Mexico returns to CDC’s highest-level COVID warning

 The Centers for Disease Control and Prevention (CDC) has updated its travel warning for Mexico, saying the country now is a Level 3 for a high rate of coronavirus cases.

In an update on Monday, the health agency said the level of COVID-19 in Mexico was being upgraded from Level 2 (moderate) to Level 3 (high). 

People who go to Mexico, it said, should be vaccinated, and those who are not should avoid travel to the country.

“If you are not up to date with your COVID-19 vaccines, avoid travel to Mexico,” the health agency said in its advisory. “Even if you are up to date with your COVID-19 vaccines, you may still be at risk for getting and spreading COVID-19.” 

Mexico is one of seven countries within the last week that the CDC has issued new warnings about.

New Caledonia, United Arab Emirates, Guyana, Mongolia, Namibia, and Saint Kitts and Nevis have also been placed in a Level 3 advisory, meaning that the virus spread in the country is at a high level. 

As of June 13, there are 113 countries and islands currently on the health agency’s Level 3 advisory. 

https://thehill.com/policy/healthcare/3522065-mexico-returns-to-cdcs-highest-level-covid-warning/

US Seeks To Expand Monkeypox Testing As Narrative Keeps On Rolling

 The Biden administration is working to expand monkeypox testing capabilities beyond a narrow group of public health labs, as infectious disease experts are now suggesting that testing for the virus needs to become part of routine care.

As the Epoch Times notes, Centers for Disease Control and Prevention (CDC) Director Dr. Rochelle Walensky said during a conference call on Friday that her agency is working with the Food and Drug Administration (FDA) and Centers for Medicare and Medicaid Services (CMS) to expand testing capacity to include commercial laboratories.

At present, monkeypox testing is done through a network of 69 public health laboratories, which send results to the CDC for confirmation.

So far, there have been 50 confirmed cases in the US across 16 states, while roughly 300 monkeypox tests have been administered.

"There is not enough testing going on now for monkeypox in the United States," said Dr. Tom Inglesby, director of the Johns Hopkins Center for Health Security. "The commercial labs are used to working with healthcare providers from across the country, moving samples around quickly, reporting results quickly in a way that providers understand and expect."

Meanwhile, as Off-Guardian notes, Monkeypox hysteria continues - with The Atlantic publishing a recent piece suggesting that Monkeypox "Could be nothing," or "Could Be the Next Syphilis."

Nature asks, "can the global outbreaks be contained?"

That said, there has been some pushback to the 'dire' sounding headlines - with the CDC declaring that it was "very unlikely" Monkeypox is airborne (in response to a NYT article claiming it can become so), and the Washington Post noting that "Number of monkeypox cases grows, but U.S. officials say overall risk is low."

And despite monkeypox's relatively low transmission rate, as we noted on Sunday, the Biden administration has ordered 500,000 more doses of monkeypox vaccine.

Denmark-based biotech group Bavarian Nordic, the manufacturer of the vaccines, said that the U.S. Biomedical Advanced Research and Development Authority (BARDA) has placed the order, to be delivered later this year.

“With the previous order from BARDA for 1.4 million doses of liquid-frozen JYNNEOS, awarded in 2020, this order will bring the total U.S. inventory of the vaccine to nearly 2 million doses,” the company announced on Friday. Many of the 1.9 million doses are being held by the company until the U.S. government requests them.

The 500,000 vaccine doses will be manufactured using bulk materials that are owned by the United States under previous contracts with BARDA, and are currently stored with the company.

“The majority of this bulk, however, will be converted to approximately 13 million freeze-dried doses of JYNNEOS during 2023-2025,” Barvarian Nordic said.

https://www.zerohedge.com/medical/us-seeks-expand-monkeypox-testing-narrative-keeps-rolling

China Flips Out After WHO Says Lab-Leak Theory Needs Further Study

 China is fuming after a Thursday report by the World Health Organization concluded that while Covid-19 is likely from animals, further study is required to explain how it jumped to humans - including the possibility of a lab-leak.

An expert panel convened by the WHO's scientific advisory group recommended "further investigations" into the lab-leak theory, and noted that there "has not been any new data made available" to come to any conclusions.

The recommendation is a sharp departure from the agency's initial report, which ruled that a lab origin was "extremely unlikely."

"All hypotheses must remain on the table until we have evidence that enables us to rule certain hypotheses in or out," said WHO director-general Tedros Adhanom Ghebreyesus at a June 9 press conference. "This make[s] it all the more urgent that this scientific work be kept separate from politics."

As the Epoch Times notes, the report stated in a footnote that three panel members from Russia, Brazil, and China objected to the recommendations, saying there is “no scientific evidence” to question the commission’s previous conclusion from March 2021.

The report was written by a team, named the Scientific Advisory Group for the Origins of Novel Pathogens (SAGO), which was tasked with advising the WHO on investigations into pathogens that might trigger the next pandemic, as well as studying the origins of the current pandemic.

The 27-member group was established last autumn following criticism from a dozen countries that raised concerns about WTO’s COVID-19 origins study, due to a lack of transparency and access to crucial data from China.

Key Data Missing

The 52-page preliminary report said “key pieces of data” are still missing to determine how the COVID-19 pandemic began.

The group said current data suggested a zoonotic origin of the novel coronavirus. The closest genetically-related virus was beta coronaviruses identified in bats in China and Laos, it added.

“However, so far neither the virus progenitors nor the natural/intermediate hosts or spill-over event to humans have been identified,” it stated.

The scientific advisory group believes the Huanan seafood market in Wuhan, where the first infections were recorded in China, “played an important role early in the amplification of the pandemic.” The team called for further studies into information such as environmental and animal samples taken from the market.

In the summer of 2021, the Office of the Director of National Intelligence assessed that one US intelligence agency determined with "moderate confidence" that the virus most likely emerged from a Chinese government lab in Wuhan.

China is pissed

As the Washington Examiner notes, Chinese officials slammed the report - with Foreign Ministry spokesman Zhao Lijian saying on Friday that the theory was nothing more than a politically motivated lie driven by "anti-China" sentiments.

"The lab leak theory is totally a lie concocted by anti-China forces for political purposes, which has nothing to do with science," he said, adding "We always supported and participated in science-based global virus tracing, but we firmly opposed any forms of political manipulation."

Zhao then suggested that the virus actually originated in a US military lab, citing "highly suspicious laboratories such as Fort Detrick."

Jamie Metzl, who sits on an unrelated WHO advisory group, has suggested that the Group of Seven industrialized nations set up their own COVID-19 origins probe, saying WHO lacks the political authority, expertise, and independence to conduct such a critical evaluation.

Metzl welcomed WHO’s call for a further investigation into the lab leak possibility but said it was insufficient.

“Tragically, the Chinese government is still refusing to share essential raw data and will not allow the necessary, full audit of the Wuhan labs,” he told The Associated Press. “Gaining access to this information is critical to both understanding how this pandemic began and preventing future pandemics.”

In Washington, a Republican-led subcommittee in the House of Representatives on the COVID-19 pandemic wrote in a tweet: “Americans were smeared as ‘conspiracy theorists’ for asking whether #COVID19 came from a lab leak. Now, the WHO is asking the same questions.”

“WE NEED ANSWERS,” added the committee, which is headed by Rep. Steve Scalise of Louisiana.

https://www.zerohedge.com/covid-19/china-flips-out-after-who-says-lab-leak-theory-needs-further-study

US manufacturers pledge to address tampon shortage

 Major tampon manufacturers in the United States have pledged to make more of the sanitary products to address shortages in the country.

One firm told the BBC the pandemic had caused staff shortages at its plants.

It comes as the war in Ukraine is making the raw materials used in sanitary products more costly.

The shortage is also adding to concerns that supply chain disruptions could further push up prices for essential goods around the world.

A spokesperson for Edgewell Personal Care, which makes Playtex and o.b. tampons, said that its stocks have been "impacted due to extensive workforce shortages caused by two separate Omicron surges in the US and Canada in late 2021 and early 2022, respectively".

"We have been operating our manufacturing facilities around the clock to build back inventory and anticipate returning to normal levels in the coming weeks," the spokesperson added.

Meanwhile, Procter & Gamble (P&G), the maker of the Tampax tampon brand, said in a statement that it was "working hard to ramp up production".

"We can assure you this is a temporary situation," said the company, which sells around 4.5bn boxes of tampons globally each year.

P&G's chief financial officer, Andre Schulten, said at a recent earnings call that it has been "costly and highly volatile" to acquire raw materials such as cotton and plastic for tampons.

"It is so important at this point for people to buy only what they need. I am not a supply chain expert but we know that some of the shortages we all experienced early in the pandemic were due to hoarding," Elise Joy, the co-founder and executive director of US charity Girls Helping Girls Period, said.

"Menstrual products are not a luxury item, and if we all take or buy what we need it will go a long way to making sure more people can get basic supplies," she added.

Social media users have been posting about their experiences as they struggle to find sanitary products.

One Reddit user said they had visited eight stores to find tampons with a cardboard applicator, before deciding to buy them online "at a noticeable mark-up".

A spokesperson for the US pharmacy chain Walgreens told the BBC that it was "experiencing some temporary brand-specific tampon shortage in certain geographies".

"While we will continue to have products at shelf and online, it may only be in specific brands while we navigate the supply disruption," the spokesperson added.

https://www.bbc.com/news/business-61793198

ResMed Nears Deal for Hg-Backed Software Provider MediFox

 ResMed Inc., a publicly traded medical equipment provider, is in advanced talks to buy MediFox Dan Holding GmbH, a German health software company owned by private equity firm Hg, according to people familiar with the matter.

ResMed, based in San Diego, could announce a deal for MediFox in the coming days, the people said, asking not to be identified because the matter is private.

https://www.userwalls.news/n/resmed-nears-deal-hg-backed-software-provider-medifox-3360351/

Rapid test to measure immunity to COVID-19

  Mount Sinai researchers have developed a rapid blood assay that measures the magnitude and duration of someone’s immunity to SARS-CoV-2, the virus that causes COVID-19. This test will allow large-scale monitoring of the population’s immunity and the effectiveness of current vaccines to help design revaccination strategies for vulnerable immunosuppressed individuals, according to a study published in Nature Biotechnology in June.

The test takes less than 24 hours to perform and is scalable to use broadly in the population. It measures the activation of T cells, which are part of our adaptive immune response to SARS-CoV-2 infection or vaccination and help protect against severe disease outcomes or death.

“The assay we have created has the ability to measure the population’s cellular immunity and broadly test the efficacy of novel vaccines,” said one of the study’s senior authors, Ernesto Guccione, PhD, Professor of Oncological Sciences, and Pharmacological Sciences, at The Tisch Cancer Institute at Mount Sinai. “We know that vulnerable populations don’t always mount an antibody response, so measuring T cell activation is critical to assess the full extent of a person’s immunity. Additionally, the emergence of SARS-CoV-2 variants like Omicron, which evade most of the neutralizing ability of antibodies, points to the need for assays that can measure T cells, which are more effective against emerging variants of concern.”

Long-term protection from viral infection is mediated by both antibodies and T cell response. Many recent studies point to the importance of determining T cell function in individuals who have recovered from or been vaccinated against COVID-19 to help design vaccination campaigns. However, before this study, measurement of T cell responses has been rarely performed because of the associated technical challenges.

In conducting this study, Mount Sinai researchers and partners at Duke-NUS Medical School optimized qPCR-based assays that had the potential to be globally scalable, sensitive, and accurate tests. Researchers narrowed their focus to the two assays that offered the most scalability. One, the qTACT assay, was accurate and sensitive but had a relatively longer processing time of 24 hours per 200 blood samples, a moderate price, and a medium level of technical skill. The other, the dqTACT assay, was accurate and had a reduced processing time and cost, and required minimal lab experience, making it easy to implement.

The dqTACT assay has recently been granted the European CE-IVD (in vitro diagnostics) certification, while U.S. Food and Drug Administration and European Medicines Agency clinical validation is ongoing.

“The assays presented here are based on the ability of SARS-CoV-2 T cells to respond to peptides covering different proteins of the virus,” said another senior author, Jordi Ochando, PhD, Assistant Professor of Oncological Sciences at the Tisch Cancer Institute at Mount Sinai and Assistant Professor of Medicine (Nephrology), and Pathology, Molecular, and Cell-Based Medicine at the Icahn School of Medicine at Mount Sinai. “With the possibility of using different peptide pools, our approach represents a flexible strategy that can be easily implemented to detect the presence of T cells responding to different viral proteins. These T cells have an important role in protection from emerging mutant strains, thus immediately gauging the impact that viral mutations might have on cellular immunity.”

Megan Schwarz, a graduate student at Icahn Mount Sinai and first author of the study, added, “Precise measurement of cellular responses underlying virus protection represents a crucial parameter of our levels of immune defense.”

This new study was conducted using laboratory diagnostic services of Synlab and Hyris SystemTM, Hyris' signature qPCR technology.

https://www.eurekalert.org/news-releases/955509

New way of generating insulin-producing cells

 Researchers at Karolinska Institutet in Sweden show how a molecule that they have identified stimulates the formation of new insulin-producing cells in zebrafish and mammalian tissue, through a newly described mechanism for regulating protein synthesis. The results are published in Nature Chemical Biology.

"Our findings indicate a new potential target for treating diabetes, in that we demonstrate a possible way of stimulating the formation of new insulin-producing cells," says the study's last author Olov Andersson, senior researcher at the Department of Cell and Molecular Biology at Karolinska Institutet.

Both type 1 and type 2 diabetes are characterised by raised levels of blood sugar, the result of low levels of endogenous insulin, the hormone needed for glucose uptake from the blood, or a physiological inability to utilise the insulin secreted -- or both.

Insulin injections and glucose-lowering drugs can control the disease, but not cure it.

Regeneration of pancreatic β cells

"One alternative could be a treatment that regulates blood glucose by increasing the number of insulin-producing pancreatic β cells, so we're researching the possible regeneration of these cells," says the study's first author Christos Karampelias, former doctoral student at the Department of Cell and Molecular Biology at Karolinska Institutet.

The team from Karolinska Institutet has previously identified a small molecule able to stimulate the regeneration of insulin-producing β cells. This they did by analysing a large quantity of substances in a zebrafish model.

In this present study, they examined the molecular mechanism of this stimulation.

By analysing a large number of molecular interactions in yeast cells, the researchers show that their molecule binds to a protein called MNK2. Subsequent studies of zebrafish and cell cultures indicate that the molecule operates by regulating the translation of mRNA and boosting the synthesis of proteins, without which the formation of new β cells cannot be increased. Zebrafish given the molecule also showed lower levels of blood glucose than controls.

The study also shows that the molecule can induce the formation of new pancreatic β cells from pigs and stimulate the expression of insulin in human organoids (organ-like cell formations).

Studies of human tissue

"We'll now be studying the effect of this and similar molecules in human tissue and analysing the molecule's target protein, MNK2, in tissue from healthy donors and donors with diabetes," says Dr Andersson.

The studied molecule was found through studies on zebrafish, providing a valuable model for testing a large number of potential diabetes drug candidates. Since the fish embryo is transparent, its development is easy to monitor with a microscope. Zebrafish larvae also have only one cluster of β cells, a so-called islet of Langerhans, which facilitates studies of how new β cells are formed after the population have been decreased in a way that mimics the onset of type 1 diabetes.

The study was financed by the European Research Council, the Swedish Research Council, the Ragnar Söderberg Foundation, the Novo Nordisk Foundation, the Strategic Research Programme in Diabetes (SRP Diabetes) and the Strategic Research Area in Stem Cell Research and Regenerative Medicine (StratRegen) at Karolinska Institutet.

---

Story Source:

Materials provided by Karolinska Institutet. Note: Content may be edited for style and length.

---

Journal Reference:

1. Christos Karampelias, Kathleen Watt, Charlotte L. Mattsson, Ángel Fernández Ruiz, Habib Rezanejad, Jiarui Mi, Xiaojing Liu, Lianhe Chu, Jason W. Locasale, Gregory S. Korbutt, Meritxell Rovira, Ola Larsson, Olov Andersson. MNK2 deficiency potentiates β-cell regeneration via translational regulation. Nature Chemical Biology, 2022; DOI: 10.1038/s41589-022-01047-x

https://www.sciencedaily.com/releases/2022/06/220613140735.htm