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Tuesday, April 7, 2020

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/

Colorado county threatens tourists with fines, jail time amid coronavirus

A Colorado county is closing its doors to tourists amid the coronavirus outbreak, threatening anyone who violates a new public health order with up 18 months in jail and a $5,000 fine.
Gunnison County officials issued a public health order Friday barring non-residents and tourists from staying in the central Colorado community or to request a waiver to explain why they should be allowed to stay, according to the order.
“The public health director finds that non-residents, visitors and non-resident homeowners from lower altitudes are at a greater risk for complications from COVID-19 infection than residents, who are acclimatized to the high altitude environment of Gunnison County,” the order states.
Anyone who doesn’t live in the county is further “imposing unnecessary burdens” on health care, food supplies, first responders and other essential public services, the new directive reads.
“Accordingly, the presence of non-residents and visitors, including non-resident homeowners, is no longer permitted in Gunnison County in order to maintain public health and safety and to continue to address the COVID-19 pandemic,” it reads.
The public health order makes Gunnison County the first jurisdiction in the state to impose criminal charges for violating Colorado’s stay-at-home order, KREX reports.
“Our goal is to maintain the health and safety of our residents and the integrity of our health care system,” Gunnison County Emergency Operations Center spokesman Daniel Kreykeys told the outlet. “To that end, there’s some language in that health care order that allows for folks to apply for an exemption. We realize there are certain things going on with out residents that may require that. We want to give people that option, if needed.”
It’s unclear exactly how the order will be enforced, KREX reports.
County officials alerted residents to the new guidance on Facebook Thursday, telling would-be visitors and those with second homes to stay home.
“Help Gunnison County begin to sink the spike of positive COVID-19 tests by simply not visiting Gunnison County,” the post read. “We miss you. We value you. We can’t wait to see you again. Just please. Not until we begin to reverse the aggressive trend of this global pandemic in our neck of the woods.”
https://nypost.com/2020/04/07/colorado-county-shuts-door-to-tourists-amid-coronavirus-crisis

Thousands of NY COVID patients are being treated with anti-malarial drug

As many as 4,000 seriously ill coronavirus patients in New York are being treated with the anti-malarial drug hydroxychloroquine, state health officials say.
President Trump has touted hydroxychloroquine as a potential life-saver, although there is no widespread scientific evidence to date showing it helps battle COVID-19.
But Gov. Andrew Cuomo last month said health care providers in the state would be using the drug in combination with the antibiotic Zithromax, or azithromycin, for some last-ditch cases, based on potentially promising research.
“Time is of the essence,’’ Albany University Public Health Dean David Holtgrave, who is on the state’s research team, said in a statement.
A state Health Department official said the DOH has shipped doses of hydroxychloroquine to 56 hospitals across New York, distributing enough “to treat 4,000 patients to date.”
Patients have received doses as part of four- or 10-day regimens, officials said.
The University of Albany’s School of Public Health is observing the drug’s impact on the patients, and its preliminary study could come back in weeks instead of the usual months, officials said.
There are also clinical trials being conducted to see whether the drug can help block transmission.
NYU Langone Medical School is conducting a random trial with a $9.5 million grant from the Bill & Melinda Gates Foundation.
“Currently, there is no proven way to prevent COVID-19 after being exposed,” said Anna Bershteyn, an assistant professor with the Department of Population Health at NYU Langone and the study’s co-principal investigator.
“If hydroxychloroquine provides protection, then it could be an essential tool for fighting this pandemic. If it doesn’t, then people should avoid unnecessary risks from taking the drug.”
The drug has long been used to treat malaria, rheumatoid arthritis and lupus.
Its potential side effects include everything from fatal heart arrhythmia to vision loss, ear-ringing, vomiting, mood changes, skin rashes and hair loss.
Health officials are treading cautiously, saying they don’t anticipate hydroxychloroquine will be a “miracle drug” against the coronavirus — but the studies are worth the gamble.
In terms of the NYU clinical trial regarding prevention, researchers are enrolling 2,000 adult volunteers at six sites.
They are recruiting people who lack any COVID-19 symptoms but have been in close contact with others who have a confirmed or pending diagnosis.
On a random basis, the trial participants will receive either hydroxychloroquine or a placebo pill — vitamin C — every day for two weeks.
Each day during the 14-day period and then again on Day 28, the participants will swab their nasal passages and send the samples to researchers to detect potential COVID-19 infection.
“If everything goes as planned, the eight-week trial could provide answers by summer on whether a preventive dose of the drug is safe and effective,’’ NYU Langone said in a release.
“If so, the strategy could give health officials a much needed boost in slowing person-to-person transmission.”
The federal Food and Drug Administration granted emergency-use authorization to use hydroxychloroquine to treat COVID-19 patients amid the pandemic.
There has been anecdotal evidence — including from China — that the drug helps patients clear the virus sooner.
But Dr. Anthony Fauci of the National Institutes of Health, asked recently whether the drug was considered a treatment for the novel coronavirus, said, “The answer is no … The evidence that you’re talking about … is anecdotal evidence.”
Meanwhile, Northwell Health facilities — including Lenox Hill, Long Island Jewish and Staten Island University hospitals — and Maimonides Medical Center are giving moderately to seriously ill coronavirus patients certain antiviral drugs such as Sarilumab, an IL-6 inhibitor, and Remdesivir, a drug that incorporates itself into the genome.
Northwell has recruited 143 patients for a Sarilumab trial.
Mount Sinai’s-Icahn School of Medicine also is one of 34 institutions nationwide participating in the National COVID-19 Convalescent Plasma Project. The program seeks blood-plasma donations from recovered coronavirus patients that contain antibodies that can be used to fight the virus in seriously ill patients.
https://nypost.com/2020/04/05/ny-coronavirus-patients-being-treated-with-anti-malarial-drug/

Lilly Offering $35 Insulin Co-Pays During Pandemic

Eli Lilly & Co. Tuesday unveiled a program offering $35 co-pays for its key insulin products during the coronavirus crisis.
The Indianapolis drug maker said the Lilly Insulin Value Program allows anyone with commercial insurance and those without insurance to fill their monthly prescriptions for $35.
Eli Lilly said the program covers most of its insulins, including all Humalog formulations.
The company in early March said it doesn’t expect any shortages of its insulin products during the pandemic.

https://www.marketscreener.com/ELI-LILLY-AND-COMPANY-13401/news/Eli-Lilly-and-Offering-35-Insulin-Co-Pays-During-Pandemic-30376571/