Overnight Healthcare

Overnight Health Care: FDA panel endorses Moderna COVID-19 vaccine | Governors say the CDC is cutting vaccine allocations | Top GOP senator warns of potential for brief shutdown

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Welcome to Thursday’s Overnight Health Care. 

Some breaking news tonight: An FDA advisory panel recommended the agency authorize Moderna’s COVID-19 vaccine candidate. Meanwhile, some governors say the CDC is cutting their state’s vaccine allocations. And members of the Sackler family made a rare public appearance to answer questions from Congress about their role in the opioid crisis. 

Let’s start with the Moderna news:  

FDA panel endorses Moderna COVID-19 vaccine

A second coronavirus vaccine is one step closer to being delivered after a federal panel of outside experts on Thursday endorsed a coronavirus vaccine from Moderna and recommended the Food and Drug Administration (FDA) move forward with emergency authorization.

The panel voted 20-0, with one abstention, that the safety and efficacy of the vaccine outweigh the risks for use in individuals aged 18 and older. 

Based on the track taken by the FDA on the vaccine manufactured by Pfizer and BioNTech, the agency could grant emergency use authorization for the Moderna vaccine as soon as Friday. 

Following FDA approval for emergency use on Friday, initial doses of Pfizer’s vaccine were administered to health workers on Monday.

Between Moderna and the vaccine from Pfizer/BioNTech, health officials said they expect to deliver enough vaccine to inoculate 20 million people with the first dose by the end of the year.

Read more here. 

Some confusion as the vaccine rolls out…Governors say the CDC is cutting vaccine allocations

At least four state governors were told by the federal government to expect fewer coronavirus vaccine doses next week than had been originally planned.

Washington Gov. Jay Inslee (D) said in a tweet that he was told his state’s allocation of the new vaccine, produced by Pfizer and the German pharmaceutical company BioNTech, would be slashed by 40 percent.

“This is disruptive and frustrating. We need accurate, predictable numbers to plan and ensure on-the-ground success,” Inslee wrote on Twitter.

However, a spokeswoman at the Department of Health and Human Services (HHS) denied that any allocation plans had changed.

“Reports that jurisdictions’ allocations are being reduced are incorrect. As was done with the initial shipments of Pfizer vaccine, jurisdictions will receive vaccine at different sites over several days. This eases the burden on the jurisdictions and spreads the workload across multiple days,” the spokeswoman said. 

The news also comes after Pfizer put out a statement earlier on Thursday saying that there has been no production issues and that the company had already delivered 2.9 million doses for the first wave.  

“We have millions more doses sitting in our warehouse but, as of now, we have not received any shipment instructions for additional doses,” the drugmaker said.

Read more here.

Sackler family points fingers at Purdue Pharma during House hearing on opioids

Members of Purdue Pharma’s Sackler family testified before the House Oversight Committee Thursday, marking one of the first times in years the family had been publicly questioned under oath on the company’s role in the opioid epidemic. 

The hearing comes as members of the Sackler family, who deny any personal wrongdoing in the opioid crisis, attempt to settle thousands of civil claims filed against them and their company, Purdue Pharma, by states and cities claiming they fueled and epidemic that has killed more than 400,000 people. 

At the center of lawsuits against Purdue Pharma and members of the Sackler family is the argument they marketed Oxycontin to doctors and others as less addictive than other painkillers.

But the Sacklers largely dodged questions about Purdue’s marketing tactics, claiming they were unaware and pointed the finger at the company instead.

“I’m angry that some people working at Purdue broke the law,” Kathe Sackler, a former Purdue board member told lawmakers when asked if she would apologize for her role in the crisis. 

The hearing did not produce much new information about the Sackler’s role in the crisis and largely served as a a public flogging for the family. 

“Watching you testify makes my blood boil,” Rep. James Cooper (D-Tenn.) said to David Sackler. “I’m not sure that I’m aware of any family in America that’s more evil.”

Read more here.

Another issue during the vaccination campaign: security

Hospitals and health care systems are taking unprecedented steps to safeguard the limited supplies of coronavirus vaccines amid concerns over security and the potential for black markets to emerge across the globe.

Operation Warp Speed, the government drive to develop and distribute the vaccines, requires medical facilities to develop a security plan. Every dose of vaccine shipped from manufacturing centers in Michigan and Belgium is tracked from the warehouse to hospitals where they are injected into staffers, medical officials said. 

Extra security personnel and constantly running cameras watch over storage units, where the locks have been upgraded.

“We’ve known from the start that this was going to be a vaccine that’s going to be rationed, so we’ve been thinking all along about how to secure it in a couple of different ways,” said Melanie Swift, a physician leading the vaccine rollout at the Mayo Clinic. “That’s making sure none of it goes missing.”

Vaccine heists? Law enforcement agencies have warned that criminal syndicates may target vaccine supply chains, either to steal doses or to run scams meant to steal money. Earlier this month, Interpol’s secretary general warned member nations to identify potential criminal activity around the vaccine.

Read more here.

Top GOP senator warns of potential for brief shutdown

Senate Majority Whip John Thune (R-S.D.) warned on Thursday that the government could briefly shut down over the weekend as talks over a sweeping deal to pass funding and provide coronavirus relief drag on.

Asked about needing a days-long continuing resolution (CR) to keep the government funded past Friday, Thune indicated senators could block a CR if leaders don’t have a larger deal in hand.

“I mean I’ve already — I know people who are gonna object to that, that want to keep pressure on the process until we get a deal,” he said.

“So, it would take consent obviously to do a short term CR,” Thune added.

Congress has until the end of Friday to either pass the deal on an omnibus and coronavirus aid — an unlikely long shot, lawmakers acknowledge, because it’s still being negotiated. If they don’t, they’ll need to buy themselves some more time by passing a CR to prevent the government from briefly shutting down a week before Christmas.

Read more here.

What we’re reading

What we know about Moderna’s coronavirus vaccine and how it differs from Pfizer’s (CNN)

Pfizer decision to turn off temperature sensors forced scramble to ensure Covid-19 vaccines kept ultra-cold (Stat News

Biden advisers warn Trump mass vaccine timeline may be too optimistic (NBC News)

Nurses are anxious and angry in 2nd wave: ‘We’re Not Prepared’ (New York Times

State by state

Chuck Grassley wants to work with Joe Biden on prescription drug pricing (The Gazette)

Facing lawsuit over restrictions on Christmas services, D.C. mayor eases coronavirus rules (Washington Post)

California activates ‘mass fatality’ program as state sets new virus records (NPR

The Hill op-eds

COVID-19 vaccine campaign must include fair compensation for side effects 

Political division is dangerously defining our COVID-19 conversation

Who gets the vaccine? It’s time to be great 

Tags Chuck Grassley Jay Inslee Joe Biden John Thune
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