In talking points emailed yesterday to surrogates and volunteers, Biden’s transition team pushed back against both possibilities.
“We are not releasing all doses and folks who have this incorrect should be corrected … we are not telling people a second dose is not required and we are leading with science and following the advice of medical and health experts,” says the memo, provided to The Health 202.
Biden’s strategy departs from the Trump administration’s more conservative approach to withhold vaccine doses now to ensure everyone who got an initial shot can get the second shot within the recommended time frame. Distributing doses to more people right away is a riskier but potentially more rewarding route, and banks on the hope that more supplies are made available by the time the second round of shots is needed.
Biden’s advisers are now clarifying that a small amount of vaccine will still be held in reserve.
Michael Osterholm, who is on Biden’s covid-19 transition advisory board, insisted the Biden team has calculated how many doses should be held back based on the expected rate of manufacturing and accounting for possible glitches.
The reserve will be smaller than under the Trump administration, but it will still exist, Osterholm stressed in a Washington Post Live interview.
“The truth of this whole situation is somewhere between the two extremes that people have been presenting, that all doses will get released, or that it will just stay the same,” he told me. “You’re going to see more doses out there, but it won’t be all of them.”
A number of health experts, including former Food and Drug Administration chief Scott Gottlieb, have also backed the idea of sending out doses more quickly, citing the urgency of getting Americans vaccinated and some evidence the first shot provides significant protection from the coronavirus.
Osterholm also emphasized that people who got the first shot should always get a second.
The Food and Drug Administration approved the coronavirus vaccines as a two-shot regimen, recommending a three-week gap between the Pfizer shots and a four-week gap between the Moderna shots. Biden received his second dose of the shot yesterday.
Similarly, the U.K. approved a coronavirus vaccine from AstraZeneca to be given three or four weeks apart. But in a controversial move, its government is now recommending a gap of up to 12 weeks in hopes of giving at least some protection to as many people as possible as quickly as possible.
That’s not a move the Biden administration will make, Osterholm said. He stressed the incoming administration will adhere to FDA guidance on when the shots should be given.
“There is absolutely no deviation from the need for a second dose at the appropriate time,” Osterholm said.
Marcus Plescia, the chief medical officer of the Association of State and Territorial Health Officials, called Biden’s move “bold.”
But he said state health officials have concerns under both approaches.
It’s not great to be holding doses back when thousands of Americans are dying every day of the coronavirus. Yet states are also worried about frustrating people who might return for a second dose only to be told none is available, Plescia told our colleague Fenit Nirappil.
“People are going to complain to state and local governments if they are not getting their doses,” Plescia said.
Biden is also promising to fix the nation’s fragmented approach to vaccinations.
It will be a tall order. Health departments and hospital executives have been pleading with the federal government for better coordination and communication, complaining of a decentralized system and a lack of adequate funding to prepare for their mission.
In this intensive look at the so-far botched vaccine rollout, our colleagues write that it’s “the product of poor coordination between the federal government and the 50 states and additional jurisdictions tasked with carrying out the most ambitious immunization campaign in history.”
“Vaccine experts say the dispiriting launch reflects more than inflated estimates,” they report. “The government’s decision to leave 64 states and other jurisdictions to devise individual plans spawned duplicative meetings, emails and telephone calls as local officials strained to share advice about common logistical challenges.”
“Since the rollout began last month, sign-up websites have crashed and long lines have snaked outside clinics, even as some people, including health-care workers, have rejected the shots out of unfounded fears about their safety — problems that veterans of immunization campaigns worldwide say could have been addressed through comprehensive, centralized planning and communication,” they add.
“All the focus was on developing the vaccines,” said Walter A. Orenstein, an epidemiologist at the Emory University School of Medicine, who was director of the U.S. Immunization Program for 16 years. “I don’t think there was enough focus on getting vaccine into the arms of the people who need them.”
Ahh, oof and ouch
AHH: Two congresswoman have tested positive for the coronavirus after the Capitol raid.
One of them is Rep. Watson Coleman (D-N.J.), a 75-year-old cancer survivor. The other is Rep. Pramila Jayapal (D-Wash.), who announced her positive test late Monday.
Both tested positive after taking shelter in a room with other lawmakers, some of whom refused to wear masks, during last week’s violent takeover of the U.S. Capitol by a pro-Trump mob, The Post’s Colby Itkowitz reports.
“I received a positive test result for COVID-19, and am home resting at this time,” Watson Coleman said in a statement. “While I am experiencing mild, cold-like symptoms, I remain in good spirits and will continue to work on behalf of my constituents.”
Watson Coleman (D-N.J.) said that she believes she contracted the virus while sheltering in a large committee room with other lawmakers during the riot. On Sunday, the attending physician to Congress warned that lawmakers and staffers in the room may have been exposed to the virus and encouraged them to get tested.
Watson Coleman was among several lawmakers who received the first dose of the coronavirus vaccine.
“Public health experts expect last week’s attempted insurrection to create a swell of new coronavirus cases. The rioters at the Capitol weren’t wearing masks or social distancing, and lawmakers, aides, members of the media and other support staff found themselves huddled together in barricaded rooms,” Colby writes.
OOF: Syringes supplied by the federal government may waste vaccine doses.
“Pharmacists discovered early in the U.S. vaccination push that the standard five-dose vials of the vaccine from Pfizer and its German partner BioNTech often contained enough material for six or even seven shots,” Politico’s Susannah Luthi and Rachel Roubein report. “But some syringes distributed by Operation Warp Speed, the federal Covid-19 vaccine program, aren’t efficient enough to extract a sixth dose, according to hospital lobbyists. They say the issue appears to stem from supply chain problems that have troubled the nation’s pandemic response from the start.”
Some of the vaccination kits provided by the federal government have included what are known as “low dead-volume syringes.” These more efficient syringes are designed to leave less vaccine trapped between the plunger and the needle. But now some health-care providers have said that they are getting less-efficient syringes and hospital providers are worried that this could make it harder to give second doses to everyone who got the first one.
“With the second dose of Pfizer that is now going into people’s arms, we’ve been given different syringes, less efficient, so you need to draw up a little bit of extra vaccine, to get the right amount of dose into the person’s arm,” said Nancy Foster, the American Hospital Association’s vice president of quality and patient safety policy. “We don’t have that sixth dose now.”
A Department of Health and Human Services spokesperson told Politico that officials were looking at reconfiguring supply kits to make it easier to get additional doses. The department said that the amount of vaccine recovered from a multidose vial was also influenced by the technique a provider uses to draw doses.
OUCH: The Centers for Disease Control and Prevention says there is no sign a U.S. coronavirus variant is driving infections.
“Infectious-disease experts say there is no evidence the massive winter surge that is killing thousands of people a day in the United States is linked to the U.K. variant or to a homegrown strain. But they acknowledge their battlefield awareness is limited,” The Post’s Joel Achenbach, Kim Bellware and Hamza Shaban report. “Some states have minimal capacity to conduct genomic sequencing that allows scientists to trace the random mutations that could give a virus variant some advantage over other strains.”
Like all viruses, the coronavirus mutates and there are countless variants in circulation. Most mutations are harmless, but two new variants of the virus identified in the U.K. and South Africa are believed to be far more contagious.
Scientists say that they cannot rule out the possibility that an undetected variant is behind a surge of new infections, although they also point out that holiday travel and social gatherings could explain that increased rate of infections.
“It could be — a possibility — that we have our own mutant that’s being more easily transmissible,” Anthony S. Fauci, director of the National Institute of Allergy and Infectious Diseases, said Monday. “We don’t know. We’re looking for it. . . . If you look at the slope of our curve, which is very steep, it looks a bit like the curve in the U.K.”
Duncan MacCannell, chief science officer with the CDC’s Office of Advanced Molecular Detection, however, said that the general scientific consensus was that there was no single variant driving the surge in U.S. cases. He estimated that the U.K. variant, known as B.1.1.7. is involved in less than 0.5 percent of current transmission, although this is expected to grow in the coming weeks.
Right now, the U.S. is only conducting genomic sequencing on a few thousand positive cases each week, but the CDC is hoping to push that number up to 6,500.
HHS in the transition
Biden’s HHS will inherit legal fights from Trump.
“Legal battles left over from the prior administration are likely to dictate which health-care policy priorities President-elect Joe Biden and his officials must focus on first,” Bloomberg News’s Lydia Wheeler reports. “Fights are ongoing over the scope of Trump administration rules that scaled back Obamacare’s anti-discrimination protections, gave health-care workers the right to refuse patients care based on their religious beliefs, and expanded access to skimpier health plans.”
“The Biden administration is going to be pretty quickly put in a position where it has to decide whether it’s going to defend Trump-era regulations, including at the Supreme Court,” Katie Keith, a health law professor at Georgetown University, told Bloomberg News.
For example, government briefs in a Supreme Court case involving state work requirements for Medicaid are due just days before Biden takes office. While the new administration is likely to notify the Supreme Court that the government has changed its position, Biden’s team will likely have to race against the clock to file new briefs.
Meanwhile, pending litigation around gender identity and termination of pregnancy is currently being litigated in the U.S. Court of Appeals for the Fifth Circuit. And on Feb. 8, the Ninth Circuit will hear arguments over the legality of so-called conscience rule that allows health-care workers to deny care based on their religious or moral beliefs.
While the administration can ask the courts to temporarily suspend the litigation while the incoming officials review the policies, they’ll be under pressure to move quickly.
HHS is mandating a review of regulations every decade.
“The outgoing Trump administration has finalized a rule that will require all new regulations by agencies under the Department of Health and Human Services to be reviewed for relevance every 10 years or face automatic expiration,” Reuters’ Antonita Madonna reports.
Under the new rule, the incoming Biden administration may also face the gargantuan task of reviewing all existing regulations since the agency’s inception in 1953. That initial review would be due in 2026.
California Attorney General Xavier Becerra, Biden’s nominee to head HHS, has criticized the rule, saying that it will take time away from pandemic-relief efforts. It’s unclear whether the Biden administration will work to overturn it, however. The rule could also face a challenge in Congress under the Congressional Review Act, which allows Congress to review and overrule new federal regulations.
Elsewhere in health care
Hundreds of nonprofits want the Biden to immediately reverse President Trump’s public charge policy.
The policy, which made it easier for the government to withhold government benefits from immigrants seeking permanent residency, was blocked by a federal judge in November. But the groups are asking the president-elect to issue an executive order that directs agencies to rescind the public charge regulations and commits the White House to bold actions ensuring immigrants feel safe in accessing public benefits.
“You must act with urgency,” says the letter, signed by groups including the American Association of People with Disabilities, the National Immigration Law Center, UnidosUS and nearly 500 others. “Immigrants must hear from the highest office in the land that they are again welcome and valued members of our society.”
The leading national health insurance association says it intends to review its political giving in light of the attack on the Capitol.
“Last week’s violence and the incitement of it are shameful, abhorrent, and intolerable,” Matt Eyles, the CEO of America’s Health Insurance Plans (AHIP), said in a statement. “Our nation, the laws of our land, and the safety of our citizens and the political leaders who serve them, are paramount. These priorities will be front and center as we immediately review our policies governing political giving.”
AHIP’s announcement comes after Blue Cross Blue Shield, which provides health insurance to 100 million people, said it will suspend donations to lawmakers who challenged the electoral college results. A growing number of businesses have sought to distance themselves from donations to political candidates who have taken positions aimed at undermining the legitimacy of Biden’s election.
Paige Winfield Cunningham
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