Bristol Myers Squibb Gets FDA Acceptance of sBLA for Reblozyl

 Bristol Myers Squibb said the U.S. Food and Drug Administration has accepted for priority review its supplemental Biologics License Application for Reblozyl luspatercept-aamt for the treatment of anemia in adults with non-transfusion dependent beta thalassemia.

The company said the FDA has set a Prescription Drug User Fee Act goal date of March 27, 2022.

Bristol Myers also said the European Medicines Agency has validated the Type II variation for Reblozyl in NTD beta thalassemia. Reblozyl is being co-developed and co-commercialized with Merck & Co. Inc. following Merck's recent acquisition of Acceleron Pharma Inc.

These applications were based on safety and efficacy results from a Phase 2 study evaluating Reblozyl plus best supportive care in patients with NTD beta thalassemia.

https://www.marketscreener.com/quote/stock/BRISTOL-MYERS-SQUIBB-COMP-11877/news/Bristol-Myers-Squibb-Gets-FDA-Acceptance-of-sBLA-for-Reblozyl-37203136/

Pfizer and Moderna jabs give best overall boost: UK trial

 The Pfizer and Moderna vaccines being used in the UK as boosters give the best overall boost response, according to a UK trial of seven different jabs.

The trial is the first study of how well Covid booster jabs work and justifies the UK's early decision to use these two vaccines for boosters.

All the vaccines tested raised immunity against Covid to some degree.

Researchers said there were promising signs the boosters would still protect against illness and death from Omicron.

To make vaccine supplies go further, even a half dose of Pfizer could be used to boost populations, they added.

The trial results are thought to have prompted the UK to order an extra 114 million doses of Pfizer and Moderna vaccines to be rolled out over the next two years.

Boosters can cut the risk of infection by more than 93%. All adults aged over 18 in the UK are being offered a booster jab - usually either Pfizer or Moderna - while scientists find out more about the Omicron variant.

Earlier this week, the head of Pfizer said boosters against Covid could become an annual event.

In the study of nearly 3,000 adults - led by the University of Southampton and published in the Lancet - boosters were given about three months after second doses of AstraZeneca or Pfizer, which is the gap now recommended in the UK.

Out of seven different vaccines tested, all were found to be safe, and the side effects, including headache, fatigue.

All seven vaccines boosted immunity when given after two doses of Oxford-AstraZeneca, and six were effective following two doses of Pfizer - but some worked better than others.

Overall, the mRNA vaccines - Moderna and Pfizer - gave the best boost to antibodies and T-cells, which are known to be important factors in how well vaccines work, particularly after two initial doses of AZ.

The vaccines were equally effective in the over-70s and under-70s.

https://www.bbc.com/news/health-59489988

Bayer’s Nubeqa drug improves survival in prostate cancer trial

 Bayer said a combination therapy including its Nubeqa drug was shown to prolong the lives of men suffering from metastatic prostate cancer in a clinical study.

The drug, also known as darolutamide, improved overall survival in a combination with standard care when compared to standard care alone, which was the primary goal of the trial, the German company said in a statement on Friday.

Details of the trial would be presented at an as yet undisclosed medical conference, it added.

https://wtvbam.com/2021/12/03/bayers-nubeqa-drug-improves-survival-in-prostate-cancer-trial/

S.Africa's health body sees threefold higher risk of reinfection from Omicron

 The new Omicron variant of the coronavirus poses a threefold higher risk of reinfection than the currently dominant Delta variant and the Beta strain, a group of South African health bodies said on Thursday.

The South African Centre for Epidemiological Modelling and Analysis (SACEMA) and the National Institute of Communicable Diseases (NICD) said the latest findings "provide epidemiological evidence for Omicron's ability to evade immunity from prior infection".

Their statement was issued after a group of South African health organisations published a paper on medrxiv.org as a pre-print, meaning the work was not yet certified by peer review.

Earlier in the day, microbiologist Anne von Gottberg at NICD had echoed the same views at an online news conference hosted by the World Health Organization, saying South Africa was seeing an increase in COVID-19 reinfections due to Omicron.

South Africa had been seeing a sudden spike in daily reported cases of coronavirus with the government reporting 11,535 new infections on Thursday, up from 312 ten days ago.

The NICD, which alongside a wider network of health organisations does genome sequencing on samples, said on Wednesday the Omicron variant was able to get around some immunity and was fast becoming the dominant variant in the country.

An analysis of routine surveillance data from South Africa from March 2020 till Nov. 27 showed the "reinfection risk profile of Omicron is substantially higher than that associated with the Beta and Delta variants during the second and third waves," NICD said in the statement on Thursday.

An increase of reinfections rather than new infections would be an indication the new variant has developed the ability to evade natural immunity from previous infection, it said.

Juliet Pulliam, director of SACEMA and the author of the pre-print paper, said in her article that Omicron's pattern is likely to be established across all provinces of South Africa by early to mid-December, NICD said.

The analysis is based on 2,796,982 individuals with positive test results at least 90 days prior to Nov. 27, out of which 35,670 were suspected reinfections, it added.

https://sports.yahoo.com/1-africas-health-body-sees-184020034.html

China Easing Rules for US Business Travelers, Approvals in 10 Days

 China will cut to no more than 10 days the time required for approval of travel by U.S. business executives, its ambassador to the United States said on Thursday, promising to turn "an attentive ear" to concerns raised by businesses.

Qin Gang, who arrived in the United States in July, told a dinner hosted by the U.S.-China Business Council that Beijing would also work to make COVID-19 testing more convenient and allow executives to work during quarantine.

Qin said Beijing was adopting President Xi Jinping's direction on upgrading "fast track" travel arrangements, a response to U.S. concerns about resumption of business travel announced after Xi met U.S. President Joe Biden last month.

"With the upgraded arrangement, the time needed for travel approval will be shorter, no more than 10 working days," he said.

Qin said Beijing would share its specific workplan "very soon" with the U.S. Centers for Disease Control.

He said Beijing was committed to implementing the spirit of the recent virtual summit of Xi and Biden, and injecting "more positive energy into our relations."

Qin called for strengthened co-operation in manufacturing, financial services and the energy sector.

He also repeated Beijing's call for Washington to abolish additional tariffs imposed on Chinese goods by the administration of former President Donald Trump.

Marc Allen, chief strategy officer for Boeing Co, welcomed the announcement of fast-track travel, and a separate decision by China's aviation authority to issue an airworthiness directive on the Boeing 737 MAX, which will pave the way for the model's return to service in China after more than 2-1/2 years.

At the same gathering, U.S. Undersecretary of State for Economic Growth, Energy and the Environment Jose Fernandez repeated a litany of U.S. complaints about China’s business practices and stressed the need for a level playing field for U.S. companies.

He reiterated U.S. concerns about human rights, including alleged forced labor, in China's Xinjiang region and highlighted U.S. government warnings to business about the risks of operating in Hong Kong.

He told the business leaders operating in China they should keep in mind that they are "not bystanders in the broader economic and strategic relationship."

"Above all, please be mindful how your activities can affect U.S. national security and the fundamental values that we all hold dear," he said.

https://www.voanews.com/a/china-easing-rules-for-us-business-travelers-approvals-in-10-days/6337836.html

Nevada to make unvaccinated state workers pay insurance surcharge

 Nevada state workers and adult dependents who are covered under public employee benefits and remain unvaccinated will soon be hit with a surcharge of as much as $55 a month starting next July in an effort to alleviate COVID-19 testing costs, the Associated Press reported.

Beginning in July 2022, unvaccinated state employees and their dependents will have to pay a monthly fee as a result of Nevada’s Public Employees’ Benefit Program Board voting in favor of a surcharge on Thursday, according to the news outlet.

Weekly testing is mandated in Nevada workplaces, and it is estimated that for 2021 alone, over $6 million in COVID-19 claims will be filed by Nevada employees. 

Some organizations have imposed policies similar to the approved surcharge in an effort to compel employees to get the vaccine while underscoring how expensive it can be to remain unvaccinated within a community.

The largest health system in Louisiana said earlier this year that it would be charging $100 per pay period, or $200 monthly, to their workers if their partners or spouses that receive benefits through the employer remain unvaccinated.

“We spent more than $9 million on COVID care for those who are covered on our health plans over the last year. We know that COVID-19 vaccination dramatically reduces transmission, severity of symptoms, hospitalizations, and death. Approximately 90% of those hospitalized with COVID in our facilities have been unvaccinated since vaccines were approved in December 2020,” Ochsner Health President and CEO Warner Thomas said in a statement at the time, according to KLFY NEWS 10.

“Widespread vaccination is critical to stopping the spread of COVID-19, and we hope this change will encourage even more community members to get vaccinated,” he added.

The news comes amid a surge in COVID-19 cases and as the United States has now confirmed a handful of omicron variant cases, including in California, Hawaii, Colorado, New York and Minnesota. 

Health officials have pointed to the new variant while further pressing people to get vaccinated or get their boosters if they have not already done so and are eligible, saying that inoculating against the virus will be crucial to curbing its spread.

The Hill has reached out to the program for comment.

https://thehill.com/homenews/state-watch/584168-nevada-to-make-unvaccinated-state-workers-pay-insurance-surcharge

Okla. sues to exempt National Guard from Pentagon vaccine mandate

 The state of Oklahoma filed a federal lawsuit on Thursday seeking to stop the Biden administration from mandating coronavirus vaccines for the National Guard.

The complaint, which names President Biden and Defense Secretary Lloyd Austin as defendants, asks the court to declare the mandate unconstitutional and to enjoin the government from enforcing it or withholding funding from the Oklahoma National Guard or its members.

“This mandate ensures that many Oklahoma National Guard members will simply quit instead of getting a vaccine, a situation that will irreparably harm Oklahomans’ safety and security,” reads the complaint.

The lawsuit, filed by Oklahoma Gov. Kevin Stitt (R) and Attorney General John O’Connor (R) is the latest development in a sparring match between the Pentagon and the Oklahoma National Guard over the vaccine mandate.

Austin required vaccinations for the military in late August, but left it up to the military services to implement the mandate.

The deadline for Air National Guard and Air Force Reserve personnel to get vaccinated was Thursday, and the Army set a June 30 deadline for its reservists and guard members.

Stitt asked Austin in early November to exempt his state’s National Guard from the vaccine mandate. Shortly after, Stitt appointed a new commander of the Guard, Army Brig. Gen. Thomas Mancino, who wrote a memo stipulating that no member of the guard is required to get vaccinated.

At issue are two federal laws concerning who controls the National Guard.

Stitt argues that under Title 32 of the U.S. Code, he holds authority over his guardsmen unless they are activated for a federal mission.

But under Title 10, the president can mobilize the guard, which places them under federal authority.

Austin issued a memo on Tuesday ordering all National Guard and Reserve service members to be vaccinated, arguing that the Pentagon can enforce the mandate even when guardsmen are on state duty.

Austin further said that those who do not comply will be marked absent without cause from drills and training, which would impact the days service members accrue towards retirement. Service members can even face loss of pay.

In a statement, Stitt maintained that he was in control of the Guard under Title 32, and said it was “unconscionable” that the Biden administration is “choosing to play politics with military paychecks, especially amid the highest inflation rate in 30 years and so close to the holiday season." 

“Threatening the pay of National Guard members is manifestly unlawful and unfair, as unvaccinated active-duty personnel do not have their pay withheld,” he said. “I will continue fighting to protect Oklahoma against this alarming pattern of unconstitutional federal overreach coming from the Biden administration.” 

Thursday’s suit extends beyond the Pentagon mandate, asking the court to block the vaccine mandate for all federal employees as well. 

Biden announced that mandate in September, and the deadline to comply was Nov. 22. However, the federal employees who do not comply will not face serious penalties until January.

“The vaccine mandate on federal employees is unlawful, unconstitutional, and tyrannical,” reads the complaint. “This does not reflect the Land of the Free. The mandate’s enforcement should permanently be enjoined.”

The Hill has reached out to the White House and Pentagon for comment.

https://thehill.com/https%3A//thehill.com/policy/defense/584143-oklahoma-sues-to-stop-pentagon-vaccine-mandate-for-national-guard