WHO's EU Chief Admits COVID Isn't Going Anywhere

 Speaking in an interview with Spain's La Vanguardia newspaper, WHO's European Director Hans Kluge warned that the COVID pandemic, which has been raging for nearly two years now, won't end until nations "learn to live with the virus", and build health-care systems that are strong enough so that they are not overwhelmed by infections and deaths if newly infectious variants ever emerge.

Kluge warned that the international health body is not able to declare an end to the pandemic while there is still a risk that health systems may be unable to cope with a spike in case numbers. But the problem is, the likelihood that every health system in the world can verifiably achieve such goals is pretty close to nil.

"We have to learn to live with the virus. As soon as our health system is not overwhelmed by hospitalizations and deaths from Covid, that is, it can provide the services it provided before, the pandemic will possibly become an endemic," Kluge said.

The comments from the WHO's Europe boss come as he addresses concerns about the situation on the Continent ahead of what's expected to be a cold, dark winter.

Responding to a question about whether "Europe is once again the epicenter of the pandemic," Kluge flagged that the WHO is expecting "half a million deaths" from the virus before February. Kluge blamed a combination of "fake news" and the "relaxation of public health and social measures," for this projection. Kluge was clear that countries have to refute opposition to the COVID vaccine and safety protocols, and proposed a "working group in Europe" to challenge critics.

Despite these concerns Kluge said the situation would have been "very difficult" without the, so far, effective vaccine rollout. However, for vaccinations to be fully effective, Kluge stressed that countries must "leave no one behind" and focus on booster shots and inoculating children to maximize the coverage provided and to reduce the spread of the virus.

To be sure, Kluge's view on vaccinations - particularly when it comes to children - is far from indisputable science. In fact, anybody who's interested in learning more about the opposing view can attend a virtual debate being held by a top NIH scientist named Dr. Matthew Memoli.

https://www.zerohedge.com/covid-19/we-must-learn-live-it-whos-eu-chief-admits-covid-isnt-going-anywhere

U.S. Brokers J&J-COVAX Deal to Send Vaccines to Conflict Zones -Blinken

 Secretary of State Antony Blinken said on Wednesday the United States has brokered a deal between Johnson & Johnson and the COVAX vaccine-sharing program for the delivery of the company's COVID-19 vaccine to people living in conflict zones.

He announced the agreement at the opening of a virtual meeting of global foreign ministers convened by Washington on the COVID-19 pandemic.

"We need to ensure that people who cannot be reached by government vaccination campaigns aren't left out of our efforts. They need to be protected too," Blinken said.

A senior administration official said the deal means doses of J&J's vaccine can be distributed in conflict zones and other humanitarian settings by organizations other than governments, which have in the past been restricted by liability concerns.

Under the deal, 300,000 doses of J&J's single-shot vaccine would be made available to frontline humanitarian workers and UN peacekeepers, the official said.

Officials did not provide a total number of doses that would be delivered to conflict zones under the deal, when, or to which countries. J&J's vaccine has faced regulatory and manufacturing issues https://www.reuters.com/business/healthcare-pharmaceuticals/exclusive-tens-millions-jj-covid-19-shots-sit-baltimore-factory-sources-2021-10-28/?taid=617a805e066627000111ca57&utm_campaign=trueAnthem:+Trending+Content&utm_medium=trueAnthem&utm_source=twitter after contamination at a Baltimore factory halted U.S. production in April.

Blinken also announced a Global COVID Corps in which the private sector would help countries with supply chains and vaccines sites.

UNEQUAL ACCESS

The International Committee of the Red Cross (ICRC) welcomed the announcement, calling it "a positive step."

“In countries suffering from years of conflict – such as the Democratic Republic of Congo, South Sudan and Yemen – less than 2% of the population have been vaccinated against COVID-19," said Esperanza Martinez, head of the ICRC's COVID-19 crisis management team. "This shocking inequality must be rectified."

Wednesday's COVID-19 meeting follows a virtual summit of world leaders arranged by U.S. President Joe Biden on Sept. 22, when he pledged that Washington would buy 500 million more COVID-19 vaccine doses to donate to other countries.

Health experts say rich countries have not done enough in that regard and criticized the United States in particular for planning booster shots for fully vaccinated Americans while much of the world's population still has no access to vaccines.

They said planned U.S. dose donations are welcome but insufficient and noted that the Pfizer/BioNTech vaccine is difficult to administer in poorer countries, which lack sophisticated infrastructure for storing and shipping the shots.

Addressing the meeting, World Health Organization chief Tedros Adhanom Ghebreyesus called on foreign ministers to fully fund the Access to COVID-19 Tools Accelerator, which funds research and production of new medicines to fight the virus, and the African Union's vaccine fund.

"We ask those countries that have promised to donate vaccines to make good on those promises, as soon as possible," Tedros said. "We ask you to support local production of vaccines."

COVAX is co-led by the WHO, GAVI, and the Coalition for Epidemic Preparedness Innovations.

https://www.usnews.com/news/world/articles/2021-11-10/blinken-says-us-brokered-deal-between-j-j-and-covax-to-send-vaccines-to-conflict-zones

Viatris Believes Eylea Biosimilar Candidate Is First To Reach US FDA’s Desk

 Viatris provided several key updates for its biosimilar pipeline during the company’s Q3 earnings call, including for its biosimilar Eylea and Botox candidates, as well as disclosing another key early-stage asset.

https://generics.pharmaintelligence.informa.com/GB151399/Viatris-Believes-Eylea-Biosimilar-Candidate-Is-First-To-Reach-US-FDAs-Desk

First OTC COVID Test Recalled

 Ellume is recalling certain lots of its at-home COVID-19 antigen test due to a higher than acceptable false-positive rate, the FDA announced on Wednesday.

If a patient received a positive result from one of the affected lots in the past 2 weeks, they should follow up with a healthcare provider for a molecular diagnostic test to confirm the result, the agency added.

FDA initially granted emergency use authorization (EUA) to the Ellume test in December 2020, for which a patient performs their own nasal swab and a smartphone app interprets the results of their test. It was the first over-the-counter COVID-19 test authorized by the agency.

The recall affects more than 2 million testing devices, and has been designated as class I by the FDA -- the most serious type of recall. In explaining this, the agency enumerated several reasons why a false-positive test result might "cause serious adverse health consequences or death." The agency noted that there have been 35 reports of false-positive tests sent to FDA, but no associated deaths.

A false positive could lead to serious COVID-related and non-COVID-related consequences, such as delaying diagnosis of a non-COVID illness and side effects from unnecessary COVID treatment, including antivirals and monoclonal antibodies. They also warned of further spread of the virus due to misclassification of status (i.e., putting someone into a group with people who actually tested positive for COVID could lead to that person contracting the virus for real).

Interestingly, the agency seemed to take a swipe at the natural immunity argument, stating that a false-positive test could cause someone to "disregard ... the recommended precautions against COVID-19, including vaccination," implying that someone who falsely believes they have immunity might not get vaccinated.

The FDA also warned of "isolation" due to limited contact with family or friends and missing school or work because of a false-positive test.

The agency noted that these tests were distributed from April 13 to August 26 of this year.

Negative results with this test are still reliable, they added.

https://www.medpagetoday.com/infectiousdisease/covid19/95583

Ramsay Health Care's 1Q Earnings Drop 28% on Covid-19 Disruption

 Private hospital operator Ramsay Health Care Ltd. said quarterly earnings fell by 28% from a year earlier due to Covid-19 lockdowns in Australia and pandemic-related disruption in the U.K. and France.

Ramsay on Thursday said unaudited earnings before interest and tax for its fiscal first quarter, which ended on Sept. 30, fell to 197.4 million Australian dollars ($145.6 million).

It said operations in all Australian states incurred higher costs due to the pandemic, with Australia hit by elective surgery restrictions and disruption caused by isolation orders and lockdowns.

Ramsay said it had terminated fixed-rate loan facilities at a first-half cost of A$11.3 million, with subsequent savings through FY 2025 totaling A$20.2 million.

https://www.marketscreener.com/quote/stock/RAMSAY-HEALTH-CARE-LIMITE-6492228/news/Ramsay-Health-Care-s-1Q-Earnings-Drop-28-on-Covid-19-Disruptions-36978530/

10 states sue Biden administration over vaccine mandate for health care workers

 A coalition of 10 states, led by Missouri, has filed a lawsuit against the Biden administration's COVID-19 vaccine mandate imposed on health care workers, which they said was "unconstitutional and unlawful."

Missouri was joined in the suit by eight other states with GOP governors: Nebraska, Arkansas, Iowa, Wyoming, Alaska, South Dakota, North Dakota, and New Hampshire. Kansas, the 10th state, has a Democratic governor, Laura Kelly, but is a reliably Republican state in presidential elections.

"Unfortunately, with this latest mandate from the Biden Administration, last year’s healthcare heroes are turning into this year’s unemployed," Missouri Attorney General Eric Schmitt said in an official statement.

 

Schmitt added that requiring health care workers to get a vaccination or face termination is "unconstitutional and unlawful, and could exacerbate healthcare staffing shortages to the point of collapse, especially in Missouri’s rural areas."

 

He said that his office will continue to challenge what he called the Biden administration's "illegal edicts."

 

Workplace vaccination mandates are at the center of controversy around the country.

 

Calling the vaccine mandates an "unprecedented federal overreach,” Schmitt said they jeopardize the healthcare interests of rural Americans.

 

The lawsuit argues that the Centers for Medicare and Medicaid Services (CMS) mandate “imposes an unprecedented federal vaccine mandate on nearly every full-time employee, part-time employee, volunteer, and contractor working at a wide range of healthcare facilities receiving Medicaid or Medicaid funding.”

 

The 58-page filing further states that vaccination requirements are matters that depend on local factors and conditions. 

 

The filing also says that the CMS vaccine mandate threatens to "exacerbate an alarming shortage of healthcare workers, particularly in rural communities, that has already reached a boiling point." 

 

A Centers for Medicare and Medicaid Services spokesperson said in the statement to The Hill that “CMS does not comment on pending litigation.”

 

The suit, filed Wednesday in a Missouri federal court, follows similar lawsuits filed by Republican-led states against the Biden administration's vaccine mandate imposed for federal contractors and businesses with more than 100 employees.

 

An appeals court recently issued a ruling temporarily halting President Biden’s coronavirus vaccine mandate for businesses with 100 employees or more. 

https://thehill.com/policy/healthcare/state-issues/581015-10-states-sue-biden-administration-over-vaccine-mandate-for

Pennsylvania K-12 mask mandate rejected by state court

 A Pennsylvania court on Wednesday rejected a statewide mask mandate for K-12 schools and child care facilities, claiming that acting Health Secretary Alison Beam did not have the authority to issue the measure.

Judge Christine Fizzano Cannon wrote in the Commonwealth Court's decision that existing disease control law “does not provide the Acting Secretary with the blanket authority to create new rules and regulations out of whole cloth, provided they are related in some way to the control of disease or can otherwise be characterized as disease control measures.” 

The legislation “does not, on its own, provide the Acting Secretary with the authority to impose the Masking Order’s non-isolation, non-quarantine control measure of requiring all individuals to wear masks or face coverings inside Pennsylvania’s School Entities to combat reports of COVID-19,” Cannon, who is conservative, added.

In September, Pennsylvania Gov. Tom Wolf’s (D) administration announced that it would require students, staff and visitors in K-12 settings to wear masks as well as at child care facilities in an effort to combat the spread of COVID-19. 

On Monday, Wolf announced that starting on Jan. 17, schools would be allowed to end their mask mandates or modify them. 

Wolf’s press secretary, Elizabeth Rementer, said in a statement on Wednesday that the state planned on filing an appeal against the decision.

“The Secretary of Health's authority is clearly outlined in existing law.  An appeal has been filed. Filing of the appeal immediately stays the Commonwealth Court’s decision,” Rementer said.

However, several state Senate Republicans applauded the decision.

“Today’s ruling validates what we have said all along – mask decisions should be made by parents and school boards, NOT unelected bureaucrats. A blanket mandate does not address the unique needs and circumstances of individual communities, and it takes power away from the people who are in the best position to protect our kids,” Senate President Pro Tempore Jake Corman (R) and Senate Majority Leader Kim Ward (R) said in a joint statement on Wednesday.

Corman, along with state Rep. Jess Topper (R) and several others, had sued against the state’s mask mandate, according to The Associated Press. 

https://thehill.com/regulation/court-battles/581010-pennsylvania-k-12-mask-mandate-rejected-by-state-court