A national COVID-19 surveillance system: Achieving containment

This report describes the features and capabilities of a national surveillance system to mitigate the current COVID-19 pandemic wave and to limit and suppress future outbreaks. Developing these capabilities in each state and region will enable the U.S. to move beyond extreme and disruptive physical isolation measures. The proposed COVID-19 surveillance system builds on existing models and principles of public health surveillance, but recognizes that the transmissibility and virulence of COVID-19 require a much more substantial capacity for rapid detection and public health response.
Timely and efficient implementation of such a surveillance system will require ongoing coordination between health care providers and state and local public health authorities, with Federal support coordinated through the Centers for Disease Control and Prevention (CDC) to achieve effective implementation throughout the country as soon as possible, and certainly in time for the Fall, when COVID-19 may become a seasonal threat.
…At the same time that we confront the current crisis, we must plan for the future by putting in place tools to enhance our ability to conduct effective surveillance, containment, and case management. As incidence of COVID-19 declines, case-based interventions will again become an option. Building those capabilities now will enable us to move beyond the extreme and disruptive physical isolation measures in place across the United States.
Every region of the country should aim for the following outbreak surveillance and response capabilities:
1)Test and Trace Infrastructure: Capacity for Widespread Diagnostic Testing and DataSharing to Enable Rapid Case-Based Interventions
a)The capacity to conduct rapid diagnostic testingfor everyone with COVID-19 symptoms and those with exposures or at higher risk of contracting or transmitting the virus (health care workers, those in congregate settings), with a robust sentinel surveillance system that routinely monitors for infection among samples of the population to enable early identification of small outbreaks, particularly in vulnerable populations;
b)Routine, straightforward, and secure electronic data sharing to support surveillance;
2)Syndromic Surveillance: Integration of Test and Trace into an Enhanced National Syndromic Surveillance System
a)Surveillance based on syndromic indicators of spikes and falls in potential COVID-19 related symptoms, building on existing public health syndromic surveillance capabilities
b)Timely and transparent reporting of COVID-19 outbreaks and testing and response capacity atthe local level
3)Serologic Testing: Capacity to Conduct Widespread Serologic Testing to Identify Reliable Markers of Immunity
a)The development of regional measures of community exposure and immunity
b)The use and integration of accurate serologic testing of individuals for effective surveillance and containment
4)Rapid Response: Capacity for Isolation, Contact Tracing,and Quarantine
a)The capacity to isolate new cases and trace, test, and quarantine contacts rapidly
b)The capacity to treat new COVID-19 cases effectively, at home or in a hospital.
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A national COVID-19 surveillance system: Achieving containment

Federal agencies buy massive supply of hydroxychloroquine

Two federal agencies have placed orders for hundreds of thousands of dollars worth of the anti-malarial drug hydroxychloroquine — using taxpayer money — even as debate rages over its effectiveness in fighting the coronavirus, according to a new report.
The Department of Veterans Affairs and the Justice Department’s Bureau of Prisons have both reported purchases of the drug — which is also used to treat rheumatoid arthritis and lupus — since March 26, according to procurement records obtained by The Daily Beast.
Veterans Affairs purchased $168,000 in hydroxychloroquine sulfate tablets from the Colorado-based generic drug distributor Golden State Medical Supply, and an additional $40,000 from the pharmaceutical company McKesson, according to the report.
Procurement records list both as “emergency” purchase orders to combat the coronavirus crisis.
The Bureau of Prisons bought $60,000 hydroxychloroquine sulfate tablets from the company Premium Rx National on March 31 — and did not mention the deadly virus in its order, but the purchase comes as federal correctional facilities saw a surge in COVID-19 cases, according to the report.
It appears to be the first time the agency has purchased the drug, the outlet reported.
Neither agency responded to questions from the outlet about whether or how their purchases would be used, either immediately or in the future, to treat coronavirus patients.
President Trump has touted the drug as a potential life-saver and promoted its use on an experimental basis, and Gov. Andrew Cuomo has agreed to provide it to thousands of seriously ill patients in New York hospitals in combination with Zithromax.
But critics have balked at the idea of promoting the drug — citing limited or anecdotal evidence about its success.
And they warn the promotion of the drug could lead to a shortage of the medication for those who use it for other illnesses.
https://nypost.com/2020/04/07/federal-agencies-purchase-large-supply-of-hydroxychloroquine/

Surgeon General warns African-Americans at greater risk for coronavirus

US Surgeon General Jerome Adams had good and bad news Tuesday on the coronavirus pandemic, saying that initial death estimates could be too high but that African-Americans were at greater risk of contracting the potentially deadly illness.
“I represent that legacy of growing up poor and black in America,” Adams said on CBS “This Morning.”
“And I and many black Americans are at higher risk for COVID, which is why we need everyone to do their part to slow the spread.”
Adams explained that black Americans were more likely to have preexisting conditions such as diabetes, high blood pressure and heart disease and lack access to health care.
In Chicago, African Americans made up 68 percent of the city’s 118 deaths and 52 percent of the roughly 5,000 confirmed coronavirus cases, despite making up just 30 percent of the city’s population, The Chicago Tribune reported, citing data from the Chicago Department of Public Health.
Those numbers take your breath away,” Chicago Mayor Lori Lightfoot told the paper on Monday. “This is a call to action for all of us.”
Those numbers demonstrate the importance of social distancing, he said.
“Now’s the time for us to really come together and say, I’m not just doing this for me and my family, I’m doing this for my community and all the communities across the country,” Adams said.
Adams on Tuesday also said he agreed with the director of the Centers for Disease Control and Prevention that some research models have projected death totals that may turn out to be too high, though neither would offer an alternate estimate.
The White House Coronavirus Task Force projected a death toll of 100,000 to 240,000 a week ago, saying containing deaths to that range was possible if strict social distance measures were respected, implying it could go even higher.
But Adams told ABC’s “Good Morning America” that he was encouraged by recent data showing a possible “flattening” of the outbreak in some areas.
Asked if he believed the death toll would come in below the dire White House estimate, Adams said, “That’s absolutely my expectation.”
“I feel a lot more optimistic, again, because I’m seeing mitigation work,” he said, adding that he agreed with CDC director Robert Redfield that deaths could fall short of totals that some computer models showed.he governors of New York, New Jersey and Louisiana pointed to tentative signs on Monday that the coronavirus outbreak may be starting to plateau but warned against complacency.
The coronavirus death toll has surpassed 10,000 in the United States and confirmed cases have topped 367,000.
President Trump responded to the recent White House projection by saying any death toll less than 100,000 would be considered a success.
Redfield said Monday that social distancing of the type ordered by nearly all state governors was effective.
“If we just social distance, we will see this virus and this outbreak basically decline, decline, decline. And I think that’s what you’re seeing,” Redfield said.
“I think you’re going to see the numbers are, in fact, going to be much less than what would have been predicted by the models.”
A research model from the University of Washington — one of several cited by leading health authorities — forecasts 81,766 US coronavirus fatalities by Aug. 4, down about 12,000 from a weekend projection.
The pandemic has upended daily life around the globe, killing more than 74,000 people and infecting at least 1.3 million.
New York Governor Andrew Cuomo said statewide deaths from COVID-19 had leveled off around 600 per day in recent days, highest in the nation, though the numbers ticked back up to 731, Cuomo said Tuesday.
“Behind every one of those numbers is an individual, is a family … a lot of pain again today for many New Yorkers,” he said during his daily news briefing.
But hospitalizations, admissions to intensive care units and the number of patients put on ventilator machines to keep them breathing had all declined, Cuomo said.
In neighboring New Jersey, the state with the second-highest number of cases and deaths, Governor Phil Murphy said efforts to reduce the spread “are starting to pay off.”
https://nypost.com/2020/04/07/surgeon-general-african-americans-at-higher-coronavirus-risk/

CDC Confirms COVID-19 is Less Severe in Pediatric Patients

A new report from the U.S. Centers for Disease Control and Prevention (CDC) confirms that in the majority of juveniles infected with COVID-19, the symptoms are less severe than in adult patients.
The report, Coronavirus Disease 2019 in Children – United States, Feb. 12-April 2, shows that fewer children with COVID-19, the disease caused by the novel coronavirus, are hospitalized. Additionally, the report shows that children with the disease are less likely than adults to experience fever, cough or shortness of breath. However, the report is quick to point out that some pediatric patients, those under the age of 18, can become seriously ill and require hospitalization. At the time the report was released Monday, there had been three juveniles in the United States who died from COVID-19.
The CDC findings were based on an analysis of 2,572 known juvenile cases of COVID-19 that were part of a batch of 149,760 laboratory-confirmed COVID-19 cases, the CDC said. The median age of pediatric patients in the study was 11 years old. The data from the CDC analysis confirms what had originally been reported from China when the outbreak of COVID-19 began. In China, data suggested that pediatric COVID-19 cases might be less severe than adult cases and that children might experience different symptoms than adults.
In its analysis, the CDC said 73% of pediatric patients had symptoms of fever, cough or shortness of breath compared with 93% of adults aged 18–64 years during the same period. When looking at the symptoms individually, 56% of pediatric patients reported fever, 54% reported cough and 13% reported shortness of breath, the CDC said.
The data used included different variables, including hospitalization status, underlying conditions and overall disease symptoms. But, some of the information that was available for these variables was low. For the symptoms, the researchers only had data for about 10% of the 2,572 patients and only knew about underlying conditions in 13% of them. Underlying conditions included asthma, immunosuppression and cardiovascular disease. The researchers also only had hospitalization information for about one-third, 33%, of the pediatric patients.
But, what those hospitalization rates showed is that juveniles were hospitalized less than adults. According to the analysis, 5.7% of all pediatric patients, or 20% of those for whom hospitalization status was known, were hospitalized, the CDC said. That was lower than the rates for adults. The data shows that adult patients aged 18 to 64 were hospitalized 33% of the time. Children under the age of 1 year accounted for the highest percentage of hospitalization among pediatric patients with COVID-19. Those youngest patients represented 15% to 62% of all children and pediatric patients hospitalized, the CDC said.
“These data support previous findings that children with COVID-19 might not have reported fever or cough as often as do adults. Whereas most COVID-19 cases in children are not severe, serious COVID-19 illness resulting in hospitalization still occurs in this age group,” the CDC said.
While pediatric patients may have less severe symptoms of the disease, the CDC said social distancing recommendations and other preventative measures are critically important to slow the spread of the disease.
Among the 2,572 pediatric cases used for the research, 850 (33%) were from New York City where the outbreak has been severe; 584 (23%) were from the rest of New York state; 393 (15%) were from New Jersey, and the remaining 745 (29%) were from other states and U.S. territories.
https://www.biospace.com/article/cdc-report-confirms-preliminary-reports-that-covid-19-is-less-severe-in-pediatric-patients/

At J&J, ‘temporary’ Tylenol shortage amid heightened demand

With anxiety about the U.S. drug supply running high these days, drugmakers have been keeping a close eye on demand spikes. Now, Johnson & Johnson, maker of ubiquitous painkiller Tylenol, is reporting shortages in certain markets as consumers stock their medicine chests.
J&J is reporting a “temporary” scarcity of Tylenol after heightened demand for the over-the-counter drug has strained supply, the drugmaker said in a statement.
The shortage is limited to specific regions, and J&J says it’s speeding up production to meet the increase demand. J&J is working with retailers to “encourage” purchasing limits and is working to keep supplies running to consumers and hospitals.

“We are committed to maintaining our increased production, including running lines up to 24/7 to maximize supply,” J&J said in a statement.
The spot shortages of Tylenol come as U.S. consumers have focused in on the global pharmaceutical supply chain’s ability to keep up with increased demand amid the novel coronavirus pandemic.

Saturday, FDA Commissioner Stephen Hahn told Fox News the administration has seen spot shortages of certain medications during the crisis but hasn’t observed state actors like China, a major producer of global active pharmaceutical ingredients, deliberately affecting U.S. supply.
Hahn did highlight the need for increased “redundancy” in the supply chain to help shore up patient access in the event of heightened and sustained demand for certain drugs.
Late last month, J&J began running its Tylenol manufacturing at top speed after the drugmaker saw between two and four times the normal amount of demand for the OTC brand, Reuters reported.

Last week, the FDA reported shortages of hydroxychloroquine and chloroquine, antimalarial meds that have been targeted by President Donald Trump and others as front-runners for a possible COVID-19 therapeutic.
Despite a “significant surge in demand,” the FDA said manufacturers are working to ramp up production of the drugs to supply ongoing clinical trials as well as fill prescriptions for existing patients. The FDA’s updated drug shortages list as of Monday listed 148 products across the pharmaceutical spectrum.
Other approved drugs and investigational candidates––including Gilead Sciences’ therapeutic hopeful remdesivir––have neared shortages as the push for a COVID-19 therapeutic continues. Earlier this week, Gilead said it had stepped up production of remdesivir to meet heightened demand, pledging to donate 1.5 million doses of the drug ready or nearly ready for shipment.
https://www.fiercepharma.com/manufacturing/johnson-johnson-reports-temporary-tylenol-shortage-amid-heightened-demand

Mallinckrodt inks debt exchange deal, but pays the price; shares up

Mallinckrodt (MNK +20.1%) inks agreements with certain institutional investors to exchange ~$495M of its outstanding 4.875% Senior Notes due 2020 for new 10.000% First Lien Senior Secured Notes due 2025 on a dollar-for-dollar basis (neither was discounted).

The deal gives the company a bit of breathing room as it tries to stabilize its finances.

Shares plummeted in mid-March after it failed to secure new term loans.

https://seekingalpha.com/news/3558974-mallinckrodt-inks-debt-exchange-deal-pays-price-shares-up-20

BAYER AG: Goldman Sachs reiterates its Buy rating

Keyur Parekh from Goldman Sachs retains his positive opinion on the stock with a Buy rating. The target price is unchanged at EUR 76.
https://www.marketscreener.com/BAYER-AG-436063/news/BAYER-AG-Goldman-Sachs-reiterates-its-Buy-rating-30364773/