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Mobile App Studied to Measure Kidney Disease Anemia

Red blood cells illustration

(Arek Socha, Pixabay.

14 Apr. 2021. A smartphone app designed to non-invasively estimate hemoglobin levels is being assessed for its ability to measure anemia in chronic kidney disease patients. Sanguina Inc. in Atlanta, developer of the AnemoCheck Mobile app, is partnering on the project with drug maker AstraZeneca and NephroNet, an advocacy organization for kidney disease research.

AnemoCheck Mobile is an app that estimates hemoglobin levels in blood by analyzing photos taken by a smartphone camera of an individual’s fingernails. Hemoglobin is a protein in red blood cells that carries oxygen to the body, and individuals with anemia have severely or continuously low hemoglobin levels. Conventional methods for measuring blood hemoglobin levels require blood samples, specialized equipment, or separate lab analysis, usually with a high cost in money and time.

The AmenoCheck Mobile app analyzes photos of an individual’s fingernails to estimate hemoglobin levels. Fingernails are an easily accessible part of the body’s surface without melanocytes, cells that provide coloring to the skin. As a result, any change in skin color can be attributed to changes in hemoglobin. Fingernail images taken by the camera are assessed with an algorithm developed by Sanguina, based on research by the app’s developers while at Emory University and Georgia Tech. The app calibrates skin tone levels for each individual, then can track even small changes in skin pallor under the nail over time. A December 2018 article in the journal Nature Communications describes the app and test results estimating hemoglobin levels compared to conventional blood tests.

Anemia common in people with chronic kidney disease

The collaboration with AstraZeneca and NephroNet aims to evaluate AmenoCheck Mobile for measuring anemia in people with chronic kidney disease. Chronic kidney disease is long-term damage often from diabetes or high blood pressure that prevents kidneys from functioning properly, thus impairing their filtering of blood. Anemia is a common complication of chronic kidney disease, particularly in more advanced cases. Sanguia cites data from the National Health and Nutrition Examination Survey showing some 39 million adults in the U.S. had chronic kidney disease in 2017, with about one in six individuals with chronic kidney disease also having anemia.

The study calls for Sanguia to train the AmenoCheck Mobile algorithm for people with chronic kidney disease. Then after the training, researchers will test the app’s hemoglobin estimates against conventional blood test measurements. The company says people in minority ethnic and racial communities will be recruited for the study, since they are at higher risk for chronic kidney disease.

“”This partnership,” says Sanguina CEO and founder, Erika Tyburski, in a company statement released through Cision, “will allow us to further test and demonstrate the unique capabilities of AnemoCheck Mobile so that we can empower patients with innovative solutions to help manage their health. As someone who has experienced anemia, I know personally the impact it has on quality of life and peace of mind. I look forward to helping improve other patients’ lives for the better.”

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Nine Campuses Join Rural Food Research Fund

Grain storage structure

Grain storage structure in Iowa (A. Kotok)

14 Apr. 2021. Nine universities in the U.S. are taking part in a program supporting research and entrepreneurs developing food and agricultural solutions in rural areas. Big Idea Ventures in New York says the nine universities are joining its $125 million Generation Food Rural Partners fund to support and commercialize campus research discoveries that benefit rural economic development.

Big Idea Ventures is a venture capital investor with start-up accelerators for new companies developing alternative food and agriculture products. The company also funds first full venture rounds of enterprises beyond the immediate start-up phase. In January 2021, BIV began the Generation Food Rural Partners fund, that sponsors university research in alternative protein sources, food technologies, agricultural innovations, and invests in new companies to commercialize those advances. And while the new start-ups may locate in the vicinity of university campuses, those locations must be in rural communities. The fund expects to invest $125 million in these projects.

The Generation Food Rural Partners fund selected its first campus collaborator in January, the College of Agriculture and Life Sciences at North Carolina State University in Raleigh. Yesterday, BIV announced nine more university departments or research centers joining the program:

Louisiana State University, College of Agriculture, in Baton Rouge

Oregon State University, College of Agricultural Sciences, in Corvallis

Penn State University in University Park, through its Invent Penn State initiative

Purdue University in West Lafayette, Indiana

Tufts University, School of Nutrition Science and Policy, in Boston, Mass.

University of Hawai‘i, Manoa campus

University of Illinois at Urbana-Champaign, College of Agricultural, Consumer and Environmental Sciences

University of Massachusetts – Amherst, Institute for Applied Life Sciences

Worcester Polytechnic Institute in Mass., Center for Advanced Research in Drying

BIV says the Generation Food Rural Partners or GFRP fund’s 10 campus partners conduct research supporting the company’s focus on food, protein, and agricultural innovation. The company expects to assign specialists to campus venture centers to review research at those universities and identify developments with the greatest commercial potential. New businesses formed to commercialize those developments then become candidates for financing from the fund.

“We believe GFRP will drive additional research and encourage entrepreneurs to establish their companies near our venture centers in rural America,” says Andrew Ive, BIV’s founder and managing partner in a company statement. “Our rural communities have always been the center of our country’s food production and this is one way to help those communities continue to grow economically into the future.”

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Gene Therapy Company Exploring DNA Circuit Technology

Circuit graphic

(Gerd Altmann, Pixabay)

13 Apr. 2021. Spark Therapeutics, a developer of gene therapies, is gaining access to a technology that programs DNA sequences like integrated electronic circuits. The agreement with Spark Therapeutics in Philadelphia could bring Senti Biosciences in South San Francisco, California more than $645 million if all terms of the deal are fulfilled.

Spark Therapeutics, a subsidiary of global drug maker Roche, is a pioneer in developing therapies addressing inherited diseases. The company is collaborating with Senti Biosciences on designing more precisely targeted gene therapies against unspecified cell targets in the central nervous system, eyes, and liver. With that partnership, Spark gains an option to license Senti Bio’s DNA circuit technology for those applications.

Up to now, Senti Bio designed therapies with computer-like logic from synthetic genes programmed to operate like software in engineered immune system cells. The company’s DNA circuit therapies allow for cells to be programmed with instructions from synthetic genes, providing more control over delivery of therapies to address varying levels of severity, and even multiple illnesses at once.

Moreover, says the company, DNA circuits can be designed, built, and tested with much the same iterative development approach as integrated circuits. And, says Senti Bio, DNA circuits can act as “smart sensors” for disease indicators to deliver treatments to precise locations in the body, and build in safeguards against adverse effects.

Smart sensors are designed to contain DNA circuits called synthetic promoters that precisely control expression of therapeutic genes. “We view gene circuits,” says Senti Bio CEO Tim Lu in a company statement, “as a critical component of any advanced cell and gene therapy, regardless of therapeutic area or delivery modality.”

Option to license synthetic promoter DNA circuits

Spark Therapeutics plans to adapt Senti Bio’s technology, including smart sensors, for gene therapies that deliver treatments to specific types of cells or meeting precise therapeutic conditions. The agreement calls for Senti Bio to design, build, and test synthetic promoter DNA circuits for gene therapies targeting specified, but undisclosed, central nervous system, eye, and liver disorders.

“We look forward to leveraging Senti Bio’s high-throughput synthetic promoter capabilities,” says Spark’s chief scientist Federico Mingozzi in a company statement, “to develop novel gene therapies directed toward specific cell types in the central nervous system, eye or liver.”

The deal gives Spark Therapeutics an option to exclusively license synthetic promoter circuits developed under the agreement. Should Spark go ahead with licensing, the company will be responsible for further preclinical and clinical development, as well as commercialization of gene therapies using Senti Bio’s synthetic promoters.

Spark is paying Senti Bio an unspecified initial fee, and funding its research under the agreement. In addition, Senti Bio is eligible for payments once the option is exercised, and for achieving specified development, regulatory, and sales milestones, as well as royalties on sales. Total value of these payments may exceed $645 million.

Senti Bio is a three year-old company, founded by researchers in biology and engineering at Harvard University, Boston University, and MIT. Science & Enterprise reported on the company’s start-up in February 2018 and second venture funding round in January 2021.

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Vaccine Stops Lyme Bacteria in Preclinical Test

Adult deer tick

Adult deer tick (U.S. National Park Service)

13 Apr. 2021. A study with lab mice shows an experimental vaccine with engineered bacteria produces antibodies and protects against microbes causing Lyme disease. A team from the biotechnology company Intravacc in Bilthoven, The Netherlands, and University of Amsterdam medical center describe the vaccine and test results in the 1 April issue of the journal Vaccine.

Lyme disease is an infection from Borrelia burgdorferi bacteria spread by bites from deer and black legged ticks already infected by the bacteria. Symptoms include fever, headache, fatigue, and a characteristic skin rash, and if caught quickly can be treated with antibiotics. If left untreated, however, Lyme disease can spread to the joints, heart, and nervous system. Centers for Disease Control and Prevention says some 30,000 cases of Lyme disease are reported each year in the U.S., while Intravacc cites data showing an estimated 85,000 cases per year in EU countries.

Intravacc develops vaccines with a technology that produces spherical containers resembling outer membranes of bacteria. The company generates these outer membrane vesicles, as they’re called, from meningococcal bacteria, engineered for vaccine delivery and rendered non-toxic to humans. Intravacc says its outer membrane vesicles act as a delivery vehicle for vaccines, as well as an adjuvant or booster. For its Lyme disease vaccine, the outer membrane vesicle expresses the outer surface protein of Borrelia burgdorferi to invoke an immune response against the bacteria.

High concentrations of antibodies

Researchers from Intravacc and University of Amsterdam injected groups of eight lab mice with the Intravacc Lyme disease vaccine, or empty outer membrane vesicles or OMVs for comparison, in three installments each 14 days apart. The results show mice receiving the Intravacc vaccine had high concentrations of anti-Borrelia immunoglobulin G antibodies, while the comparison mice with empty vesicles produced no antibodies.

The team also vaccinated groups of eight mice with the Intravacc vaccine or empty outer membrane vesicles, then injected the mice under the skin, similar to tick bites, with live Borrelia bacteria. After 20 days, blood and organs from all but one of the vaccinated mice showed no Lyme disease infections, while all of the comparison mice developed infections. In addition, vaccinated mice had lower Borrelia bacterial loads than the comparison mice.

The authors conclude the tests show the Intravacc vaccine generates antibodies against Borrelia bacteria and protects against Lyme disease infections in mice, but further preclinical tests are needed with actual tick bites rather than simulated needle injections. Nonetheless, say the authors, the vaccine appears promising for eventual human trials.

“We show that it is possible to couple OMV to external antigens,” says Intravacc CEO Jan Groen in a company statement, “and that the bacterium can also be modified to express the antigens.” Groen adds that “the platform can be utilized for vaccine development for virtually any disease.”

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Antibody Cocktail Prevents Covid-19 Disease Symptoms

Intradermal injection

Intradermal injection (British Columbia Institute of Technology, Wikimedia Commons,

12 Apr. 2021. A clinical trial shows two synthetic antibodies given together reduce the risk of symptomatic infections among household members of Covid-19 patients. Other findings from the trial show the antibody cocktail, made by Regeneron Pharmaceuticals Inc. in Tarrytown, New York, helps prevent individuals already infected with SARS-CoV-2 viruses from developing Covid-19 disease symptoms. The results are released by Regeneron and are not peer reviewed.

In the trial, Regeneron tested its antibody therapy for Covid-19, code-named Regen-Cov, as a preventive drug against SARS-CoV-2 infections. Regen-Cov is a combination of the company’s synthetic antibodies casirivimab and imdevimab authorized by the Food and Drug Administration in November 2020 as a treatment for non-hospitalized Covid-19 patients with mild to moderate symptoms.

The company designed the casirivimab and imdevimab cocktail to be given as an intravenous infusion for neutralizing the SARS-CoV-2 virus responsible for Covid-19 infections. The antibodies attach to separate receptor binding domains of the SARS-CoV-2 spike protein that enters and begins infecting cells. Notably, Regeneron reformulated Regen-Cov for the trial to be given as an injection under the skin, instead of an infusion as given as a therapy.

The late-stage clinical trial enrolled 3,750 participants without Covid-19 symptoms at 134 sites mainly in the U.S., all household contacts of people with Covid-19 infections. The study, conducted with National Institute of Allergy and Infectious Diseases, or NIAID, at National Institutes of Health, includes participants in different age groups randomly assigned to receive 1,200 milligrams of Regen-Cov or a placebo.

Among participants in the trial are 1,505 individuals without SARS-CoV-2 infections, divided almost evenly between Regen-Cov or placebo recipients. The results show, after 29 days, 11 Regen-Cov recipients or 1.5 percent developed SARS-CoV-2 infections, compared to 59 placebo recipients, or 7.8 percent. When calculated in terms of infection risk, Regen-Cov recipients show an 81 percent lower risk than placebo recipients.

No Regen-Cov recipients hospitalized

In addition, Regen-Cov recipients who developed Covid-19 symptoms cleared their symptoms in 1.2 weeks on average, compared to 3.2 weeks for placebo recipients. And infected Regen-Cov recipients experienced high viral loads for less than three days on average, compared to nine days for those receiving a placebo.

Also among participants in the trial are 204 participants with recent SARS-CoV-2 infections, but not exhibiting Covid-19 symptoms, randomly assigned to receive Regen-Cov or a placebo. Among Regen-Cov recipients, 29 percent later developed Covid-19 symptoms, compared to 42 percent of placebo recipients, a 31 percent lower risk of symptoms, and a difference large enough for statistical reliability. None of the Regen-Cov recipients required hospitalization for their symptoms, while six of the placebo group were hospitalized.

Among the 1,505 non-infected participants, adverse events were reported in 20 percent of Regen-Cov and 29 percent of placebo recipients, with one percent of each group reporting serious adverse effects. In the group of 204 SARS-CoV-2 infected participants, about one-third (34%) of Regen-Cov recipients, and nearly half (48%) of placebo recipients experienced adverse effects, with none of the Regen-Cov and three percent of placebo group rated as serious.

Regeneron says among the non-infected participants, 41 percent are of Hispanic origin and nine percent are Black Americans, with 31 percent having at least one high-risk factor of severe Covid-19 disease, such as obesity or age 50 and over. Among the infected participant sample, 35 percent are of Hispanic origin five percent are Black, and 32 percent exhibit at least one high-risk severe disease factor.

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Infographic – Global Venture Funds Hit Record High

Global venture funds, Q1 2021

Click on image for full-size view (Crunchbase)

10 Apr. 2021. Venture investing, a key source of capital for research-based companies, hit a record high level worldwide in the first quarter of 2021. According to data compiled by Crunchbase, total venture capital funding across the globe reached $125 billion in the first quarter of 2021, a 50 percent increase over the fourth quarter of 2020, and nearly double the funds raised in the first quarter of 2020.

Most of the investment gains worldwide in the first quarter were made in companies that are already off the ground. Early-stage investments, those made in companies’ first two venture funding rounds, reached nearly $36 billion, a 45 percent increase over the fourth quarter of 2020 and 63 percent more than the first quarter of 2020. The total number of deals in these first two rounds rose to 1,605 in the first quarter, compared to 1,503 in the fourth quarter of 2020, but still lower than the 1,813 transactions in the first quarter of 2020.

Later-stage funding in the first quarter — investments in companies’ third venture rounds or later — likewise rose sharply. Venture companies invested nearly $86 billion in businesses worldwide, a gain of 56 percent over the fourth quarter of 2020, and a jump of 122 percent over the first quarter of 2020. The 751 later-stage deals in the first quarter is also a sharp increase from 597 in the fourth quarter of 2020, and 572 in the first quarter of 2020.

For companies just getting started, however, the numbers are less encouraging. Seed-round funding worldwide, which includes angel and crowd-funded investing, recorded $4.1 billion in 2,981 deals in the first quarter. Investment dollars in new start-ups has stayed essentially flat since the first quarter of 2020, when venture companies invested $3.9 billion. And since the first quarter of 2020, the number of seed-stage deals has steadily declined, from more than 5,200 to less than 3,000 in the first quarter of 2021.

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Arthritis Drug Unsuccessful for Covid-19 Hospital Patients

Hospital room

(Fernando Zhiminaicela, Pixabay.

9 Apr. 2021. A clinical trial shows a drug designed to reduce inflammation in autoimmune disease patients does not clearly help patients hospitalized with Covid-19 disease. Findings from the trial were released by pharmaceutical companies Incyte in Wilmington, Delaware that developed the drug baricitinib, and Eli Lilly and Co. in Indianapolis that licenses baricitinib from Incyte.

Incyte and Lilly developed baricitinib as a treatment for autoimmune disorders rheumatoid arthritis, marketed under the brand name Olumiant, and are testing the drug in clinical trials as a therapy for systemic lupus erythematosus, commonly known as lupus, and alopecia areata that causes patchy hair loss. Baricitinib is among a class of small-molecule, or low molecular weight, drugs known as Janus kinase or JAK inhibitors that block the actions of enzymes interrupting the immune system. Limiting the pathway for signals from JAK enzymes helps treat autoimmune diseases like rheumatoid arthritis, by reducing the signals that encourage inflammation. The drug is designed to be taken as a once-a-day pill.

The companies proposed a test of baricitinib as a treatment for patients hospitalized with severe Covid-19 lung inflammation. The late-stage clinical trial enrolled 1,525 participants hospitalized at 98 sites worldwide with Covid-19 infections, and biological indicators of inflammation. Participants were randomly assigned to receive a daily 4 milligram dose of baricitinib plus standard care, or standard care alone. Standard care included corticosteroids or the drug remdesivir.

Difference not large enough for statistical reliability

The study team from the companies looked primarily at the percentage of participants who need non-invasive ventilation, high-flow oxygen, invasive mechanical ventilation, or who died up to 28 days after treatment. Baricitinib recipients were 2.7 percent less likely to require any of these ventilation/oxygen treatments or die than patients receiving the standard care, but the difference was not large enough for statistical reliability.

The companies report, however, that the death rate in the trial for baricitinib recipients within 28 days from any cause (8%) was lower than for standard care recipients (13%), a statistically reliable difference. In addition, rates for all adverse effects and serious adverse effects were similar among baricitinib recipients (45% and 15%, respectively) and recipients of standard care alone (44% and 18%, respectively).

“Even though the study did not show a statistically-significant benefit on the primary endpoint,” says Ilya Yuffa, president of Lilly Bio-Medicines in a statement, “this trial showed the largest effect reported to date for reduction in mortality observed for this patient population with Covid-19. As there remains an urgent need to reduce Covid-related deaths in hospitalized patients, we hope these results will provide further understanding and support for baricitinib’s potential role in treatment on top of the current standard of care.”

Baricitinib continues to be assessed in clinical trials as a treatment for patients hospitalized with Covid-19 infections in combinations or against other drugs, or standard care. The studies are mid- to late-stage trials in the U.S. sponsored by National Institute of Allergy and Infectious Diseases, part of National Institutes of Health, and in the U.K. by University of Oxford.

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First U.S. Quantum Tech Incubator Underway

Quantum physics

(Gerd Altmann, Pixabay.

8 Apr. 2021. The first incubator program in the U.S. for start-up enterprises developing quantum technologies is now accepting applicants in Chicago. Duality, as the program is known, is a joint undertaking of University of Chicago’s entrepreneurship center, affiliated with its business school, and the Chicago Quantum Exchange, a research center in the university’s molecular engineering school.

Quantum technology handles information in terms of probabilities, which describes infinite information components called quantum bits, or qubits, between values of 1 and 0. Conventional digital technologies, on the other hand, assign values of 1 or 0 to bits as the basis for nearly all of today’s systems. Quantum technology is based on quantum mechanics, a branch of physics for describing the behavior of matter and energy at atomic and sub-atomic levels. This behavior varies widely from deterministic forms of physics, allowing for matter and energy to exist in multiple simultaneous states and interact while interconnected.

Translated into information technologies, quantum properties open up opportunities to tackle difficult and complex challenges with simultaneous operations that would break most digital systems. Many of those challenges are complex scientific issues, such as discovering new drugs or addressing climate change. This increased power and sophistication can also focus on encryption, making quantum technology both a threat and a defense against hostile actors.

Duality — the name reflects the principle of quantum mechanics in which an entity can simultaneously occupy two states, as a particle and wave — offers founders of start-up businesses in quantum technology initial training, seed funding, and mentorship to get their companies off the ground. The program offers entrepreneurs a 12-month incubation period, with training courses, mentorship and business expertise, and a one-time $50,000 award. Duality also plans to provide participants with advanced labs and technical facilities, once Covid-19 restrictions are lifted.

One-on-one feedback from Corporate Collision

Duality’s courses are given during the first three months of the incubation program, covering principles of business strategy, finance, intellectual property, and managing human resources, as well as instruction in specific tasks like preparing Small Business Innovation Research proposals. The program also offers a a two-day session called Corporate Collision, where new company founders get one-on-one feedback from executives. However, Duality says the program offers opportunities to engage with industry leaders throughout the incubation period.

Taking part in Duality with University of Chicago are University of Illinois at Champaign-Urbana, Argonne National Laboratory affiliated with the U.S. Department of Energy, and P33, a not-for-profit organization promoting economic development in the Chicago region based on technology. The partners committed $20 million for the program over the next 10 years.

Duality plans to support 10 quantum technology start-ups a year in the Chicago region. Applications for the first class of start-ups are now open, and close on Friday, 21 May, although applications are considered on a rolling basis until then. A virtual information session for prospects is scheduled for 15 April.

“We are building the future of technology right here in Chicago,” says the city’s mayor Lori Lightfoot in a university statement. “This program taps the extraordinary talent in the city across fields from science and innovation to entrepreneurship, manufacturing and development, and is a testament to the strengths of this incredible city and its residents.”

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Growing Your Health Care Business in 2021

– Contributed content –

Doctor with tablet

(Rawpixel, Unsplash)

8 Apr. 2021. There’s no doubt that 2020 was a challenging and eventful year for the health care sector. As the COVID-19 vaccine rollout gets underway, however, businesses can reassess their growth strategies and redefine their objectives. To get started, take a look at these top tips for growing your health care business in 2021:

  1. Increase remote services

Throughout the COVID-19 pandemic, many health care providers introduced remote services in a bid to keep patients safe and prevent transmission of the virus. However, the popularity of these remote services means that there’s now increased demand for at-home diagnostic testing, telehealth consultations, and medication deliveries.

Savvy business owners who want to grow their health care company will respond to this demand accordingly. By partnering with reputable service providers, such as MedComp Sciences, increasing your range of remote services could be easier than you think. With access to laboratory services and logistics solutions, health care businesses can broaden their service range with minimal disruption.

  1. Maximize patient retention

Retaining existing customers is almost always easier and more cost-effective than acquiring new ones, so make patient retention a primary objective when growing your health care business. By offering new services, you can increase the lifetime value of each patient but there are other ways to optimize retention.

Delivering omnichannel customer service and outperforming competitors makes your health care business a go-to provider, for example. When you can offer reduced wait times or speedier deliveries, clients or patients will be eager to choose your business over any others.

  1. Accept more payment methods

No matter what type of health care firm you’re running, increasing the range of payment options you offer can be a small but effective way of acquiring new customers. If you provide patient care, working with more insurance providers can expand your target audience and increase patient acquisition rates, for example.

Alternatively, if you provide B2B or B2C services or products, consider offering a wider variety of transaction options. In addition to accepting credit and debit card payments, you could introduce online payments via PayPal and similar platforms or accept payment in the form of Bitcoin and other cryptocurrencies.

  1. Partner with other companies

When you partner with other businesses within your niche, you have the opportunity to benefit from direct endorsements and word-of-mouth referrals. If you have your own orthodontics practice, for example, partnering with a dentist can assist with patient acquisition as they’ll be able to refer patients to you directly.

By partnering with businesses that offer relevant and complementing services or products but aren’t direct competitors, you can forge valuable industry connections and maximize your revenue.

Creating a growth strategy

There are a number of ways you can scale a health care business but having a clearly set out growth strategy is critical to success. When you define your objectives and set key performance indicators, for example, you can track your progress and ensure that you’re scaling at the right speed. With a strategic approach, you can minimize the risk that’s associated with business growth and optimize your success instead.

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NIH Trial Testing mRNA Vaccine Allergic Effects


(frolicsomepl, Pixabay)

8 Apr. 2021. A clinical trial is underway testing for allergic reactions to Covid-19 vaccines using messenger RNA for invoking an immune response. The trial is conducted by National Institute of Allergy and Infectious Diseases or NIAID, part of National Institutes of Health, to study adverse allergic effects from vaccines made by BioNTech/Pfizer and Moderna.

Among the first vaccines authorized to combat the Covid-19 pandemic are those developed by biotechnology companies BioNTech in Mainz, Germany and licensed to global drug maker Pfizer, and Moderna in Cambridge, Massachusetts. Both the BioNTech and Moderna technologies are based on messenger RNA, a nucleic acid derived from the genetic code in DNA, and used by cells to produce amino acids in proteins for cellular functions. Both companies deliver messenger RNA or mRNA in lipid, or natural oil, nanoscale particles, where they instruct cells to produce antigens to invoke an immune response against the SARS-CoV-2 virus responsible for Covid-19 infections.

The clinical trial aims to better understand allergic reactions to mRNA vaccines among people predisposed to allergies, and non-allergic individuals. Early reports from Covid-19 vaccination sites show a few immediate allergic reactions to these vaccines, particularly among people with a history of allergies. The study is specifically recruiting participants known to be highly allergic or with a mast cell disorder, a condition where mast cells, a type of white blood cell in the immune system, overreact to drugs, some foods, or insect bites.

Two-thirds of participants are women

The mid-stage trial is enrolling 3,400 participants not yet vaccinated against Covid-19, age 18 to 69, of which two-thirds are women, since the vast majority of severe allergic reactions known as anaphylaxis to Covid-19 vaccines occur in women. Sixty percent of participants will have a history of severe allergies or a mast cell disorder, while 40 percent will have no history of allergies.

Participants are randomly assigned to receive a two-dose regimen of the BioNTech/Pfizer or Moderna vaccines, or a placebo. In the placebo group, however, placebos are given only as the first shot. About a month after the placebo injection, participants in this group will receive either the two-dose regiment of BioNTech/Pfizer or Moderna vaccines.

The study team is looking primarily for immediate allergic reactions to the mRNA vaccines. Trained clinicians will monitor vaccine recipients for allergic reactions in the 90 minutes following injections, and rate reactions from mild to severe on a standard five-point scale. Treatment for more severe reactions, says NIAID, will be available from clinician-monitors at the trial sites. Researchers are also collecting blood and urine samples before and after injections, and nasal swabs before injections, to find any associations between genetic characteristics and allergic reactions, as well as reveal biological mechanisms for these reactions.

“The public understandably has been concerned about reports of rare, severe allergic reactions to the Moderna and Pfizer-BioNTech Covid-19 vaccines,” says NIAID director Anthony Fauci in an NIH statement. “The information gathered during this trial will help doctors advise people who are highly allergic or have a mast cell disorder about the risks and benefits of receiving these two vaccines.”

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Disclaimer: The author owns shares in Pfizer.

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