The panel voted 21-0 in favor of XBB-targeted shots, and the committee’s discussion indicated that the XBB.1.5 Omicron subvariant would be preferred.

FDA official Dr. Peter Marks indicated the agency was likely to settle on XBB.1.5, which manufacturers suggested could be ready for inoculations soonest.

COVID-19 vaccine makers Pfizer-BioNTech, Moderna, and Novavax, are already developing versions of their respective vaccines targeting XBB.1.5 and other currently circulating subvariants. Preclinical data from all three was presented at the meeting.

“It seems like it’s the most feasible to get across the finish line early without resulting in delays in availability,” Melinda Wharton, vaccine policy official at US Centers for Disease Control and Prevention (CDC) said of a shot aimed at XBB.1.5.

If XBB.1.5 is chosen as the target for this year’s campaign, it would be especially helpful to Novavax, as their protein-based vaccine takes longer to manufacture than rival mRNA-based shots. If the FDA chose a different target, Novavax could again find itself playing catch up to rivals.

“The fact that most of the manufacturers are ready to work on XBB.1.5 is an added reason to select this strain or this variant given the immunologic data,” said meeting chair Dr. Arnold Monto.

After the meeting, Novavax issued a release saying it expects to be able to deliver its XBB-targeted COVID-19 shot this fall.

FDA staff reviewers in documents released this week said available evidence suggests this year’s shots should target an XBB subvariant. XBB and its offshoots, which now account for most US infections, are descendants of the Omicron variant that caused COVID-19 cases to surge to record levels early last year.

US health regulators are looking to bring the next COVID-19 shots more closely in line with the circulating virus.

Pfizer, in its presentation, said it could supply its monovalent shots targeting the XBB.1.5 subvariant by the end of July, while Moderna said it was prepared to supply a new variant-containing shot for fall season.

A so-called monovalent, or single target, vaccine would be a change from the most recent bivalent COVID-19 boosters that targeted both the original strain of the coronavirus and Omicron.

The FDA takes recommendations from its outside experts into consideration before making a final decision on composition of the shots.

Thursday’s proceedings comes after an advisory group to the World Health Organization (WHO) last month recommended the next wave of COVID-19 booster shots be updated to target XBB subvariants. Europe’s medicine regulators have also backed that recommendation.

The CDC recommended booster shots broadly last year. But panel member Dr. Paul Offit questioned whether the shots needed to be recommended for “everybody every season,” noting that the highest risk groups are those most likely to benefit from an annual booster.

Only about 17% of the U.S. population – some 56.5 million people – received a COVID-19 booster during the 2022-2023 vaccination season, according to government data through early May. Older Americans were boosted at a higher rate than the general population.

Between Moderna and Pfizer, Morningstar analyst Karen Andersen expects 75 million doses to be sold in the United States during the 2023-2024 campaign.

Moderna last month said it continues to expect the US annual COVID-19 market to be 100 million doses, largely in line with Pfizer’s view of 102 million.

COVID-19 deaths and hospitalizations have declined in 2023, and the US government in May ended its COVID Public Health Emergency, which had allowed millions of Americans to receive vaccines, tests and treatments at no cost. – Rappler.com

The woman, exercising her right under German privacy law for her name not to be made public, is suing the German vaccine maker for at least 150,000 euro ($161,500) in damages for bodily harm as well as compensation for unspecified material damage, according to the regional court in Hamburg which is hearing the case and law firm Rogert & Ulbrich, which is representing her.

The plaintiff claims she suffered upper-body pain, swollen extremities, fatigue, and a sleeping disorder due to the vaccine.

The first hearing is on Monday.

Tobias Ulbrich, a lawyer at Rogert & Ulbrich, told Reuters he aimed to challenge in court the assessment made by European Union regulators and German vaccine assessment bodies that the BioNTech shot has a positive risk-benefit profile.

German pharmaceutical law states that makers of drugs or vaccines are only liable to pay damages for side-effects if “medical science” shows that their products cause disproportionate harm relative to their benefits or if the label information is wrong.

BioNTech, which holds the marketing authorisation in Germany for the shot it developed with Pfizer, said it concluded after careful consideration that the case was without merit.

“The positive benefit-risk profile of Comirnaty remains positive and the safety profile has been well characterised,” the biotech firm said, referring to the vaccine’s brand name.

It noted about 1.5 billion people had received the shot across the world, including more than 64 million in Germany.

The European Medicines Agency (EMA) says that BioNTech’s Comirnaty, the most commonly used in the Western world, is safe to use.

In a media briefing last week, the EMA reaffirmed the benefit of all COVID shots it approved, including BioNTech’s, saying in the first year of the pandemic alone, vaccines were estimated to have helped save almost 20 million lives globally.

It has said there is a very small risk of myocarditis and pericarditis, two types of heart inflammation, following vaccination with Comirnaty, mainly for young males.

Unexpected side-effects after a drug has regulatory approval are rare. The unprecedented speed at which COVID vaccines were developed during the pandemic meant that potential uncommon side-effects may not have been detected as readily as they might have been in traditionally longer trials.

EMA has said that safety monitoring had not been compromised during the fast-track assessment.

The EMA had registered almost 1.7 million spontaneous reports of suspected side-effects by May, which translates into about 0.2 for every 100 administered doses.

Almost 768 million vaccine doses have been administered in the European Economic Area (EEA), which includes the 27 EU member states plus Iceland, Liechtenstein and Norway.

The most common temporary side-effects are headache, fever, fatigue and muscle pain.

The EMA also monitors adverse events or illness after vaccination, and checks for frequencies that surpass normal rates in the non-vaccinated population.

Liability

It is not clear who would pay the legal costs or compensation if the plaintiff wins the case.

Sources have said some of the EU’s bulk purchase agreements with vaccine makers, including BioNTech-Pfizer, contained full or partial liability waivers for both legal costs and potential compensation, which could force EU governments to bear some of the costs.

Like many countries, Germany also has a public sector financial support scheme for people who suffer permanent harm from vaccines, known as a no-fault compensation programme, but participation in the programme does not block someone seeking damages separately.

The United States has granted manufacturers immunity from liability for COVID vaccines that receive regulatory approval.

Rogert & Ulbrich says it has filed about 250 cases for clients seeking damages for alleged side-effects of COVID-19 vaccines.

Another law firm, Caesar-Preller, says it is representing 100 cases, with both firms saying separately they cover almost all cases in Germany between them.

A handful of similar cases have been filed in Italy. – Rappler.com

Their more recent dark state article was published in the prestigious journal Physical Review Letters in April 2023, with co-authors Jim Skulte, Phatthamon Kongkhambut, Sahana Rao, Ludwig Mathey, Hans Keßler, and Andreas Hemmerich.

With almost the same set of authors, they published their prior article in August 2022, which led to their surprising discovery of a dark state. This previous groundbreaking study created another type of time crystal, called continuous time crystal, for the first time in physics history.

Similar to the Big Bang Theory‘s theoretical physicist Sheldon Cooper, Cosme, along with his colleagues, created a theory or mathematical model and successfully verified it in their experimental design.

As a theorist, that’s something that excites you because we’re able to understand something at the fundamental level and that it works.

JAYSON COSME

Cosme clarified that what they found, the dark state, is different from dark matter, as the latter is mostly a theoretical form of matter and has not been detected yet. The dark state or dark quantum state, on the other hand, is the state of an atom or molecule that does not absorb or emit light (photons), hence “dark.” More importantly, the dark state is not just a theory as its existence has been proven and repeatedly created.

“It is closer to an invisibility cloak in Harry Potter,” he said, describing the dark state. “It’s practically invisible.”

Using the Bose-Einstein condensate (BEC) for their system, the study showed a unique way of creating a dark state using two key ingredients: the interaction between the atoms as facilitated by light via the laser beam, and the shaking of the laser itself.

He shared that different types of interactions create various states of matter, similar to how water molecules can become solid (ice), liquid (water), or gas (vapor), depending on how the molecules interact.

Their original setup was initially designed to create an incommensurate time crystal. By shaking the system harder, Cosme shared that they were surprised to see the transformation of the time crystal into something new and realized it was a dark state.

“We’re able to show that you can create a new state, which is a dark state, by combining periodic driving and interaction between the constituent particles that make up the Bose-Einstein condensate.”

While the study is fundamental research, the concept of the dark state can already be applied to quantum computing. Quantum computing is a multidisciplinary field that uses quantum mechanics to solve problems quicker than classical computers that exist nowadays.

While quantum computing has more possibilities for combinations of 1s and 0s, its state is not stable. For example, classical computers are more stable, which makes current devices like laptops and cameras function properly. Hence, its state of 1, for instance, will always remain 1, and so forth.

However, in a quantum bit, state 1, for instance, will at some point become 0.

With the dark state, a quantum bit will be more stable in creating a system that can solve more complex problems or perform faster functions than today’s supercomputers.

Cosme first started working with the team when he was working as a postdoctoral researcher and theorist in Hamburg, Germany, under Mathey, from 2017 to 2020. When he started working as an associate professor at UP Diliman in 2020, their collaboration continued.

As the principal investigator for the study, Cosme shared his idea with his close collaborator, Jim Skulte, to improve the mathematical model behind it and work on the experiment to prove their theory, along with their other colleagues from Hemmerich’s experimental group. 

“Apart from the joy of discovery and doing the physics itself, also seeing that your fellow scientists, colleagues, [and] your peers appreciate the work that you have done and make use of your ideas, to me, that’s one of the reasons that I’m still here doing physics, still doing science,” he said. – Rappler.com

The 16-member body, formed last year among leading experts from scientific fields ranging from physics to astrobiology, held a four-hour session streamed live on a NASA webcast to deliberate their preliminary findings ahead of issuing a report expected later this summer.

The panel’s chairman, astrophysicist David Spergel, said his team’s role was “not to resolve the nature of these events,” but rather to give NASA a “roadmap” to guide future analysis.

NASA officials said several panelists had been subjected to unspecified “online abuse” and harassment since beginning their work in June last year.

“It is really disheartening to hear of the harassment that our panelists have faced online because they’re studying this topic,” NASA’s science chief, Nicola Fox, said in her opening remarks. “Harassment only leads to further stigmatization.”

The greatest challenge panel members cited, however, was a dearth of scientifically reliable methods for documenting UFOs, typically sightings of what appear as objects moving in ways that defy the bounds of known technologies and laws of nature.

The underlying problem, they said, is that the phenomena in question are generally being detected and recorded with cameras, sensors, and other equipment not designed or calibrated to accurately observe and measure such peculiarities.

“If I were to summarize in one line what I feel we’ve learned, it’s we need high-quality data,” Spergel said. “The current existing data and eyewitness reports alone are insufficient to provide conclusive evidence about the nature and origin of every UAP event.”

Taboos surrounding the issue also remain.

While the Pentagon in recent years has encouraged military aviators to document UAP events, many commercial pilots remain “very reluctant to report” them due to the lingering stigma surrounding such sightings, Spergel said.

The NASA advisory panel represents the first UFO inquiry ever conducted under the auspices of the US space agency for a subject the government once consigned to the exclusive and secretive purview of military and national security officials.

Pentagon-based investigation

The NASA study is separate from a newly formalized Pentagon-based investigation of sightings reported in recent years by military aviators and analyzed by US defense and intelligence officials.

The US military has documented more than 800 cases over the past two decades, said Sean Kirkpatrick, director of the Pentagon’s newly formed All-domain Anomaly Resolution Office, or AARO.

But just a few percent are considered beyond relatively simple explanation, while the rest can be attributed to mundane origins such as aircraft, balloons, debris or atmospheric causes, he said.

The parallel NASA and Pentagon efforts highlight a turning point for the government after decades spent deflecting, debunking, and discrediting reports of unidentified flying objects, or UFOs, dating back to the 1940s.

But in finally addressing the issue head-on, both NASA and the Pentagon have emphasized the imperative of protecting US airspace, and by extension public safety and natural security.

In a departure from the Pentagon, NASA’s panel is examining only unclassified reports from civilian observers, an approach Spergel said permits open sharing of information among scientific, commercial and international entities, as well as the public.

The term UFOs, long widely associated with notions of flying saucers and aliens, has been replaced in official government parlance by the abbreviation UAP.

Recent US law revised the UAP acronym, previously confined to “aerial” phenomena, to stand for “unidentified anomalous phenomena,” expanding the NASA study team’s research scope to include puzzling events in space or at sea.

Panel members said the majority of their work still focused on aerial phenomena.

Moreover, both NASA and defense-intelligence officials have stressed that while the existence of intelligent alien life has not been ruled out, they have found no evidence suggesting an extraterrestrial origin for UFO sightings.

“To make the claim that we see something that is evidence of non-human intelligence would require extraordinary evidence, and we have not seen that,” Spergel said. – Rappler.com

Mostafa Waziri, the head of Egypt’s Supreme Council of Antiquities, told reporters that the two large “embalming workshops” date back to the 30th dynasty (380-343 BC) and the Ptolemaic (305-30 BC) eras.

The discovery was made after a year-long excavation near the sanctuary of the goddess Bastet, which is home to the catacombs of mummified cats in Saqqara, some 30 kilometers (18.6 miles) south of Cairo.

It was the same spot where hundreds of mummified animals and statues were uncovered in 2019.

“We found embalming workshops, one for humans and one for animals. We found all the tools that they used (in mummification) in ancient times,” Waziri said.

Both workshops featured stone beds, clay pots, ritual vessels, natron salt, which is one of the main ingredients for mummification, and linens among other mummification instruments.

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The Saqqara excavations also led to the unearthing of two small 4,400 and 3,400-year-old tombs nearby, belonging to two priests, Ne Hesut Ba of the Old Kingdom’s fifth dynasty and Men Kheber of the late kingdom’s 18th dynasty respectively.

Inscriptions of cultivation, hunting and other daily activities were found on the walls of Ne Hesut Ba’s tomb while “scenes showing the deceased in different positions” were engraved in Men Kheber’s tomb, officials said.

Egypt has carried out extensive digging operations in Saqqara and other ancient locations in recent years, which resulted in a number of high-profile discoveries.

The country plans to inaugurate the Grand Egyptian Museum, a state-of-the-art facility near the Giza Pyramids on the outskirts of Cairo, after construction is completed later this year.

Egypt hopes it can further lure back tourists after the industry started to rebound of late, having been battered by the aftermath of the COVID-19 pandemic and the conflict in Ukraine.

Tourism revenues climbed to $7.3 billion in the second half of 2022, a 25.7% increase compared with the same period a year earlier, according to recently released central bank data. – Rappler.com

The FDA nod “represents an important first step that will one day allow our technology to help many people,” Neuralink said in a tweet. It did not elaborate on the aims of the study, saying only that it was not recruiting yet and more details would be available soon.

The FDA acknowledged in a statement that the agency cleared Neuralink to use its brain implant and surgical robot for trials on patients but declined to provide more details.

Neuralink and Musk did not respond to Reuters requests for comment.

Victor Krauthamer, an adjunct biomedical engineering professor who spent three decades at the FDA, including a stint overseeing the office that reviews human-trial requests for brain implants, said the FDA does not typically inspect facilities as part of their review of applications for clinical trials. But he added this would have been warranted in this case, given the concerns around Neuralink’s animal experiments.

“If the animal testing is unreliable, then (human trial) approval may be based on flawed animal safety data. The FDA should have verified their trust of animal study results,” Krauthamer said.

Several predictions

Neuralink had hoped to receive approval to implant its device in 10 patients, Reuters has reported. But more recently, the company was negotiating a lower number of patients with the agency after it raised safety concerns, current and former employees said. It is not known how many patients the FDA ultimately approved.

Musk envisions brain implants could cure a range of conditions including obesity, autism, depression and schizophrenia as well as enabling Web browsing and telepathy. He made headlines late last year when he said he was so confident in the devices’ safety that he would be willing to implant them in his children.

On at least four occasions since 2019, Musk predicted Neuralink would begin human trials. But the company sought FDA approval only in early 2022, and the agency rejected the application, Reuters reported in March.

The FDA had pointed out several safety concerns to Neuralink that needed to be addressed before sanctioning human trials, Reuters reported. Some of the issues involved the lithium battery of the device, the possibility of the implant’s wires migrating within the brain, and the challenge of safely extracting the device without damaging brain tissue. – Rappler.com

US Surgeon General Vivek Murthy said that while social media offers some benefits, there are “ample indicators that social media could also harm children’s well-being.”

“We are in the middle of a national youth mental health crisis, and I am concerned that social media is an important driver of that crisis – one that we must urgently address,” Murthy said.

Social media use may cause and perpetuate body image issues, affect eating behaviors and sleep quality, and lead to social comparison and low self-esteem, especially among adolescent girls, the advisory said, citing responses from a survey conducted among adolescents.

Adolescents who spend more than three hours per day on social media face double the risk of experiencing poor mental health outcomes, such as symptoms of depression and anxiety, according to the advisory.

Most adolescents say social media helps them feel more accepted, more supported during tough times, more connected to their friends, and more creative, the advisory also said.

It said policymakers should strengthen safety standards in ways that enhance those benefits for children of all ages, while noting that inappropriate and harmful content continues to be easily and widely accessible to children.

Tech companies should adhere to age limits to control access to social media platforms, and be transparent about data regarding the impact of their products on children, the advisory urges.

Algorithms and platform design should seek to maximize the potential benefits of social media instead of features designed to make users spend more time on them, it said.

“The first principle of healthcare is to do no harm – that’s the same standard we need to start holding social media platforms to,” said Saul Levin, CEO of the American Psychiatric Association.

The report includes suggestions for what parents, tech companies, as well as children and adolescents, can do to avoid dangerous pitfalls and make the social media experience more positive. They include creation of a family media plan, encouraging of in-person friendships, talking to children about how they spend their time online, and encouraging them to seek help should they need it.

It included a reminder of the new 988 Suicide and Crisis Lifeline “if you or someone you know is experiencing a mental health crisis.” – Rappler.com

Back in March, a cockroach species discovered in Singapore named Nocticola pheromosa, went viral as it was named after the Pokémon Pheromosa.

Among those who made the discovery was University of the Philippines Los Baños Museum of Natural History entomologist Cristian Lucañas, who was fascinated by the story of how Pokémon came about as the game’s creator, Satoshi Tajiri, was into collecting insects.

Know more about the entomologist who became a Pokémon professor through this short video report by Rappler digital communications specialist Russell Ku.

You can also read the full story below.

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Meet Cristian Lucañas, the UPLB entomologist who became a Pokémon professor

– Rappler.com

But the scarcity of Homo sapiens fossils from early in our evolutionary history and the geographical spread of those remains in Africa in places like Ethiopia and South Africa have made it difficult to piece together how our species emerged and dispersed across the continent before trekking worldwide. A new study tapping into genome data from modern-day African populations is offering insight into how this may have unfolded.

The research indicated that multiple ancestral groups from across Africa contributed to the emergence of Homo sapiens in a patchwork manner, migrating from one region to another and mixing with one another over hundreds of thousands of years. It also found that everyone alive today can trace their ancestry to at least two distinct populations that were present in Africa dating back about a million years.

The findings did not support a longstanding hypothesis that a single region in Africa gave rise to Homo sapiens or a scenario involving mixture with an unidentified closely related species in the human evolutionary lineage within Africa.

“All humans share relatively recent common ancestry, but the story in the deeper past is more complicated than our species evolving in just a single location or in isolation,” said University of Wisconsin-Madison population geneticist Aaron Ragsdale, lead author of the study published this week in the journal Nature.

The ancestral groups were likely spread across a geographic landscape in a population structure that, Ragsdale said, “was ‘weak,’ meaning that there was ongoing or at least recurrent migration between groups, and this maintained genetic similarity across ancestral populations.”

Because of the paucity of fossil remains and archaeological evidence, the researchers turned to genome data from living people to find clues about the past. They examined genome data from 290 people, mostly from four geographically and genetically diverse African peoples, to trace the similarities and differences between the populations and identify genetic interconnections over hundreds of thousands of years.

These included: 85 individuals from a West African group called the Mende from Sierra Leone; 44 individuals from the Nama Khoe-San group from southern Africa; 46 individuals from the Amhara and Oromo groups in Ethiopia; and 23 individuals from the Gumuz group, also from Ethiopia. Genome data also was examined from 91 Europeans to account for post-colonial era influence and from a Neanderthal, the extinct human species that was concentrated in Europe until about 40,000 years ago.

The fossil record is scanty in the time period that would be most informative about the emergence and spread of Homo sapiens, and there is no ancient DNA from skeletal or dental remains from these time periods, the researchers said.

“While we find evidence of anatomically modern human remains and artifacts in different parts of Africa, they are so sparse in space and time that it is difficult to understand their relationships with each other, and with us,” said study geneticist and study co-author Simon Gravel of McGill University in Montreal. “Were they related to each other? Are they related to our ancestors, or were they local populations who went extinct?”

“Genetic data was inherited from a continuous chain of transmissions dating back to well before the origins of modern humans. The relatedness among contemporary humans contains a lot of information about this chain of events,” Gravel added. “By building models of how these transmissions occurred, we can test detailed models that relate past populations to present-day populations.” – Rappler.com

Eventually, the researchers hope it could lead to a more natural feeling of loved ones when he is wearing his prosthetic.

With thermal electrodes placed on the skin of their residual arm, amputees such as Fidati reported feeling hot or cold sensations in their phantom hand and fingers, as well as directly on the arm, according to the trials by the École polytechnique fédérale de Lausanne (EPFL).

The 59-year-old Italian is among 27 amputees who took part in the trials, with 17 of them reporting a successful test.

“The first time I took part in the experiment, I felt like I had rediscovered feeling in my phantom hand,” he said.

Those tested have also been able to differentiate between plastic, glass and copper, pointing to where they feel the sensations on images of a hand.

“By stimulating specific parts of the residual arm of the amputees, we could induce sensation in the missing phantom hands,” said Solaiman Shokur, a senior scientist neuroengineer at EPFL who co-led the study, published in the journal Science.

“What they feel in this phantom hand is similar to what they feel on their intact hand.”

A woman who also took part the study, Francesca Rossi, said she had previously been able to feel tingling in her missing hand when she touched the end of her arm, but said: “Feeling the temperature variation is a different thing, something important…something beautiful.”

The technology, which has been tested for more than two years, does not need to be implanted. It can be worn on the skin and combined with a regular prosthetic.

Silvestro Micera, who co-led the study with Shokur, said they now wanted to test the device on a larger scale before combining it with other technologies to improve tactile sensations in amputees.

“We think that we could give people a better sense of embodiment of their hands and maybe even give them the possibility to feel their loved ones in a much more natural way,” Shokur added.

Fidati said that beyond helping amputees with daily tasks such as cooking, the technology could open the door for him to feel the warmth of others.

“There is also a social aspect that is important,” he said. “When I meet someone and shake his hand, I expect to feel heat.”

Micera, a professor at EPFL and Sant’Anna School of Advanced Studies, said: “Temperature feedback is essential for relaying information that goes beyond touch, it leads to feelings of affection. We are social beings and warmth is an important part of that.” – Rappler.com