Month: March 2021

More Infectious COVID-19 Variant Now Seen in Nine States

HealthDay News — The more contagious coronavirus variant that has brought Britain to its knees in recent weeks is showing signs that it is spreading widely throughout the United States, health officials and experts say.

Indiana, Texas, Pennsylvania, and Connecticut joined California, Florida, New York, Georgia, and Colorado on Monday with reports of variant cases, The Washington Post reported. A South African variant that is also more contagious has not been detected in the United States yet. Scientists also say they cannot rule out the possibility that an undetected U.S. variant is accelerating the rapid spread seen in recent weeks.

“It could be — a possibility — that we have our own mutant that’s being more easily transmissible,” Anthony Fauci, M.D., director of the National Institute of Allergy and Infectious Diseases, said Monday. “We don’t know. We’re looking for it … If you look at the slope of our curve, which is very steep, it looks a bit like the curve in the U.K.”

On Monday, the U.S. Centers for Disease Control and Prevention said its strain surveillance program is on track to more than double the number of genomic sequences being uploaded to public databases by the end of the week.


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“The general consensus is there’s no single variant driving current U.S. cases. That said, we need to be on the lookout for these variants of concern,” Duncan MacCannell, Ph.D., chief science officer with the CDC Office of Advanced Molecular Detection, told The Post on Monday.

The Washington Post Article

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Drop in ED Visits for Cardiac Conditions Tied to Later Cardiac Deaths

HealthDay News — Reduced emergency department visits for suspected cardiac disease during the COVID-19 pandemic peak in England are associated with a time-lagged increase in cardiac mortality, according to a research letter published online Dec. 20 in Circulation: Cardiovascular Quality and Outcomes.

Michail Katsoulis, Ph.D., from University College London, and colleagues used data from the Public Health England Emergency Department Syndromic Surveillance System to quantify the change in daily emergency department visits for suspected cardiac disease before and during the COVID-19 pandemic.

The researchers found that during the COVID-19 pandemic period (March 12 to April 15, 2020), there was a decline of 2,750 emergency department visits per week for suspected cardiac disease (~35 percent decrease) compared with the average weekly admission before the pandemic in 2020. Every 100 nonattendances at emergency departments for suspected cardiac disease were associated with 3.1 to 8.4 excess cardiac deaths, corresponding to the estimated mortality lag times of zero and 18 days, respectively. During the pandemic period, weekly excess cardiac mortality due to nonattendance at emergency departments was 84 to 232 deaths, corresponding to an 18 percent increase in weekly non-COVID-19 cardiac mortality versus the previous five years. This finding suggests that one cardiac death could have been prevented or delayed for every 12 emergency department visits with suspected cardiac disease.

“These findings should alert policymakers to the importance of ensuring that any measures introduced to control and manage severe acute respiratory syndrome coronavirus 2 infection do not adversely impact the management of acute cardiovascular disease,” the authors write.


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Abstract/Full Text (subscription or payment may be required)

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Female Doctors Are Especially Vulnerable to Online Harassment

Social media can be a toxic jungle for many people, but new research shows that it’s especially bad for women physicians. They are twice as likely as male doctors to be sexually harassed on the internet and are often subject to other online abuse, including personal attacks, coordinated harassment and barrages of negative reviews. Doxing — a term that can mean publishing private information, such as doctors’ home addresses or license numbers, online — is also a problem. It can also include contacting doctors’ employers and licensing boards.

Tricia Pendergrast, lead author of a recent study published in JAMA Internal Medicine and a medical student at Northwestern University Feinberg School of Medicine, should know. She was in the midst of researching broader online physician behavior when she got doxed herself. Another doctor, upset at an opinion she posted on social media, dug through Pendergrast’s posts to figure out where she studied and called the medical school dean.

“It was very frustrating,” Pendergrast says. “Luckily, my administration was supportive and could see I was a victim of harassment and not the person at fault. But it was still stressful and a very invasive kind of bullying.”

When she shared her distress with two mentors, also the study co-authors, they suggested that Pendergrast extrapolate the harassment data from the still-unpublished results of the original study, looking at broader uses of social media. The current paper stemmed from “that existing dataset, catalyzed by my personal experience,” says Pendergrast.


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The study analyzes responses from 564 participants, with 108 of the doctors who responded saying they’d been attacked on social media. Approximately 16% of women reported online sexual harassment, whereas only 1.5% of men reported being sexually harassed online. Women doctors are often harassed in the form of lewd images.

Though sexual harassment seems to target more women online, the study result is cause for concern for all doctors, with men and women equally likely to say they’ve been attacked in general. Many nasty posts focus on race or religion, especially for doctors who are Muslim or Jewish. Jewish doctors report receiving Holocaust photos, for instance. Others doctors are badgered because of advocacy work, such as on vaccines, abortion, vaping or gun control. A Black physician who responded in the survey indicated that when she posted about civil rights, she got both rape and lynching threats via her direct messages, for example.

And it’s likely, given the highly rancorous atmosphere on social media surrounding the coronavirus, that online doctor-bullying is getting worse.

“While these findings are unfortunate, we collected this data before the pandemic,” says oncologist Shikha Jain, a co-author of the study. “I’m pretty sure if we had done it now, it would be significantly worse — the number of people attacking doctors online about COVID-19 has been alarming.”

So what are physicians — especially women and those in less-represented ethnic and religious groups — to do? An easy answer might be to avoid social media. But that’s the wrong conclusion, say Jain and Pendergrast.

“There is so much good we can do on social media, in terms of public-health education,” says Jain, who is also the director of communication strategies in medicine for the University of Illinois Cancer Center in Chicago. “The power of my voice shouldn’t be silenced by people who want to intimidate me or promote nonsense that is actually killing people.”

She says it is especially important in countering the misinformation and false claims spread by wellness companies, often selling “cures” that have been debunked.

Besides public education, social media is also a practical way to let people know about resources, like connecting patients to COVID-19 vaccines. “Doctors have always spread this kind of information in their community,” says Jain. “But with social media, our communities are much bigger.”

Besides, adds Pendergrast, staying off social media cheats women and under-represented groups out of advancement opportunities — and that increases disparities. “An online presence helps build professional networks,” Pendergrast says. “That’s especially important since women are underrepresented at every level of leadership in medicine.”

So what are some pointers on having a more positive social media experience? Pendergrast and Jain have advice for providers as they weigh the costs and benefits of boosting their social media presence.

Review the social-media policies of your institution and your specialty, and ask questions. Almost all organizations offer some social media guidelines, Pendergrast says, but many are less clear about how they protect providers from online attacks, including negative reviews. That’s especially important since platforms themselves aren’t good at self-policing. “We hope this data motivates institutions and employers to plan for these attacks, to protect employees,” she notes.

Be clear about your goals. Staying anonymous can be safer and cathartic, she says, even though there is always some risk of discovery. Purely professional accounts, “where you might just share papers you’re working on or reading,” Pendergrast says, also aren’t immune from harassment but are lower risk. Posting more outspoken views online is likely to gain more visibility — and makes doctors more of a target.

Don’t play with hate. There’s a fine line between countering misinformation and feeding into the game. “Once someone starts challenging me, I share one article with them to present the facts,” says Jain. “After that, I don’t engage.” Blocking and muting bullies is effective, and many people don’t allow direct messaging.

Hit pause. When the attacks get too personal, “it can make you feel sick to your stomach,” says Jain. “It’s very upsetting, and many people — me included — sometimes take breaks from social media.”

Call in the cavalry. If you’re targeted, ask for help. Shots Heard Round the World, for example, is an organization that swoops in to defend vaccination advocates from coordinated anti-vaxxers. And IMPACT, an Illinois-based group Jain works with, offers a toolkit to handle harassment.

And finally, don’t let the ugliness blind you to the good, say the researchers. The most severe forms of abuse, such as doxing, “are the exception, not the rule,” says Jain. “Social media is a powerful way to promote public health.”

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Breaking Barriers: Harvard Medical School Students Connect Minority Communities with Care

When Harvard Medical School switched to remote learning last March, Silvia Huerta Lopez went back to her family in New Jersey. She had quarantined for two weeks before leaving Boston, to avoid potentially bringing the novel coronavirus home. But her entire family was already sick and coughing — months later they all tested positive for coronavirus antibodies. The virus swept through her Latino community; many lived in crowded conditions and worked at factories that remained open. “It was terrible. Every week you heard of someone dying,” Huerta Lopez says. “My own grandfather died too.”

Despite fears of the virus, many people in her community wouldn’t go to the doctor. Some called Huerta Lopez with health questions. As a student, she couldn’t answer them, but as a person whose family came to America as undocumented immigrants, she understood the problem. Some people didn’t think they could afford care. Some didn’t believe they were eligible for it. Others were downright afraid to go to the hospital because they feared deportation. She couldn’t fix those ills, but she could help people overcome their barriers to care. And she decided to do this on a larger scale than by answering individuals’ phone calls on her own.

The pandemic disproportionally affects minority populations, but Latinx communities often fare worse than other groups. A team of Johns Hopkins University doctors wrote that while Latinx residents comprised only 5.5% of the Baltimore population, more than 40% of Latinx patients who tested for the coronavirus had positive results — compared with 17.6% of non-Hispanic Black patients and 8.8% of non-Hispanic whites. That disparity, at least in part, stems from the fact that many Latinx individuals are immigrants, and some are undocumented. That means they prefer to keep a low profile and stay away from official institutions, including those that would help with no questions asked. 

“There are federally qualified healthcare centers mandated to provide healthcare to everyone regardless of their insurance, immigration status, the language they speak and their ability to pay,” explains Margaret Sullivan, a postdoctoral fellow at Harvard’s François-Xavier Bagnoud Center for Health and Human Rights, who directs a small immigrant clinic at a Boston community center. Yet the individuals often don’t know about these centers, can’t find them, or have to wait a long time for an appointment. “Undocumented immigrants have a very fragmented access to safety-net institutions,” Sullivan says.


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To create a better system for her people, Huerta Lopez teamed up with Lianet Vazquez and Brendan Eappen, also students from Harvard Medical School.  Together, they formed an organization that helps immigrants gain access to medical care, regardless of their status, insurance or financials. Named Quetzales de Salud — quetzal refers to an iconic Central American bird, and salud means health — the organization connects immigrants in need of medical care to places that provide it. The name is symbolic, Huerta Lopez explains. “Birds have limitless ability to fly over borders and boundaries,” she says. “We decided on that image to indicate that we will work very hard to overcome whatever barriers that exist.”

The group first built a database of COVID-19 testing sites and federally qualified healthcare centers in New Jersey that treat patients regardless of their status. They also recruited volunteers — bilingual Spanish-speaking medical students who would help walk people through the CDC’s COVID-19 self-checking symptom list and direct them to the testing sites or care centers. The organization does not provide medical advice, as medical students wouldn’t be qualified to do that, the founders explain, and building a real patient care system would pose legal challenges. Instead, the organization simply connects immigrants to the resources they need, explains what rights potential patients have to medical care, and helps translate and de-jargon complex medical topics. “We found a way to make it legal by communicating publicly available medical guidance and connecting people to existing healthcare services,” Huerta Lopez says.

Finding medical student volunteers wasn’t hard, but finding immigrants in need was. When they first launched their effort, the group created an online form where individuals could request help. But that generated few requests — people didn’t know the form existed. So the group worked with Cosecha, a grassroots organization that advocates for undocumented immigrants’ rights. That helped reach a larger immigrant population. Within months, 70 Quetzales volunteers helped more than 200 individuals — and continue working with them.

They also started assisting people with health problems beyond those related to COVID-19. “It was so common that people had other health issues, some of which were chronic,” Eappen says. “So we gradually evolved into connecting them to primary care.” To help people financially, the group started a fundraiser and looked to charity organizations for large sums. “If we can’t cover something, such as surgery, which can be thousands of dollars, we connect people with local community organizations, like churches, that may be willing to pay,” Huerta Lopez says.  Eappen feels that aiding the disenfranchised in navigating the medical system is as important as administering it. “Learning clinical knowledge prepares me to be a good doctor,” he says. “But this bridge to care I am able to provide over the phone is just as impactful as the clinical work I will be doing as a physician.”

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Telehealth Use Up Markedly Among Parkinson Patients

HealthDay News — Parkinson disease (PD) symptoms and management practices were markedly affected by COVID-19, according to a study published online Jan. 21 in npj Parkinson’s Disease.

Megan P. Feeney, M.P.H., from the Parkinson’s Foundation in New York City, and colleagues surveyed 1,342 patients with PD in May 2020 to assess emotional and behavioral consequences of the public health policies implemented to mitigate the spread of severe acute respiratory syndrome coronavirus 2 and to explore factors contributing to accessing health care via alternative means, such as telehealth.

The researchers found that approximately half of respondents reported a negative change in PD symptoms, particularly around emotional well-being, with 66.5 percent experiencing nervousness or anxiety, 50.9 percent reporting feeling down or depressed, and 66.2 percent reporting sleep disturbances. There was a large uptick in telehealth use, which increased from 9.7 percent prior to the pandemic to 63.5 percent during the pandemic. Telehealth use was associated with higher income and higher education. Telehealth was more often used for doctor’s appointments than for physical, occupational, speech, or mental health therapies. Nearly half of respondents (46 percent) reported a preference for continuing to use telehealth always or sometimes after the pandemic had ended. A desire to continue using telehealth was associated with having received support/instruction for telehealth and having a care partner, friend, or family member to help them with the telehealth visit.

“The survey highlights PD-specific issues and potential coping mechanisms, including online social support and telemedicine to reduce the burden caused by the pandemic,” a coauthor said in a statement.


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Abstract/Full Text

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Modifications Can Improve Mask Efficacy for Reducing Exposure

HealthDay News — Good fit is important for maximizing mask performance to reduce exposure to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) respiratory droplet particles, according to research published in the Feb. 10 early-release issue of the U.S. Centers for Disease Control and Prevention Morbidity and Mortality Weekly Report.

John T. Brooks, M.D., from the CDC COVID-19 Emergency Response Team, and colleagues conducted experimental simulations using pliable elastomeric source and receiver headforms to assess the extent to which two modifications could improve the fit of medical procedure masks and reduce the receiver’s exposure to an aerosol of simulated respiratory droplet particle of the size considered most important for SARS-CoV-2 transmission. The modifications were wearing a cloth mask over a medical procedure mask and knotting the ears of a medical procedure mask, then tucking in and flattening the extra material close to the face.

The researchers found that the cumulative exposure of the unmasked receiver was reduced by 82.2 and 62.9 percent, respectively, by adding a cloth mask over the source headform’s medical procedure mask or knotting and tucking the medical procedure mask. The reductions were 83.0 and 64.5 percent, respectively, when the source was unmasked and receiver fitted with a double mask or the knotted and tucked medical procedure mask, and 96.4 and 95.9 percent, respectively, when the source and the receiver were both fitted with double masks or knotted and tucked masks.

“Continued innovative efforts to improve the fit of cloth and medical procedure masks to enhance their performance merit attention,” the authors write


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Abstract/Full Text

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COVID-19 Vaccines Adapted to Fight Variants Will Not Require Long Clinical Trials: FDA

HealthDay News — Long clinical trials will not be needed to prove the effectiveness of approved COVID-19 vaccines that have been adapted to protect against variants of the new coronavirus, the U.S. Food and Drug Administration said Monday. Instead, vaccine developers will be asked to conduct small clinical trials such as those required for annual flu vaccines, The New York Times reported.

The recommendation was among a number of new documents released Monday by the FDA, including how antibody treatments and diagnostic tests might need to be altered to respond to coronavirus variants. Experts are growing increasingly concerned about how the variants may hinder or reverse progress against the pandemic, The Times reported.

“The emergence of the virus variants raises new concerns about the performance of these products,” acting FDA Commissioner Janet Woodcock, M.D., said in a statement. “We want the American public to know that we are using every tool in our toolbox to fight this pandemic, including pivoting as the virus adapts.”

Most makers of approved COVID-19 vaccines or candidate vaccines in late-stage trials have said they plan to adapt their vaccines to tackle variants, The Times reported. The Moderna and Pfizer vaccines use mRNA technology that the companies have said can be used to alter the existing vaccines within six weeks, although testing and manufacturing would take longer.


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Moderna has begun developing a new version of its vaccine that could be used as a booster shot against a virus variant that originated in South Africa, known as B.1.351, which seems to weaken the effectiveness of the existing vaccines.

The New York Times Article

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Physicians Ponder Telehealth’s Post-Pandemic Future

Last spring, doctors’ offices across the country were eerily quiet. Almost overnight, patients stopped coming in as COVID-19, and the fear that the novel coronavirus begat, spread through communities across the country.  

Healthcare providers quickly adapted. “We were able to pivot to using telemedicine as another mode in terms of connecting with patients,” recalls physician Thomas Caprio, a professor of medicine and geriatrics at the University of Rochester Medical Center in New York.

In-person visits didn’t stop altogether, of course, but they dropped precipitously while telehealth visits rose. In the first quarter of 2020, telehealth appointments increased by 50%, according to the Centers for Disease Control and Prevention. In the last week of March alone, they were up 154% compared to the same period a year earlier. 

As the weather warmed and cases declined, the telehealth spike deflated somewhat; the number of virtual appointments declined while in-person visits ticked upward. But with the arrival of colder weather and a second COVID wave, telehealth surged anew.


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Despite the unprecedented number of confirmed cases in the U.S., more people are opting for in-person visits compared to the spring, when less was known about transmission. With widespread vaccination distribution in sight, the question becomes: What’s the long-term state of the telehealth union? Is it where its boosters or skeptics believe it to be, or somewhere in between? 

“Our prediction is that the market has fundamentally changed,” says Peter Alperin, an internal medicine doctor in San Francisco and VP of product at Doximity, a social network for physicians.

According to Doximity, before COVID-19 less than 10% of doctor appointments were virtual. In its 2020 State of Telemedicine Report, the company predicted that telehealth appointments will account for 20% of all medical visits in 2020, representing $29.3 billion of medical services. Doximity projects that figure to increase to a whopping $106 billion by 2023.

Caprio’s personal experience broadly aligns with this. While telehealth usage remains elevated compared to pre-pandemic levels, during the summer and into the fall most of his patients wanted to see him in-person. His wife, a nurse practitioner, has noticed a similar trend among her patients. Overall, telehealth has proved itself to be, if not a game changer, then “another tool in our toolkit,” Caprio says. 

Much hinges on long-term telehealth adoption, which remains an open question. For providers and patients, it’s often a matter of personal preference.

When it comes to his patients, Caprio has yet to find a formula for determining who is or isn’t open to virtual visits. Ostensibly revealing indicators such as digital literacy and medical history don’t seem to have much of a determinative effect. Many patients who are tech-savvy and have a straightforward question prefer in-person visits; others who are less comfortable with computers and have complicated medical histories have few reservations about making the transition to telehealth. 

Before COVID, Caprio was “ambivalent” about telemedicine. Now, he sees its distinctive advantages and believes that, for many medical needs, the visits can be just as informative as in-person ones.

“There is a lot I can do by observing patients on camera,” he says, pointing to depression screenings and cognitive tests. He adds that new patient visits rarely pose a problem, particularly when the patient provides a detailed medical history.

What’s more, Caprio has seen firsthand telehealth’s ability to increase access. Patients who were unable to make early morning appointments because of the commute or who might have canceled during poor weather conditions can now log in from home.

“We can meet with a patient and family and come up with recommendations and care plans,” Caprio continues. “I don’t want to do 100% telemedicine practice, but I can see this being a significant portion of what I do in the future.”

Of course, it’s important to note that telehealth doesn’t eliminate issues around access. A significant percentage of Americans, particularly those in vulnerable demographics and in rural communities, lack adequate broadband connection to support video visits.

And then there’s the question of coverage. In the spring, payers agreed to cover the full cost of a range of additional telehealth services. According to David Lindeman, director of health IT firm CITRIS Health, many of these provisions were enacted as waivers. As a result, it’s unclear whether they will evaporate once vaccines become readily available.

“It depends on whether the Centers for Medicare & Medicaid Services, the state governments and providers work together to make many of the changes permanent,” Lindeman notes. While a number of private payers “have moved in that direction,” Alperin adds, “Medicare is the 800-pound gorilla.”

Mental healthcare has proven a natural fit for a from-afar approach. On the other end of the spectrum are specialties such as oncology, which never saw a significant drop in in-person visits even during the spring of 2020. As for general practice, well, it falls somewhere in the middle.

Even a telemedicine booster, such as Caprio, can’t entirely hide his reservations. “I do have a sense of a loss of not being in the same room as the patient,” he says. “I can connect with them and I can see them, but it doesn’t quite feel the same as being in the same room.”

Trained in the art of physical examination, Caprio typically uses all his senses when examining a patient. “I’m not doing that to the same extent with telemedicine,” he continues. “There are trade-offs.”

Still, for Caprio, telehealth’s benefits — as a complement to, if not an outright replacement for in-person care — outweigh the costs. Going forward, he expects many providers and patients will opt for a hybrid approach.

Lindeman agrees. “I do think telehealth is here to stay. We have shown how effective it can be.”

This article first appeared on mmm-online.com.

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Plant-Based Vaccine Manufacturing for Influenza, Implications for Future Vaccines

Currently, the development of vaccines for influenza and other viruses typically relies on egg-based manufacturing. This approach, and the newer technique of vaccine production in cell cultures, carry the risk of mutations that may reduce the efficacy and immunogenicity of the vaccines. Additionally, there are ongoing needs for greater production speed and capacity to enable adequate epidemic and pandemic response.

An emerging body of research highlights plant-based vaccine manufacturing as a potential solution to some of these limitations. In a recent issue of the Lancet, investigators from the Research Institute of the McGill University Health Centre in Montreal, Quebec, and Medicago Inc., a Quebec-based biopharmaceutical company, described results of 2 randomized, observer-blinded phase 3 studies evaluating the efficacy of a recombinant quadrivalent virus-like particle (QVLP) influenza vaccine manufactured in Nicotiana benthamiana, a relative of the common tobacco plant.1 These studies represent the first large trials of any plant-derived human vaccine.

One trial tested the vaccine in adults aged 18-64 years (Clinicaltrials.gov Identifier: NCT03301051), while the other trial consisted of adults aged 65 years and older (Clinicaltrials.gov Identifier: NCT03739112) across North America, Asia, and Europe. Participants from both groups were required to be generally healthy at baseline. The studies were conducted during the 2017-2018 and 2018-2019 influenza seasons, respectively.

In the first trial, 5077 individuals were assigned to the QVLP vaccine group and 5083 were assigned to a placebo group. In the final per-protocol analysis, the groups consisted of 4814 and 4812 participants, respectively. The primary outcome was 70% absolute efficacy of the vaccine to prevent “laboratory-confirmed, respiratory illness caused by antigenically matched influenza strains,” which the study did not meet (35.1%; 95% CI, 17.9%-48.7%). Serious adverse events occurred in 1.1% of the QVLP group and 1.0% of the placebo group; 0.1% of each group experienced severe treatment-related or treatment-emergent adverse events.


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In the second trial, 6396 participants were assigned to receive the QVLP vaccine and 6398 were assigned to receive a quadrivalent inactivated vaccine (QIV). The final per-protocol analysis included 5996 and 6026 participants, respectively. The primary outcome was the relative efficacy of the QVLP vaccine against laboratory-confirmed influenza-like illness caused by any strain of influenza, which was met with a relative efficacy of 8.8% (95% CI, -16.7% to 28.7%). Serious adverse events occurred in 4.1% of the QVLP group and 4.2% of the QIV group; 0.1% of each group experienced severe treatment-related or treatment-emergent adverse events.

These results indicate that while the “QVLP vaccine did not meet the success criterion for its primary endpoint in the 18-64 study, [the] vaccine can provide substantial protection against respiratory illness and influenza-like illness,” the authors concluded. Vaccine efficacy estimates are similar to other licensed vaccines on the market. The findings also indicate that the vaccine was well-tolerated, with a favorable safety profile in both studies.

In addition to the influenza vaccine evaluated in these trials, Medicago Inc. recently reported promising phase 1 results of a similar produced vaccine candidate for severe acute respiratory virus coronavirus 2 (SARS-CoV-2). To combat the coronavirus disease 2019 (COVID-19) pandemic, Medicago Inc. stated that their vaccine “induced robust neutralizing antibody and cellular immune responses” after 2 doses, as stated in a press release.2 “The Coronavirus-Like Particle COVID-19 vaccine candidate (CoVLP) is composed of recombinant spike (S) glycoprotein expressed as virus-like particles (VLPs).” The company is now conducting phase 2/3 trials of CoVLP using GlaxoSmithKline’s proprietary pandemic adjuvant and plans to submit results for regulatory review in 2021.3,4

To learn more about plant-derived vaccine manufacturing, we interviewed Ed Rybicki, PhD, professor and director of the Biopharming Research Unit in the Department of Molecular and Cell Biology at the University of Cape Town in South Africa. His team has been investigating these technologies for nearly 2 decades.

What does plant-based manufacturing of vaccines involve, and what are some of the benefits of this method?

Dr Rybicki: This is a big subject, but basically it involves using plants (usually N benthamiana) to produce the essential proteins needed in a subunit vaccine. This is done either by making the plants transgenic with a foreign gene inserted into the genome or – much more often lately – by using a bacterium called Agrobacterium tumefaciens to transfer recombinant DNA encoding gene(s) of interest into normal plants for transient expression.

The advantage of this technique is that one can go from having a gene sequence – for example, SARS-CoV-2 S protein – to having lots of protein in the time it takes to synthesize a gene, clone it into Agro, grow up a small volume of Agro, and use it to put the gene into a large number of plants (which could be kept as standby biomass, as they’re cheap to grow) to give you protein a week or so later. Medicago Inc. did this for SARS-2 S in 20 days or so.  

Benefits include the most rapid scale-up time for any production method, very rapid preparation of cloned DNA to do it with, and far cheaper upstream costs compared to any of the stainless steel fermentation methods. So, this is a good pandemic response technology!

What is the significance of the current findings by Ward, et al?

Dr Rybicki: The findings suggest that a plant-made candidate 4-valent seasonal influenza vaccine is at least equivalent to conventional egg-made vaccine, and quite possibly better in terms of eliciting cellular responses because of its nature as virus-like particles instead of subunit proteins. There are no viable VLP-based flu vaccines available that are made in any other way. The clinical trial results established the Medicago flu vaccine candidate as a viable alternative to conventional offerings, and moreover, one that can be very quickly tailored to account for changes in circulating influenza virus strains, unlike egg production which involves a 6-month turnaround.

What are the potential implications of this technology for future vaccine manufacturing?

Dr Rybicki: The potential implications are that subunit vaccines, including for hepatitis B as well as papillomaviruses, which we have worked on here (HPV), may be more cheaply and conveniently produced in plants because proofs of concept already done. In addition, the flexible scaling of production volume may be a significant benefit in pandemic and epidemic response compared to conventional manufacturing methods. Plant-based vaccine manufacturing could possibly expand the range of candidate human and animal vaccines available and to enhance the rapid response capability.

Disclosure: Ed Rybicki, PhD declared affiliations with Medicago Inc.

References

1. Ward BJ, Makarkov A, Séguin A, et al. Efficacy, immunogenicity, and safety of a plant-derived, quadrivalent, virus-like particle influenza vaccine in adults (18-64 years) and older adults (≥65 years): two multicentre, randomised phase 3 trials. Lancet. 2020;396(10261):1491-1503. doi:10.1016/S0140-6736(20)32014-6

2. Medicago. Press release: Medicago announces positive phase 1 results for its COVID-19 vaccine candidate. Published online November 10, 2020. Accessed online January 4, 2021.

3. Medicago. Press release: Medicago and GSK announce start of phase 2/3 clinical trials of adjuvanted COVID-19 vaccine candidate. Published online November 12, 2020. Accessed online January 4, 2021.

4. Medicago. Medicago’s development programs: COVID-19. Accessed online January 4, 2021.

Additional Suggested Reading

1. Rybicki EP. Plant molecular farming of virus-like nanoparticles as vaccines and reagents. Wiley Interdiscip Rev Nanomed Nanobiotechnol. 2020;12(2):e1587. doi:10.1002/wnan.1587

2. Rybicki E. Plant-made vaccines and reagents for SARS-CoV-2 in South Africa. ViroBlogy. Accessed online January 4, 2021.

3. Rosales-Mendoza S, Márquez-Escobar VA, González-Ortega O, Nieto-Gómez R, Arévalo-Villalobos JI. What does plant-based vaccine technology offer to the fight against COVID-19? Vaccines (Basel). 2020;8(2):183. doi:10.3390/vaccines8020183

4. Rockman S, Laurie KL, Parkes S, Wheatley A, Barr IG. New technologies for influenza vaccines. Microorganisms. 2020;8(11):1745. doi:10.3390/microorganisms8111745

5. Dhama K, Natesan S, Iqbal Yatoo M, et al. Plant-based vaccines and antibodies to combat COVID-19: current status and prospects. Hum Vaccin Immunother. 2020;16(12):2913-2920. doi:10.1080/21645515.2020.1842034

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New Coronavirus May Be Cause of Viral Pneumonia Outbreak in China

HealthDay News — A new type of coronavirus may be responsible for dozens of viral pneumonia illnesses in China, according to state broadcaster CCTV.

As of Sunday, 59 people in the central Chinese city of Wuhan were being treated for the respiratory illness, and seven were in critical condition, according to health officials.

As of Wednesday evening, the new coronavirus had been detected in 15 of those cases, CCTV reported. There was no immediate confirmation by Chinese health officials, the Associated Press reported.

The new coronavirus is different than previously identified ones, according to CCTV. Some coronaviruses can cause colds, while others can trigger severe respiratory diseases such as SARS and MERS, the AP reported.


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AP News Article

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