Age groups that sustain resurging COVID-19 epidemics in US

 As of October 2020, individuals aged 20-49 were the only groups sustaining COVID-19 transmission with reproduction numbers well above 1 in the US, according to the latest publication in Science today by the Imperial College COVID-19 Response team.

Following initial declines, numbers of COVID-19 cases started to rise again halfway through 2020 in the United States and Europe. In September the team published report 32, using age-specific mobility data from across the United states and linking these to age-specific COVID-19 mortality. Their findings pointed out that targeting interventions to adults aged 20-49 could facilitate safe reopening of schools and kindergartens.

The peer reviewed publication in Science today includes new data up to October 2020. The updated analysis of aggregated age-specific mobility data from more than 10 million individuals in the US, shows that 65 of 100 COVID-19 infections still originated from individuals aged 20-49 in the US.

Across the US as a whole, the mobility trends indicate substantial initial declines in venue visits (such as visit by an individual to locations like supermarkets and restaurants) followed by a subsequent rebound for all age groups. In contrast with the large fluctuations in the share of age groups among reported COVID-19 cases, the study describes the share of age groups among the observed COVID-19 deaths remarkably constant.

The researchers find that in locations where novel highly-transmissible SARS-CoV-2 lineages have not yet established, additional interventions among adults aged 20-49, such as mass vaccination with transmission-blocking vaccines, could bring resurgent COVID-19 epidemics under control and avert deaths.

The work is presented in the latest report from Imperial's Department of Mathematics and the WHO Collaborating Centre for Infectious Disease Modelling within the MRC Centre for Global Infectious Disease Analysis, Abdul Latif Jameel Institute for Disease and Emergency Analytics (J-IDEA), Imperial College London.

Since the emergence of the new coronavirus (COVID-19) in December 2019, the Imperial College COVID-19 Response Team has adopted a policy of immediately sharing research findings on the developing pandemic.

Dr. Samir Bhatt, from Imperial College London, said, "This work is a big step in understanding how age affects the dynamics of COVID-19 epidemics. We would like thank in particular all epidemiologists at state Departments of Health who work tirelessly to update data on the evolving COVID19 epidemics. Without this effort, this study would not have been possible."

Dr. Melodie Monod, from Imperial College London, said, "We find adults aged 20-49 are a main driver of the COVID-19 epidemic in the United State and are the only age groups contributing disproportionally to onward spread, relative to their population size. While children and teens contribute more to COVID19 spread since school closure mandates have been lifted in fall 2020, we find these dynamics have not changed substantially since school re-opening."

Dr. Oliver Ratmann, from Imperial College London, concluded, "We believe this study is important because we demonstrate that adults aged 20-49 are the only age groups that have consistently sustained COVID-19 spread across the US, despite large variations in the scale and timing of local epidemics. Thus—at least where highly transmissible variants have not established—additional interventions targeting the 20-49 age group could bring resurgent epidemics under control and avert deaths."

More information: "Age groups that sustain resurging COVID-19 epidemics in the United States," Science (2021). science.sciencemag.org/cgi/doi … 1126/science.abe8372

https://medicalxpress.com/news/2021-02-age-groups-sustain-resurging-covid-.html

FDA to streamline approval for vax updated to protect against virus variants

 Peter Marks, MD, director of the FDA's Center for Biologics Evaluation and Research, said the agency is working to streamline the process for authorizing COVID-19 vaccines after they have been updated to protect against new variants of the novel coronavirus, according to The Hill.

During a Jan. 29 webinar hosted by the American Medical Association, Dr. Marks said the agency would work to "get these variants covered as quickly as possible."

Dr. Marks also said updated COVID-19 vaccines would not have to complete another phase 3 trial to ensure efficacy. Rather, they will be required to go through "some small clinical trials" to ensure they incite an immune response and protect against both the new variants and earlier versions of the novel coronavirus.

Experts have not reached a consensus on whether updated vaccines are necessary, but the possibility is being pursued, as B.1.351, the variant first identified in South Africa, has shown it diminishes the effects of COVID-19 vaccines to varying extents.

Vaccines using the mRNA platform, like the ones developed by Moderna and Pfizer, are relatively easy to update for protection against new virus variants. However, experts recommend as many people as possible be vaccinated with current vaccines to slow the spread of the virus, which continues to spread and mutate.

https://www.beckershospitalreview.com/pharmacy/fda-to-streamline-process-to-approve-vaccines-updated-for-protection-against-virus-variants.html

US COVID-19 testing is 'problematic' : Gottlieb

 Former FDA Commissioner Scott Gottlieb, MD, told CNBC Feb. 2 that the country's COVID-19 testing system is "discontinuous" and "problematic" and that he doesn't expect any large-scale improvements until fall. 

"You don’t have an efficiently run system because no one really built this rationally," Dr. Gottlieb said. 

He said that the U.S. has reached a point where we can do "a tremendous amount of testing," and that on some days more than 2 million new tests are conducted. But, "We need to be able to do 3, 4 million tests a day and get back a result back within 24 hours or else ... it’s useless. A PCR-based result that takes more than a day or two isn’t useful," he said, according to CNBC. 

A big issue is that because of the way the system is currently organized, test samples aren't getting to labs that have the capacity to quickly run the tests and return the results to patients in a timely manner, Dr. Gottlieb told CNBC. 

Dr. Gottlieb said there will still be a need for COVID-19 testing in the fall, even though many Americans will likely be vaccinated like then. 

“We need to build this out for the fall when testing volumes are going to come up again, and we’re going to be pressed again," he told CNBC. 

https://www.beckershospitalreview.com/supply-chain/us-covid-19-testing-is-problematic-former-fda-chief-says.html

Vertex target cut by Wainwright

 To $275 from $315; retains Buy.

https://finviz.com/quote.ashx?t=VRTX

Neurocrine axes Parkinson's collab with Voyager after safety issues

 Six years ago, Third Rock Ventures launched Voyager Therapeutics with $45 million and a goal of bringing gene therapy into some of the most notorious neurological diseases, most notably Parkinson’s. Now that program, long their lead and only clinical asset, is in jeopardy.

Voyager announced Tuesday afternoon that Neurocrine Biosciences has terminated their agreement to co-develop the Parkinson’s gene therapy after safety issues put the program on hold last year. Voyager said they are still evaluating whether or not to continue developing the gene therapy internally. They pinned Neurocrine’s decision on a “portfolio review and prioritization of its current pipeline assets.”

The Parkinson’s program was the centerpiece not only of the Cambridge biotech but also of the $1.8 billion collaboration they signed with Neurocrine 2 years ago, along with earlier stage collaborations on Friedreich’s ataxia and two undisclosed diseases. Neurocrine has now become the second company to back out of a deal with Voyager on the Parkinson’s program, after Sanofi opted in 2017 to decline an option they had under a larger $845 million partnership. They ditched the rest of the partnership two years later, although Voyager is still led by Sanofi alum Andre Turenne.

Voyager and Neurocrine will continue to work together on Friedreich’s ataxia and the undisclosed diseases, Voyager said.

The company’s stock $VYGR, already eroded by the Sanofi exit and last year’s safety delays, was not majorly impacted, sliding 5% after the bell from $8.00 to $7.55.

The Parkinson’s program was already in the clinic when Voyager launched in 2014 and three years later it offered them an early glimpse of success, reducing the need for Parkinson’s medications and increasing motor function in a 10-patient cohort. They also showed increased expression of AADC, an enzyme needed to turn levodopa into dopamine, the key molecule Parkinson’s patients need.

After releasing similar tentative results in a 15-patient group a year later, they moved into a pivotal trial, where the setbacks began. In November, the trial’s data safety and monitoring board paused the study after finding worrying signs in “certain patient imaging data.” The FDA followed up a month later with a formal clinical hold, citing “MRI abnormalities.”

Voyager has still not disclosed details on what triggered the pause, but concern around the industry has been over the route of administration. Neurosurgeons inject the therapy directly into the brain.

Without the Parkinson’s program, Voyager would become a pre-clinical biotech. The FDA has prevented the No. 2 project in the pipeline, a gene therapy for Huntington’s disease, from going into the clinic over what Voyager said were CMC issues.

https://endpts.com/neurocrine-axes-parkinsons-collab-with-voyager-after-safety-issues-jeopardizing-biotechs-longrunning-centerpiece/

Verily spinout Onduo expands virtual care to Spanish speakers

 The virtual care company Onduo is widening its reach: On Tuesday, the Alphabet-owned company announced it was bringing its chronic disease management platform to patients with certain cardiometabolic conditions, including hypertension and prediabetes.

The move marks a significant expansion of the mission of the company, which was spun out of Alphabet’s life science unit Verily and initially targeted patients with type 2 diabetes. But it’s not the only change aimed at broadening the company’s user base: Onduo will also start providing its services in Spanish.

Digital medicine in the U.S. has long fallen short when it comes to caring for non-English-speaking patients.

“We’ve seen study after study after study showing that Spanish speakers are less likely to use digital health portals,” said Jorge Rodriguez, a hospitalist and technology equity researcher at Brigham and Women’s Hospital.

Those inequities have become more pronounced during the pandemic. As telemedicine visits increased over the last year, Spanish-speaking patients were about 40% less likely to complete video visits than average, based on an analysis Rodriguez and his colleagues conducted of more than 200,000 doctor’s visits during the pandemic.

To support care for the 5% of Americans who speak Spanish but are not fluent in English, some digital health providers have added Spanish-language services in recent years, including complex networks of third-party interpretation services. “Before it was a nice to have,” said Rodriguez. “Now it’s like, ‘Oh shoot, we need to move fast.’” A full half of the employers served by one of Onduo’s large health plan clients have requested Spanish-language services, according to a company spokesperson.

In some ways, Onduo’s self-contained virtual care system is easier to adapt than entrenched telemedicine systems. The company is adding Spanish-language capabilities to both its app and its team of health coaches, which help users establish long-term habits to support their general health and manage their chronic conditions.

“We brought on Spanish-speaking coaches as of the end of last quarter,” said Vindell Washington, Onduo’s chief executive officer. The spokesperson said that 20% of its coaches are now bilingual.

“The software piece was more straightforward, as an Alphabet spinoff,” said Washington. “They know how to do languages.” Onduo worked with Google’s localization team on the new Spanish language services.

Onduo’s sister company, Google Cloud, is also offering automated translation as just one part of its $100 million investment in telehealth company Amwell, announced in August.

Making an app accessible to a new population isn’t as simple as translation. Many digital health platforms start in English, and are then adapted for non-English-speaking users, but their updates may not account for other differences in populations.

“Oftentimes when we speak of Spanish speakers, not only is there limited English proficiency but there’s also lower health literacy and often lower digital literacy,” said Rodriguez. “If you’re developing something for an English-speaking audience you’re automatically targeting a slightly different perspective. It’s not so much the Spanish that makes a big difference, it’s all the other associated pieces.” 

Ideally, developers would be able to show that digital health platforms worked equally well for patients regardless of language. But even the methods used to determine how well digital health tools work can bring their own set of limitations. Digital care portals like those provided by Onduo are often vetted using the System Usability Scale (SUS) to make sure they’re easy for patients to use. But the SUS was originally developed in English.

When Magdalena del Rocio Sevilla-Gonzalez, a postdoc at Massachusetts General Hospital’s clinical and translational epidemiology unit, wanted to test the usability of a digital health app with a patient population in Mexico City, “we didn’t find anything to measure the usability in our population.” So she and her team set out to verify that a Spanish-language SUS questionnaire can accurately gauge usability of digital tools in Spanish. It’s that kind of tool that will be necessary to validate both the usability of an app — and ultimately, the health outcomes it supports.

“I care about tech equity, but only so much as it gets me to health equity,” said Rodriguez. “It doesn’t matter if everyone has a phone and a portal if their diabetes outcomes are not better.”

Now that Onduo has made a step toward tech equity, it can collect the data to show how its platform impacts health outcomes across populations.

https://www.statnews.com/2021/02/02/onduo-verily-spanish-language/

VBI hep B vax application accepted by FDA

 VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a commercial-stage biopharmaceutical company developing next-generation infectious disease and immuno-oncology vaccines, today announced that the U.S. Food and Drug Administration (FDA) has accepted its filing of the Biologics License Application (BLA) for the Company’s 3-antigen prophylactic hepatitis B vaccine candidate for the prevention of infection caused by all known subtypes of the hepatitis B virus (HBV) in adults. The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of November 30, 2021.

https://finance.yahoo.com/news/vbi-vaccines-announces-u-fda-130000274.html