An infectious disease expert explains new federal rules on ‘mix-and-match’ vaccine booster shots
by ilene - October 22nd, 2021 11:31 pm
An infectious disease expert explains new federal rules on ‘mix-and-match’ vaccine booster shots
Discuss with your doctor whether or not you need a booster – and if so, which vaccine will work best for you. Justin Sullivan/Getty Images News via Getty Images
Courtesy of Glenn J. Rapsinski, University of Pittsburgh Health Sciences
Many Americans now have the green light to get a COVID-19 vaccine booster – and the flexibility to receive a different brand than the original vaccine they received.
On the heels of the Food and Drug Administration’s Sept. 22, 2021, emergency use authorization of a third dose – or “booster shot” – of the Pfizer/BioNtech vaccine for certain Americans, on Oct. 20, the agency also gave emergency authorization to a third Moderna shot and a second dose of the Johnson & Johnson vaccine.
On Oct. 21, the Centers for Disease Control and Prevention also recommended these vaccinations in light of the FDA’s authorization. The CDC’s signoff will make the Moderna booster shot available to people 65 and older, younger adults at higher risk of severe COVID-19 due to medical conditions and those who are at increased risk due to their workplace environment. People are now eligible for the Moderna booster six months after completion of their original series – as is already the case for the third Pfizer shot. The authorization made all Johnson & Johnson vaccine recipients eligible for a second shot two months after the initial dose.
Notably, the FDA and CDC also authorized a “mix-and-match” strategy, enabling eligible Americans to get a booster shot from a brand different from their original vaccine.
As an infectious disease expert, I have closely followed the development of the COVID-19 vaccines and the research on how immunity and vaccine efficacy shift over time.
With the swirling mass of news around how effective the COVID-19 vaccines are and who needs booster shots and when, it can be challenging and confusing to make sense of it all. But understanding how the immune system works can help bring clarity to the reasons some people could benefit from the authorized shots.
How vaccine efficacy evolves
The…
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Decades of hype turned protein into a superfood – and spawned a multibillion-dollar industry
by ilene - October 21st, 2021 5:34 pm
Decades of hype turned protein into a superfood – and spawned a multibillion-dollar industry
A protein-rich shake is often the way many people try to get more of this nutrient into their diets. andresr E+ via Getty Images
Courtesy of Hannah Cutting-Jones, University of Oregon
Do you ever blend up a protein smoothie for breakfast, or grab a protein bar following an afternoon workout? If so, you are likely among the millions of people in search of more protein-rich diets.
Protein-enriched products are ubiquitous, and these days it seems protein can be infused into anything – even water. But the problem, as Kristi Wempen, a nutritionist at Mayo Clinic, points out, is that “contrary to all the hype that everyone needs more protein, most Americans get twice as much as they need.”
Many of us living in the most economically developed countries are buying into a myth of protein deficiency created and perpetuated by food companies and a wide array of self-identified health experts. Global retail sales of protein supplement products – usually containing a combination of whey, casein or plant-based proteins such as peas, soy or brown rice – reached a staggering US$18.9 billion in 2020, with the U.S. making up around half of the market.
I am a food historian and recently spent a month at the Library of Congress trying to answer the question of why we have historically been – and remain – so focused on dietary protein. I wanted to explore the ethical, social and cultural implications of this multibillion-dollar industry.
Experts weigh in
Weight-loss surgeon Garth Davis writes in his book “Proteinaholic” that “‘eat more protein’ may be the worst advice ‘experts’ give to the public.” Davis contends that most physicians in the U.S. have never actually examined a patient with protein deficiency because simply by eating an adequate number of daily calories we are also most likely getting enough protein.
In fact, Americans currently consume almost two times the National Academy of Medicine’s recommended daily intake of protein: 56 grams for men and 46 grams for women – the equivalent of two eggs, a half-cup of…
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Ivermectin is a Nobel Prize-winning wonder drug – but not for COVID-19
by ilene - October 14th, 2021 12:21 pm
Ivermectin is a Nobel Prize-winning wonder drug – but not for COVID-19
While ivermectin was originally used to treat river blindness, it has also been repurposed to treat other human parasitic infections. ISSOUF SANOGO/AFP via Getty Images
Courtesy of Jeffrey R. Aeschlimann, University of Connecticut
Ivermectin is an over 30-year-old wonder drug that treats life- and sight-threatening parasitic infections. Its lasting influence on global health has been so profound that two of the key researchers in its discovery and development won the Nobel Prize in 2015.
I’ve been an infectious disease pharmacist for over 25 years. I’ve also managed patients who delayed proper treatment for their severe COVID-19 infections because they thought ivermectin could cure them.
Although ivermectin has been a game-changer for people with certain infectious diseases, it isn’t going to save patients from COVID-19 infection. In fact, it could cost them their lives.
Let me tell you a short story about the history of ivermectin.
Developing ivermectin for animal use
Ivermectin was first identified in the 1970s during a veterinary drug screening project at Merck Pharmaceuticals. Researchers focused on discovering chemicals that could potentially treat parasitic infections in animals. Common parasites include nematodes, such as flatworms and roundworms, and arthropods, such as fleas and lice. All of these infectious organisms are quite different from viruses.
Merck partnered with the Kitasato Institute, a medical research facility in Japan. Satoshi Omura and his team isolated a group of chemicals called avermectin from bacteria found in a single soil sample near a Japanese golf course. To my knowledge, avermectin has yet to be found in any other soil sample in the world.
Research on avermectin continued for approximately five years. Soon, Merck and the Kitasato Institute developed a less toxic form they named ivermectin. It was approved in 1981 for commercial use in veterinary medicine for parasitic infections in livestock and domestic pets with the brand name Mectizan.
The chemical compounds that make up ivermectin were first discovered in bacteria found in the soil of a Japanese
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Merck To Double Production Of ‘Breakthrough’ COVID Drug As Nations Line Up To Buy
by clarisezoleta - October 12th, 2021 6:45 pm
Courtesy of ZeroHedge
Despite safety concerns raised by multiple scientists, Merck is signing deals with countries left and right for its new COVID therapeutic, molnupiravir, as the pharmaceutical giant is already planning to double production of the drug in 2022 as experts expect it to face the same kind of early-days gold rush that greeted approval of the initial COVID jabs.
Merck said it aimed to increase its own production from 10m courses of the drug this year to at least 20m in 2022, which is equivalent to 800m tablets.
But it could provide no guidance on the likely production schedule or pricing for generic manufacturers, which will largely be responsible for supplying developing nations with the treatments.
“We are doing these special purchase agreements as a sort of initial way to get therapy to people as quickly as possible in certain countries and there’s a large number of them that we’re working through,” said Nicholas Kartsonis, Merck’s senior vice-president of clinical research. “But I don’t want to underestimate the second tier of this, which is trying to get to as many people around the world as we can.”
As it submits its data to the FDA for approval (the agency now faces a difficult decision to balance potentially harmful side effects like cancer and birth defects with the drug's ability to cut hospitalization and death rates in half), Merck has signed deals with New Zealand, Singapore, Australia and South Korea in just the past week, and it's already in talks with other countries (the US has already agreed to buy more than a million courses).
While Merck prepares for molnupiravir to be one of the most lucrative drugs of all time, the firm has signed deals with 8 generic manufacturers to accelerate production of the drug.
While Merck will likely be first to market with a COVID anti-viral that can be taken in pill form, the competition is already ramping up.
AstraZeneca, which produced a COVID jab in partnership with Oxford that was later found to have dangerous side effects, announced on Monday that its COVID antibody cocktail also halves the risk of severe disease or death in vulnerable patients. It has also sought emergency authorization for its drug, called AZD7442.
So far, the only COVID therapeutics approved outside hospital…
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Flu season paired with COVID-19 presents the threat of a ‘twindemic,’ making the need for vaccination all the more urgent
by ilene - October 12th, 2021 5:51 pm
Flu season paired with COVID-19 presents the threat of a ‘twindemic,’ making the need for vaccination all the more urgent
A bad flu year on top of the pandemic could mean trouble for already-stressed hospitals. George Clerk/E+ Collection via Getty Images
Courtesy of Mark S Roberts, University of Pittsburgh and Richard K Zimmerman, University of Pittsburgh
As winter looms and hospitals across the U.S. continue to be deluged with severe cases of COVID-19, flu season presents a particularly ominous threat this year.
We are researchers with expertise in vaccination policy and mathematical modeling of infectious disease. Our group, the Public Health Dynamics Laboratory at the University of Pittsburgh, has been modeling influenza for over a decade. One of us has been a member of the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices and the CDC’s Flu Vaccine Effectiveness Network.
Our recent modeling work suggests that last year’s tamped-down influenza season could lead to a surge in flu cases this coming season.
Anti-COVID-19 strategies reduced flu too
As a result of the numerous measures put in place in 2020 to curb transmission of COVID-19 – including limiting travel, wearing masks, social distancing, closing schools and other strategies – the U.S. saw a dramatic decrease in influenza and other infectious diseases during the last flu season.
Flu-related deaths in kids dropped from nearly 200 in the 2019-2020 season to one in the 2020-2021 season. Overall, the 2020-2021 flu season had one of the lowest recorded number of cases in recent U.S. history.
While flu reduction is a good thing, it could mean that the flu will hit harder than normal this winter. This is because much of the natural immunity that people develop to disease comes from the spread of that disease through a population. Many other respiratory viruses demonstrated a similar drop during the pandemic, and some of those, including interseasonal respiratory syncytial virus, or RSV, have increased dramatically as schools have reopened and social distancing, masking and other measures have declined.
Deciphering viral transmission
Immunity to influenza involves…
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How Theranos’ faulty blood tests got to market – and what that shows about gaps in FDA regulation
by ilene - October 5th, 2021 5:14 pm
How Theranos’ faulty blood tests got to market – and what that shows about gaps in FDA regulation
Theranos promised that a drop of blood could yield many health secrets. RapidEye/E+ via Getty Images
Courtesy of Ana Santos Rutschman, Saint Louis University
One of the most high-profile trials of the year is underway to decide whether Theranos founder Elizabeth Holmes defrauded patients and investors.
Her blood testing startup, once valued at almost US$10 billion, was based on a seemingly revolutionary premise. Company executives promised investors, and later business partners and patients, that their technology could run hundreds of tests off a single drop of blood. It could not.
While the ongoing trial focuses on the specific wrongdoings of Theranos and Holmes, as a researcher on health technology regulation I believe it also offers an important cautionary tale about problems with how certain medical devices are made available to patients in the United States.
The story of Theranos
Holmes founded the company that became known as Theranos in 2003 with a plan to develop a new blood testing technique.
The technology was two-fold: It involved a device called a nanotainer, which was used to collect blood through a finger prick. The blood would then be tested by another device, called the Edison. Theranos claimed that it could perform a wildly large number of tests, such as measuring glucose levels and detecting different types of antibodies, or even marijuana and opiates.
Despite a lack of transparency about how the technology actually worked, investors poured money into the company, which made its tests available to patients in 2013, including through a partnership with Walgreens.
As a result, more people began to suspect what studies would later show: The limited number of tests Theranos was able to offer did not provide reliable results. To give but one example, recent court testimony revealed that a Theranos test indicated a patient had suffered a miscarriage when, in fact, she had not.
While the ongoing trial is primarily about the company’s wrongdoing, the fact that faulty tests became so widely available –…
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New Johnson & Johnson data shows second shot boosts antibodies and protection against COVID-19 – but one dose is still strong against delta variant
by ilene - September 27th, 2021 5:47 pm
New Johnson & Johnson data shows second shot boosts antibodies and protection against COVID-19 – but one dose is still strong against delta variant
Public health officials have been waiting for good data before making any decisions about booster shots for people who received Johnson & Johnson’s Janssen COVID-19 vaccine. AP Photo/Mary Altaffer
Courtesy of Maureen Ferran, Rochester Institute of Technology
On Sept 22, 2021, Johnson & Johnson released data that answers two questions many people have likely been wondering about its vaccine: How good is it against the delta variant, and do I need a booster? Maureen Ferran, a virologist at the Rochester Institute of Technology, has been keeping tabs on the Johnson & Johnson vaccine. She breaks down the new data and explains what it all means.
1. How effective is one dose of the Johnson & Johnson vaccine?
Early clinical trial data released in January 2021 showed that four weeks after the first dose, the Johnson & Johnson single-shot vaccine was 66.3% effective at preventing COVID-19 infection. The initial studies also showed that it was 85% effective at preventing severe or critical disease.
But the original clinical trials and most subsequent studies were done before the delta variant became responsible for almost all of the COVID-19 cases in the U.S. Early studies suggest that although COVID-19 vaccines are still effective against this variant, in general their efficacy is lower compared to protection against the original strain.
On Sept. 21, 2021, Johnson and Johnson announced the results of a large, real-world Phase 3 clinical trail of its COVID-19 vaccine. This study collected data from March 1, 2020, through July 31, 2021, and found that the effectiveness of the vaccine did not diminish over the duration of the study, even after the delta variant became dominant in the U.S. The one-dose vaccine was 79% protective against COVID-19 infections and 81% protective for COVID-19-related hospitalizations. This indicates that a single Johnson & Johnson shot performs well, even in the presence of the delta and other variants.
Vaccination produces antibodies, shown here as the
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COVID smell loss can have profound effects on your life, from weight change to intimacy barriers
by ilene - September 27th, 2021 1:49 am
COVID smell loss can have profound effects on your life, from weight change to intimacy barriers
Courtesy of Vincent Deary, Northumbria University, Newcastle and Duika Burges Watson, Newcastle University
It took a while to be officially recognised, but smell loss eventually became known to be one of the defining features of COVID-19. It’s now widely acknowledged that COVID-19 has a unique effect on smell receptors, and about 10% of those who lose their smell are still reporting problems with smell and taste six months later.
The effects of this can be profound. So we wanted to document what it was like to live with long-term smell and taste problems, and we did this by working with the smell-loss charity AbScent, which has an online support group for people with post-COVID smell problems.
By speaking to people in this group, we were able to build a picture of the wider impacts of disrupted smell following COVID-19. At the time of conducting our research, over 9,000 people had joined the group. Every day we were seeing new accounts of the devastating effect of sensory change.
We started posting questions to get a better sense of what was going on, and the response was overwhelming. People really wanted their experiences to be heard. With the consent of participants, we began to analyse their responses. We ran every theme we detected past the group and got them to comment on our research paper before we finalised it. We wanted to be sure we were telling their stories correctly. Here’s what we found out.
The end of food satisfaction
It’s been hard for people even close to me to understand the severity of the loss and how it’s affected my life.
Before we go further, let’s define a few key terms. Anosmia is total loss of smell. Parosmia is where normal smells are distorted, usually unpleasantly. Taste is what is picked up by the receptors on the tongue. Flavour is the total sensory experience of food, to which smell is the major contributor, but the other senses are also involved. This means that even if your taste (tongue) is fine,…
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Tense decision-making as CDC joins FDA in recommending Pfizer booster shot for 65 & up, people at high risk and those with occupational exposure to COVID-19
by ilene - September 26th, 2021 5:42 pm
Tense decision-making as CDC joins FDA in recommending Pfizer booster shot for 65 & up, people at high risk and those with occupational exposure to COVID-19
The FDA and CDC are recommending use of a third shot, or “booster dose” for certain groups of people in the U.S. Patrick T. Fallon/AFP via Getty Images
Courtesy of Matthew Woodruff, Emory University
Following the recommendations of its vaccine advisory committee, the Food and Drug Administration gave emergency use authorization to Pfizer-BioNTech’s COVID-19 vaccine booster dose for certain populations. The single shot is to be administered six months following completion of the original two-dose course.
The FDA’s Sept. 22, 2021, decision to not extend boosters to the general population – at least not yet – was a direct rebuke to the Biden administration’s announcement in August that booster shots would be rolled out to all eligible Americans beginning in late September. Biden’s pledge had been widely criticized for getting out in front of the science and the regulatory process.
The FDA instead limited its authorization of the third Pfizer dose to people 65 and older, people ages 18-64 at high risk of severe COVID-19 due to pre-existing conditions, and individuals with frequent risk of exposure to the coronavirus through their work, such as health care workers and teachers.
The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices then issued its own booster recommendations on Sept. 23, 2021. Its guidance aligned with the FDA’s authorization of boosters for use in ages 65 and up and people at high risk of severe COVID-19, but stopped short of endorsing booster shots for people with frequent occupational exposure. However, in an effort to realign the two agencies’ recommendations, CDC director Dr. Rochelle Walensky overrode the CDC advisory committee, providing the go-ahead for all groups listed under the FDA’s emergency use authorizations – including those with increased job-site risk.
Despite the mixed messaging between the agencies, the immediate effect is that millions of Americans will be in line for added protection amid concerns over waning vaccine immunity. An ongoing evaluation of whether COVID-19 boosters should be administered more broadly among vaccine-eligible people is…
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Evidence shows that, yes, masks prevent COVID-19 – and surgical masks are the way to go
by ilene - September 26th, 2021 12:27 pm
Evidence shows that, yes, masks prevent COVID-19 – and surgical masks are the way to go
What type of mask is best? Brais Seara/Moment via Getty Images
Courtesy of Laura (Layla) H. Kwong, University of California, Berkeley
Do masks work? And if so, should you reach for an N95, a surgical mask, a cloth mask or a gaiter?
Over the past year and a half, researchers have produced a lot of laboratory, model-based and observational evidence on the effectiveness of masks. For many people it has understandably been hard to keep track of what works and what doesn’t.
I’m an assistant professor of environmental health sciences. I, too, have wondered about the answers to these questions, and earlier this year I led a study that examined the research about which materials are best.
Recently, I was part of the largest randomized controlled trial to date testing the effectiveness of mask-wearing. The study has yet to be peer reviewed but has been well received by the medical community. What we found provides gold-standard evidence that confirms previous research: Wearing masks, particularly surgical masks, prevents COVID-19.
Laboratory studies help scientists understand the physics of masks and spread.
Lab and observational studies
People have been using masks to protect themselves from contracting diseases since the Manchurian outbreak of plague in 1910.
During the coronavirus pandemic, the focus has been on masks as a way of preventing infected persons from contaminating the air around them – called source control. Recent laboratory evidence supports this idea. In April 2020, researchers showed that people infected with a coronavirus – but not SARS-CoV-2 – exhaled less coronavirus RNA into the air around them if they wore a mask. A number of additional laboratory studies have also supported the efficacy of masks.
Out in the real world, many epidemiologists have examined the impact of masking and mask policies to see if masks help slow the spread of COVID-19. One observational study – meaning it was not a controlled…
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Philip R. Davis is a founder Phil's Stock World, a stock and options trading site that teaches the art of options trading to newcomers and devises advanced strategies for expert traders...
Ilene is editor and affiliate program
coordinator for PSW.
