Morning Rounds Shraddha Chakradhar

FDA advisory panel to convene for first time today on Covid-19 vaccines

The Vaccines and Related Biological Products Advisory Committee — an independent advisory group made up mostly of academics and physicians — is convening today for the first of a number of meetings to review available safety and efficacy data for Covid-19 vaccines in development. Amid recent concerns about the politicization and rush to get a Covid-19 vaccine approved, the fact that VRBPAC is meeting is a sign that the FDA plans to do what it usually does — which is rely on the committee to inform the agency's own decision-making about vaccines. And while the FDA is under no obligation to follow the advice of this group, experts see the group as a way of assuring the public that vaccines being fast-tracked right now are being evaluated with the same rigor as any other vaccine. 

Purdue will plead guilty to federal charges, reaches $8.3 billion deal over opioid crisis

Purdue Pharma will plead guilty to three felony criminal charges as part of an $8.3 billion deal that also resolves civil charges brought against the company. Purdue is the manufacturer of the potent painkiller OxyContin, which helped trigger an opioid crisis that led to 470,000 deaths over the past two decades. As part of the deal, Purdue admitted to reporting misleading information to the DEA in order to boost the company's manufacturing quotas and violating anti-kickback laws by paying doctors — through speaker programs — to write more prescriptions. And while the settlement is the most notable so far in the federal government's attempts to hold a drug company accountable for the opioid crisis, no Purdue executives or members of the Sackler family — who founded the company — have been charged as part of this deal. 

Trump, Biden will take the stage in final presidential debate tonight

President Trump and former Vice President Joe Biden will square off in the final presidential debate tonight in Nashville, Tenn., starting at 9 p.m. ET. Covid-19 is once again, as expected, on the list of topics for the debate, which will be moderated by Kristen Welker of NBC News. Since the last in-person debate, Trump has been diagnosed with Covid-19 and has seemingly recovered. His illness, the treatments he received, his continued downplaying of the seriousness of the virus, and his recent attacks on infectious disease expert Anthony Fauci are likely to be specific areas of interest. One new development for this debate: In light of Trump's frequent interruptions during the last debate, the Commission on Presidential Debates said it will mute Trump and Biden's microphones for parts of tonight's event. 

Inside STAT: Democrats want to overhaul Operation Warp Speed. But if Biden wins, should he?

Operation Warp Speed leader Moncef Slaoui (left) and Democratic presidential nominee Joe Biden. (ALEX HOGAN/STAT)

For months, ethics questions have dogged Moncef Slaoui, the former pharma executive tapped to lead the government's vaccine development initiative known as Operation Warp Speed. There's been the question of his refusal to sell off a $10 million investment in GlaxoSmithKline, his former employer and a company that has been a major recipient of OWS funding. And House Democrats are investigating his employment contract, as advocacy groups have labeled his hiring illegal. Democrats have called for Slaoui's firing, but given his experience bringing 14 different GSK vaccines to market, among other credentials, public health experts also say that Slaoui is the perfect person to lead the vaccine development effort. This raises the question of whether Joe Biden, were he to win the presidential election, can afford to fire Slaoui as the head of OWS. STAT's Nicholas Florko has more from Washington here.   

CDC expands definition of ‘close contacts’ of someone with Covid-19

The CDC yesterday expanded its definition of a "close contact" of someone with Covid-19. The agency now defines this as someone who spent a cumulative 15 minutes or more within six feet of someone who was infectious over 24 hours, even if the time isn’t consecutive. Previously, the agency defined "close contact" as someone who spent 15 minutes or more within six feet of someone who was infectious. Close contacts are those who are tracked down during contact tracing and are recommended to quarantine. The expanded definition comes as the agency released a new study describing how a correctional officer in Vermont appeared to have been infected with the coronavirus after multiple brief encounters with six incarcerated individuals with Covid-19. 

Investigation into retina fatigue wins premier STEM competition for middle-schoolers

Research into fatigue of the eye's retina and how it could result in seeing "imaginary colors" took home the top prize at last night's virtual ceremony of the Broadcom MASTERS awards. Presented by the Broadcom Foundation and the Society for Science and Public, the competition bills itself as the premier science and engineering competition for middle school students. Ishana Kumar, a 12-year-old student from Chappaqua, N.Y., won $25,000 for investigating how staring at a brightly lit, colored area for too long could trick the eye and brain into seeing imaginary colors. Other notable projects: an AI-based system for authenticating heartbeat sounds, a low-cost glove that can convert sign language into text or speech, and research into finding plant-based painkillers that works across genders. 

What to read around the web today

  • In the nation’s asthma capital, plans to burn wood for energy spark fury. The Boston Globe
  • Boston Children’s Hospital will no longer perform two types of intersex surgery on children. The 19th
  • Ireland is first European country to reimpose a lockdown amid a coronavirus resurgence. The Washington Post
  • Californians asked to pony up for stem cell research — again. Kaiser Health News
  • The EPA refuses to reduce pollutants linked to coronavirus deaths. ProPublica

Thanks for reading! More tomorrow,


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Thursday, October 22, 2020


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