All testing is overseen by a board-certified internal medicine physician and carried out in a government approved testing laboratory.

All testing is overseen by a board-certified internal medicine physician and carried out in a government approved testing laboratory.



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COVID-19 Vaccine Update

Published on 9/9/2020

Many of the leading vaccine candidates in development (eg Moderna, Pfizer, Sanofi) are based upon injection of DNA or RNA genetic material that is taken up into the body’s cells, programmed to produce SARS-CoV-2 viral proteins, and then generate a specific immune response. While this approach has shown promising early results in Phase I and II trials, the genetic vaccine model is completely new and there are no existing vaccines currently in use based on this technology.

So today’s report will first look back in order to look forward, by focusing on Merck’s existing viral vector technology that has been previously used in a vaccine to the Ebola virus. Merck currently has two SARS-CoV-2 vaccine candidates based on the same technology: the first uses a recombinant vesicular stomatitis virus platform to infect host cells to first produce and then release viral proteins leading to the production of protective antibodies. A second Merck vaccine utilizes a measles virus vector platform which was earlier developed by the renown Institut Pasteur (and exclusively licensed to Merck) to create the same immune response. 

Together, these two vaccine candidates have given Merck a separate lane within the vaccine development pipeline with a few distinct advantages. First, both vaccine candidates are based upon single-dose administration and do not require a second booster dose. Secondly, the measles-based vaccine can potentially be given orally, which could be advantageous for very young or older populations. And finally the Merck vaccines have a slightly different mechanism of action compared to similar viral-vector models (eg Oxford/Astrazeneca, Johnson and Johnson, CanSino). While many of these are further along in clinical trials, all of the competitor vaccines are based on the common adenovirus (compared to Merck’s use of the measles or stomatitis virus). Recent data has raised concerns about a potential obstacle to widespread use of these vaccines as many individuals have pre-existing immunity to the adenovirus. With existing circulating antibodies to the adenovirus vector, this could block the body from developing an immune response. 

Merck has announced the beginning of clinical trials for both vaccines set to begin later this month and should have initial results by later this year. While their late start to clinical trials may not be leading the pack, their unique model could parlay their other advantages to ultimately put them ahead compared to the other vaccine models in development.

Please click here to see the original press release.

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Sanofi and GSK land $2.1 billion deal with U.S. for Covid-19 vaccine development

Published on 8/31/2020

While there are more than 150 vaccines in development worldwide, one of the more recent candidates could be a frontrunner within a few short months. Despite more sensational study results from competitors with an earlier start, Sanofi Pasteur has re-engineered their seasonal flu vaccine (FluBlok) to target the SARS-CoV-2 virus with promising results from their early Phase 1 and 2 studies.

Sanofi’s vaccine candidate is a recombinant vaccine, where genetic material from the surface protein of the SARS-Cov-2 is used to first generate copies of the viral protein in laboratory host cells. These viral proteins are purified into a vaccine that is injected into the host which then generates a targeted immune response to this specific protein. What further separates this Sanofi vaccine from others in development is that their model involves an additional compound that gives an added boost to the body’s natural immune response, thereby requiring smaller doses of vaccine- and potentially reducing the likelihood of any side effects. Current testing is underway to determine whether a protective immune response can be achieved by a one or two dosing regimen.

By utilizing a mass-production vaccine model already in use for the seasonal flu, Sanofi is the only vaccine in development using technology from an approved platform. They recently announced a $2.1 billion collaborative agreement with GlaxoSmithKline as part of “Operation Warp Speed” to produce 100 million doses of their COVID-19 vaccine by the end of 2020. With Phase 3 trials now expected to start in September, Sanofi has caught up to its competitors’ earlier clinical trials, and if effective, has hopes to produce up to 1 billion vaccine doses in 2021 through the FDA’s emergency use pathway.

Please click here to see the original press release.

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Regeneron Pharmaceuticals Inc. Vaccine Update

Published on 8/19/2020

Regeneron Pharmaceuticals Inc., a US-based biotechnology company, recently announced exciting results from two animal studies testing its COVID-19 antibody drug formulation. Utilizing its proprietary platform called “VelocImmune”, the company is able to rapidly manufacture fully human antibodies – the proteins that circulate in the blood and attack pathogens by attaching to their surface. The two studies involved injecting rhesus monkeys and hamsters with an antibody cocktail targeted towards the SARS-CoV-2 virus. In both animals, injecting the antibodies nearly completely blocked the establishment of an infection after exposure to the SARS-CoV-2 virus. In addition, when treated with increasing viral loads, the same antibody regimen minimized the effects of infection, thereby showing potential benefit for both prevention and treatment for COVID-19.

Furthermore, treated animals who did show signs of infection did not exhibit signs of increased viral load (i.e. symptom severity) nor did they show any signs of pathology after treatment (i.e. no organ damage from the administration of the antibody cocktail). Researchers are hopeful that they will see a similar response in humans. Antibody regimens have been used to successfully treat cancer and block overactive immune systems in people.

By applying this technology to the SARS-CoV-2 virus, these studies outline yet another avenue of treatment towards the goal of discovering a vaccine before the end of this year. Regeneron is also the recipient of a $500 million contract with the US government as part of “Operation Warp Speed”, and with continued success from late Stage III trials, Regeneron says they are prepared for rapid production of its antibody treatment in early 2021.

Please click here to read the original press release from the United States Department of Health and Human Services.

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Novavax Vaccine Update

Published on 8/6/2020

This week there was another encouraging report in the race to develop a vaccine to the SARS-CoV-2 virus. Novavax, a small company that recently made news as a recipient of $1.6 billion by the White House “Operation Warp Speed”, just released its preliminary results on an early trial of their vaccine candidate. In this study, 130 volunteers were given one of two doses of the vaccine, and each group responded with the expected immune response – production of “virus-neutralizing” antibodies (or antibodies that attack the part of the SARS-CoV-2 virus that prevent it from causing further infection) at the target level. Furthermore, side effects were limited – mild or moderate symptoms which resolved within a few days.

What makes this particular vaccine different is that it contains a viral protein that elicits an immune response unlike other leading vaccines to date that use viral genetic material (such as the vaccines from Moderna and Pfizer/BioNTech recently profiled). This type of protein-based vaccine may have an additional advantage, as vaccines of this type have been in use for much longer and have a proven successful track record for diseases such as hepatitis B and shingles.

Still much more data will be required to show that this vaccine is safe and effective. Novavax enters into its own Stage III trials this fall on a larger number of subjects. If successful, Novavax has already signed a contract with Serum Institute of India for mass production of its vaccine, with a goal of having up to 100 million doses available by early 2021.

Please click here to read the Novavax press release.

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COVID-19 Vaccine Update

Published on 7/31/2020

The COVID-19 virus has continued to spread throughout the United States, with an alarming increase in new cases no longer contained to mostly urban hotspots. This underscores the need for all Americans to continue exercising proper precautions, including wearing a mask in public spaces, thorough hand washing, and social distancing whenever and wherever possible.

The development of a successful vaccine is our best hope to end this pandemic. It is likely that more than one vaccine will be needed, because some vaccines may be more effective in older or younger populations and others may have cost or manufacturing limitations. As a result, there are over 150 potential vaccines in development around the world. We will be monitoring the results of the most promising vaccine candidates and profiling them on this blog. Please return back to this page for regular updates as we navigate this pandemic together.

July 20th, 2020. One of the most promising potential vaccines is being developed at Oxford University’s Jenner Institute in England. This vaccine involves modifying a respiratory virus that resembles COVID-19 by first neutralizing its infectious capability and then re-engineering it with genetic parts from the COVID-19 virus. This inactivated virus can then be injected into humans where it won’t cause infection but will stimulate the body’s immune response in a way that may be protective against COVID-19. Early results from a Phase I/II study involving over 1,000 subjects show that the vaccine does prompt a strong immune response for up to two months, and that a booster dose (or second dose) leads to a stronger immune response without significant side effects.

The vaccine is now entering Phase III trials involving 7,000 subjects in Brazil and South Africa, with additional studies enrolling up to 50,000 more people by the end of 2020. The goal of these trials is to determine if the immune response elicited by the vaccine is enough to prevent COVID-19 infection, and to show how lasting that protection is for different age groups and with various comorbidities. If the study proves that the vaccine is both safe and highly effective against COVID-19 in diverse populations, emergency regulatory approval could allow a first wave of doses to be delivered in early 2021, with widespread production of up to 2 billion doses in 2021.

Please click here to see the original article from The Lancet.

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Vaccine Being Developed by Pfizer and BioNTech

Published on 7/29/2020

July 29, 2020: A promising vaccine candidate is being developed in partnership with Pfizer (USA) and BioNTech (Germany). This particular vaccine candidate targets the full length of the “spike” glycoprotein S (the part of the virus that attaches to cells enabling viral entry and eventual replication), which is the target of virus neutralizing antibodies generated by the immune response. This vaccine has a mechanism of action that is different than any human vaccine to date. The vaccine introduces a piece of genetic material (messenger RNA (mRNA)) into host cells whereby the host cells use that material to make a protein (in this case the SARS-CoV-2 spike protein) and then display that protein on their surface. This triggers an immune response to the protein which mimics the effective (or neutralizing) immune response that an infected person should mount. Recent results showed that the vaccine caused the production of protective IgG antibodies in increased concentrations both when given higher doses and after a second dose, all with a mild side effect profile.

Given their early clinical success, the two companies have announced they are proceeding to Phase II/III trials with 30,000 subjects worldwide set to receive two doses 4 weeks apart. If this larger study shows equal efficacy and safety, the U.S. Food and Drug Administration (FDA) has already given this vaccine Fast Track designation for approval, and the Trump administration has awarded Pfizer a $1.9 Billion contract to purchase up to 100 million doses of the vaccine. Furthermore, Pfizer estimates that they can produce over 1 billion doses for worldwide use by the end of 2021.

Please click here to read the original research article.

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Early Vaccine Research in Macaques Shows Promise

Published on 5/20/2020

In this exciting original research published in Science on May 20th, 6 DNA vaccine candidates targeting SARS-CoV-2 were tested in rhesus macaque primates. At the start of the study 35 animals were treated with the vaccines followed by a booster dose at week 3. By week 5 all of the vaccinated animals demonstrated appropriate immune response. At week 6 the animals were exposed to SARS-CoV-2. Viral load was found to be significantly lower in the immunized animals vs. control. Of the 6 candidate vaccines tested, some variants demonstrated stronger protections than others, with some of the animals developing no detectable virus at any time point, while others developed mild symptoms. This very exciting early research not only demonstrates a potentially effective vaccine against SARS-CoV-2, but also develops the framework by which a vaccine could be tested and refined.

Please click here to view the original article from Science.

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Research in Macaques Demonstrates Development of Successful Immune Response Following Sars-CoV-2 Infection

Published on 5/20/2020

In this original research published in Science on May 20th, 9 rhesus macaques were infected with SARS-CoV-2 virus and developed an interstitial viral pneumonia, mimicking the human clinical course. All animals survived, and 35 days later the same animals were inoculated again with the same exposure to SARS-CoV-2 virus. Extensive immunologic testing demonstrated robust immune response in the rhesus macaques and none of animals developed recurrent clinical symptoms. This is an extremely important finding for two reasons. First, it demonstrates that the rhesus macaque may be an important scientific model for human disease and an important platform for further immunologic research. Second, this is one of the first prospective controlled studies demonstrating that infection with SARS-CoV-2 virus can induce appropriate immune response and subsequent immunity. In short, this is a small but very promising study showing that getting sick with COVID-19 may offer strong protection from future exposure.

Please click here to see the original article in the journal Science.

via the New York Times

Early and Limited Evidence of Moderna Vaccine Efficacy

Published on 5/18/2020

As reported in the New York Times, early preliminary results released by Moderna, a Cambridge, MA-based company, suggests that its experimental vaccine is safe and capable of stimulating a robust immune response against SARS-CoV-2. Moderna’s novel technology delivers pieces of SARS-CoV-2 genetic code (also known as messenger RNA or mRNA) into cells. This stimulates the human immune system to produce antibodies against the spike protein of the virus. The widely publicized report includes results from 8 healthy volunteers who were part of a larger group of healthy volunteers ages 18 to 55 vaccinated in Moderna’s ongoing Phase 1 study. Each volunteer received two doses of the experimental vaccine. Reportedly, the immune systems of these individuals made antibodies that were able to stop the virus from replicating in laboratory tests. These so-called “neutralizing antibodies” are the types of antibodies generally thought to be needed for an effective vaccine. While this data appears promising, it is just the beginning of the antibody testing and development pipeline. These preliminary findings must now be repeated in a second phase of tests involving hundreds of people to begin soon, and a third phase this summer will involve thousands. If trials are successful, the company anticipates that some doses of a vaccine could become available for widespread use as early as late 2020. This would be an important milestone, as vaccines are widely expected to be an essential component of the effort to slow or stop the spread of COVID-19.

Please click here to see the original article from The New York Times.

via the New York Times

A Silent Danger for Coronavirus Patients: Low Blood Oxygen

Published on 5/13/2020

The majority of patients affected by COVID-19 will have a self-limited illness that will not require hospitalization or significant medical intervention. Unfortunately, some patients with COVID-19 will develop acute lung injury, usually after about 7 days of illness. This results in a sudden decrease in the ability for the body to absorb oxygen. These patients often require hospitalization and may require intensive care and to be placed on a ventilator. One of the first signs that a patient may be headed down this second path may be a low oxygen reading on a pulse oximeter.

What is a pulse oximeter and do I really need one?

A pulse oximeter is a small device that clips onto your fingertip and is able to noninvasively measure oxygen saturation (the amount of oxygen being carried by your blood). While this device is commonplace in the healthcare setting, it was previously unusual for patients to be measuring their oxygen saturation at home. For patients sick with COVID-19, however, this device may be a lifesaver.

While the science behind this is not yet clear, many doctors have found that even before a patient with COVID-19 realizes they are getting seriously ill, they may develop a low oxygen level or “silent hypoxia”. For this reason, some doctors recommend daily home monitoring with pulse oximeters for patients with COVID-19. Emergency departments have even begun providing pulse oximeters to patients with COVID-19 to take home after an ED visit. By monitoring their oxygen levels at home, patients with COVID-19 may be able to detect serious respiratory issues earlier and get back to the hospital before it is too late.

So do you need one? For patients who have not been seen by a doctor and diagnosed with COVID-19, it is very unlikely that a pulse oximeter is going to be helpful (and will likely cause undue stress!). But if you, or someone you care about, has been diagnosed with COVID-19, it might not be a bad idea to speak with a doctor about home pulse oximetry monitoring.

Please click here for access to the original article in the New York Times.

Please click here to listen to Dr. Dagan’s interview on this subject on NPR’s Weekend Edition.

Please click here for an article on this subject in The Guardian in which Dr. Dagan is quoted.

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New England Journal of Medicine – Transmission of SARS-CoV-2 in Domestic Cats

Published on 5/13/2020

In this letter to the editor in the New England Journal of Medicine, researchers examine the capacity of domestic cats to contract and transmit COVID-19. In the study, domestic cats were infected with the virus and were housed with uninfected cats. Within 5 days, the virus had infected all of the cats. This confirms earlier anecdotes that domestic cats (and even tigers and lions in the Bronx zoo) can become infected with COVID-19 and potentially spread the virus. While more study is needed, this is important for households with cats to be aware as infected animals may not have any appreciable symptoms. More information regarding COVID-19 and pets is available from the CDC here:

Please click here to see the original Correspondence in the New England Journal of Medicine.

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Harvard Business Review – Which Covid 19 Data Can You Trust

Published on 5/8/2020

This article from the Harvard Business Review addresses the important role that data analytics has played in understanding the COVID-19 pandemic and some of the dangers associated with models and predictions coming from unvetted sources. In our globalized world, this pandemic has generated an incredible amount of data in a very brief amount of time. With all of this data, however, has come a slew of well-meaning but misguided attempts at analysis by individuals and companies without the appropriate expertise. Faulty models and predictions can lead to changes in public policy that could affect millions. This article recommends readers look for data that is generated by groups that are collaborative, open, and include health professionals and epidemiologists. “When making your own decisions, read closely, trust carefully, and when in doubt, look to the experts.”

Please click here to see the original article from the Harvard Business Review.

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New England Journal Study Finds That Hydroxychloroquine Does Not Prevent Respiratory Failure Requiring Intubation or Death in Patients with COVID-19

Published on 5/7/2020

In this observational study of 1446 patients with COVID-19 admitted to a large New York City medical center, no benefit was found for those treated with hydroxychloroquine. Hydroxychloroquine has been widely touted as a treatment for COVID-19 but the data for its effectiveness has been unclear. This retrospective study examined hospitalized patients that were treated with hydroxychloroquine vs. those that were not and compared rates of respiratory failure requiring intubation and death. When controlled for disease severity, there was found to be no difference between the two groups. This is very important data suggesting that the use of hydroxychloroquine is likely ineffective at altering important outcomes in COVID-19. Prospective randomized control trials are currently underway to further confirm this finding.

Please click here to see the original article from The New England Journal of Medicine

via the New York Times

Majority of Patients with Confirmed COVID-19 Develop Antibodies

Published on 5/7/2020

This New York Times article discusses recent research demonstrating that the majority of individuals with confirmed COVID-19 develop antibodies (proteins made by the body’s immune system to fight invading pathogens) to the causative viral agent, SARS-CoV-2. The work, performed by researchers at Mount Sinai Hospital in New York City, surveyed 1,343 people, including 624 who had recovered after testing positive for the virus and 719 people who suspected they had COVID-19 but did not have a formal diagnosis. Using a highly sensitive and specific antibody test, 99% of those with confirmed COVID-19 were eventually found to have measurable antibodies, as compared to 37% of those in the “suspected” group. Importantly, individuals with mild COVID-19 symptoms were capable of mounting a robust antibody response. The presence of antibodies, however, does not prove immunity to the virus. Finally, the authors also report detection of the SARS-CoV-2 viral genome in the nasopharyngeal samples from a large number of patients for weeks after symptom resolution. However, as other researchers have noted, it is unclear if this represents infectious virus. This intriguing online report awaits gold standard review by experts prior to publication in a scientific journal.

Please click here to see the full article from The New York Times.

via the New York Times

Coronavirus Mutates at a Fairly Slow Rate – Good News for Vaccine Development

Published on 4/30/2020

This article from the New York Times describes how the ability of scientists to determine the genetic code of SARS-CoV-2 has allowed them to understand the spread of disease locally and around the globe. Viruses such as SARS-CoV-2 make copies of themselves in cells of the human body. During that process, the virus can make mistakes as it attempts to replicate, and does so at a fairly constant rate. Using this knowledge, researchers were able to trace the source of the first confirmed US case of COVID-19 in a Seattle man, to his recent travel from Wuhan, China. Sequencing also allowed researchers to determine that virus circulating in the earliest days in California likely came from a separate introduction from China as opposed to a continued transmission chain from Seattle. In contrast, the genetic code of the majority of SARS-CoV-2 isolates from New York patients suggests that virus was introduced from several locations, including Europe, Asia and other parts of the United States. In contrast to similar viruses, SARS-CoV-2 appears to mutate relatively slowly – this is good news for vaccine development for COVID-19. The less it mutates or changes, the more likely it is that one vaccine could successfully immunize or protect the population against the virus. In addition, there is no scientific evidence that the mutations that is has acquired have significantly changed viral behavior thus far. Continued sequencing of additional genomes from all over the world will surely continue to be a major source of important information.

Please click here to view the original article from The New York Times.

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New England Journal of Medicine: Telemedicine Offers Many Benefits During the COVID-19 Pandemic

Published on 4/30/2020

This Perspective article from the NEJM discusses current strategies, benefits and challenges for the effective implementation of innovative telemedicine approaches during the COVID-19 pandemic. Specifically, the authors discuss the use of telemedicine in the effective initial evaluation of patients prior to their arrival in the Emergency Room or other hospital settings. Benefits of such screening, in which physicians and patients communicate using smartphone or computer, include the potential for expanded access to physicians, the ability to integrate community-based automated screening and referral programs and the maintenance of effective social distancing during patient evaluation and symptom review. Telemedicine-enabled COVID-19 management is growing throughout the country and will likely expand as the availability of centralized coordinating testing centers improves. Telemedicine cannot entirely replace traditional health care delivery. However, the most effective use of this technology can be achieved through its integration within the current healthcare infrastructure. Coordinated support from a wide variety of agencies, including those controlling federal and local testing, medical reimbursement, licensing and credentialing will be required to maximize the potential of telemedicine in the provision of effective COVID-19 care.

Please click here to read the full Perspective article in the New England Journal of Medicine.

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NIH clinical trial shows Remdesivir accelerates recovery from advanced COVID-19

Published on 4/29/2020

The National Institutes of Health (NIH) made headlines when it reported encouraging data from a trial studying Remdesivir, the first experimental anti-viral medication developed by Gilead to treat COVID-19. The trial, called the Adaptive COVID-19 Treatment Trial (ACTT) was a randomized placebo-controlled study of 1063 hospitalized patients with COVID-19. Participants were recruited from 68 sites in 22 countries starting in February, 2020.

Researchers were looking the impact of Remdesivir on the time it took for patients to be medically ready for hospital discharge or return to normal activity. Patients in the placebo group had a median recovery time of 15 days, whereas those who received Remdesivir had a shorter median recovery of 11 days- the difference was highly statistically significant. In addition, the mortality rate in the Remdesivir group was 8.0% as compared to 11.6% in the placebo group. Though perhaps clinically significant, the mortality data did not achieve statistical significance in this study.

Initial results from the SIMPLE trial, which is an open-label phase 3 study, suggest that 5-day and 10-day courses of intravenous Remdesivir led to similar percentages of patients being discharged from the hospital by day 14 (60.0% in the 5-day group and 52.3% in the 10-day group). Mortality varied by geography.

The Food and Drug Administration issued an Emergency Use Authorization for Remdesivir on May 1, 2020. Remdesivir is only indicated for inpatient use at this time. Dr. Anthony Fauci, Director of the National Institute of Allergy and Infectious Diseases, stated that “this will be the standard of care.”

Please click here to read the original article on the National Institutes of Health website.

via the New York Times

New Saliva Test for Diagnosing COVID-19 Infection Receives Emergency-Use Authorization By the Food and Drug Administration

Published on 4/29/2020

This recent article in the New York Times discusses the growth of saliva-based tests for the diagnosis of infection with SARS-CoV-2, the virus that causes COVID-19. Currently, the most widely employed diagnostic tests use nasopharyngeal (NP) swabs. While many NP swab tests can yield results in minutes, swab testing of the deep nasal passages can be unpleasant, requires the involvement of a medical professional wearing appropriate protective attire and can be hampered by false negative results due to incorrect sampling. In contrast, saliva tests are easy to self-administer, require no special equipment and may make it easier to detect virus more reliably. The number of testing sites offering saliva tests are growing, and the Food and Drug Administration (FDA) has granted an emergency-use authorization, to a saliva test made by a Rutgers University lab. Currently, these tests must be performed under the supervision of a medical professional, even for testing at home – a telemedicine visit during sample collection will suffice. The development of another viable, user-friendly option for COVID-19 testing is welcome.

Please click here to read the full article about the new saliva test for COVID-19.


Those who recovered and are asymptomatic might still be able to spread COVID-19

Published on 4/22/2020

This report, from Wuhan, China describes the growing realization that a subset of infected individuals may continue to shed SARS-CoV-2 (COVID-19) virus weeks to months after symptomatic recovery from COVID-19 the infection.

While the implications of this finding are not clear, they raise the possibility that a subset of patients who have had the infection and recovered may be able to infect others long after symptom resolution.

In China, the current recommended period of isolation after COVID-19 exposure is 14 days and hospitalized patients who recover and remain asymptomatic are discharged after two negative nucleic acid tests (swab tests), taken at least 24 hours apart.

What are the clinical and public health implications of these new finding that individuals have persistent viral shedding after symptom resolution?

The answers to these important, yet unanswered questions will impact individuals, families, and public health policy. These findings support the need for continued ongoing testing in groups of people to detect asymptomatic shedding both from new cases and those who recovered from COVID-19 infection in the past.

Please click here to read the full article about asymptomatic Covid-19 shedding.