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The Readout Damian Garde & Meghana Keshavan

Pfizer/BioNTech vaccine will be tested in young children

Pfizer and BioNTech have begun testing their Covid-19 vaccine in children as young as 6 months. Results are likely to come out later this year, meaning that, if the study is positive, the vaccine could be available for young children at some point in early 2022.

Separately, Pfizer is running a trial in children ages 12 to 15. That study, fully enrolled since January, could lead to results in the next few months, which then might lead to an emergency use authorization from the FDA and administration to that cohort in the fall. 

“The FDA, if it sees fit to do this, could, grant an EUA and get them into children in that age group by the fall, provided the CDC also agrees and that that should be the vaccine they receive,” one Pfizer vaccine exec told STAT’s Matthew Herper.

Read more.

Underused Novartis gene therapy plant shut down

Early last year, Novartis opened up a large gene therapy manufacturing plant in Longmont, Colo. Now, just 14 months later, the drug maker is shuttering the 692,000-square-foot complex. The facility will shut down by July 9 and about 400 employees will be laid off. 

The plant had primarily come into existence to manufacture Zolgensma, a gene therapy for newborns with spinal muscular atrophy. But the abrupt shutdown suggests that demand may not be as robust as Novartis had expected, FiercePharma reports. The company also said it has made “process improvements” to other plants that manufacture gene therapies. 

“Based on the evolving dynamics of the gene therapy landscape …. we now know that we can fulfill our long-term demand, including patients who may benefit from our next wave of gene therapies, with two commercial sites,” a Novartis spokesman told Fierce. 

FDA panel says Pfizer's pain drug is risky

An FDA panel yesterday concluded that Pfizer’s experimental pain drug, tanezumab, may be too risky for use in patients. It’s a judgment call that may undermine the drug’s eventual approval, STAT’s Damian Garde writes.

The injectable drug has been studied in osteoarthritis, but has been linked to rare but serious cases of joint damage. In a 19-to-1 vote, the experts found that the company’s post-approval plan to monitor and prevent adverse events was insufficient. 

“One of the basic principles of medicine is first do no harm,” one FDA panelist said. “I’m concerned about the long-term side effects of the sponsor’s drug.” 

Read more.

Who's to blame for the AstraZeneca vaccine scandal?

Can boldness backfire for pharma CEOs? And is the special relationship on the rocks?

We discuss all that and more this week on “The Readout LOUD,” STAT’s biotech podcast. We're devoting this week's episode to the week of whiplash news about AstraZeneca's Covid-19 vaccine, subject of a baffling international incident with consequences still unfolding.

First, we explain the series of late-night announcements that made global headlines. Then, our STAT colleague Helen Branswell joins us to discuss the implications for AstraZeneca, vaccine confidence, and the global effort to get doses in arms. Finally, STAT's Matthew Herper calls in to talk about Pascal Soriot, the hard-charging AstraZeneca CEO whose previously feted boldness might have backfired when it came to Covid-19.

Listen here.

Advocacy group: U.S. should share vaccine patent globally

Wealthy countries have received the vast majority of available Covid-19 vaccines, while less affluent countries have been largely ignored. In order to help right this imbalance, a group of academics and advocacy groups are urging the Biden administration to use a key patent used by the U.S. government to boost production and distribution of the Moderna vaccine.  

The group writes in a letter that Moderna ought to share its manufacturing processes with contract manufacturers, so they might ramp up production on a global scale. The argument is that U.S. taxpayers invested more than $2.5 billion into the development of mRNA vaccines for Covid-19, and it’s the government’s duty to ensure that it’s widely accessible. 

“Moderna appears to rely on foundational coronavirus vaccine technology invented and patented by NIH in every vial it sells,” one signatory told STAT’s Ed Silverman. 

Read more.

More reads

  • With time running out, an ALS patient fights with Biogen over expanded access to its drug (STAT)
    U.S. to no longer distribute Eli Lilly’s bamlanivimab alone due to coronavirus variants. (Endpoints)
  • Startup pursues new drugs for human diseases by searching gut microbes from wild animals. (FierceBiotech)
  • The microbiome and human cancer. (Science)

Thanks for reading! More next week,

Damian

Friday, March 26, 2021

STAT

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