with Alexandra Ellerbeck
“I think there are mixed feelings on that,” said Marcus Plescia, chief medical officer for the Association of State and Territorial Health Officials. “The decision was made because it’s the most straightforward.”
Federal officials could have taken a more targeted — yet also more complicated — approach.
Earlier this month, members of the Center for Disease Control's Advisory Committee on Immunization Practices considered exactly how to give each state an appropriate share of covid-19 vaccines, which will be especially limited in the first few months of 2021.
They discussed whether and how to tie states' allocations to the size of their most vulnerable populations, namely, the elderly and racial minorities, who tend to be lower-income and have higher rates of obesity and other medical conditions that increase risk for serious covid-19 illness and death.
For example, people over 65 make up 21 percent of the population in Maine and Florida but just 11.5 percent of it in Utah. Population variance is much wider when it comes to race; Black people make up 38 percent of the population in Mississippi but less than 1 percent of it in Montana.
One idea on the table was to use a social disadvantage formula created by the Centers for Disease Control and Prevention. The formula takes into account 15 factors — things such as poverty, lack of vehicle access or crowded housing — to determine the social vulnerability of different communities.
But the committee ultimately suggested basing state vaccine allocation on population size.
Administration officials at the Department of Health and Human Services and Operation Warp Speed, the Trump administration’s vaccine initiative, agreed. The overarching goal is to get the vaccine out the door as quickly and efficiently as possible — not to spend time quibbling over how to precisely allocate it based on the exact needs of each state.
“It’s transparent, it’s understandable,” said Jen Kates, a senior vice president at the Kaiser Family Foundation. “States can plan, and they know what they’re going to get.”
Plescia, whose group represents state public health agencies, said his members seem to be generally okay with the decision to base the state distributions on population size, given the simplicity of the approach.
“I think everybody has decided they are going to go along with this allocation,” he said. “I haven’t heard any griping.”
And states can send their allotted vaccines wherever they want.
They don’t have to follow federal recommendations, although many will. The CDC advisory committee has said health-care workers and long-term care residents should be prioritized first. Its members are scheduled to meet on Friday and again on Sunday to finalize recommendations for who should come next.
Some states, including Arizona, California, Georgia, Louisiana, New Jersey, Ohio and Vermont, have chosen on their own to use a social vulnerability index or health equity framework to target priority groups, according to the Kaiser Family Foundation.
Pfizer’s vaccine is on the brink of approval in the United States.
The company’s two-shot vaccine appears to be on the cusp of regulatory clearance, my colleagues report. Yesterday the FDA published a 53-page review confirming that the vaccine seems to meet the standard for emergency use authorization.
“The Food and Drug Administration briefing document is the first hint of U.S. regulators’ assessment of the vaccine as the agency’s career scientists approach one of the most momentous decisions in the FDA’s history,” Carolyn Y. Johnson and Laurie McGinley report. “It is also the most detailed independent review yet of data that has so far been known only through company news releases.”
Britain, which has already approved Pfizer’s vaccine for emergency use, began the first injections yesterday as part of a massive campaign.
And a new study confirms AstraZeneca’s coronavirus vaccine is effective.
A study published in the British medical journal Lancet confirmed earlier claims that the company’s vaccine, developed in conjunction with the University of Oxford, is 70 percent effective overall.
“The results show a safe, well-tolerated and effective vaccine, and one that is cheaper — at $2 or $3 a dose — and easier to manufacture, transport and store than its competitors, Maria Deloria Knoll of John Hopkins Bloomberg School of Public Health wrote in a commentary accompanying the article.
AstraZeneca is now asking regulators for approval to deploy the vaccine in Britain, other nations in Europe, Brazil and India. But the company isn’t expected to report results of its 30,000-person trial in the United States until late January or early February, leaving its timeline here unclear.
Correction: The committee advising the government on how to prioritize vaccines is an advisory committee to the CDC, not the FDA, as an earlier version misstated.
Ahh, oof and ouch
AHH: Biden has laid out a plan for combating the coronavirus during his first 100 days.
The president-elect committed to signing an executive order on his first day in office to require Americans to wear masks on buses and trains crossing state lines, as well as in federal buildings, Amy Goldstein reports. Biden also pledged to distribute 100 million vaccine shots during his first 100 days, although it was unclear if he meant the number of people who would be vaccinated or the number of doses, two of which are required per person.
While Biden has often urged Americans to wear masks and said he would work closely with mayors and governors, encouraging them to impose mandates, his remarks on Tuesday were the first time he committed to signing an executive order.
CNN's Maegan Vazquez, noting comments on masks from Trump's lawyer Rudy Giuliani:
Rudy Giuliani -- who flouted CDC quarantine guidelines, has been seen maskless at events while jetting across the country and has subsequently been hospitalized with coronavirus -- had this to say today on 77 WABC about Biden's 100 day mask mandate:— Maegan Vazquez (@maeganvaz) December 8, 2020
"You can overdo the mask."
Biden also highlighted reopening schools as a top priority, saying he hoped to enable the majority of schools to open and remain open. He said educators should get the vaccine “as soon as possible” after they are given to health-care workers and people who live or work in long-term care facilities.
And he formally introduced six people who will lead his administration's coronavirus response during his remarks in Wilmington, Del. They include California Attorney General Xavier Becerra (D), his nominee for health and human services secretary; Jeff Zients, as the White House’s coordinator of the pandemic response; Vivek H. Murthy, as surgeon general, a role he held during the Obama administration; and Rochelle Walensky, as the next director of the Centers for Disease Control. Anthony S. Fauci will serve as chief medical adviser on the coronavirus, in addition to continuing with his current role as the director of the National Institute of Allergy and Infectious Diseases.
OOF: Biden’s choice to run the CDC is a respected specialist but lacks experience at the helm of a large agency.
Rochelle Walensky is a “widely respected infectious-diseases specialist regarded as a strong communicator unafraid to speak her mind, qualities critical to returning the beleaguered public health agency to its traditional front-line role and to bringing the coronavirus pandemic under control, Lena H. Sun reports.
Walensky, 51, heads the infectious-diseases department at Massachusetts General Hospital and is a professor of medicine at Harvard Medical School. While Walensky oversees more than 70 physicians at Massachusetts General, she has no experience leading an agency or organization as large or complex as the CDC.
Walensky has conducted pioneering research on HIV/AIDS, and her appointment was celebrated by many infectious-disease experts. But “some public health experts worry that a singular focus on infectious diseases could lead to neglecting chronic diseases, which account for a huge and growing proportion of the country’s long-term health-care costs,” Lena writes.
I began my medical career at the height of the HIV/AIDS crisis, and I've spent my life ever since working to research, treat, and combat infectious diseases.— Rochelle Walensky, MD, MPH (@RWalensky) December 7, 2020
I'm honored to be called to lead the brilliant team at the CDC. We are ready to combat this virus with science and facts.
Walensky will be tasked with taking over an agency that has suffered a loss in institutional credibility and is plagued by low morale.
“Walensky will replace Robert Redfield, who was appointed in April 2018. In a September Washington Post article, many inside and outside the agency blamed Redfield for weak leadership and a failure to protect CDC’s career staff and science-based guidance from political meddling by the White House and Department of Health and Human Services officials,” Lena writes.
OUCH: Senate stimulus negotiations partly hinge on whether companies can be held liable for outbreaks.
“The liability issue has for months proved an insurmountable divide between congressional Democrats and Republicans. Democrats have insisted that workers need assurances that workplaces are safe, while Republicans have said that employers need protection from frivolous lawsuits,” Eli Rosenberg, Jeff Stein and Mike DeBonis report.
Congress has just weeks to reach an agreement before federal relief expires, but the GOP’s insistence on including a corporate “liability shield” has resulted in an impasse that could sink the wider deal.
McConnell has warned of a “second epidemic of frivolous lawsuits,” calling the liability shield a red line in negotiations in May. Democrats, for their part, have characterized the issue as a non-starter, alleging that the Trump administration has already exercised lax enforcement of worker safety issues during the pandemic.
Sen. Bernie Sanders (I-Vt.) has said he would oppose the package if a liability shield is included:
Workers at meat processing plants, at Amazon, and around the country have been treated shamefully during this pandemic— Bernie Sanders (@BernieSanders) December 7, 2020
Working class Americans need $1200 payments to get them through this crisis, not immunity for corporations putting their lives at risk. pic.twitter.com/1Lf6djc3Bg
So far, the GOP’s prediction of a flood of lawsuits has not materialized. Complaint trackers from legal firms show that legal complaints from employees or consumers related to coronavirus exposure constitute just a small fraction of lawsuits filed this year. Companies, themselves, have been a much bigger source of litigation through suits filed against insurers related to business interruption claims, as well as challenges to local and state public health restrictions.
A small group of lawmakers expressed optimism after a meeting on the issue on Monday. Sen. Mitt Romney (R-Utah), one of the architects of the $908 billion bipartisan stimulus plan, proposed immunity from federal lawsuits should only last through 2020 and allow an exemption for gross negligence or willful misconduct.
Meanwhile, the White House on Tuesday added an element of uncertainty into negotiations with a new proposal that would include skimpier unemployment benefits in exchange for $600 stimulus checks.
More in coronavirus
Hawaii is the only state that really enforces coronavirus quarantine rules.
If you flew into Honolulu International Airport after the start of the pandemic, you would find yourself stuck in your hotel room, where you would be ordered to stay for the state’s 14-day mandatory quarantine period, the Atlantic’s Olga Khazan reports. “And Hawaii does mean stay. At one point, hotels issued visitors single-entry key cards,” she writes.
While the state has relaxed its quarantine rules if tourists show a recent negative coronavirus test, legislators are thinking of upping the requirement to at least two negative tests.
Violations of quarantines in other states rarely result in fines or jail time, or any consequences at all. But Hawaii — which cannot borrow ICU capacity or ship in doctors from another state — has arrested honeymooners out to buy pizza, and other quarantine violators. A citizen activist group of 6,700 Hawaii residents called the Kapu Breakers tracks down tourists who might be breaking kapu, or “sacred laws.”
“Hawaii was an independent country before the U.S. annexed it and turned it into a state. And the reason Hawaii has been so ruthlessly effective at quarantine is that it in some ways still acts as its own country with its own border controls. The strategy has paid off: The state consistently has some of the lowest case numbers in the nation,” Olga writes.
Health officials are holding back doses for the second round of shots in a two-dose regimen.
“By the end of the year, the United States government hopes to have close to 40 million doses of COVID-19 vaccine. It plans to distribute half of those in December and hold back the other half to give the same people their second dose of the two-shot regimen,” USA Today’s Adrianna Rodriguez reports.
Operation Warp Speed leaders have said they want to be sure everyone who got the first shot is able to receive the second dose within the recommended time period.
They've expressed concerns that supply chain disruptions could cause delays in the deliveries of vaccines, potentially disrupting the vaccine schedule for thousands of people who had received the initial shot. Pfizer and its partner BioNTech slashed the number of expected doses to be delivered before the end of the year in half after running into issues scaling up the raw materials needed for vaccine production.
Operation Warp Speed chief science adviser Moncef Slaoui, told CBS News's “Face the Nation” on Sunday that “it would be inappropriate to partially immunize large numbers of people and not complete their immunization.”
But Scott Gottlieb, a Pfizer board member and former head of the FDA, is arguing the government should use up all of its shots immediately, rather than reserving half of them for the second dose.
“I don’t think we should be holding onto supply now, anticipating something goes wrong that’s going to cause a lot of other challenges,” Gottlieb told the USA Today editorial board on Monday. “We should be taking some risk.”
Gottlieb said that he anticipates another 40 million doses will be available by the time for the second round of shots, which is supposed to occur three or four weeks after the first dose. Documents released by the FDA on Tuesday suggested that Pfizer’s vaccine offered some protection after the first dose.
Elsewhere in health care
Xavier Becerra, Biden's HHS pick, played a role in a clemency scandal at the end of the Clinton years.
Becerra and Alejandro Mayorkas, now Biden’s pick for homeland security secretary, were among several prominent Los Angeles figures who reached out to the White House about the sentence of Carlos Vignali Jr., whose father was a wealthy entrepreneur and major Democratic donor in California, Rosalind S. Helderman and Tom Hamburger report.
Then-President Bill Clinton commuted Vignali’s sentence on his last day in office in 2001 — one of 176 last-minute acts of clemency he granted that were the subject of investigations for years. The early release of the convicted cocaine trafficker raised complaints of political favoritism and drew sharp condemnations from prosecutors.
“The Vignali commutation drew intense scrutiny because a group of well-connected California Democrats who were friendly with Vignali’s father, Horacio — including Becerra, then a U.S. congressman, and Mayorkas, then the U.S. attorney in Los Angeles — communicated with White House officials about the matter before Clinton acted,” they write. “Vignali’s father also paid $200,000 to Hugh Rodham, the brother of then-first lady Hillary Clinton, to help secure Vignali’s release.”
United States of Care is suggesting specific and incremental ways for Biden to improve the nation's health-care system.
The nonpartisan group has sent Biden's transition team recommendations for how to resolve the coronavirus pandemic, further expand health coverage, improve the individual insurance marketplaces, improve mental health care and reduce inequities.
The paper, provided first to The Health 202, urges the incoming administration to encourage states to provide public option plans. It also says the federal government should pay for 100 percent of Medicaid expansion for the 14 states that have yet to expand the program and remove the income cap on getting subsidies in the individual marketplaces.
Many of these ideas have been backed by moderate Democrats — including Biden himself — but a Congress hopelessly divided over health care hasn't acted on any major health insurance expansions since the 2010 Affordable Care Act.
“Our national health care debate has seemingly been stuck in neutral for the past decade,” the paper says.