Research Roundup: Using AI for Disease X vaccine preparedness, Mpox vaccine trial, RSV monoclonal antibody approval

TOP NEWS IN R&D

FDA advisers recommend approval of monoclonal antibody to protect newborns and young children from RSV

STAT?(6/8)

Last week, a US Food and Drug Administration (FDA) advisory committee voted to recommend a monoclonal antibody product to protect children one year and under, as well as high-risk children between one and two years old, from respiratory syncytial virus, or RSV. Nirsevimab, which will be marketed as Beyfortus, was developed by AstraZeneca and will be marketed in the United States by Sanofi. The product is intended to be administered to babies via a single injection during RSV season or at birth depending on birth timing. RSV is a major challenge in children, particularly in very young children, causing up to 80,000 hospitalizations and 300 deaths a year in the United States. Pfizer’s RSV vaccine for pregnant people, which is also aimed at protecting babies, is currently being considered by regulators as well.

Moderna to test mpox vaccine in humans this summer

Fierce Biotech?(6/7)

Moderna will launch a phase 1/2 trial of their mpox vaccine this summer with the goal of generating data to inform dose selection and eventually licensure. The company announced the start of preclinical work on an mpox vaccine back in May of last year, with the vaccine being swiftly developed using the company’s mRNA platform. After the immediate mpox outbreak waned in the United States, the vaccine was deprioritized by Moderna, but ahead of this summer, when mpox is expected to re-emerge, Moderna has announced the trial and has been meeting with the US mpox response team.

Scientists set AI to work on finding vaccines to combat the next Disease X

The Telegraph?(6/6), features the Coalition for Epidemic Preparedness Innovations (CEPI)

The Coalition for Epidemic Preparedness Innovations (CEPI) last week announced ￡1.5 million in funding for Germany’s Leipzig University, where researchers have created artificial intelligence technology that will be used to build a vaccine library aimed at streamlining the development of a new generation of vaccines against a future pathogen with pandemic potential, or Disease X. The technology will analyze the genetic structures of pathogens from ten high-risk viral families, starting with those families that include Nipah and Lassa viruses; model protein sites in the viruses that are crucial targets for generating immune responses in human; and then use those viral protein targets to develop vaccine blueprints. Future scientists will hopefully be able use the library to develop vaccine candidates within 100 days of identifying a pathogen with pandemic potential.

NEWS FROM GHTC

CEPI and aVaxziPen partner on vaccine delivery for access

Vaccine Nation?(6/6), features CEPI

FIND inks deals to support diagnostic development in South Korea

360Dx?(6/6), features FIND

Opinion: Encouraging first-in-human results for a promising HIV vaccine

NIH Director's Blog?(6/6), features IAVI

Novavax and Gates partner for adjuvant in vaccine research

Vaccine Nation?(6/5), features the Bill & Melinda Gates Foundation

HIGHLIGHTS FROM THE WEEK

We finally have malaria vaccines. The next hurdle: Distributing them.

Vox?(6/11)

How global action can meet local needs in emerging outbreaks

Health Policy Watch?(6/9)

DxVx secures $2.8M government contract for urine-based disease monitoring

360Dx?(6/9)

T2 Biosystems, Vanderbilt University Medical Center partner on prospective bacterial sepsis Dx study

360Dx?(6/9)

Alarming rise in paratyphoid fever cases in Cambodia linked to antibiotic resistance

Doherty Institute?(6/9)

Prenosis wins $749K BARDA contract for sepsis prediction software

360Dx?(6/7)

GSK’s RSV vaccine wins European approval

STAT?(6/7)

Generation game: gene-edited mosquitos to fight malaria

SciDevNet?(6/7)

Diagnostic testing, disease preparedness bills introduced in Congress

360Dx?(6/6)

Tanzania’s researchers offered US$22,000 to publish in international journals

Nature?(6/6)

Biological clocks of people and malaria parasites tick in tune

Duke Today?(6/6)

China's Fosun to build African drug manufacturing plant with help from World Bank

Fierce Pharma?(6/6)

New certification system could promote responsible antibiotic manufacturing

CIDRAP?(6/5)

COVID-19 R&D ROUNDUP

Acutis Diagnostics gets FDA Emergency Use Authorization for COVID-19 RT-PCR test

360Dx?(6/9)

Large study shows safety of COVID mRNA vaccines in young children

CIDRAP?(6/6)

FDA grants marketing authorization for Cue Health COVID-19 at-home molecular test

360Dx?(6/6)

EU regulators back WHO's COVID vaccine update recommendation

Reuters?(6/6)

Novavax exec says its new COVID shot should work against variants on the rise

Reuters?(6/5)

UPCOMING EVENTS

June 13-15

Vaccine Acceptance Research Network 2023

Bangkok, Thailand

June 29

Webinar on rectal microbicide research

Virtual

October 18-22

ASTMH 2023 Annual Meeting

Chicago, Illinois

December 5-7

13th International Conference on Typhoid & Other Invasive Salmonelloses

Kigali, Rwanda

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