CDC is now 'monitoring' XBB Covid variant deemed 'most vaccine resistant'

 US health chiefs are 'monitoring' a new Covid variant that is feared to be the 'most vaccine-resistant yet' after it sent cases spiraling in Singapore.

The Centers for Disease Control and Prevention (CDC) said the strain — dubbed 'XBB' — was still 'very rare' in the US with just 52 cases detected in 15 states to date.

But in a variant update today they confirmed they were keeping 'a close eye' on it after Singapore's cases doubled in a fortnight.

Health chiefs are also tracking the BQ.1 and BQ.1.1, which they said was spreading 'relatively quickly' on American soil. 

They now account for one in five infections, double the level a week ago.

XBB is another spin-off of the Omicron variant and has been blamed for Singapore's sudden surge in infections.

The alarm has been sounded by experts including Dr Raj Rajnarayanan at the New York Institute of Technology who said it was the 'most immune evasive yet'.

But there is no evidence that it is more likely to cause severe disease or death compared to its parent or sister strains — which have all proven to be mild for most.

Nearly three people are dying in Singapore from Covid every day on average, figures show.

While in the past there have been just one or two dominant global variants, the virus now appears to have splintered into a swarm of closely-related subvariants.

Just last month scientists were worried about BA.2.75, which took off in South Asia. In the US, there were concerns over strain BA.5 which is now dominant.

Shown above are the American states that have picked up variant XBB, which is a merger of two Omicron subvariants

The above graph shows the infection rate in Singapore per million people. It is now showing early signs of peaking after spiraling with the emergence of the XBB variant

It is currently recording three deaths from Covid a day. There is no evidence to date that XBB causes more severe disease or raises the risk of death from Covid

The above graph shows the proportion of cases in Singapore by variants. It reveals that XBB (red) has been surging in the country

The above shows the proportion of variants in the United States for week. Officials are keeping an eye on BQ.1 (light green) which is now behind one in ten infections

This map shows the variant proportions across the United States. BQ.1 is represented by light green, while BQ.1.1 is the darker green

XBB arrived in America on September 15, data shows, and has now been detected in 15 states.

Most cases are in New York with 22 infections to date and California where it has been detected ten times.

But it has also been registered in New Jersey, Washington, Hawaii, Michigan, Arizona, Arkansas, Minnesota, Nebraska, New Mexico, North Carolina, Ohio, Texas and Virginia.

Limited testing for Covid — currently at its lowest level since the pandemic began — and variant monitoring means this is likely an undercount of the true scale of infections.

Revealing it was keeping an eye on XBB today, the CDC said: 'CDC is also keeping a close eye on a sublineage called XBB based on international reports.

'[But] it's still very rare in the United States.'

On a separate variant, they added: 'BQ.1 and BQ.1.1 are offshoots — grandchildren, if you will — of the BA.5 that's been dominant for months.

'CDC data shows they seem to be spreading relatively quickly, but they're still a small proportion of overall variants.'

The World Health Organization (WHO) also revealed it was monitoring the XBB variant this week. 

XBB has accumulated mutations in its receptor binding domand, a key part of the spike protein where virus-fighting antibodies dock and block infections.

Changes to this spot make the virus less recognizable to the immune systems of people who are vaccinated or have been infected with Covid previously. 

Singaporean scientists estimate it is 30 per cent milder than the previously dominant BA.5 Omicron strain.

'XBB' is formed of two variants scientifically named BJ.1 and BA.2.75 which have merged.

It was first detected in India back in August, authorities said, but did not spark a wave until now.

Covid variants can merge — in a process scientifically known as recombination — if they infect the same cell in the same person at the same time, and then swap genes.

There have been several recombinant variants already — such as 'Delta-plus' last year — but none have led to a major surge in infections.

Instead, most quickly die out because the merger has left them less infectious than their rivals.

But XBB appears to be the most successful yet, and is behind 54 per cent of infections in Singapore, up from 22 per cent a week ago.

One possible cause for concern is that Singapore's reinfection rate has risen dramatically since the arrival of XBB — from five to 17.5 per cent of all cases.

It is not clear yet if this is simply due to waning vaccine protection.

There are now early signs that this is starting to peak, however, much earlier than the mid-November expected in Singapore. 

Dr Rajnarayanan is tallying cases of the XBB variant in the United States using data from GISAID which is the top platform for monitoring variants.

He told DailyMail.com today: 'XBB is the most immune evasive variant yet... that's why we're worried about it.

'XBB can pick up additional convergent mutations and get fitter.' 

It comes as America struggles to turbo-charge its winter vaccination drive despite warnings of another Covid wave.

The US is currently rolling out a bivalent vaccine to all over-5s, which is designed to protect against Covid variants BA.5 and BA.5.

It is unclear whether it will also protect against XBB, although scientists say it will still help to refresh people's immunity.

Just six per cent of people who are eligible have come forward so far, a month after the program started.

Last week eligibility was expanded from over-12s to over-5s, with American health chiefs saying they should also get jabs.

But the move goes against that in other nations which are quietly raising the age limit for their Covid jabs amid concerns over side-effects like heart inflammation and limited evidence that it will benefit children

https://www.dailymail.co.uk/health/article-11342131/CDC-monitoring-XBB-Covid-variant-deemed-vaccine-resistant-strain-ever.html

Govt lab in Md plans to create hybrid monkeypox strain MORE deadly than one currently spreading in US

 

• NIAID research will see experts swap genes between two monkeypox strains
• They will attempt to make currently dominant clade more lethal and infect mice
• The aim of the project is to spur the development of better drugs for humans
• But it comes amid growing concern about virus manipulation research in labs
• DailyMail.com exposed last week how a hybrid Covid virus was made in Boston

A Government laboratory in Maryland plans to make the circulating monkeypox strain more lethal in highly controversial research in mice.

The team wants to equip the dominant clade - which mostly causes a rash and flu-like symptoms - with genes from another strain that causes severe disease.

They hope the experiment will reveal how different genes make monkeypox more deadly, and spur the development of better drugs and vaccines for humans.

It comes just a week after DailyMail.com revealed a similar experiment involving a hybrid Covid strain was conducted at Boston University. 

The latest monkeypox study is being funded by the National Institute of Allergy and Infectious Diseases (NIAID), a research arm of National Institutes of Health (NIH).

But the modified virus 'poses an exceptionally high risk' to the public if it accidentally leaks, according to Dr Richard Ebright, a microbiologist at Rutgers University in New Jersey.

The team in Maryland would argue their work does not involve 'enhancing' a pathogen because they are swapping natural mutations rather than creating new ones, meaning the hybrid cannot be more deadly than the existing clades.

But the news will no doubt surprise many Americans that such research continues to go on in the US despite fears similar practices may have started the pandemic. 

There have been more than 27,000 cases of monkeypox in the US since the current outbreak took hold earlier this year

The Maryland study will involve extracting dozens genes from the more severe clade 1 (pictured left) monkeypox virus and putting them into the less virulent clade 2 virus. They will then infect mice with the hybrid virus and monitor how the disease progresses

The Maryland team's work is being led by NIAID scientist Bernard Moss at the agency's headquarters in Bethesda  (shown)

The Maryland team's work is being led by NIAID scientist Bernard Moss at the agency's headquarters in Bethesda.

This phase of the study will involve extracting dozens genes from the more severe clade 1 monkeypox virus and putting them into the milder clade 2 virus.

They will then infect mice with the hybrid virus and monitor how the disease progresses. 

The team had initially attempted the reverse: swapping genetic materials in the less virulent clade into clade 1 to make it less deadly, but without success.

The current global outbreak is confirmed to be driven by clade 2, the less deadly West African monkeypox strain, which has a mortality rate of less than one percent.

Clade 1, meanwhile, kills one in 10 people it infects. It has its origins in the Democratic Republic of the Congo and primarily spreads in the Congo Basin. 

 Cases of monkeypox are in decline after peaking over the summer

The Maryland experiment was exempt from oversight when it was given the green light in 2018 because monkeypox did not meet the threshold for a 'potential pandemic pathogen'.

To be considered a PPP, the pathogen has to be widely transmissible with the potential of spreading uncontrollably and being highly dangerous. 

But at that time, monkeypox outbreaks were confined to Africa and the virus did not spread easily between people.

US cases could almost always be traced back to imported animals or travelers who had visited Central or Western African countries.

Now, with monkeypox widespread and more than 26,000 US cases, the National Institutes of Health (NIH) is planning to reexamine the work.

But the study still might not qualify as 'enhancing' a PPP, the agency says, because the team are using existing mutations.

Dr Ebright told DailyMail.com: 'A laboratory-generated monkeypox virus... more lethal than, and as transmissible as, the monkeypox virus currently circulating in humans potentially likely would defeat protection by vaccines and likely would spread beyond current at-risk populations to the general population.

'The risk-benefit ratio is essentially infinite, comprising potentially existential risks.'

Amid growing concern about such experiments, the NIH and the  Department of Health and Human Services met last month to devise recommended rule changes to the NIH's Potential Pandemic Pathogen Care and Oversight policy.

Among those proposed changes is an expansion of what constitutes a 'potential pandemic pathogen' to include those that are highly transmissible though less virulent, as well as those that are less transmissible but have more severe negative outcomes. 

The rule change, if adopted next year, would place stricter regulations on the kind of research on monkeypox viruses set to begin at NIH.

The latest controversy surrounding risky monkeypox research comes on the back of years of ferocious debate over gain of function research, which many believe resulted in the Covid pandemic.

The pandemic shed a light on the risky research practices, which the government has funded for decades with pushback, having temporarily paused in 2014 only to resume three years later.

High-profile debates about the merits of gain of function remain centered on the unproven theory that the coronavirus escaped from a lab in Wuhan, China.

It comes after DailyMail.com revealed that a team from Boston University had developed a hybrid Covid virus — combining the Omicron and original Wuhan strains — which had an 80 per cent lethality rate in mice.

Boston University has argued that their research was not gain of function, as the original wild strain killed 100 per cent of mice exposed to it, which they argue means their work actually reduced the lethality of the virus.

Researchers equipped the original Wuhan strain of Covid with Omicron's spike protein - the part which helps it invade cells and makes it more infectious. 

Some experts defended the work, claiming it could advance our understanding of Covid and how to treat and vaccinate against it, but critics warn the benefits did not outweigh the risk of a potential leak.

The hybrid strain was of immediate concern due to its combination of the worst attributes of the virus - Omicron's high rate of transmissibility and the original's high lethality.

https://www.dailymail.co.uk/health/article-11349241/Lab-Maryland-plans-create-hybrid-monkeypox-strain-contagious-lethal.html

New bivalent Covid vaccines DON'T give people better immunity, studies show

 The new bivalent Covid vaccines are no more effective than the original shots, according to two new studies.

Made by Moderna and Pfizer, the updated vaccines were advertised as being able to boost protection against Omicron subvariants that have become world-dominant.

The US Government spent $3.4billion in taxpayer money for 105million doses of the shots to help protect against the mild but highly transmissible strains this winter.  Britain has purchased at least 26million doses for an undisclosed fee.

But research by Harvard and Columbia University found 'essentially no difference' between the immunity gained from the old or new shots.

In both studies, people who had already been triple vaccinated were given either a standard Covid shot or an updated bivalent booster.

Blood samples were taken three to five weeks later and analyzed for antibodies and T-cells — immune molecules that fight off the virus. 

Dr David Ho, a microbiologist at Columbia University who led one of the studies, said: 'We see essentially no difference [between the shots].

'We can't say that a few months from now there won't be any difference... [but] at least at this time point, there's no discernible benefit.'

Uptake of the bivalent shots is sluggish in the US with less than 19.5million out of the 225million people who are eligible having come forward.

President Joe Biden got his updated booster yesterday — his fifth shot to date — in the latest White House effort to boost the numbers getting inoculated. 

The above graph shows antibody levels in people given the old vaccine (left) versus the bivalent (right). It shows there is virtually no difference in immunity triggered between the two. For the original booster levels of antibodies were boosted by 15 times compared to before shots, while for the updated one they were raised by 17 times. But scientists said this was not significant, meaning the difference could be down to chance

The updated Omicron shot works the same way as the original vaccines.

These vaccines see mRNA — the building block for proteins — injected into human cells.

It codes for cells to manufacture Covid spike proteins — which the virus uses to invade cells — triggering an immune response.

The old boosters shore-up protection against the Wuhan strain.

But the updated versions also aim to boost protection against BA.4 and BA.5 which have risen to prominence.

In the Columbia trial, scientists recruited 40 people who were already triple vaccinated against Covid.

Half were given a fourth dose of the original vaccine, while the other half received the updated booster shot. It was not clear whether it was from Pfizer or Moderna.

Blood samples showed antibody levels against the variants were 'slightly higher' in those who got the updated booster three to five weeks later.

But this was not significant, meaning the difference may be down to chance rather than one shot producing a stronger immune response.

In the Harvard trial, scientists looked over data from 33 people in Israel. 

Like in the other study half received the original booster but the other half got the bivalent Covid vaccine.

Blood tests showed that antibody levels rose 15-fold in about four weeks in those who got the original dose, but surged 17-fold in those who got the top-up.

The scientists also measured T-cell levels, but saw no change in their levels between the two groups.

Other areas of the immune system were not measured, however.

But the independent results are the first sign that the new vaccines may not be as effective as hoped.

Dr Dan Barouch, a virologist at Harvard who led the study, said: 'Unfortunately, neither one increased T-cell responses very much.

'We believe that T-cell responses in addition to antibody responses are important for protection against severe disease.'

Earlier this year Pfizer and Moderna claimed their updated shots sparked a larger immune response than the original Covid vaccines.

The Food and Drug Administration (FDA) later approved the shots based on data from mice and previous human trials using a slightly different booster shot.

At the time, little was known about how protective they might be in people.

It comes as the US urges people to get the updated booster vaccine with uptake languishing at 8.5 per cent more than a month into the roll out.

President Joe Biden got his fifth Covid shot yesterday and called on other Americans to also get the booster.

But it still lags behind with 19.4million of the 225million eligible over-5s coming forward.

https://www.dailymail.co.uk/health/article-11356647/New-bivalent-Covid-vaccines-DONT-people-better-immunity-studies-show.html

AcelRx: Non-Opioid Pain Agent Launched in Europe

 Physicians across Europe will now have access to DZUVEO®, a novel sublingual approach to acute pain management in medically supervised settings

AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX), (AcelRx), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings, today announced that its commercial partner, Laboratorie Aguettant ("Aguettant"), has launched DZUVEO® (sufentanil sublingual tablet, 30 mcg), which is branded as DSUVIA® in the U.S., across Europe.

Aguettant entered into a commercial collaboration with AcelRx in 2021 and has formally launched across key European countries, except Spain, Portugal and Italy, for which commercialization is expected to begin in the first half of 2023.  Physicians across Europe will now have access to DZUVEO, a sublingual alternative to standard intravenous (IV) opioid analgesics which have undesirable pharmacokinetic and pharmacodynamic performance profiles characterized by high peak plasma concentrations and the requirement for frequent redosing.  DSUVIA/DZUVEO was designed to provide rapid analgesia via a non-invasive route and to eliminate high peak plasma levels, provide longer duration of action, and avoid dosing errors associated with IV administration.  In addition, a number of recently published U.S. studies demonstrate that a sufentanil sublingual tablet, 30 mcg administered in various medically supervised settings can lower overall perioperative opioid use, as well as shorten recovery time, compared to IV opioids.

https://finance.yahoo.com/news/acelrx-pharmaceuticals-announces-european-launch-123000925.html

Clovis Presents Phase 3 Trial Data on Rubraca at Prostate Cancer Foundation Meet

 Clovis Oncology, Inc. (NASDAQ: CLVS) today announced the presentation of data from the TRITON3 Phase 3 trial in men with metastatic castration-resistant prostate cancer with BRCA or ATM mutations. The presentation titled, "TRITON3: A Phase 3 Study of Rucaparib vs. Physician’s Choice of Therapy in mCRPC Associated with Homologous Recombination Deficiency (HRD)" is being presented by Alan H. Bryce, MD, chair of the Division of Hematology and Medical Oncology at the Mayo Clinic and co-principal investigator of the TRITON3 trial during the session titled, "Novel Clinical Trial Updates" at the 29th Annual Prostate Cancer Foundation (PCF) Scientific Retreat.

The presentation is available at https://clovisoncology.com/pipeline/scientific-presentations/.

"We believe that the positive results from TRITON3 further demonstrate the important role that Rubraca may play as a treatment option for men with metastatic castration-resistant prostate cancer associated with homologous recombination deficiency. This is the first and only PARP inhibitor that has demonstrated superior radiographic PFS compared to a control arm containing docetaxel chemotherapy, which is today the standard of care for these patients," said Patrick J. Mahaffy, President and CEO of Clovis Oncology. "We look forward to submitting additional data for presentation during a medical meeting in 2023."

Earlier this month, the Company reported top-line data from the TRITON3 (NCT02975934) study evaluating Rubraca monotherapy versus chemotherapy or second-line second-generation androgen pathway inhibitor in patients with chemotherapy-naive mCRPC with mutations in BRCA or ATM achieved the primary endpoint of improved radiographic progression-free survival (rPFS) by independent radiology review (IRR).

https://finance.yahoo.com/news/clovis-oncology-presents-data-triton3-210500478.html

Contract labor costs to decline up to 50% in 2023, CHS says

 Labor costs were one of the prime reasons Community Health Systems reported a net loss of $42 million for the third quarter, but the Franklin, Tenn.-based hospital group remains optimistic about lowering some of those costs going forward.

Next year should see a 40 percent to 50 percent reduction in contract labor costs compared with 2022, President and CFO Kevin Hammons said on an investor conference call Oct. 27. That will build on a reduction from $240 million in the first half of the year to $100 million in the third quarter and a continued decline in the last three months of this year, he said.

"That should give us some meaningful lift," in terms of improved operating income, Mr. Hammons said of the continued reduction in contract labor costs.

Other areas of persistent focus on reducing costs include reducing the length of inpatient stays in the company's hospitals, particularly for non-COVID-19 cases and often with patients the hospital group is not getting reimbursed for, CEO Tim Hingtgen said. "We have been very, very vigilant in our efforts to control what we can control," he said.

Such a reduction in inpatient days also has an added advantage of freeing space for others in the community needing care, Mr. Hingtgen added.

CHS, which also reported a net loss of $369 million for the nine months ending Sept. 30, operates across 16 states with 81 acute care hospitals and more than 1,000 other clinical sites. The company reported positive net income for both the third quarter and first nine months of 2021.

https://www.beckershospitalreview.com/finance/contract-labor-costs-to-decline-up-to-50-in-2023-chs-says.html