CVS, Walgreens Expanding Covid-19 Vaccinations

 CVS Health Corp. and Walgreens Boots Alliance Inc. each outlined details Tuesday about plans for Covid-19 vaccinations in stores.

CVS Health said it will begin to offer Covid-19 vaccinations to eligible populations at a limited number of CVS Pharmacy locations across 11 states starting Feb. 11.

Supply for the initial rollout, sourced directly from the federal government through the pharmacy partnership program, will be about 250,000 total doses, CVS said. As more supply becomes available the company will expand to additional states while increasing the number of stores offering vaccinations.

CVS said the states include California, Connecticut, Hawaii, Maryland, Massachusetts, New Jersey, New York, Rhode Island, South Carolina, Texas and Virginia.

CVS Health said it is also working directly with Indiana and Ohio to provide in-store vaccinations to eligible populations using state allocations.

CVS Health said it has administered the first round of Covid-19 vaccine doses to nearly 8,000 skilled nursing facilities, and second doses are more than 60% complete. First doses at all long-term care facilities that selected CVS Health to provide Covid-19 vaccinations--more than 40,000 in total--will be complete by mid-February, the company said. The company said most states chose activation dates for assisted living and other facilities well into January, which prevented clinics from being scheduled earlier.

Walgreens separately said it would provide a limited number of Covid-19 vaccinations across 15 states and jurisdictions as part of the Federal Retail Pharmacy Program.

Vaccinations will begin in stores Feb. 12 to eligible individuals based on state and jurisdiction guidelines, and may include healthcare workers, people ages 65 and older, and individuals with pre-existing conditions.

Walgreens also said it continues to support vaccinations across long-term care facilities. The company said it completed first dose vaccinations in more than 75% of long-term care facilities that selected Walgreens as their vaccine provider and remains on track to complete remaining first doses by mid-February.

https://www.marketscreener.com/quote/stock/CVS-HEALTH-CORPORATION-12230/news/CVS-Walgreens-Expanding-Covid-19-Vaccinations-32339469/

Amgen fourth-quarter profit rises, 2021 outlook below Street view

 

Amgen Inc on Tuesday reported a higher-than-expected quarterly profit as sales of newer drugs offset lower revenue from older off-patent medications, but the biotech company forecast 2021 earnings below Wall Street estimates.

For the full year, Amgen said it expects adjusted earnings of $16.00 to $17.00 per share on revenue of $25.8 billion to $26.6 billion. Analysts were looking for $17.03 per share on revenue of $26.45 billion, according to IBES data from Refinitiv.

Due to the COVID-19 pandemic, Amgen said physician-patient interactions remained below normal levels in the fourth quarter and it expects that to continue through 2021.

In a statement, the company said recovery in the latter part of the year is contingent on the speed and effectiveness of the global vaccination rollout.

For the fourth quarter, Amgen reported adjusted earnings per share of $3.81, beating the average analyst estimate of $3.40 per share. The number of Amgen shares outstanding fell 13% from a year earlier.

Net profit for the quarter fell 3% to $2.76 per share.

Quarterly revenue rose 7% to $6.6 billion, in line with analysts' estimates.

Sales of older rheumatoid arthritis drug Enbrel fell 5% to $1.27 billion, shy of analysts' estimate of $1.3 billion.

Sales of newer migraine drug Aimovig totaled $104 million for the quarter, short of the $115 million projected by analysts. But sales of cholesterol fighter Repatha rose 27% to $253 million, beating Wall Street estimates of $223 million.

Sales of Neulasta, which fights infections by boosting white blood cells, fell 19% to $536 million, while sales of kidney drug Sensipar dropped 58% to $45 million in the face of increased competition from cheaper generics and biosimilars.

Amgen, which produces its own biosimilar versions of drugs from rival companies, said sales of those medicines rose in the fourth quarter.

https://www.marketscreener.com/quote/stock/AMGEN-INC-4847/news/Amgen-fourth-quarter-profit-rises-2021-outlook-below-Street-view-32340110/

J&J Vision Gets FDA OK For Intraocular Lens For Cataract Treatment

 Johnson & Johnson Vision**, a global leader in eye health and part of the Johnson & Johnson Medical Devices Companies***, today announced that the U.S. Food and Drug Administration (FDA) approved the TECNIS Eyhance™ and TECNIS Eyhance™ Toric II intraocular lens (IOL) for the treatment of cataract patients in the United States. With this approval and subsequent commercial launch, ophthalmologists in the U.S. now have the ability to choose this next generation monofocal as the lens of choice for their patients with or without astigmatism. The first implantation of TECNIS Eyhance IOL in the U.S. will happen in Texas next week.

More than 90% of people develop cataracts—the clouding and yellowing of the lens in the eye—by the age of 65.2 While part of the normal aging of the eye, left untreated, cataracts cause vision to deteriorate over time. In fact, cataracts are the leading cause of preventable blindness worldwide, impacting more than 100 million eyes.3 Cataract surgery is one of the most common outpatient procedures performed today and has a success rate of approximately 98%.4 Today, cataract treatments can also offer patients vision correction, reducing or eliminating the need for glasses, in addition to removing the cataract.5,6

"84% of surgeons7 choose monofocal IOLs for their cataract patients, so it's thrilling to see the first breakthrough in monofocal technology in decades enter the market to add to our treatment portfolio," said Douglas Koch, M.D., Houston, TX****. "It's the first monofocal designed to provide a slight increase in the depth of focus,1*,8 which is something I need for the patients in my practice looking for more from a monofocal."

The latest innovation in the TECNIS® Family of IOLs - TECNIS Eyhance and TECNIS Eyhance Toric II IOLs – is defining the future of monofocals, with a breakthrough refractive surface designed to:

• Slightly extend the depth of focus1* through the unique shape of the lens
• Deliver better image contrast in low light9 TECNIS Eyhance IOLs deliver 30% improvement in image contrast compared to AcrySof IQ SN60WF at 5mm
• Provide safe and easy delivery using the new TECNIS Simplicity® system that streamlines lens delivery and protects against contamination10

"Built on the proven TECNIS® platform,11 TECNIS Eyhance combines low-light performance with breakthrough refractive surface design, providing a new kind of monofocal experience for cataract patients,12" said Rajesh K. Rajpal*****, MD, Chief Medical Officer and Global Head of Clinical and Medical Affairs at Johnson & Johnson Vision. "Additionally, the TECNIS Eyhance Toric II lens is engineered with a new squared and frosted haptic design for added friction inside the capsular bag to treat cataract patients with astigmatism."

https://www.streetinsider.com/Corporate+News/Johnson+%26+Johnson+%28JNJ%29+Vision+Receives+FDA+Approval+For+Next+Generation+Monofocal+Intraocular+Lens+For+The+Treatment+Of+Cataract+Patients/17899708.html

Jefferies Starts Gracell Biotechnologies Inc (GRCL) at Buy

  'Unmatched Innovation to Deliver Faster, Better, and Cheaper CAR'

https://www.streetinsider.com/Analyst+Comments/UPDATE%3A+Jefferies+Starts+Gracell+Biotechnologies+Inc+%28GRCL%29+at+Buy%2C+Unmatched+Innovation+to+Deliver+Faster%2C+Better%2C+and+Cheaper+CAR/17898132.html

Reinfection by SARS-CoV-2 in healthy young adults is common: Mt Sinai study

 Paper title: SARS-CoV-2 seropositivity and subsequent infection risk in healthy young adults: a prospective cohort study

Corresponding Author:  Stuart C. Sealfon, MD, Professor of Neurology, Neuroscience and Pharmacological Sciences, Icahn School of Medicine at Mount Sinai

Bottom Line: Although antibodies induced by infection to SARS-CoV-2 are largely protective, they do not guarantee effective immunity against subsequent infection, as evidenced through a longitudinal, prospective study of young Marine recruits. Previously infected study participants identified by seropositivity are susceptible to repeat infection, with nearly one-fifth the incidence rate of those without evidence of previous infection. Among the seropositive group, those who became infected again had lower antibody titers than those that were uninfected, and most lacked detectable baseline neutralizing antibodies. Findings suggest that COVID-19 vaccination may be necessary for control of the pandemic in previously infected young adults.

Results:  Among 189 seropositive participants, 19 (10.1%) had at least one positive PCR test for SARS-CoV-2 during the six-week follow-up. In contrast, 1,079 (48.0%) of the 2,246 seronegative participants tested positive. The incidence rate ratio was 0.18 (95% CI 0.11-0.28, p<0.00001). Among seropositive recruits, infection was associated with lower baseline full-length protein IgG titers (p=<0.0001). Compared with seronegative recruits, seropositive recruits had about 10-fold lower viral loads and trended towards shorter duration of PCR positivity (p=0.18) and more asymptomatic infections (p=0.13). Among seropositive participants, baseline neutralizing titers were detected in 45 of 54 (83.3%) uninfected and in 6of 19 (31.6%) infected participants during the 6 weeks of observation.

Why the Research Is Interesting: With the onset of mass SARS-CoV-2 vaccination programs and the increasing proportion of previously infected individuals, the risk of reinfection after natural infection is an important question for modeling the pandemic, estimating herd immunity, and guiding vaccination strategies. And since young adults, of whom a high percentage are asymptomatically infected and become seropositive in the absence of known infection, can therefore be a source of transmission to more vulnerable populations, it’s important to evaluate protection against subsequent SARS-CoV-2 infection conferred by seropositivity to determine the need for vaccinating previously infected individuals in this age group.

Who: Scientists from the Icahn School of Medicine at Mount Sinai, in collaboration with researchers from the Naval Medical Research Center, utilized the COVID-19 Health Action Response for Marines (CHARM) study, a longitudinal, prospective cohort study that has been previously described and published in NEJM, to examine how protective detectable antibodies are to preventing subsequent infections with SARS-CoV-2, the virus that causes COVID-19. The study population consisted of 3,249 predominantly male, 18-20-year-old Marine recruits who, upon arrival at a Marine-supervised two-week quarantine prior to entering basic training, were assessed for baseline SARS-CoV-2 IgG seropositivity (defined as a 1:150 dilution or greater on receptor binding domain and full-length spike protein enzyme-linked immunosorbent [ELISA] assays.) The presence of SARS-CoV-2 was assessed by PCR at initiation, middle and end of quarantine. After appropriate exclusions, including participants with a positive PCR during quarantine, the study team performed three bi-weekly PCR tests in both seronegative and seropositive groups once recruits left quarantine and entered basic training.

When: All study data was collected between May and October, 2020. The prospective study observation period began when Marine recruits arrived at Marine Corps Recruit Depot – Parris Island (MCRDPI) to commence basic training.

What: The study evaluated protection against subsequent SARS-CoV-2 infection conferred by seropositivity in young adults to determine the need for vaccinating previously infected individuals in this age group.

How: After appropriate exclusions, including participants with a positive PCR during quarantine, the study team performed three biweekly PCR tests in both seropositive and in seronegative groups once recruits left quarantine and entered basic training and baseline neutralizing antibody titers on all subsequently infected seropositive and selected seropositive uninfected participants.

Study Conclusions: Seropositive young adults had about one-fifth the risk of subsequent infection compared with seronegative individuals. Although antibodies inducted by initial infection are largely protective, they do not guarantee effective SARS-CoV-2 neutralization activity or immunity against subsequent infection. These findings may be relevant for optimization of mass vaccination strategies.

Funding: Defense Health Agency and Defense Advanced Research Projects Agency (DARPA)

https://www.newswise.com/coronavirus/new-study-finds-reinfection-by-sars-cov-2-in-healthy-young-adults-is-common

Moderna needs more teens for COVID-19 vaccine trial

The Centers for Disease Control and Prevention reported Monday that more than 30 million Americans have received at least one dose of a coronavirus vaccine.

About 25 million people have received one shot and another 5 million have received both required doses in the United States.

Now that the vaccine is rolling out to more Americans, researchers are turning their attention to younger patients. Studies are firing up to focus on a safe vaccine for children as young as 12 years old.

Last month, the U.S. Food and Drug Administration approved the Pfizer-BioNTech vaccine trial for 16- and 17-year-olds. Since then, the company has had enough volunteers sign up to begin the trial.

Moderna still needs about 3,000 teenagers to volunteer for its COVID-19 vaccine trial. They are searching for teenagers from 12 to 17 years old. Anyone interested in this trial can find more information here.

Adolescents are typically not among the most serious cases of COVID-19, however, studies show they can still spread the virus to high-risk individuals. Since they make up about about a fifth of the U.S. population, it’s important for them to get vaccinated to achieve herd immunity, doctors say.

“It is really important that we have COVID-19 vaccines available for children,” Norton Healthcare’s Dr. Kris Bryant said. “Children make up 22 percent of the population, so if we really want to get control of the virus, ultimately we’re going to need to be able to vaccinate children.”

On Monday, Bryant explained to WAVE 3 New Now how the coronavirus could affect teenagers and children, what to expect with the vaccine trial, and when it could be available to them.

https://www.wave3.com/2021/02/01/moderna-needs-more-teens-covid-vaccine-trial/

Line cooks at highest risk of dying from COVID: UCSF study

 According to a new UCSF study, food and agricultural workers are at the highest risk of death from COVID-19 among working age Californians. The study, which analyzed deaths of essential workers between ages 18 to 65, found line cooks to be at the highest risk of all, more so than packaging machine operators, construction laborers and even nurses.

When Gov. Gavin Newsom announced on Monday that the state would be shifting its vaccine rollout to an age-based system, some worried that this meant restaurant workers would no longer be prioritized. However, as a California Department of Public Health spokesperson confirmed to the San Francisco Chronicle, this is not true — restaurant workers will be categorized under “food and agricultural workers,” an essential group that should be next in line for the vaccine.

The results of the UCSF study underline the importance of prioritizing cooks and other food workers for the vaccine: While working adults saw an overall 22% increase in deaths during the pandemic, food and agriculture workers saw an even more devastating increase of 39%.

Jobs associated w greatest risk of death during pandemic in CA?

Cooks
Packaging machine operators
Agricultural workers
Bakers
Construction workers
Production workers
Sewing machine operators
Shipping clerks

Full list in new preprint @UCSF_Epibiostat https://t.co/FGtLWaHFHB pic.twitter.com/PSBwU99hxA

— Kirsten Bibbins-Domingo (@KBibbinsDomingo) January 22, 2021

And while cooks have the highest "risk ratio for mortality," with 828 deaths between March and October of 2020, other food-related jobs were also found to be in the top riskiest channels of employment. Agricultural workers and bakers ranked in the top five, with chefs/head cooks and bartenders following close behind.

"Though non-occupational risk factors may be relevant, it is clear that eliminating COVID-19 will require addressing occupational risks," wrote the authors of the study. "... As jurisdictions struggle with difficult decisions regarding vaccine distribution, our findings offer a clear point of clarity: vaccination programs prioritizing workers in sectors such as food/agriculture are likely to have disproportionately large benefits for reducing COVID-19 mortality."

https://www.sfgate.com/food/article/Cooks-restaurant-workers-risk-death-COVID-UCSF-15905789.php