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Friday, December 4, 2020

Magenta Therapeutics, bluebird bio team up for MGTA-145 combo sickle cell trial

 

Lilly, UnitedHealth in real-world study of COVID-19 med in diverse high-risk population

 

  • Eli Lilly (NYSE:LLY) will team up with UnitedHealth Group (NYSE:UNH) on a pragmatic study of bamlanivimab (LY-CoV555) in a large diverse population of high-risk COVID-19-infected people.
  • pragmatic study is designed to assess the effectiveness of an intervention in real-life practice conditions.
  • The large-scale study will draw on UNH's health benefits business and its Optum health services business to detect and treat high-risk symptomatic patients who test positive for COVID-19, including daily symptom tracking, in-home SARS-CoV-2 testing and in-home infusion services. Bamlanivimab will be administered via home infusions to allow for quarantining.
  • Medicare Advantage members who meet FDA-authorized criteria for treatment will be invited to volunteer for the study through United in Research, UNH's virtual community and technology platform for citizen scientists.
  • Those who volunteer and are in an area where they can receive treatment will be directed to download Optum's symptom-checking ProtectWell app and complete a daily questionnaire. Participants experiencing symptoms of COVID-19 will take an in-home SARS-CoV-2 test which they will self-administer and return. Those that are COVID-19 positive will receive outreach from an Optum Infusion Pharmacy nurse to schedule a home infusion treatment of bamlanivimab.
  • The study will enroll up to 500,000 people, with at least 5,000 people expected to receive bamlanivimab therapy.
  • The FDA signed off on emergency use of the antibody on November 9 for pediatric and adult patients with mild-to-moderate symptoms.
  • https://seekingalpha.com/news/3641707-lilly-partners-unitedhealth-on-real-world-study-of-covidminus-19-med-in-diverse-high-risk

Nov. jobs gain of 245K slows from 610K in Oct., misses estimates for 500K

 

  • November nonfarm payrolls+245K vs. +500K consensus and +610K previous (revised from +638K).
  • Unemployment rate: 6.7% vs. 6.8% consensus and 6.9% prior.
  • The job report illustrates the continuing slowdown in the recovery as the number of COVID-19 cases increases across the country.
  • In November, notable job gains occurred in transportation and warehousing, professional and business services, and health care. Employment declined in government and retail trade.
  • 10.7M people are unemployed, 4.9M higher than in February.
  • In November the number of long-term unemployed increased by 385K to 3.9M, accounting for 36.9% of the total unemployed.
  • Labor force participation rate edged down to 61.5% from 61.7% in October; down from 63.2% in November 2019.
  • Average hourly earnings for all employees on private nonfarm payrolls increased to $29.58 from $29.49; that's up from $28.34 a year ago.
  • Unemployment rate by specific groups: adult women 6.1%, down from 6.5% in October; adult men 6.7%, unchanged M/M; White 5.9% vs. 6.0% in October; Black or African American 10.3% vs. 10.8%; Hispanic or Latino ethnicity 8.4% vs. 8.8%; Asian 6.7% vs. 7.6%.
  • https://seekingalpha.com/news/3641692-november-jobs-gain-of-245k-slows-from-610k-in-october-and-misses-estimates-for-500k

Thursday, December 3, 2020

Meatpacker Smithfield Foods offers to store COVID-19 vaccines in ultra-cold freezers

 Smithfield Foods, the world’s biggest pork processor, said on Thursday it had offered to help U.S. health officials distribute COVID-19 vaccines and store them in ultra-cold freezers that are in high demand to support a public vaccination campaign.

U.S. states, cities and hospitals are scrambling to buy freezers that can safely store Pfizer’s COVID-19 vaccine at temperatures of minus 70 Celsius (minus 94 Fahrenheit), significantly below the standard for vaccines.

Moderna’s vaccine can be stored at minus 20 Celsius.

Smithfield, owned by China’s WH Group, has multiple “ultra-cold” freezers and will work with local authorities to provide assistance as needed, said Chief Administrative Officer Keira Lombardo, without providing details.

The company is “ready and willing to assist health agencies should storage capacity become constrained,” she said in a statement to Reuters.

Thousands of meatpacking workers employed by Smithfield and rivals like Tyson Foods and JBS USA have been infected with COVID-19. Nearly 20 U.S. meat plants were shut in the spring due to outbreaks, tightening supplies, raising prices and making meatpacking one of the industries most impacted by the pandemic in the United States.

Smithfield may be able to keep Moderna’s vaccine in static freezers that store meat before it is exported or sold, said Chris Hodges, a former senior vice president of business development for the company.

Other “blast” freezers that push cold air on to meat before it is moved into static freezers could potentially get cold enough to hold Pfizer’s version, although it would be very expensive to run them for long periods of time, he said.

“As it becomes more clear that successful vaccines will become available, we have communicated our capabilities and continued willingness to partner with health officials, including with vaccine distribution and storage,” Lombardo said.

Working with health agencies, Smithfield expects it can help distribute vaccines rapidly to food and agricultural workers hit hard by the pandemic, Lombardo said. The company also offered to aid distribution to other essential workers through healthcare offices at its facilities.

Meatpacking workers are considered essential in many states, but not at the top of the list for vaccines, which are expected to be distributed first to healthcare workers and nursing home residents.

Organizations representing food and meat companies have asked U.S. President Trump and President-elect Joe Biden for priority access to vaccines for workers.

Tyson Foods said in an e-mail to Reuters it was closely monitoring the development of vaccines and working with healthcare experts on planning and distribution models for employees.

https://www.reuters.com/article/us-health-coronavirus-vaccine-meatpackin/u-s-meatpacker-smithfield-foods-offers-to-store-covid-19-vaccines-in-ultra-cold-freezers-idUSKBN28D2JW

Moderna to supply up to 125m COVID-19 vaccine doses globally in 1st quarter

 Moderna Inc said on Thursday it expects to have between 100 million and 125 million doses of its experimental COVID-19 vaccine available globally in the first quarter of 2021.

The company said 85 million to 100 million of those doses would be available in the United States, with 15 million to 25 million available outside the country.

The first-quarter doses are within the 500 million to up to 1 billion doses the company expects to manufacture globally in 2021, Moderna said.

Results from an early-stage trial showed that the vaccine, mRNA-1273, produced high levels of binding and neutralizing antibodies that declined slightly over time, but remained elevated in all participants three months after the booster vaccination, the company said.

https://www.reuters.com/article/us-health-coronavirus-moderna/moderna-to-supply-up-to-125-million-covid-19-vaccine-doses-globally-in-first-quarter-idUSKBN28D3FA

Uber asks CDC to deem ride-hail drivers essential for COVID-19 vaccine distribution

 Uber Technologies Inc on Thursday asked the U.S. Centers for Disease Control and Prevention to designate its ride-hail and delivery drivers as non-health essential workers entitled for early COVID-19 vaccine distribution.

The company in a letter to the CDC’s Advisory Committee on Immunization Practices said its drivers continued to provide critical transportation for essential workers and allowed others to stay home and order food.

https://www.reuters.com/article/us-health-coronavirus-uber-vaccine/uber-asks-u-s-cdc-to-consider-ride-hail-drivers-essential-for-covid-19-vaccine-distribution-idUSKBN28E04L

Moderna: Study shows vaccine candidate indicates durable immunity

 

  • Moderna (NASDAQ:MRNA) says participants in the Phase 1 study led by the National Institute of Allergy and Infectious Diseases of mRNA-1273, its COVID-19 vaccine candidate, retained high levels of neutralizing antibodies through 119 days following the first vaccination and 90 days following the second vaccination.
  • The interim Phase 1 data suggests that mRNA-1273 "can generate durable neutralizing antibodies across all age groups including in older and elderly adults," Moderna Chief Medical Officer Tal Zaks says. "These data give us further optimism to expect that the high level of efficacy recently demonstrated by mRNA-1273 to prevent COVID-19 disease will be durable."
  • The company reaffirms it expects to have 100M-125M doses available globally in Q1 2021, including 85M-100M in the U.S. and 15M-25M available outside the U.S.
  • The update follows Moderna's Nov. 30 announcement that the mRNA-1273's primary efficacy analysis of the Phase 3 study conducted on 196 cases confirmed the high efficacy observed at the first interim analysis, with the data analysis indicating a vaccine efficacy of 94.1%.
  • https://seekingalpha.com/news/3641591-moderna-says-study-shows-vaccine-candidate-indicates-durable-immunity