Alcohol-free hand sanitizer just as effective against COVID as alcohol-based

 A new study from researchers at Brigham Young University finds that alcohol-free hand sanitizer is just as effective at disinfecting surfaces from the COVID-19 virus as alcohol-based products.

The BYU scientists who conducted the study suspected that the CDC's preference for alcohol sanitizer stemmed from as-yet limited research on what really works to disinfect SARS-CoV-2. To explore other options, they treated samples of the novel coronavirus with benzalkonium chloride, which is commonly used in alcohol-free hand sanitizers, and several other quaternary ammonium compounds regularly found in disinfectants. In most of the test cases, the compounds wiped out at least 99.9% of the virus within 15 seconds.

"Our results indicate that alcohol-free hand sanitizer works just as well, so we could, maybe even should, be using it to control COVID," said lead study author Benjamin Ogilvie.

Alcohol-free hand sanitizers, which are also effective against common cold and flu viruses, have a number of advantages over their alcohol-based counterparts, Ogilvie explained.

"Benzalkonium chloride can be used in much lower concentrations and does not cause the familiar 'burn' feeling you might know from using alcohol hand sanitizer. It can make life easier for people who have to sanitize hands a lot, like healthcare workers, and maybe even increase compliance with sanitizing guidelines," he said.

In the face of shortages, "having more options to disinfect hospitals and public places is critical," added Ph.D. student Antonio Solis Leal, who conducted the study's experiments.

Switching to alcohol-free hand sanitizer is logistically simple as well.

"People were already using it before 2020," said BYU professor and coauthor Brad Berges. "It just seems like during this pandemic, the non-alcohol-based hand sanitizers have been thrown by the wayside because the government was saying, 'we don't know that these work,' due to the novelty of the virus and the unique lab conditions required to run tests on it."

Since benzalkonium chloride typically works well against viruses surrounded by lipids--like COVID--the researchers believed that it would be a good fit for disinfecting the coronavirus.

To test their hypothesis, they put COVID samples in test tubes and then mixed in different compounds, including .2% benzalkonium chloride solution and three commercially available disinfectants containing quaternary ammonium compounds, as well as soil loads and hard water.

Working fast to simulate real-world conditions--because hand sanitizer has to disinfect quickly to be effective--they neutralized the disinfecting compounds, extracted the virus from the tubes, and placed the virus particles on living cells. The virus failed to invade and kill the cells, indicating that it had been deactivated by the compounds.

"A couple of others have looked at using these compounds against COVID," said Berges, "but we're the first to actually look at it in a practical timeframe, using four different options, with the realistic circumstance of having dirt on your hands before you use it."

The team believes their findings "may actually provide a change in government directions about hand sanitizer," Berges said.

Ogilvie hopes that reintroducing alcohol-free sanitizers into the market can relieve the shortages--and reduce the chances of people encountering some potentially "sketchy" alcohol sanitizers that have cropped up in response to the demand.

"Hand sanitizer can play an especially important role in controlling COVID," he concluded. "This is information that could affect millions of people."

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The study is published online in the Journal of Hospital Infection.

https://www.eurekalert.org/pub_releases/2020-12/byu-ahs120120.php

Gottlieb: Covid vaccine seen in ‘rationing type of environment’ well into spring

 Dr. Scott Gottlieb told CNBC on Wednesday the availability of coronavirus vaccine doses is likely to be limited in the next few months should U.S. regulators grant emergency approval later this month.

“We’re going to be in this sort of rationing type of environment for this vaccine probably well into the spring,” the former Food and Drug Administration commissioner said on “Squawk Box.”

Gottlieb, a Pfizer board member, made his remarks shortly after the company’s Covid-19 vaccine received approval from the U.K. government. Britain’s rollout of the Pfizer vaccine, developed in partnership with German biotech firm BioNTech, is set to start next week for health-care workers and elderly people in long-term care facilities.

A day earlier, an advisory panel for the U.S. Centers for Disease Control and Prevention recommended that a similar group of Americans be the first to receive a Covid-19 vaccine after it receives regulatory clearance in America. In addition to Pfizer’s application with the FDA, Moderna also has submitted for the same limited authorization. The FDA could grant approval in just a few weeks, with distribution across the U.S. beginning shortly thereafter.

The U.S. expects about 40 million doses of vaccine will be available by the end of 2020, Health and Human Services Secretary Alex Azar told CNBC in mid-November. Since both Pfizer and Moderna’s vaccines require two doses, that would be enough for roughly 20 million Americans. There are approximately 21 million health-care workers in the U.S. and 3 million residents of long-term care facilities.

Most states and other localities expect the process of vaccinating all their health-care workers to take three weeks, according to Dr. Nancy Messonnier, director of the CDC’s National Center for Immunization and Respiratory Diseases, who spoke during Tuesday’s CDC panel meeting.

Gottlieb, who led the FDA from 2017 to 2019 during the Trump administration, touted the potential benefits of a vaccine to help turn the tide of the coronavirus pandemic. However, he stressed it will take time for widespread deployment.

“Really the biggest variable right now is that we’re going to have limited supply for the remainder of this year certainly and even into next year,” Gottlieb said. That means even when additional groups of Americans are cleared to receive the vaccine, “we’re going to be limited with those tranches,” he said.

“It’s going to be certain essential workers in the next waves of vaccination and also older individuals who are at higher risk of having a bad outcome for Covid. Those will be the groups that get vaccinated next,” he added.

Despite initial supply constraints, manufacturing capacity is expected to be ramped up throughout the next year. Pfizer and BioNTech have said they can make up to 1.3 billion doses in 2021. Last month, Massachusetts-based Moderna said it is still on pace to produce 500 million to 1 billion doses of its vaccine globally in 2021.

On Tuesday, the Trump administration’s vaccine chief, Dr. Moncef Slaoui, said he believes every American could be inoculated against Covid-19 by June. The country has almost 331 million people.

“Very quickly we’ll start having more than 150 million doses a month in March, April, May,” Slaoui told The Washington Post, should vaccines from companies beyond Pfizer and Moderna become available.

A number of other companies are in various stages of testing Covid-19 vaccines including U.K.-based AstraZeneca and U.S. drug giant Johnson & Johnson.

Gottlieb has said he expects the intensity of the U.S. coronavirus outbreak to be less severe in 2021, even when just portions of the population start to get vaccinated against Covid-19. That’s because up to 30% of Americans are likely to have been infected by year-end, he told CNBC earlier this week.

“You combine a lot of infection around the country with vaccinating 20% of the population [and] you’re getting to levels where this virus is not going to circulate as readily, once you get to those levels of prior immunity,” Gottlieb said Monday.

The U.S. has 13.7 million confirmed cases of coronavirus and at least 270,728 deaths, according to data compiled by Johns Hopkins University.

https://www.cnbc.com/2020/12/02/dr-scott-gottlieb-sees-covid-vaccine-in-rationing-type-of-environment-well-into-the-spring-.html

COVID-19 Vaccine Expected To Arrive In TX Week Of Dec. 14

 According to a news release from Governor Greg Abbott on Wednesday, about 1.4 million Texans will receive their first coronavirus vaccines beginning the week of December 14th.

Chris Van Duesen, spokesman for the Texas Department of State Health Services, said that the second dosage of vaccines for the same group will come in January. The vaccine developers applied for emergency authorization of the vaccines that require two dosages per individual, Statesman reported.

Abbot said, "The state of Texas is already prepared for the arrival of a COVID-19 vaccine, and will swiftly distribute these vaccines to Texans who voluntarily choose to be immunized. As we await the first shipment of these vaccines, we will work with communities to mitigate the spread of COVID-19."

Health care workers will be first in line for the vaccines.

"First tier" health care workers, which will receive the vaccine first, include hospital staff working directly with COVID-19 patients, long-term care staff working with vulnerable residents, emergency workers, and home health care workers.

According to Van Duesen, the initial distribution points will include hospitals, large clinics, doctors offices, and medical practices "that can vaccinate a large number of people initially."

https://961now.iheart.com/content/2020-12-02-covid-19-vaccine-expected-to-arrive-in-tx-the-week-of-december-14th/

Antipsychotic-induced immune dysfunction: A consideration for COVID-19 risk

MeghanMay, MatthewSlitzkyBahmanRostamaDeborahBarlowKaren L.Houseknect

DOI: https://doi.org/10.1016/j.bbih.2020.100097

PDF: https://www.sciencedirect.com/science/article/pii/S2666354620300624/pdfft?md5=821f1e210afd9e9a7bf067bce642bc08&pid=1-s2.0-S2666354620300624-main.pdf

Highlights

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Risperidone caused a highly dysregulated immune response in healthy mice.

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Short term, low-dose risperidone therapy altered cytokine response to LPS challenge.

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Risperidone caused failure to seroconvert following vaccination with Pneumovax23®.

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Antipsychotic-induced immune dysfunction has serious implications for older adults.

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Antipsychotic immune-dysregulation has implications for COVID-19 vulnerable patients.

Abstract

Patients with severe mental illness are more susceptible to infections for a variety of reasons, some associated with the underlying disease and some due to environmental factors including housing insecurity, smoking, poor access to healthcare, and medications used to treat these disorders. This increased susceptibility to respiratory infections may contribute to risk of COVID-19 infection in patients with severe mental illness or those in inpatient settings. Atypical antipsychotic (AA) medications are FDA approved to treat symptoms associated with schizophrenia, bipolar disorder, depression and irritability associated with autism. Our team and others have shown that AA may have anti-inflammatory properties that may contribute to their efficacy in the treatment of mental health disorders. Additionally, AA are widely prescribed off-label for diverse indications to non-psychotic patients including older adults, who are also at increased risk for COVID-19 complications and mortality. The aim of this study was to determine if AA medications such as risperidone (RIS) alter the ability to mount an appropriate response to an acute inflammatory or adaptive immune challenge using a preclinical model. Short-term treatment of healthy mice with a dose of RIS that achieves plasma concentrations within the low clinical range resulted in disrupted response to an inflammatory (LPS) challenge compared to vehicle controls. Furthermore, RIS also prevented treated animals from mounting an antibody response following vaccination with Pneumovax23®. These data indicate that short-to intermediate-term exposure to clinically relevant levels of RIS dysregulate innate and adaptive immune responses, which may affect susceptibility to respiratory infections, including COVID-19.

https://www.sciencedirect.com/science/article/pii/S2666354620300624

Slaoui: U.S. should be able to immunize nearly 1/3 of population by end of Feb.

 The U.S. should be able to distribute enough coronavirus vaccine doses to immunize 100 million people by the end of February, President Donald Trump’s Covid-19 vaccine czar said Wednesday.

That will be enough doses to protect a “significant portion” of the most at-risk Americans, which are the elderly, health-care workers and people with preexisting conditions, Dr. Moncef Slaoui, who is leading the Trump administration’s vaccine program Operation Warp Speed, told reporters during a news briefing.

There is a chance the U.S. could have more doses than expected that month if Johnson & Johnson’s potential vaccine is authorized by then, Slaoui said, adding he expects the company to release key late-stage trial data in January.

The federal government is expected to ship 6.4 million doses of Pfizer’s vaccine to jurisdictions across the nation within 24 hours after an emergency use authorization from the Food and Drug Administration, Army Gen. Gustave Perna, chief operations officer for Operation Warp Speed, said at the same briefing. Officials plan to ship 12.5 million doses of Moderna’s vaccine following an emergency authorization, he added.

The planning “is not about getting in front of the EUA,” Perna told reporters. “It is making sure we have everything locked so when EUA decisions come, distribution to the American people becomes immediate.”

The briefing Wednesday came as states prepare to distribute a Covid-19 vaccine in as little as two weeks. Moderna and Pfizer late last month requested emergency clearances from the FDA for their Covid-19 vaccines. The reviews by the FDA are expected to take a few weeks, and the agency has scheduled a meeting for Dec. 10 to discuss Pfizer’s request for authorization.

Earlier Wednesday, the U.K. became the first country to authorize the Pfizer vaccine for emergency use, marking another step in the global battle against the pandemic.

Initial doses will be limited as manufacturing ramps up, with top U.S. health officials predicting it will take months to immunize everyone who wants to be vaccinated against Covid-19 in the United States. The federal government has deals lined up with several drugmakers to buy some of their first doses.

A Centers for Disease Control and Prevention panel on Tuesday voted 13-1 to give health-care workers and long-term care facility residents in the U.S. the first coronavirus vaccine doses once it’s cleared for public use. There are roughly 21 million health-care workers and 3 million long-term care facility residents in the United States, according to the CDC.

Medical experts have previously advocated for health-care workers to get the vaccine first, followed by vulnerable Americans -- the elderly, people with preexisting conditions and essential workers. Children and young adults are expected to get the vaccine last.

Before the vote, Dr. Nancy Messonnier, director of the CDC’s National Center for Immunization and Respiratory Diseases, said most states and local jurisdictions expect it to take three weeks to vaccinate all of their health-care workers. Pfizer’s and Moderna’s vaccines require two doses about a month apart. Both vaccines are using messenger RNA, or mRNA, technology. It’s a new approach to vaccines that uses genetic material to provoke an immune response.

Perna said Wednesday that the federal government has asked states to finalize plans for distribution by the end of this week.

States have already submitted early plans to the CDC on how they intend to inoculate some 331 million Americans against Covid-19 once a vaccine is approved. The CDC has allocated $200 million to jurisdictions for vaccine preparedness, though much of that funding hasn’t trickled down to the local level.

https://www.cnbc.com/2020/12/02/trump-covid-vaccine-czar-says-us-should-be-able-to-immunize-nearly-third-of-population-by-end-of-february.html

Colorado issuing $375 stimulus payments to residents hardest-hit by Covid

 Eligible Coloradans will soon have a little extra cash thanks to the state government.

The state has begun issuing one-time $375 stimulus payments to residents needing the most financial help, the governor’s office announced Wednesday morning.

“Whether you’ve suffered from the virus itself, faced economic struggles, or felt the mental toll -- no one is left unscathed by this pandemic. This direct cash payment will help cover rent or put food on the table for over 400,000 Coloradans who have struggled, but we know that Colorado or any state can only do so much, and national help is urgently needed,” said Gov. Jared Polis. “I’m thankful for the partnership of legislative leadership and the legislature’s efforts this week to provide real relief to Coloradans and our small businesses. We see light at the end of the tunnel with news of a vaccine, but the consequences of this pandemic will be far lingering if Washington fails to act.”

As outlined by Polis when he first announced the plan in October, any Coloradan who was eligible to receive between $25 and $500 in weekly unemployment insurance benefits between March 15 and Oct. 24 qualifies for this stimulus payment. That includes residents who received payments from the Pandemic Unemployment Assistance (PUA), Pandemic Emergency Unemployment Compensation (PEUC), or other similar programs. The state says all eligible claimants will receive an email or call from the Colorado Labor Department.

The only action claimants need to take is logging into their benefits account to make sure their selected payment method and address are up to date.

https://www.kktv.com/2020/12/02/colorado-begins-issuing-375-stimulus-payments-to-residents-hardest-hit-by-pandemic/

Considerations for Authorization of Pfizer's COVID Vax

 A rainbow is on the horizon, as we anticipate that the FDA will issue an emergency use authorization (EUA) for the Pfizer-BioNTech candidate COVID-19 vaccine, following an advisory committee meeting scheduled for Dec. 10. Based on data from the phase III placebo-controlled trial, the Pfizer-BioNTech vaccine is reported to have an overall efficacy rate of 95%, consistent across age, gender, race, and ethnicity demographics; and the observed efficacy in adults over 65 years of age was over 94%. The trial involved more than 43,000 participants (with a 1:1 randomization to vaccine or placebo) and a total of 170 confirmed cases of COVID-19 were evaluated, with 162 observed in the placebo group versus eight in the vaccine group.

Vaccine efficacy is a measure of the performance of the vaccine under "ideal and controlled circumstances" as in a research study -- a randomized controlled trial, whereas effectiveness refers to its performance under "real-world" conditions, where other variables come to bear, allowing for a pragmatic evaluation. A critical consideration is that the primary efficacy endpoint of this phase III trial was the development of symptomatic COVID-19 infection; therefore, participants who may have developed asymptomatic coronavirus infection (after receiving the vaccine or placebo) were not identified or accounted for in this study. Consequently, if an EUA is issued, the FDA will have to be clear about the spectrum of COVID-19 infection that this vaccine is efficacious against, noting that asymptomatic transmission is a key driver of the spread of COVID-19.

In deciding whether to recommend authorization, advisory group members will address the following overarching questions:

1. Based on the totality of scientific evidence available, including data from adequate and well-controlled trials, is it reasonable to believe that the candidate vaccine may be effective to prevent SARS-CoV-2 infection?

2. Do the known and potential benefits of the candidate vaccine outweigh the known and potential risks of the candidate vaccine?

The adequacy and overall quality of the evidence will come under scrutiny from multiple angles, including attention to statistical power, which refers to the probability that the trial will detect a particular effect, if it truly exists. Power is a function of multiple factors but strongly linked to sample size, and adequate power is necessary in order to differentiate between an actual vaccine effect and a difference occurring by chance.

According to the Pfizer-BioNTech study protocol, the sample size is sufficient to provide 90% power to conclude that the true vaccine efficacy is greater than 30%, which is the lower bound required by the FDA for estimating vaccine efficacy using appropriate confidence intervals. Of note, however, is that the power of this phase III trial was calculated to detect an overall effect for vaccine efficacy, and does not specifically account for subgroup differences by age, gender, race, and ethnicity. Such subgroup analyses will require multiple comparisons, and if this component of the study is underpowered, that could increase the probability of obtaining biased and spurious subgroup differences in vaccine efficacy, even with multiplicity adjustment.

Regarding vaccine reactogenicity, the companies' topline announcement said the vaccine was well tolerated across all populations with no serious safety concerns. The only grade 3 (severe) adverse events or side effects were fatigue at 3.8% and headache at 2.0%. No statistical data were reported for the frequency of mild (grade 1) and moderate (grade 2) adverse events. A previous, smaller study of this vaccine noted frequent occurrences of adverse effects encompassing injection site pain, fever, chills, headaches, and fatigue, which were primarily mild or moderate, and these are recognized as common side effects of vaccines.

This phase III trial sought to blind participants to whether they received the vaccine or placebo. However, it is reasonable to assume that given the widespread awareness of common vaccine side effects, those who had that experience may have associated it with receiving the vaccine and hence become unblinded, and this could potentially confound the study outcome, resulting in biased estimates of vaccine efficacy. Those in the placebo group could have been similarly affected by associating the absence of vaccine side effects with receiving the placebo. Experimental studies without adequate and appropriate blinding tend to show larger treatment effects than studies with proper blinding. Therefore, performance and observer bias cannot be ruled out.

Based on the evidence available in the public domain, at this time, the general expectation is that the FDA will issue an EUA for this candidate COVID-19 vaccine, with the caveat that the evidence supports that the vaccine can protect against symptomatic disease, but it is not known if it prevents infection and transmission. The FDA may be less inclined to make any recommendation or determination regarding vaccine efficacy for specific subgroups. Additional prospective data are required to determine the level of effectiveness of this vaccine including subgroup differences, the durability of its protection, as well as to monitor safety and tolerability.

Rossi A. Hassad, PhD, MPH, is an epidemiologist and professor at Mercy College, in Dobbs Ferry, New York. He is a member of the American College of Epidemiology and a fellow and chartered statistician of Britain's Royal Statistical Society.

https://www.medpagetoday.com/infectiousdisease/covid19/89964