Covid-19 hospitalizations rising in South Africa’s omicron hot spot

 Covid-19 hospitalizations are rising rapidly in a populous South African province where the new omicron variant of the coronavirus has been detected. 

Hospitalizations across the country have increased by 63 percent since the beginning of the month, according to data from the country’s National Institute for Communicable Diseases. In Gauteng, a province that includes the country’s largest city, Johannesburg, hospitalizations are up by nearly 400 percent since the beginning of the month, from 120 for the week ending Nov. 6 to 580 for the week ending Saturday.

The South Africa diseases institute, part of the group of researchers and government institutions that first reported the variant to the World Health Organization, said in a statement that omicron cases were found in Gauteng at “a relatively high frequency.”

In a statement Sunday, the WHO cautioned against drawing conclusions about a link between the omicron variant and the increase in hospitalizations.

South Africa has vaccinated about 28 percent of its 60 million residents with at least one dose, according to data collected by the science publication Our World in Data. As a whole, African countries have vaccinated about 10 percent of their populations, compared to 64 percent in North America.

The WHO, which labeled omicron a “variant of concern” Friday, said Monday that it poses a “very high” risk to the world. In the wake of the news, multiple countries have issued bans on travel from southern African countries, which the WHO has criticized.

The variant was first detected in Botswana. Since then, it has been identified in Israel, Canada and other countries.

According to the data, hospitalizations have barely increased in any other of South Africa's nine provinces this month, with just two provinces posting increases in recent weeks.

There have been 29,373 cases and 219 deaths reported in South Africa in the previous seven days, according to an analysis of data from the Johns Hopkins Coronavirus Resource Center. Deaths have increased compared to the previous seven-day period, and cases are up, as well. Adjusted for population, South Africa’s recent case rate ranks it among the half of countries with the highest rates.

Since the start of the pandemic, South Africa has reported 2,963,679 cases and 89,822 deaths.

https://www.nbcnews.com/data-graphics/covid-19-hospitalizations-rising-south-africas-omicron-hot-spot-rcna6922

Regeneron says Covid antibody drug could be less effective against Omicron

 Regeneron Pharmaceuticals said on Tuesday prior analyses suggested its Covid-19 antibody cocktail, and similar drugs, could have reduced activity against the Omicron variant.

The drugmaker said the analyses of the individual mutations present in the Omicron variant indicate "that there may be reduced neutralization activity of both vaccine-induced and monoclonal antibody conveyed immunity."

Further analyses are ongoing, the company said, adding that there was no direct data testing Omicron’s resistance to immunity gained from vaccines and monoclonal antibodies.

The findings follow comments from Moderna’s chief executive officer, who said Covid-19 vaccines are unlikely to be as effective against the Omicron variant as they have been previously.

https://www.nbcnews.com/news/us-news/regeneron-says-covid-drug-less-effective-omicron-variant-rcna7039

Poorly-Controlled Asthma Tied to Worse COVID Outcomes in Kids

 Children with poorly-controlled asthma were at much greater risk for COVID-19 hospitalization, a retrospective study from Scotland found.

Among roughly 750,000 children ages 5 to 17, those with an asthma-related hospitalization in the 2 years before the pandemic -- a marker for uncontrolled asthma -- had a more than sixfold higher risk of being hospitalized for COVID-19 (adjusted hazard ratio [aHR] 6.40, 95% CI 3.27-12.53) compared to kids without asthma, reported Aziz Sheikh, MD, MBBS, of the University of Edinburgh in Scotland, and colleagues.

In contrast, well-controlled asthma -- marked by no asthma-related hospitalization before the pandemic -- was associated with only a modest risk increase (aHR 1.36, 95% CI 1.02-1.80), driven mostly by children ages 5 to 11 (aHR 2.05, 95% CI 1.35-3.12), according to their findings in Lancet Respiratory Medicine.

When using prescriptions to define uncontrolled asthma, a significantly higher risk for COVID-19 hospitalization was seen among kids with asthma who were prescribed two or more courses of oral corticosteroids in the past 2 years, as compared to kids without asthma:

• Two courses: aHR 3.53 (95% CI 1.87-6.67)
• Three or more courses: aHR 3.38 (95% CI 1.84-6.21)

"The key takeaway from this study is that keeping children's asthma under control is critical as this greatly reduces the risk of COVID-19 hospitalization," Sheikh said in a press release. "Understanding which children with asthma are at increased risk of serious COVID-19 outcomes is critical to ongoing policy deliberations on vaccine prioritization."

"As we enter the holiday season, this study reminds us the importance of influenza and COVID-19 vaccinations to protect all school-aged children, including those with underlying medical conditions like asthma, from vaccine-preventable hospitalizations," said Katherine Poehling, MD, of the Wake Forest School of Medicine in Winston-Salem, North Carolina, who was not involved in the study.

In an accompanying editorial, Rachel Harwood, PhD, and Ian Sinha, PhD, both of the University of Liverpool in England, called the increased COVID-19 hospitalization risk among the 5 to 11-year-olds with well-controlled asthma, as defined by the study, "particularly interesting."

"The study design results in the youngest of children not receiving corticosteroids or being admitted to hospital with asthma before entering the study due to the diagnostic criteria for asthma," they noted. "However, this might not reflect their subsequent asthma control during the study period and the data for this youngest group of children should be treated with caution."

For their study, Sheikh and colleagues evaluated data from the Early Pandemic Evaluation and Enhanced Surveillance of COVID-19 (EAVE II), which included 752,867 children ages 5-17, including 63,463 (8.4%) with asthma.

Among those with asthma, 6.8% tested positive for COVID-19 during the study period (March 1, 2020 to July 27, 2021), as compared to 5.8% of those without asthma. Rates of hospitalization for COVID-19 among those testing positive were 1.54% and 0.95%, respectively. Overall, nine children in the study were admitted to intensive care or died, too few to make comparisons between groups, the authors noted.

The main purpose of the study was to identify children with asthma at increased risk of serious COVID-19 outcomes. Follow-up occurred until patients were hospitalized with COVID-19, died, or by study completion. Analyses adjusted for demographics, comorbidities, and prior hospitalizations.

The study had several limitations, the researchers noted, including that the overall risk of COVID-19-related hospitalization was low in kids with poorly controlled asthma (one of every 380 kids).

Disclosures

This study was supported by the U.K. government.

Sheikh reported relationships with AstraZeneca and the Scottish Government's Standing Committee on Pandemics. Coauthors dislcosed relationships with the Scientific Pandemic Influenza Group on Modelling and the Scottish Government's Expert Reference group on Ethnicity and COVID-19.

Harwood reported receiving a KRUK fellowship.

Primary Source

The Lancet Respiratory Medicine

Source Reference: Shi T, et al "Risk of COVID-19 hospital admission among children aged 5-17 years with asthma in Scotland: a national incident cohort study" Lancet Resp Med 2021; DOI: 10.1016/S2213-2600(21)00491-4.

Secondary Source

The Lancet Respiratory Medicine

Source Reference: Harwood R, Sinha IP "Risk of COVID-19 hospital admission among children with asthma" Lancet Resp Med 2021: DOI:10.1016/S2213-2600(21)00509-9.

https://www.medpagetoday.com/allergyimmunology/allergy/95938

FDA advisers narrowly endorse Merck's COVID-19 antiviral pill

 An advisory group for the Food and Drug Administration (FDA) has voted to recommend Merck’s COVID-19 antiviral pill for infected adults at high risk for severe coronavirus illness, hospitalization or death.

The panel narrowly endorsed Merck’s five-day oral treatment in a 13-10 vote on Tuesday.

The advisers recommended the FDA authorize the pill, developed with Ridgeback Biotherapeutics, for adult patients enduring mild to moderate COVID-19 who face a higher risk of serious illness, including due to underlying health conditions. 

The drug manufacturer filed for an emergency use authorization last month after its study suggested molnupiravir reduced the risk of hospitalization by 50 percent. But updated data from Friday showed a 30 percent reduction in hospitalizations among more participants. 

The close vote came as experts considered concerns about the decreased risk reduction in Merck's updated data as well as the risks the drug could present for pregnant people. 

Several who backed the pill for high-risk infected adults pointed to the ongoing state of emergency amid COVID-19 and the limited treatments for the virus. 

"I see this as an incredibly difficult decision," the committee's chairperson, Lindsey Baden, said. "There are many, many more questions than answers."

"But I can see scenarios where there are benefits and therefore having this available for those scenarios makes sense to me," he added. 

Those who voted against the endorsement cited a "modest" effectiveness shown in the data.

Approval of these pills could expand accessibility of at-home COVID-19 treatments, pending FDA authorization and Centers for Disease Control and Prevention approval. The U.S. has already agreed to buy 3.1 million courses of the drug, with the option to purchase more.

Antiviral COVID-19 drugs have been considered a potential game changer in the pandemic since all current drugs require an injection or IV. Other pills are in development, including Paxlovid from Pfizer, which requested FDA authorization earlier this month. 

The vote comes after the FDA released its review of Merck’s data on the drug last week that concluded molnupiravir's effectiveness but raised concerns about its effects on pregnant people. 

Merck representatives recommended during the meeting that people who are pregnant or breastfeeding do not take the pills due to potential risks, including possible toxicity and birth defects. 

The pharmaceutical company suggested women of childbearing age use contraception while receiving molnupiravir. Merck plans to launch a pregnancy surveillance program to further track the drug’s effects on pregnant people. 

Several advisers supported a warning for pregnant people not to take the drug, and some suggested requiring pregnancy testing for patients before they receive the drug.  

Merck is also not currently seeking authorization for the pill to be administered to children.  

Some experts expressed worries that the drug, which inserts small errors into the virus’s genetic code to prevent replication, could spark the virus to mutate into more dangerous strains, although the FDA considers the issue a “theoretical” concern.

Merck’s pill would not function as a preventative treatment, as it would be administered to already infected individuals to avoid worse outcomes. 

The treatment is not designed to replace vaccinations, as COVID-19 vaccines would still be needed to stop infection in the first place. Merck did not study the drug’s effects among vaccinated people. 

The advisers’ decision also comes as anxiety has mounted over the World Health Organization’s most recent variant of concern: the omicron strain.

A Merck representative told the FDA in the meeting that the company has not tested molnupiravir against the omicron variant, but they expect the pill to remain effective against the strain.

https://thehill.com/policy/healthcare/583618-fda-advisers-endorse-mercks-covid-19-antiviral-pill

CDC expands surveillance at 4 big U.S. airports to detect omicron

 The Centers for Disease Control and Prevention (CDC) is expanding its current COVID-19 variant surveillance program at several major U.S. airports in an effort to detect the new omicron variant. 

CDC Director Rochelle Walensky on Tuesday said the agency is ramping up testing and surveillance in collaboration with XpresCheck, a testing service at airport terminals, at four key international airports around the country, including those that have direct flights to and from South Africa, where the variant was first discovered. 

“As we have done throughout the pandemic, CDC is evaluating how to make international travel as safe as possible, including pre-departure testing closer to the time of flight, and considerations around additional post-arrival testing and self-quarantine,” Walensky said during a White House COVID-19 briefing. 

“Currently, CDC is expanding a surveillance program with XpresCheck to JFK, San Francisco, Newark and Atlanta airports, four of the busiest international airports in the country,” Walensky said. 

“This program allows for increased Covid testing for specific international arrivals, increasing our capacity to identify those with COVID-19 on arrival to the United States, and enhancing our surveillance for the omicron variant,” she added. 

The program will test passengers entering the U.S. traveling from southern Africa, including those making connections through Europe, XpresCheck said in a release. 

Walensky said the agency is also working with airlines to collect passenger information that can be used to ramp up contact tracing efforts. 

The effort is an expansion of a biosurveillance program that started in September that provided testing for travelers from India at JFK, Newark and San Francisco airports. 

The Biden administration imposed travel restrictions from South Africa and seven other African countries in an effort to control the spread of the new omicron variant. 

The new travel restrictions do not apply to American citizens and lawful permanent residents, though they must show proof of a negative test prior to traveling to the U.S.

https://thehill.com/changing-america/well-being/583684-cdc-expanding-surveillance-at-four-large-us-airports-to-detect

New court rulings halt Biden vaccine mandate for fed contractors, health workers

 A pair of rulings by separate federal judges Tuesday temporarily halted parts of the Biden administration’s mandatory COVID-19 vaccine policy for certain workers.

One ruling, issued by a Louisiana-based federal judge, effectively blocked a vaccine mandate for health workers across the country at hospitals that receive federal funding. 

A second ruling, by a Kentucky-based federal judge, paused the administration's vaccine mandate for federal contractors in Kentucky, Ohio and Tennessee.

The developments are just the latest in a string of legal setbacks for President Biden as his administration seeks to blunt the effects of a global pandemic that has already killed more than 750,000 people in the U.S. 

The ruling from the Louisiana-based judge dovetails with a Monday decision by yet another federal judge, based in Missouri, who on Monday blocked the mandate for health workers in 10 states. Tuesday’s ruling effectively extended that order nationwide.

The Republican attorney general of West Virginia, one of the state plaintiffs in the latest case, celebrated the temporary win. 

“We are pleased that the court made a sensible decision and sided with individual freedoms for health care workers,” West Virginia attorney general Patrick Morrisey said in a statement. “Our group has successfully stopped this mandate from taking effect for the time being, and we believe the mandate will be struck down permanently moving forward.”

https://thehill.com/regulation/court-battles/583694-new-court-rulings-halt-biden-vaccine-mandate-for-federal-contractors

Why Deciphera Pharmaceuticals Shot 12% Higher

 On a bad day for the stock market overall, Deciphera Pharmaceuticals (NASDAQ:DCPH) was quite the happy standout. Shares of the biotech closed more than 12% higher on Tuesday thanks to the launch of a new company initiative.

Deciphera is in restructuring mode, with the aim being "to prioritize clinical development of select programs, streamline commercial operations, maintain a focus on discovery research, and extend the company's cash runway," as it wrote in a statement.

Meanwhile, Deciphera said it would "streamline" the commercial development of stomach cancer treatment Qinlock on the U.S. market to boost commercialization on certain European markets. The company added that this should reduce operating expenses and extend its cash runway into 2024. 

As is typical in restructuring programs, the company's workforce is going to be affected. Deciphera said that it will reduce its headcount by around 35% in total, meaning roughly 140 workers. 

At the end of September, Deciphera had nearly $53.2 million in cash on its books, down considerably from the year-ago level of over $111 million.

With these moves, Deciphera said it is now prioritizing two pipeline programs, that for tenosynovial giant cell tumor treatment vimseltinib, and DCC-3116, which targets autophagy (a survival mechanism utilized by cancer cells).

All told, the company said its restructuring moves will result in an approximately $32 million cash charge in the fourth quarter.

https://www.fool.com/investing/2021/11/30/why-deciphera-pharmaceuticals-shot-12-higher-today/