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Morning Rounds Shraddha Chakradhar

Good morning, and welcome to a new week! Andrew Joseph here filling in for Shraddha for the day.

The latest on the Covid-19 vaccine sprint

Some important weekend vaccine updates: First, AstraZeneca has resumed the Phase 2/3 trial of its Covid-19 vaccine candidate in the U.K. The trial was paused after a potential adverse reaction to the vaccine in a participant, which appeared to be transverse myelitis, a serious condition involving inflammation of the spinal cord. But so far, the trial has only picked up again in the U.K. The company is also conducting Phase 2/3 and Phase 3 trials in the U.S., Brazil, and South Africa. “The Company will continue to work with health authorities across the world and be guided as to when other clinical trials can resume,” an AstraZeneca spokesperson told STAT.
And second, in a move that would allow them to collect more data and expand diversity among study participants, Pfizer and BioNTech are planning to enlarge the Phase 3 trial of their joint Covid-19 vaccine from 30,000 people to 44,000. The FDA needs to give an OK before the plan can go forward.

In preelection move, Trump proposes last-ditch drug pricing plan

Drug pricing politics just ratcheted up ahead of the election. President Trump yesterday released a sweeping executive order that would force drug makers to charge Medicare the same prices they do in other countries for virtually all their medicines. It’s Trump’s boldest drug pricing move yet, and one that’s sure to inflame the administration’s relationship with the pharmaceutical industry. But crucially, it’s not clear if the administration can implement the policy ahead of the election. It’s also possible the drug industry challenges the proposal in court. More here

More progress needed on HPV vaccine coverage

More children are getting vaccinated against HPV, but the numbers are still lagging behind targets, a study out this morning in Pediatrics found. U.S. officials had set a goal of 80% of 15-year-olds — both boys and girls — having two doses of the HPV vaccine by 2020. The study of 7.8 million children, however, found that the share of 15-year-olds with two-dose coverage went from 30% and 2% in 2011 for girls and boys, respectively, to 46% and 39% in 2017, with variation in part based on local policy. Washington, D.C., and Rhode Island, for example, both had school requirements and no personal belief exemptions and had wide coverage. The researchers also found a correlation between vaccination rates and the density of pediatricians in that state. The vaccine can prevent certain cancers and genital warts.

Inside STAT: Answers to your coronavirus questions


She rocks in the tree tops all day long, Hoppin' and boppin' and tweetin' her  song
(alex hogan/stat)

Asymptomatic spread, reinfection, what an effective vaccine looks like. These were some of the topics you had questions about after STAT queried its Twitter followers what they wanted to know about Covid-19 and the new coronavirus. And lucky for you, Helen Branswell, STAT's senior writer for infectious disease, took some time to answer a selection of questions submitted. You can hear what Helen has to say in this new video from STAT's Alex Hogan. 

The CRISPR patent fight goes to the tape

The yearslong and bitter brawl over who will get crucial — and potentially lucrative — CRISPR patents could be headed toward a climax, and the University of California has some work to do. A new decision from a government patent board means that UC and its partners will have to prove that their scientists, led by Jennifer Doudna of UC Berkeley, demonstrated that CRISPR-Cas9 systems could edit DNA in eukaryotes (plant and animal cells, not bacteria or free-floating DNA) before Feng Zhang and colleagues at the Broad Institute. The next phase will likely involve testimony from the researchers themselves and reviews of their lab notebooks as the patent board tries to figure out who invented what and when, with fortunes and, perhaps, Nobel glory on the line.

Impact of updated OxyContin unclear, experts find

It’s not clear whether a reformulated version of OxyContin designed to be harder to misuse led to declines in overdoses and deaths, an FDA advisory panel has found. The experts determined that the newer drug, released in 2010, was, as designed, snorted and injected less compared to the original version, but that there wasn’t firm evidence that it contributed to less misuse or fewer overdoses overall. At the meeting, which came as the FDA reviews whether opioid painkillers meant to discourage misuse fulfilled that claim, experts acknowledged that it can be difficult to disentangle which substances cause overdoses given that people often mix them. 

What to read around the web today

  • Trump officials interfered with CDC reports on Covid-19. Politico
  • Inside Gilead’s $21 billion purchase of Immunomedics: Lamb chops, steak, and a chance for transformation. STAT Plus
  • Your questions about air quality, answered. LA Times
  • Israel to shut down again as second coronavirus wave hits. Wall Street Journal
  • Opinion: When private equity firms invest in women’s health clinics, who benefits? STAT

Thanks for reading!


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Monday, September 14, 2020


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