The World Health Organization hasrecommendedcountries scrap lockdowns and ease all remaining COVID-19-related travel restrictions.
The WHO’s International Health Regulations Emergency Committee issued the surprising suggestion during its tenth meeting on Wednesday.
The agency cited the rapid spread of the Omicron variant as proof that blanket travel bans are inefficient and that international restrictions should be lifted or relaxed.
Travel bans may “discourage transparent and rapid reporting of emerging Variants of Concern (VOC) in a transparent and timely manner” and “contribute to the economic and social stress” of nations.
Further, the report states that biosafety measures like “masking, testing, isolation/quarantine, and vaccination, should be based on risk assessments and avoid placing the financial burden on international travelers in accordance with Article 40 of the IHR.”
In fact, the agency urged governments not to require proof of vaccination against COVID-19 as “the only pathway” for international travel due to its “limited global access” and “inequitable distribution.”
On a separate report, the same agency warned that the pandemic will not be over when Omicron reaches all countries because the high levels of infection will likely lead to new variants as the virus mutates.
“We’re hearing a lot of people suggest that omicron is the last variant, that it’s over after this,” Maria Van Kerkhove, the WHO’s Covid-19 technical lead, said during a coronavirus update in Geneva.
“And that is not the case because this virus is circulating at a very intense level around the world.”
In any case, a number of countries have already started to announce the dates when their COVID-19 restrictions would be lifted.
The French government stated on Thursday that most of the COVID-19 restrictions will be lifted in February; however, the “vaccine pass” and the requirement to wear an indoor mask will remain.
Ireland’s hospitality curfew, which was enforced in December, is expected to be lifted as early as next Wednesday. The government will set out the details of the restrictions lifting in a national address on Friday evening.
The UK government stated on Wednesday that the restrictions placed in England last month to address the Omicron outbreak will be lifted as of next week.
“I encourage everyone across the country to continue with all the cautious behaviors that we know help to keep each everybody safe,” said the UK Primer Minister.
A new sub-variant of Omikron is spreading in Denmark and accounts for almost half of all Danish cases of infection. But should we be worried?
These days, both the authorities' and the world's eyes are on Denmark, where a new variant of Omikron is spreading at high speed. The variant already accounts for close to half of all cases of infection and is expected to be the dominant one in Denmark shortly.
This is a so-called sub-variant of Omikron, and it goes by the name BA.2.
Stop calling COVID-19 a “pandemic,” Bay Area doctors said Friday.
Four doctors with the University of California San Francisco sent an online petition to Gov. Gavin Newsom, all public school superintendents, and every county public health officer in the state, calling for a pivot in language that recognizes the virus as an “endemic.”
They are calling for the language pivot to emphasize that California should work toward “an end to all remaining restrictions, particularly as they apply to children.”
“We are particularly concerned about the toll that our state policies continue to have on children and teens. We are writing to ask California officials to acknowledge the endemic nature of COVID-19 after the omicron surge and immediately shift our public dialogue toward defining a path for removing all remaining COVID-19 restrictions in public schools,” the petition states.
The petition was signed by Dr. Jeanne Noble, director of COVID response for the UCSF Parnassus Emergency Department, Jennifer Nguyen, a pediatrician for UCSF Benioff Children’s Hospital Oakland, Dr. Vinay Prasad, an associate professor of epidemiology and biostatistics at UCSF, Dr. Jarrett Moyer, and registered nurse Laura Chinnavaso.
The term “endemic” means “growing or existing in a certain place or region,” while “pandemic” means “an epidemic occurring worldwide, or over a very wide area, crossing international boundaries and usually affecting a large number of people,” according to the Dictionary of Epidemiology.
“An endemic phase of viral infections means … it’s not causing the terrible hospitalizations of the pandemic phase … that we’ll have enough immunity of a population so it’s kept down to low levels,” Dr. Monica Gandhi told KRON4.
The omicron variant surge is finally declining in San Francisco, the city’s top health official acknowledged Thursday.
Despite a record number in cases, most infected people reported mild or asymptomatic infections with the latest surge, city officials said.
Eighty-two percent of San Franciscans are vaccinated, and 61 percent of the city’s eligible population has received a booster shot.
“Omicron has changed the game – it is extremely contagious and it’s also less severe and often mild for those who are vaccinated and boosted. Our goal is no longer to prevent every case of COVID,” said Dr. Grant Colfax. “Instead, our goal is to prevent the worst outcomes of the disease, such as hospitalizations and deaths.”
The post-omicron pivot petition asserts that San Francisco COVID safety restrictions are currently too restrictive, especially in public schools, and should change in the near future.
Masked students wait to be taken to their classrooms at Enrique S. Camarena Elementary School in Chula Vista, Calif. (AP Photo/Denis Poroy)
The petition writes, “Since this pandemic began, we have been living under the most restrictive COVID-19 policies in the country. For those of us in the Bay Area, we continue to navigate the most restrictive policies in the state.”
The petition continues, “These restrictions persist despite California’s high vaccination rate and low COVID-19 hospitalization rates. California’s COVID policies have failed to evolve with the advent of highly protective and widely accessible vaccines. Our restrictive policies, that have caused considerable collateral damage throughout the pandemic, have long lost their justification as necessary for prevention of serious illness and death. These pervasive policies continue to negatively affect our professional and personal lives without clear benefit nor any end in sight.”
The petition calls for 17 changes in California:
1. Acknowledge that any adult and most school age children have now had the opportunity to be fully vaccinated, and that forcing further mandates, particularly requiring boosters for children, is likely to increase mistrust and resentment of government and public health officials.
2. Acknowledge that many families in California vaccinated their children for the good of society since children are at lower risk of severe disease.
3. Acknowledge that vaccinated individuals of all ages in this state have been waiting for a reward for their efforts in the form of a major relaxation of restrictions which they have yet to receive.
Solome Walker, 9, looks down at her bandage after getting her first Pfizer COVID shot at a vaccination clinic for young students. (AP Photo/Laura Ungar)
4. Acknowledge that the public is weary from two years of restrictions, shifting messages from government officials, and a failure to acknowledge that the risk of severe COVID among children is significantly lower than in adults; indeed, it could take well over a generation for government leaders and infectious disease experts to regain the public’s trust.
5. Acknowledge the smaller risk that COVID-19 illness poses to children compared to the disproportionate toll that mitigation measures have taken on children.
6. Acknowledge the ongoing mental health crisis that is present in our children and teens due to social isolation and anxiety that has been created by this pandemic.
7. Acknowledge the ongoing educational crisis that is unfolding before us so long as children cannot see their teachers’ and peers’ faces and adequately hear and interact with them.
8. Immediately allow school children to unmask while outdoors, including during sports, by clarifying that outdoor exposures to COVID-19 are exceedingly low risk encounters and should not qualify as close contacts for the purpose of quarantines.
9. Make masks optional while indoors in school settings when California’s general mask mandate expires on February 15, 2022, or no later than February 24, 2022, twelve weeks after the last public school child became eligible for the vaccine.
10. Acknowledge the potential developmental harm that is caused to infants and toddlers who do not get to see their caregivers’ and teachers’ mouths when they are being spoken to nor see their full facial expressions in their interactions.
11. Immediately allow preschool and daycare teachers and students to unmask at all times if they so choose. If they do not choose to, please provide them with the CDC guidance on masking options, emphasizing one-way masking as a protective strategy.
12. Work towards ending the mindless testing of asymptomatic individuals with no clear purpose given that COVID-19 is here to stay.
13. Acknowledge that policies on college campuses should recognize that population’s relative low risk and high vaccination rate, thus not warranting returns to distance learning that deprive our young adults of social interaction that is formative for a lifetime.
14. Immediately shift away from a public health response that is based on case rates to one that strictly looks at hospitalizations and deaths in a broader context.
15. Acknowledge that the present Omicron variant is less deadly than prior variants.
16. Acknowledge that true COVID-19 hospitalizations remain low in this state and particularly in the Bay Area, and that we should refrain from panic-driven restrictions that inflict additional collateral damage on our most vulnerable populations, unjustified by a less deadly variant.
17. Commit to a rigorous cost-benefit analysis for all COVID restrictive policies to ensure that benefit always outweighs harm, without disproportionately prioritizing prevention of COVID-19 transmission above all other health considerations.
European Union health ministers were told on Friday to prepare to deploy a fourth dose of Covid-19 vaccines as soon as data showed it was needed, as the bloc faces a surge in cases of the Omicron variant of the coronavirus.
The EU drugs regulator said this week it would be reasonable to give a fourth dose to people with severely weakened immune systems, but more evidence was needed.
"If we see data which is conclusive on whether a fourth dose is needed, we need to be ready to act," EU Health Commissioner Stella Kyriakides told EU ministers in a video conference, her speaking points showed.
The meeting was organised at short notice by the French government, which holds the rotating presidency of the EU, and focused on whether a fourth dose is needed and on adapted vaccines against variants.
In a tweet after the conference, Kyriakides noted that the priority should be to immunise the unvaccinated, who still constitute about a quarter of the EU population.
EU members Hungary and Denmark have already decided to roll out a fourth dose of Covid-19 vaccines.
Copenhagen said it would do so for the most vulnerable, while the Hungarian government said everybody could get it after a consultation with a doctor.
The rollout of fourth doses began in Israel last month, making it the first country to administer a so-called second booster. The campaign is set to continue despite preliminary findings that the fourth dose is not enough to prevent Omicron infections.
Wealthier nations decided to speed up the rollout of third doses amid a wave of new cases caused by the more contagious Omicron variant, but remain divided over a fourth.
Many consider that more data is needed before deciding.
Adapted vaccines
The meeting also discussed coordination of other policies, including possible new joint purchases, as "vaccines adapted to variants are coming soon," the French presidency said.
Vaccines adapted to Omicron could be ready as early as March, but the EU drugs regulator has said it is not yet clear whether they are needed.
Work is underway to develop multivalent vaccines that could protect against multiple variants, but it is not known when or if they could be available.
"It is clear that a new generation of vaccines that are effective against several variants, and ideally protect against infection, must be prioritised," Kyriakides told ministers.
The Glycogen Storage Disease Program atConnecticut Children's andUConn Healthreported success in a Phase I/II trial of a gene therapy for GSD-Ia.
Glycogen Storage Disease Type Ia (GSD-Ia) is a metabolic disease in which the liver is unable to break down glycogen into glucose. This causes blood sugar levels to plummet. It can damage the kidneys and liver, with serious side effects, including death. In order to prevent seizures and death, patients drink a cornstarch and water solution every couple of hours, but they can’t miss a dose by even 15 minutes.
Dr. Rebecca Riba-Wolman, director of the Glycogen Storage Disease Program, and a member of the Division of Pediatric Endocrinology at Connecticut Children’s said, “The participants of the Phase I/II trial overall have seen a 70% decrease in cornstarch needs. Some participants who could previously not go more than four hours without cornstarch are now able to last from 12-15 hours, significantly changing their lives.”
GSD-Ia is caused by a defective gene for the enzyme glycose-6-phosphatase (G6Pase). The gene therapy is developed with Ultragenyx and is dubbedDTX401. It is an investigational AAV8 gene therapy engineered to deliver stable expression and activity of G6Pase-alpha using a single intravenous infusion.
The UConn and Connecticut Children’s program was initiated by Dr. David Weinstein, who left to become Vice President, Clinical Development for PassageBio, which focuses on central nervous system disease.
“Dr. Weinstein left me with an incredible team of people and I couldn’t do this without them,” Dr. Riba-Wolman said. “Including co-principal investigator Dr. Karen Loechner, and nurses with GSD and ICU experience, the team also includes a metabolic dietician, Malaya Mount, who monitors the participant’s diet and cornstarch intake based on the data from their glucose monitor.”
On January 18, 2022, the inpatient clinical trial unit at UConn John Dempsey Hospital infused the first patient in the Phase III trial of the gene therapy. In the study, 50% of participants will receive the therapy, and 50% will receive a placebo. It is blinded and is planned to last two years. After the first year, depending on the success of the therapy, anyone who received the placebo will be shifted to gene therapy.
The first participant in the trial was first diagnosed at the age of five months. The patient is now a young adult and, instead of a water-corn starch solution, takes Glycosade, which was approved by the U.S. Food and Drug Administration (FDA) in 2012. It is a “superstarch” that maintains blood sugar levels for seven to eight hours overnight.
Dr. Juan C. Salazar, Physician-in-Chief, Connecticut Children’s and Department Chair of Pediatrics at UConn School of Medicine, said, “This is very exciting. It’s a culmination of over 20 years of research initiated by our colleague Dr. David Weinstein, who was the visionary and who had the lasting capacity to move this from an idea to the animal model to trial that we are now in, Phase III, and closer to bringing this innovative, life-changing gene therapy to the broader GSD community. To me, this is very exciting that together, UConn Health, the Department of Pediatrics at the UConn School of Medicine, in partnership with Connecticut Children’s, are able to be the first in the world to move to the next phase of the trial.”
Tech magnate Elon Musk is taking his neurotech company the next step toward in-human trials of his implantable brain-machine interface.
Neuralink is now hiring a clinical trial director, a clear signal the device is moving toward clinical trials. The Neuralink system hopes to be the first neural implant that will allow control of a computer or mobile device anywhere you go.
In a December interview with the Wall Street Journal, CEO Musk said they hope to have the device in humans with severe spinal cord injuries, like tetraplegic and quadriplegic patients, “by next year, depending on FDA approval.”
If you’ve followed news on Tesla, Musk’s futuristic all-electric vehicle company, you know that his promised timelines are not always on point. Visionaries often have dreams bigger than reality, but it’s those “unrealistic” dreams that push the boundaries of the impossible to bring breakthroughs in disruptive technology.
After proving its potential in monkeys, Musk is “cautiously optimistic” that Neuralink has a chance to restore full-body functionality to someone that has a spinal cord injury. A chance to help someone who has lost the ability to walk to be able to walk again.
Once a clinical trial director has been hired, discussions with the FDA will likely move forward regarding trial design. Neuralink would have to prove its device provides meaningful improvement over existing options. Improvements that far outweigh any risks.
The operation for trial patients would include a small 8 mm burr hole. The device implantation is too fine for human hands. With as many as 3072 electrodes distributed across 96 threads, the company is building a robotic system for fine-tuned implantation.
The first version will focus on enabling paralyzed patients to interact with their smartphone using their minds “faster than someone using thumbs,” according to an April tweet from Musk.
He followed up with, “Later versions will be able to shunt signals from Neuralinks in the brain to Neuralinks in body motor/sensory neuron clusters, thus enabling, for example, paraplegics to walk again.”
The device is flush under the skin and charges wirelessly so patients get to live without wires poking out from the skin, drawing unwanted attention and increasing the chance of infection.
If approved, it won’t be the only brain-implanted medical device out there. In 2019, the FDA approved a “brain pacemaker” that sends electrical impulses, deep brain stimulation, to targeted areas of the brain to relieve movement disorders in patients with Parkinson’s disease and severe epilepsy. In clinical trials, the device showed up to a 70% reduction in seizure frequency for the latter.
Neuralink clarifies these DBS devices modulate brain activity and do not transfer information to and from the brain as the Link does. Other brain machine interface systems are currently in clinical trials but only have a few hundred electrodes on the brain’s surface or in fixed arrays. Musk’s company is designing a device with an “unprecedented scale, with over 1024 channels of information.”
Pfizer Inc Chief Executive Albert Bourla said on Saturday that an annual COVID-19 vaccine would be preferable to more frequent booster shots in fighting the coronavirus pandemic.
Pfizer/BioNtech's COVID-19 vaccine has shown to be effective against severe disease and death caused by the heavily-mutated Omicron variant but less effective in preventing transmission.
With cases soaring, some countries have expanded COVID-19 vaccine booster programmes or shortened the gap between shots as governments scramble to shore up protection.
In an interview with Israel's N12 News, Bourla was asked whether he sees booster shots being administered every four to five months on a regular basis.
"This will not be a good scenario. What I'm hoping (is) that we will have a vaccine that you will have to do once a year," Bourla said.
"Once a year - it is easier to convince people to do it. It is easier for people to remember.
"So from a public health perspective, it is an ideal situation. We are looking to see if we can create a vaccine that covers Omicron and doesn't forget the other variants and that could be a solution," Bourla said.
Bourla has said Pfizer could be ready to file for approval for a redesigned vaccine to fight Omicron, and mass produce it, as soon as March.
Citing three studies, the U.S. Centers for Disease Control and Prevention (CDC) said on Friday that a third dose of an mRNA vaccine is key to fighting Omicron, providing 90% protection against hospitalization.
A preliminary study published by Israel's Sheba Medical Center on Monday found that a fourth shot increases antibodies to even higher levels than the third but was likely not enoughto fend off Omicron. Nonetheless, a second booster was still advised for risk groups, Sheba said.
