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Wednesday, February 3, 2021

Recovered COVID patients likely protected at least 6 months: study

 Almost all people previously infected with COVID-19 have high levels of antibodies for at least six months that are likely to protect them from reinfection with the disease, results of a major UK study showed on Wednesday.

Scientists said the study, which measured levels of previous COVID-19 infection in populations across Britain, as well as how long antibodies persisted in those infected, should provide some reassurance that swift cases of reinfection will be rare.

“The vast majority of people retain detectable antibodies for at least six months after infection with the coronavirus,” said Naomi Allen, a professor and chief scientist at the UK Biobank, where the study was carried out.

Among participants who had tested positive for previous COVID-19 infection, 99% retained antibodies to SARS-CoV-2 for three months, the results showed. After the full six months of follow-up in the study, 88% still had them.

“Although we cannot be certain how this relates to immunity, the results suggest that people may be protected against subsequent infection for at least six months following natural infection,” Allen said.

She said the findings were also consistent with results of other studies in the United Kingdom and Iceland which found that antibodies to the coronavirus tended to persist for several months in those who have had the disease and recovered.

A study of UK healthcare workers published last month found that people who have had COVID-19 were likely to be protected for at least five months, but noted that those with antibodies may still be able to carry and spread the virus.

The UK Biobank study also found that the proportion of the UK population with COVID-19 antibodies - a measure known as seroprevalence - rose from 6.6% at the start of the study period in May/June 2020 to 8.8% by November/December 2020.

SARS-CoV-2 seroprevalence was most common in London, at 12.4%, and least common in Scotland at 5.5%, it found.

https://www.reuters.com/article/us-health-coronavirus-antibodies/recovered-covid-patients-likely-protected-for-at-least-six-months-study-finds-idUSKBN2A3002

Vaccines may protect against severe disease even as variants evolve: Oxford's Pollard

 COVID-19 vaccines might offer protection against severe disease even as coronavirus variants evolve to better allow continued transmission between people, the head of the Oxford Vaccine Group Andrew Pollard said on Wednesday.

Asked how effective the Oxford/AstraZeneca will be against new variants, he said “they are making changes that allow them to avoid human immune responses, so that they can still transmit.”

“So, that does mean that it’s likely over time that the virus will find ways of adapting so that can continue to pass between people,” he told BBC TV.

“But that doesn’t mean that we won’t still have protection against severe disease... The virus is much more about the virus being able to continue to survive, rather than trying to cause harm to us.”

https://www.reuters.com/article/us-health-coronavirus-astrazeneca-pollar/vaccines-may-protect-against-severe-disease-even-as-variants-evolve-oxfords-pollard-says-idUSKBN2A30WV

Tuesday, February 2, 2021

Melatonin-Index as biomarker for presymptomatic, asymptomatic SARS-CoV-2 carriers

Fernandes, P.A., Kinker, G.S., Navarro, B.V., Jardim, V.C., Ribeiro-Paz, E.D., Córdoba-Moreno, M.O., Santos-Silva, D., Muxel, S.M., Fujita, A., Moraes, C., Nakaya, H.I., Buckeridge, M.S. and Markus, R.P.

DOI: https://doi.org/10.32794/mr11250090

PDF: https://www.melatonin-research.net/index.php/MR/article/view/109/737

Abstract

The pandemic dissemination of the SARS-CoV-2 led, on the one hand, to a worldwide effort to develop mechanistic-based therapeutics and vaccines, and on the other hand, the searching for determining the spreaders and the mechanisms of transmission. Melatonin, a multitask molecule, orchestrates defense responses by allowing the proper mounting, duration, and magnitude of innate immune responses. Melatonin is synthesized on demand by immune-competent cells and constitutively by resident macrophages such as alveolar macrophages. Here we investigated whether the expression of genes relevant to virus invasion and infection varies according to a genic index (MEL-Index) that estimates the capacity of the lung to synthesize melatonin. A COVID-19-Signature composed of 455 genes of 288 human lungs (GTEX, UCSD) was correlated with MEL-Index by Pearson correlation test, gene-set enrichment analysis, and networking tool that integrates the connectivity between the most expressed genes, allowing us to compare the same set of genes under different states. The three independent procedures point to a negative relationship between MEL-Index and SARS-CoV-2 infection. The entry in epithelial AT2 cells should be hampered by a positive correlation TMRPSS2  and a negative correlation with the coding gene for furin, suggesting dysfunctional processing in virus spike. Moreover, MEL-Index also negatively correlates with the genes that codify the proteins of multi-molecular receptor complex CD147, the gateway in macrophages, and other immune cells. In summary, the perspective that lung and respiratory tract melatonin could be a natural protective factor opens new epidemiological and pharmacological perspectives, as high MEL-Index scores could be predictive of asymptomatic carriers, and nasal administrated melatonin could prevent evolution of presymptomatic carriers.

https://www.melatonin-research.net/index.php/MR/article/view/109


Cultural tightness–looseness and COVID-19 cases and deaths


PDF: https://www.thelancet.com/action/showPdf?pii=S2542-5196%2820%2930301-6

Summary

Background

The COVID-19 pandemic is a global health crisis, yet certain countries have had far more success in limiting COVID-19 cases and deaths. We suggest that collective threats require a tremendous amount of coordination, and that strict adherence to social norms is a key mechanism that enables groups to do so. Here we examine how the strength of social norms—or cultural tightness–looseness—was associated with countries' success in limiting cases and deaths by October, 2020. We expected that tight cultures, which have strict norms and punishments for deviance, would have fewer cases and deaths per million as compared with loose cultures, which have weaker norms and are more permissive.

Methods

We estimated the relationship between cultural tightness–looseness and COVID-19 case and mortality rates as of Oct 16, 2020, using ordinary least squares regression. We fit a series of stepwise models to capture whether cultural tightness–looseness explained variation in case and death rates controlling for under-reporting, demographics, geopolitical factors, other cultural dimensions, and climate.

Findings

The results indicated that, compared with nations with high levels of cultural tightness, nations with high levels of cultural looseness are estimated to have had 4·99 times the number of cases (7132 per million vs 1428 per million, respectively) and 8·71 times the number of deaths (183 per million vs 21 per million, respectively), taking into account a number of controls. A formal evolutionary game theoretic model suggested that tight groups coordinate much faster and have higher survival rates than loose groups. The results suggest that tightening social norms might confer an evolutionary advantage in times of collective threat.

Interpretation

Nations that are tight and abide by strict norms have had more success than those that are looser as of the October, 2020. New interventions are needed to help countries tighten social norms as they continue to battle COVID-19 and other collective threats.

Funding

Office of Naval Research, US Navy.

Get Your Homebound Parent a COVID-19 Vaccine

 On January 9, Donna Lackner-Horn made appointments for her parents, Trudy and Werner Lackner, and an aunt and uncle, to get their COVID-19 vaccines the following week at HealthAlliance Hospital-Foxhall in Kingston, N.Y., 45 minutes from their homes in Poughkeepsie, NY. Though she needed to transport them to the vaccination site, Lackner-Horn considered herself lucky to nab the appointments since her mom, 78, and uncle, 88, are mostly homebound with chronic health issues and she couldn't find a way to get them vaccinated where they live.

"On Facebook, I follow various COVID awareness groups, but it was actually my town's supervisor who posted that the vaccines were being scheduled the next county over," says Lackner-Horn, 59, a nonprofit executive who lives in Hyde Park, NY. So, she clicked on a link in the Facebook post, which brought her to an app that allowed her to schedule all four appointments at the hospital. "It was just sheer luck I was scrolling through Facebook that day," says Lackner-Horn.

As her experience shows, getting homebound relatives vaccinated against COVID-19 isn't easy. But it's a problem a lot of caregivers will be facing: About 1.9 million adults over 65 are mostly homebound and another 5.3 million have health conditions that make leaving home difficult, according to the health policy think tank Commonwealth Fund.

There is no national plan for getting COVID-19 vaccines delivered to older homebound adults.

The phased rollout plans for the vaccines have been drawn up at the state level, and the early phases do include adults over 75 (in some cases, over 65). But it's logistically challenging to get the vaccines into homes, because the first two on the market, from Moderna and Pfizer, must be stored at ultra-cold temperatures.

How to Be Proactive for a Homebound Person's Vaccine

So, it's likely that family members or other caregivers will need to arrange for homebound people to be transported to vaccine centers, says Dr. Steven Albert, professor and chair of the University of Pittsburgh Graduate School of Public Health's department of behavioral and community health sciences.

"It is a very confusing picture right now," Albert says. "It's easy to get vaccines to nursing homes. But for every one person in a nursing home, there are probably five people in their homes with equal levels of disability who rely on a combination of family and community-based services."

So where should you start if you need to get a homebound parent vaccinated?

If they use a home health agency, calling there for guidance may lead you in the right direction. Home health aides aren't licensed to administer vaccines, but the agencies that employ them might partner with other health care providers who can bring vaccines to people's homes.

Some companies providing in-home health services are arranging transportation to COVID-19 vaccination sites for their homebound clients.

They include Landmark Health, a Huntington Beach, Calif. company that provides in-home care in 16 states. While Landmark physicians can't bring the vaccines to homes because of the cold-storage requirement, they can assist patients getting to vaccination sites, says Dr. Michael Le, chief medical officer.

"Our social workers can help them make appointments for vaccination at places that will minimize their time out of the home. They can also tap into community resources to arrange for transportation," Le says.

Alternatively, you might try the local government where your parent lives, but don't get your hopes up. Just a few local governments are beginning to arrange for COVID-19 vaccines for their homebound populations.

What Some Local Governments Are Doing

Florida's Miami-Dade County, for example, recently posted online that it started scheduling those vaccines. The Miami Beach fire department took 600 doses of the Moderna vaccine to a local apartment building for low-income older adults and the city has taken 200 older residents to a nearby medical center to get vaccinated.

According to The Orlando Sentinel, older homebound residents in the area's Seminole County can call to have a paramedic sent to them through a new, little-known program. (Florida's governor has prioritized COVID-19 vaccinations for people 65 and older but hasn't implemented a statewide plan for the homebound.)

And the township of Nutley, N.J., just announced that it will deploy medical staff from nearby RWJ Barnabas Health to bring a COVID-19 vaccine to those who are homebound due to illness or immobility.

Check with your parent's community's social media channels and local news websites.

If your parent is part of a Medicaid waiver program (state-funded providers of long-term home care), see if there's a care coordinator to call for information about a COVID-19 vaccination, Albert says.

An Expert's Advice for Family Caregivers

Le's advice for family caregivers who need to transport parents to vaccination sites: Do some research in advance to minimize the hassle. He speaks from personal experience.

When Le got his COVID-19 vaccine at a site set up by the Orange County Fire Department, he was surprised that he had to wait nearly three hours in his car just to get into the vaccination parking lot.

Bottom line: "If you're bringing your mom or dad to a vaccination site, be proactive," Le says. "If there's a line, make sure there's a way for them to be seated in the shade or to have their spot saved in line, so it's not so much of a physical struggle for them."

As for Lackner-Horn's four relatives, they got their first dose of the COVID-19 vaccine on January 12. The check-in and administrative work was "seamlessly efficient," Lackner-Horn says.

What's more, they were able to make appointments for the required second dose onsite. "They are all very pleased, and a bit elated," Lackner-Horn says. She's relieved.

PerkinElmer Q4, Full Year 2020 Results, 2021 Projections

 PerkinElmer, Inc.. (NYSE: PKI), a global leader committed to innovating for a healthier world, today reported financial results for the fourth quarter and full year ended January 3, 2021.

Fourth Quarter 2020

The Company reported GAAP earnings per share from continuing operations of $3.38, as compared to GAAP earnings per share from continuing operations of $0.58 in the fourth quarter of 2019. GAAP revenue for the quarter was $1.355 billion, as compared to $805 million in the fourth quarter of 2019. GAAP operating income from continuing operations for the quarter was $510 million, as compared to $138 million for the same period a year ago. GAAP operating profit margin was 37.7% as a percentage of revenue, as compared to 17.2% in the fourth quarter of 2019.

Adjusted earnings per share from continuing operations for the quarter was $3.96, as compared to $1.35 in the fourth quarter of 2019. Adjusted revenue for the quarter was $1.355 billion, as compared to $806 million in the fourth quarter of 2019. Adjusted operating income from continuing operations for the quarter was $571 million, as compared to $192 million for the same period a year ago. Adjusted operating profit margin was 42.2% as a percentage of adjusted revenue, as compared to 23.9% in the fourth quarter of 2019.

Full Year 2020

The Company reported GAAP earnings per share from continuing operations of $6.50, as compared to GAAP earnings per share from continuing operations of $2.04 in 2019. GAAP revenue for the year was $3.783 billion, as compared to $2.884 billion in 2019. GAAP operating income from continuing operations for the year was $979 million, as compared to $362 million in 2019. GAAP operating profit margin was 25.9% as a percentage of revenue, as compared to 12.6% in 2019.

Adjusted earnings per share from continuing operations for the year was $8.30, as compared to $4.10 in 2019. Adjusted revenue for the year was $3.784 billion, as compared to $2.884 billion in 2019. Adjusted operating income from continuing operations for the year was $1.203 billion, as compared to $596 million in 2019. Adjusted operating profit margin was 31.8% as a percentage of adjusted revenue, as compared to 20.7% in 2019.

Adjustments for the Company's non-GAAP financial measures have been noted in the attached reconciliations.

“While the fourth quarter and full year financial results are certainly impressive, we have many accomplishments beyond the headline financial numbers to be proud of,” said Prahlad Singh, president and chief executive officer of PerkinElmer. “The team’s response to the pandemic, and their resolute focus throughout 2020 to be a part of the solution, was humbling and inspiring to watch. As we look ahead, I could not be more excited about the future for PerkinElmer.”

 

Financial Overview by Reporting Segment for the Fourth Quarter and Full Year 2020

Discovery & Analytical Solutions

  • Fourth quarter 2020 revenue was $503 million, as compared to $496 million for the fourth quarter of 2019. Reported revenue increased 1% and organic revenue decreased 2% as compared to the fourth quarter of 2019. Full year 2020 revenue was $1.716 billion, as compared to $1.746 billion in 2019. Full year reported revenue decreased 2% and organic revenue decreased 4%.
  • Fourth quarter 2020 operating income from continuing operations was $73 million, as compared to $91 million for the comparable prior period. Full year 2020 operating income was $183 million, as compared to $238 million in 2019.
  • Fourth quarter 2020 adjusted operating income was $92 million, as compared to $116 million for the fourth quarter of 2019. Full year 2020 adjusted operating income was $267 million, as compared to $338 million in 2019.

Diagnostics

  • Fourth quarter 2020 revenue was $852 million, as compared to $309 million for the fourth quarter of 2019. Reported revenue increased 176% and organic revenue increased 172% as compared to the fourth quarter of 2019. Full year 2020 revenue was $2.067 billion, as compared to $1.138 billion in 2019. Full year reported revenue increased 82% and organic revenue increased 81%.
  • Fourth quarter 2020 operating income from continuing operations was $460 million, as compared to $61 million for the comparable prior period. Full year 2020 operating income was $874 million, as compared to $189 million in 2019.
  • Fourth quarter 2020 adjusted operating income was $502 million, as compared to $91 million for the fourth quarter of 2019. Full year 2020 adjusted operating income was $1.010 billion, as compared to $316 million in 2019.

Initiates Financial Guidance: First Quarter and Full Year 2021 Guidance

For the first quarter of 2021, the Company forecasts GAAP revenue of approximately $1.19 billion. GAAP earnings per share from continuing operations of at least $2.52 and, on a non-GAAP basis, which is expected to include the adjustments noted in the attached reconciliation, adjusted earnings per share of at least $3.00.

For the full year of 2021, the Company forecasts GAAP revenue of at least $4.08 billion. GAAP earnings per share from continuing operations of at least $6.73 and, on a non-GAAP basis, which is expected to include the adjustments noted in the attached reconciliation, adjusted earnings per share of at least $8.50.

Conference Call Information

The Company will discuss its fourth quarter and full year 2020 results and its outlook for business trends in a conference call on February 2, 2021 at 5:00 p.m. Eastern Time. To access the call, please dial (720) 405-2250 prior to the scheduled conference call time and provide the access code 2779705.

A live audio webcast of the call will be available on the Investors section of the Company’s Web site, www.perkinelmer.com. Please go to the site at least 15 minutes prior to the call in order to register, download, and install any necessary software. An archived version of the webcast will be posted on the Company’s Web site for a two-week period beginning approximately two hours after the call.

https://www.biospace.com/article/releases/perkinelmer-announces-financial-results-for-the-fourth-quarter-and-full-year-of-2020/

FDA to Require Additional Study for Eagle’s Generic Vasopressin

 Eagle Pharmaceuticals is still struggling to get its generic vasopressin to market, announcing both a regulatory stall and an additional trial delay for a patent case with Endo Par Innovation Company over the drug.

Eagle received a complete response letter from the U.S. Food and Drug Administration (FDA), and after additional consultation with FDA, it has determined it will begin an additional, short-duration study by mid-March.

In the patent case, Eagle received word from the United States District Court for the District of Delaware last week its court data has been postponed to July 7, from February 1. According to the company, Endo Par has asserted claims in its patents for a vasopressin formulation with a pH between 3.7-3.9. However, Eagle says its vasopressin product would not be in that range.

Vasostrict – Endo Par’s branded version of injectable vasopressin – was approved in 2014 in hypotensive adult patients with vasodilatory shock, and works by increasing blood pressure. Vasopressin is a naturally occurring hormone and was previously marketed without FDA approval until 2011, when FDA required New Drug Applications (NDAs) from drugmakers. Endo Par was the first to win approval, and the company negotiated exclusive deals with the largest vasopressin suppliers, effectively blocking out existing competitors. At least one competitor, Fresnius SE, sued Endo over the moves but lost its case last year.

Eagle was the first of at least three companies that have submitted Abbreviated NDAs to FDA for approval of a generic vasopressin, and the complete response letter came following a priority review that was granted in November. The company said it has already met with FDA twice about the letter and “believes it can fully respond to the questions raised.” FDA and Eagle will meet again within a month.

Eagle estimates that Endo Par had over $700 million in sales for Vasostrict last year, up 20% over the previous year, and says FDA has flagged it as a COVID priority. Vasopressin has been used in adults with severe COIVD-19 with shock. If its Abbreviated NDA is approved, the company expects it will be eligible for a 180-day generic exclusivity period.

https://www.biospace.com/article/fda-to-require-additional-study-for-eagle-s-generic-vasopressin/