Coverage From ID Week 2020

A new podcast episode featuring Mei Mei Hu of Covaxx, whose company has made great strides toward a preventive option in mere months.

What It's Like to Make a COVID-19 Vaccine

One of the most important aspects during the coronavirus disease 2019 (COVID-19) has been the emphasis placed on policies that will help to keep the pandemic in check. However, not all official policies and guidelines have the same impact as far as decreasing case numbers and keeping people safe.

Anita McGahan, a professor at the University of Toronto’s Munk School of Global Affairs & Public Policy and a professor of Strategic Management at the Rotman School of Management, where she holds the George E. Connell Chair in Organizations & Society, recently authored a paper discussing which COVID-19 policies provide the most impact.

“We identified 2 different categories of policies, core policies and additional high impact policies. Core policies were no public events, restricting gatherings to fewer than 100 people, implementing stay at home recommendations, [and] restricting internal movement within countries,” McGahan said.

She further went on to discuss which of those core policies outlined provide the highest benefit to a society.

“It depends a lot on what’s going on in a particular country,” the professor said.

She stressed the fact that variables like enforcement of policies and how the local populations respond to the restrictions that are in place play a vital role in how effective they can be.

“We’re interested in getting COVID growth down below zero, because if you can stop the replication of this disease overtime, if you can get growth down, then the epidemiology of the disease loses its control.”

Articles

Good compliance to guidelines can help workplace and schools to reopen safely.

Discussing Effective Policies to Control the COVID-19 Pandemic

A recent study conducted at the Washington University School of Medicine in St. Louis has suggested that some individuals with upper gastrointestinal (GI) tract issues may be more vulnerable to an infection with the coronavirus disease 2019 (COVID-19). Data from the study was published in the journal 

Investigators analyzed tissue samples from patients who have a common disorder called Barret’s esophagus and found that their esophageal cells have receptors for the virus which bind to COVID-19, opening them up for a potential infection. However, they found that healthy esophageal cells cannot bind to SARS-CoV-2.

"There is no evidence yet that people with Barrett's esophagus have higher rates of COVID-19 or are at any greater risk, but part of the reason is because that hasn't been studied," Jason C. Mills, senior investigator on the study said. "Now that we've connected these dots, it may be worthwhile to look and see whether people with Barrett's have higher rates of infection."

The study was conducted with 30 participants who have Barret’s esophagus, as well as samples from those who don’t. Investigators collected tissue samples from each of them and then built and cultured mini organs from the samples, called organoids, in a dish to model how they interacted with the SARS-CoV-2 virus.

Findings from the study demonstrated that the virus was able to bind and infect the organoids. Additionally, they found that the more the cells in a specific sample resembled intestine, the more the virus was able to bind and infect the culture.

"The worry would be that, particularly for Barrett's patients, there even may be a susceptibility to infection from foods containing viral particles," Mills said. "This study provides data to indicate that we need to take a closer look to investigate whether a substantial portion of the population may be susceptible to infection through what they swallow."

Intestinal-type metaplasia of the esophagus and stomach aberrantly express the proteins critical for SARS-CoV-2 binding.

COVID-19 Infection and GI Tract Vulnerability 

 in distributed five-dose vials of Pfizer-BioNTech 

BNT162b2 due to overfill, Pfizer intends to count the supplemental doses toward its commitment of 200 million doses distributed to the US by the end of July 2021.

, comes at a time when vaccine administration has been slower than the rate of distribution itself—and with administering pharmacists are stating the uncovered overflow “sixth doses” are not consistent with each vial.

According to the report, Pfizer executives have been challenging wording of the vaccine’s Emergency Use Authorization (EUA) to acknowledge distributed vials contain 6 doses, not 5. The difference, acknowledged by the FDA on January 6, influences the pharmaceutical company’s contract with the US government.

Rather than the company being able to provide up to 20% more doses of the agreed-upon 100 million vaccine doses in the US—as hoped for upon discovery of the vial overfills—they will be able to renegotiate with the government at the end of their distribution deal.

that the company’s supply commitment pertains to a delivery of doses, not vials. They added the intent of the FDA label change was to “provide clarity to health care providers, minimize vaccine wastage, and enable the most efficient use of the vaccine.”

As clinicians noted, this decision adds the pressure of properly procuring a full sixth vaccine dose in every vial during a still-rampant pandemic.

“This is gross, money-extracting behavior in the midst of the greatest health emergency our world has seen,” Megan Ranney, MD, MPH, of Brown University, 

Dr. Maurizio Cecconi, president of the European Society of Intensive Care Medicine (ESICM), 

 that the decision is perceivably bad given the “advantage of the sixth (sic) dose for the vaccination campaign.”

“Pfizer will make a lot of money from these vaccines, and the US government assumed a lot of the upfront risk in this case, so I’m not sure why Pfizer didn’t just continue to fill their supply as planned, even if it meant oversupplying a little,” Aaron S. Kesselheim, MD, JD, MPH, a professor of medicine at the Brigham and Women’s Hospital and Harvard Medical School, said in the report.

In a move being ill-received by clinicians, the COVID-19 vaccine producer is lessening the count of vials being supplied to the government through Jyl.

Pfizer Will Count COVID-19 Vaccine Vial Overfills Toward US Quota of Doses

In a recent study published in the journal 

, investigators have demonstrated that a simple blood test that gives rapid results can predict within a day of hospital admission which patients with the coronavirus disease 2019 (COVID-19) are at the highest risk for developing severe complications or death. The study was conducted at the Washington University School of Medicine in St. Louis.

The study consisted of 97 patients who were newly admitted to Barnes-Jewish Hospital with a confirmed case of COVID-19. The blood test used measures the patient’s levels of mitochondrial DNA, a unique molecule which typically resides in a cell’s energy factories. When these molecules begin to spill out into the bloodstream, this is a good indication that some type of violent cell death is occurring somewhere in the body.

"Doctors need better tools to evaluate the status of COVID-19 patients as early as possible because many of the treatments -- such as monoclonal antibodies -- are in short supply, and we know that some patients will get better without intensive treatments," Andrew E. Gelman, co-senior author on the study said. "There's so much we still don't understand about this disease. In particular, we need to understand why some patients, irrespective of their ages or underlying health in some cases, go into this hyperinflammatory death spiral.”

Findings from the study showed that mitochondrial DNA levels were significantly higher in the patients who were eventually admitted to the ICU, intubated or died. The levels in those who developed severe lung dysfunction or died were, on average, 10 times higher. They were also found to have a 6 times higher chance of intubation, 3 times more likely to be admitted to the ICU and almost 2 times as likely to die in comparison to those with lower levels.

Additionally, the blood test was able to predict the outcomes of patients just as well or even better than existing markers of inflammation that are currently measured in patients who are hospitalized.

"Viruses can cause a type of tissue damage called necrosis that is a violent, inflammatory response to the infection. The cell breaks open, releasing the contents, including mitochondrial DNA, which itself drives inflammation,” Gelman said. “In COVID-19 patients, there has been anecdotal evidence of this type of cell and tissue damage in the lung, heart and kidney. We think it's possible that measures of mitochondrial DNA in the blood may be an early sign of this type of cell death in vital organs."

The method allows mitochondrial DNA levels to be quantified directly in the blood, without requiring intermediate steps.

Patients at High Risk of Severe COVID-19 Identified With Rapid Blood Test

Biden Administration Announces Plans to Increase Vaccine Distribution

Newly inaugurated President Joseph Biden has announced plans to combat the ongoing 

 (COVID-19) pandemic with a goal of increasing vaccine distribution by setting up community vaccination sites nationwide.

Other goals of the Biden plan include scaling up testing and tracing programs, eliminating supply shortage problems, while investing in high-quality treatments. In addition, Biden wants to provide paid sick leave to contain the spread of the virus, address health disparities, and make the necessary investments needed to reopen a majority of K-8 schools in the first 100 days of the administration.

The vaccination plan is part of the larger $1.9 trillion 

, which centers on providing financial support to struggling communities, including small businesses, while protecting the jobs of first responders, transit workers, and other essential workers.

While the American Rescue Plan ultimately requires congressional approval, Biden is expected to take a number of measures during his first days in office that would be effective immediately.

As part of a package of 17 executive orders, Biden has required masks be worn on federal property and is expected to reversed the Trump Administration’s decision to withdraw from the World Health Organization (WHO) and reengage with the organization in the coming days.

As of January 18, the US was close to administering 800,000 daily COVID-19 vaccines, while the US Centers for Disease Control and Prevention (CDC) is reporting just 36% of the 30.6 million available vaccines have been administered.

However, according to several media reports, Amazon CEO Dave Clark has reached out to the new administration to offer assistance in distributing vaccines.

“As you begin your work leading the country out of the Covid-19 crisis, Amazon stands ready to assist you in reaching your goal of vaccinating 100 million Americans in the first 100 days of your administration,” Clark said in a letter, first reported by 

Since the first reported cases of COVID-19 in 2020, there has been 24.9 million cases in the US and 97 million cases worldwide. The US has also seen 414,094 deaths of the more than 2 million deaths globally.

Project aims for additional good-paying jobs, combatting the climate crisis, advancing racial equity, and building back better than before. 

Increase in Vaccine Distribution Announced by President Biden

Presence of GI symptoms with COVID-19 was associated with increased likelihood of severe illness.

Gastrointestinal Symptoms Could Signal Severity of COVID-19

If the current recommended dosing schedules for the vaccines are not “feasible,” then the agency said vaccines may be scheduled for administration up to 42 days between the first and second doses.

CDC Modifies Interval Time Between Dosing for mRNA COVID-19 Vaccines to 6 Weeks

The President declared a “full-scale wartime effort” to combat the ongoing pandemic.

Executive Orders Signed by President Biden Target COVID-19

The cabotegravir and rilpivirine formulation was approved on the basis of 2 trials assessing its viral suppression capability in 1100-plus adults with HIV.

FDA Approves First Long-Acting Injectable Drug for HIV

Viral loads in treatment group were consistent with previously disclosed data from the BLAZE-1 trial.

Bamlanivimab Reduces Risk of COVID-19 for Residents in Nursing Homes 

Discovery may have important implications on vaccine development and efficacy.

Relatives of SARS-CoV-2 Evolve Against Immune Responses

Anthony Fauci, MD, made the announcement Thursday morning to the World Health Organization’s (WHO) executive board.

United States Will Stay a WHO Member

Following the resignation of Stephen Hahn, MD, at the very end of the Trump administration, Janet Woodcock, MD, has been appointed as acting commissioner of the US Food and Drug Administration (FDA).

Veteran of FDA Appointed as Acting Commissioner 

Avian flu outbreaks have been detected in countries all over the world, but influenza activity in humans remains uncharacteristically low for this point in the season. 

Flu Activity Lower than Usual, Likely Due to Coronavirus Precautions 

Smaller cities and towns with a short supply of intensive care units and tight budgets need effective precautionary measures.

Top Medical News

Discussing Effective Policies to Control the COVID-19 Pandemic

COVID-19 Infection and GI Tract Vulnerability

Pfizer Will Count COVID-19 Vaccine Vial Overfills Toward US Quota of Doses

Patients at High Risk of Severe COVID-19 Identified With Rapid Blood Test

Increase in Vaccine Distribution Announced by President Biden

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