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America's vaccine sprint may be more like a relay race

June 30, 2020

By: Dan Diamond & Adam Cancryn

Drug and Syringe

(Politico) — Operation Warp Speed continues to ramp up, with military and Coast Guard personnel all over the Humphrey building and two vaccine candidates getting close to Phase III trials.

But the Trump administration is increasingly pinning its hopes on a vaccine that may never come — or at least, not on the president’s timeline, POLITICO’s Dan Diamond reports.

— The administration’s view: Operation Warp Speed will break records on vaccine development. The ongoing effort incorporates some of the lessons from early stumbles in the coronavirus response: lean on military logistics experts, proactively engage the industry — and move faster than officials ever thought possible to combat a historic pandemic.

It took four years to come up with the mumps vaccine, the fastest ever developed; officials are vowing to produce a Covid-19 vaccine in the next six months.

“The January 2021 goal to begin administering a safe and effective vaccine to Americans is ambitious but achievable,” an HHS spokesperson said. “The president has made it abundantly clear that this is the team that can get it done.”

“I think it's coming along great … and we will have an answer very soon,” President Donald Trump said at a Fox News town hall on Thursday. “I think it will be even before the end of the year we will have a vaccine.”

— But Trump’s focus on a vaccine has come at the expense of other public-health efforts, experts warn. They’ve lamented that the White House has increasingly sidelined its public-health messages even as more than 125,000 Americans have died from the virus, and many more could perish while waiting for a vaccine to arrive.

“There’s no guarantee that a vaccine is going to work,” said Luciana Borio, who served as the FDA’s acting top scientist and worked on White House pandemic preparedness efforts earlier in the Trump administration. “And even if it does, there’s no guarantee that it’ll be the right product for most people, or that people will want to take it, or that the virus won’t mutate.”

Even senior Republicans are publicly urging Trump — who repeatedly touted the progress toward a vaccine at a rally last week in Arizona and at his Fox News town hall, but failed to mention the value of masks once — to focus on simple measures to help protect Americans right now.

— Meanwhile: the Operation Warp Speed vaccines may be supplanted relatively quickly, with scientists saying that the program may produce vaccines that are only partially protective and don’t halt transmission.

“In time, better vaccines that induce high titers of virus neutralizing antibodies will come along, but this will be an evolving process,” said Peter Hotez, dean of the National School of Tropical Medicine.

It’s also possible that Trump will lose reelection or the vaccine effort will run behind his timetable and the next administration will pick up the baton.

In the meantime, Hotez says he’s worried about political pressures over rushing a vaccine colliding with the antiscience movement that could resist it.

“The coming months will be an unstable time in America,” he predicts.

PATTY MURRAY: WE NEED A VACCINE PLAN FROM TRUMP — The ranking member of the Senate HELP committee will insist on a rigorous vaccine blueprint, in remarks shared with PULSE.

“We need the Trump Administration to show us how they’ll ensure a vaccine is safe and effective,” according to Murray’s prepared remarks. “Because while I’m as eager for a vaccine as anyone, this isn’t just about doing things fast, it’s about doing them right.”

— Today’s HELP Committee hearing will focus on the Trump administration’s pandemic response and efforts to get businesses and schools reopened.

FDA Commissioner Stephen Hahn is set to testify alongside CDC Director Robert Redfield, testing czar Brett Giroir and top infectious disease doctor Anthony Fauci.

‘WAY TOO MUCH VIRUS’: CDC EXPERT SAYS WE’RE WELL BEYOND TRACING — Anne Schuchat, CDC’s principal deputy director, painted a dire picture of the U.S. outbreak in an interview with JAMA’s Howard Bauchner on Monday.

“We’re not in the situation of New Zealand or Singapore or Korea where a new case is rapidly identified and all the contacts are traced and people are isolated who are sick and people who are exposed are quarantined and they can keep things under control,” Schuchat said. “We have way too much virus across the country for that right now, so it’s very discouraging.” CNBC has more.

MIKE PENCE GRAPPLES WITH COVID RESURGENCE — After weeks of public hiatus, the vice president quickly organized a televised briefing of the coronavirus task force on Friday, revealing an undercurrent of fear behind the scenes of the federal government as the virus mounted its resurgence.

Over the weekend, Pence stepped up his urgency, POLITICO reports. Other Trump officials and allies issued stark new warnings as case counts soared in some of the nation’s largest states. And the machinery that had lined up behind Trump’s mission-accomplished message suddenly started to fade away.

— Pence’s ever-sunny tone on coronavirus had aggravated public health experts and frustrated officials inside HHS.

After Pence took a victory lap during Friday’s news conference about the amount of medical supplies and equipment procured by the administration, he was swiftly followed by top health officials sounding alarms.

“There are more cases. There are more hospitalizations in some of those places and soon you’ll be seeing more deaths,” Dr. Anthony Fauci, one of the health experts on the White House coronavirus task force, said during the task force briefing as Pence quietly looked on.

PANDEMIC HAS UNLEASHED SPIKE IN OVERDOSE DEATHS — A White House drug policy office analysis shows an 11.4 percent year-over-year increase in fatalities for the first four months of 2020, POLITICO’s Brianna Ehley reports.

The data confirms experts’ early fears that precautions like quarantines and lockdowns, combined with economic uncertainty, would exacerbate the addiction crisis.

— Drug czar JIM CARROLL: “The pandemic has caused my level of concern to go up.” According to Carroll, overdose deaths were already starting to rise in the past year, after posting the first decline in three decades in 2018.

FIRST IN PULSE: HOUSE WATCHDOGS WANT ANSWERS ON CDC — The Trump administration must explain how it’s incorporating the public-health agency into the coronavirus response, according to House Energy and Commerce Chair Frank Pallone and Oversight subcommittee chair Diana DeGette.

“It is clear that CDC is being positioned as a scapegoat for the Administration’s own COVID-19 pandemic response failures,” Pallone and DeGette wrote to HHS on Monday, in a letter shared first with PULSE. The two Democrats cite dozens of media reports about how the CDC was “muzzled” or how scientific advice has been overlooked in the administration’s response.

MITCH McCONNELL TO AMERICANS: KEEP WEARING MASKS — The Senate Majority Leader on Monday emphasized that personal small steps can help the nation expedite its fight against the virus.

“We must have no stigma — none — about wearing masks when we leave our homes and come near other people,” McConnell said in a floor speech. “Wearing simple face coverings is not about protecting ourselves. It is about protecting everyone we encounter.”

HOUSE DEMOCRATS PASS OBAMACARE EXPANSION — Monday's vote on H.R. 1425 is the party's latest effort to draw an election-year contrast with President Donald Trump, who's repeatedly worked to eliminate the law, POLITICO's Susannah Luthi and Alice Miranda Ollstein report.

— The bill pitches a moderate health care coverage platform aimed at safeguarding vulnerable Democrats in swing districts and flipping more purple territory in 2020 – focusing on expanding subsidies for private insurance plans in the health exchanges and trying to nudge the hold-out red states to expand Medicaid.

It's a non-starter in the GOP-controlled Senate, but even that may add fuel to Democrats' ongoing message that Republicans are trying to attack Obamacare, not improve it.

— Monday's floor debate was a reprise of the past decade's health care fights, as Republicans knocked the bill as an insurer bailout that wouldn’t help Obamacare’s skyrocketing premiums or health care costs – while Democrats doubled down on attacks of the GOP's failure to devise a replacement that robustly covers people with pre-existing health conditions, Susannah and Alice write.

Progressive lawmakers who have pushed sweeping “Medicare for All” legislation largely backed the bill, although it veers to the right of the party’s presumptive nominee Joe Biden’s health care proposal to expand public coverage through Medicare.

AL SHARPTON to launch health disparities campaign. Rev. Sharpton and several other Black community leaders are forming the Healthcare Equality Network – a campaign aimed at highlighting racial disparities in health care and pressing for greater access to care for Black Americans.

Sharpton will announce the campaign today alongside Congressional Black Caucus Chair Karen Bass, telling PULSE that the last few months have put “Black America’s pain on full display” and underscored the need for more attention on issues like hospital closings, maternal mortality and “surprise” medical bills that can disproportionately affect African Americans.

LAURA CALIGUIRI to depart FDA. Caliguiri, who serves as the agency’s associate commissioner for external affairs, told staff on Monday that she would be departing this week for a role in the private sector. Caliguiri, who first joined HHS in 2017, held several senior roles in the immediate office of the secretary. Her FDA bio.

FEDERATION OF AMERICAN HOSPITALS announces slew of moves. The lobbying group for investor-owned hospitals has promoted LEAH EVANGELISTA to senior vice president of external affairs and ERIN RICHARDSON to senior vice president of government affairs. SEAN BROWN is now the vice president of public affairs and digital strategy, while CLAUDIA SALZBERG is vice president of health services research and policy.

Original article published here on Politico.

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