Covid-19, the disease caused by the novel coronavirus, also remained high on Tuesday, according to data from The Atlantic's COVID Tracking Project. The data showed that 131,326 Americans with Covid-19 were hospitalized for treatment on Tuesday, including 23,881 who were receiving care in an ICU and 7,879 who were on a ventilator.
On Tuesday, U.S. officials reported about 4,406 new deaths tied to the coronavirus, setting a single-day record, the Times reports. The United States' average daily number of newly reported deaths linked to the coronavirus over the past week was 3,300, which is up by more than 217% from mid-November, CNN reports.
As of Wednesday morning, U.S. officials had reported a total of about 380,882 U.S. deaths linked to the novel coronavirus since the country's epidemic began, up from about 376,476 deaths reported as of Tuesday morning.
(Ellison, Becker's Hospital Review, 1/12; Murray, CNN, 1/8; Baker, Axios, 1/12; Shear et al., New York Times, 1/12; LaVito/Tozzi, Bloomberg, 1/13; Branswell, STAT News, 1/12; Alonso-Zaldivar/Miller, Associated Press, 1/12; Miranda Ollstein/Roubein, Politico, 1/12; Gay Stolberg/Goodnough, New York Times, 1/13; Maxouris, CNN, 1/13; Ives, New York Times, 1/13; New York Times, 1/13; "The COVID Tracking Project," The Atlantic, accessed 1/13).