Covid News Watch
Unvaccinated & Vaccinated COVID Case Rates Nearly Equal, DHS Says + More
DHS: Unvaccinated & Vaccinated COVID Case Rates Nearly Equal
On the day Wisconsin was set to cross a new milestone for the number of new cases recorded in the state, the Dept. of Health Services removed that figure from its COVID-19 dashboard. The graph showing the total number of deaths from COVID-19 or complications related to the virus has also been eliminated.
Although these figures, and others listed below, no longer appear on the main pages for COVID-19 statistics, they are still available on the DHS website in the form of downloadable spreadsheets that include all metrics recorded by the agency, listed by date.
One metric that did reemerge in this latest report juxtaposes COVID-19 infections, hospitalizations and deaths for vaccinated and unvaccinated people in Wisconsin. The newly released numbers find those differences declined significantly in the three months since the agency last published these numbers.
In fact, the difference between the two groups for the number of new cases per capita has been all but eliminated. Whereas, as COVID-19 cases began to spike in December, an unvaccinated person was three times more likely to contract the virus than someone who completed their initial series, now the difference has fallen to just five percent.
India’s Drug Regulator Has Ignored Red Alerts on Covaxin, Imperiling Millions of Lives
In a shocking turn of events, the World Health Organization warned United Nations agencies against procuring Covaxin, India’s indigenously developed and manufactured COVID-19 vaccine, just five months after granting approval to the made-in-India vaccine. The warning came after a WHO inspection of a manufacturing facility owned by Bharat Biotech International Ltd. revealed “deficiencies in good manufacturing practices.”
The WHO has not revealed the extent or nature of the deficiencies at Bharat Biotech’s facility; but given its recent instructions to U.N. agencies, the deficiency must have been significant from a public health perspective.
Violations of current good manufacturing processes are nothing new to the Indian pharmaceutical industry. There is a sordid history of warning letters from the U.S. Food and Drug Administration documenting systematic compliance issues over the last decade. Foreign inspections all but ceased during the pandemic.
This is not the first time that a foreign regulator has found problems with the manufacturing facility at Bharat Biotech which produces Covaxin. Exactly one year ago, the Agência Nacional de Vigilância Sanitária (ANVISA), Brazil’s drug regulator, pointed out serious lapses at Bharat Biotech’s manufacturing facility in India that makes this vaccine. ANVISA inspectors discovered issues with quality control at the facility that are meant to confirm that the live virus at the core of this vaccine has been inactivated.
Rural Treatment Options Lag as Eating Disorders Spike During Pandemic
Eating disorders, including anorexia nervosa, bulimia nervosa and binge eating disorder, are some of the most fatal mental illnesses — second only to opioid addiction. Yet treatment options remain sparse, particularly in rural states such as Montana.
Emergency department visits for teenage girls dealing with eating disorders doubled nationwide during the pandemic, according to a study from the Centers for Disease Control and Prevention. The same report notes that the uptick could have been due in part to reduced access to mental health services, a reality even more acute in rural states.
Pfizer May Have COVID Booster That Addresses Omicron, Other Variants by Fall
By this fall, pharmaceutical giant Pfizer and its partner BioNTech could potentially have a COVID-19 booster that specifically addresses the Omicron variant as well as its subvariants and other known strains of the virus, CEO Albert Bourla said during a panel Wednesday.
“It is a possibility that we have it by then; it’s not a certainty,” Bourla said. “We are collecting data right now, and as far as I know, Moderna, as well as us, we are working on Omicron or different enhanced vaccines.”
It would be simple to create a vaccine specifically targeting Omicron, he explained, but it is scientifically and technically more difficult to create a vaccine that addresses all known variants.
Two New Highly Infectious Omicron Subvariants Are Driving up COVID Cases in New York
Two new Omicron subvariants that appear even more transmissible than the highly-contagious BA.2 are driving an uptick in COVID cases in New York, the state’s health department said Wednesday.
While there’s no evidence that either causes more severe disease, the department estimates they have a 23% to 27% growth advantage over the BA.2 variant that was itself more infectious than the original Omicron. It’s the first reported instance of significant community spread due to the two subvariants in the U.S.
“We are alerting the public to two Omicron subvariants, newly emerged and rapidly spreading in upstate New York, so New Yorkers can act swiftly,” State Health Commissioner Mary Bassett said in a statement. “While these subvariants are new, the tools to combat them are not.”
To Find out Where the COVID Pandemic Is Headed, Look Here: The Sewer
The first clues appear in sewer water. And those clues are piling up.
As the United States enters year three of the coronavirus pandemic, disease trackers are trying to stay one step ahead of the constantly evolving virus — by hunting for it in feces.
The secrets of the virus can be found in wastewater because most infected people shed tiny pieces of virus when they use the toilet. So regularly analyzing wastewater from sewage treatment plants allows scientists to measure when those levels are rising or falling — and what variants are present — about four to six days before people start testing positive.
Stuck in the Great COVID in-Between
Life in a COVID world is getting awkward again as Americans rush headlong back to their old ways of life even as case counts rise and new variants threaten to dash their hopes.
We can’t say we’re in a post-pandemic period yet. But large segments of the public are embracing pre-COVID norms, a fact that’s maddening for those who are — or must — continue taking precautions.
“It’s definitely weird,” said Bob Wachter, chairman of the University of California, San Francisco Department of Medicine. “We’re going back to work, which is a little odd. We’re not sure whether to do handshakes or fistbumps,” he said. “Every encounter is this little negotiation with the people ‘Do you want to? Do I want to?’ It’s all very odd.”
Case rates and hospitalizations have plummeted after the Omicron surge.
Is Herd Immunity for COVID Still Possible?
With herd immunity, if someone does get infected by a virus, they are surrounded by enough people who are shielded against infection that the virus has nowhere to go. It fails to spread.
As a country, we had reached this point against some formidable viruses, such as rubella and measles. We thought we could get there with COVID-19. We were probably wrong.
“The concept of classical herd immunity may not apply to COVID-19,” Dr. Anthony Fauci, director of the National Institutes of Allergy and Infectious Diseases, said in an interview with CNN.
And that “means we’re not going to be without SARS-CoV-2 in the population for a considerable period of time,” said Fauci, who recently co-authored a paper on herd immunity for the Journal of Infectious Diseases.
FDA Authorizes Breath Test That Can Detect COVID in Three Minutes
The Food and Drug Administration has granted emergency use authorization to a new COVID-19 test that can detect infections with only a sample of a patient’s breath, using a device that can yield results in less than three minutes.
The agency says the InspectIR COVID-19 Breathalyzer will only be available for tests “by a qualified, trained operator under the supervision of a healthcare provider.” The test, designed for use in hospitals, doctors’ offices or mobile testing sites, requires a piece of equipment around the size of a piece of carry-on luggage. The FDA says the company will be able to produce around 100 instruments per week. Each test can evaluate around 160 samples every day.
InspectIR’s test works by analyzing a person’s breath using “gas chromatography gas mass-spectrometry” to detect five compounds typically exhaled when people are infected by SARS-CoV-2.
‘Last Few Tweaks’ Being Made to COVID IP Waiver Deal — WTO Chief
The head of the World Trade Organization told Reuters on Thursday that negotiations on an intellectual property deal for COVID-19 vaccines were ongoing between the four parties, saying they were seeking to agree on the proposal’s final terms.
Since the draft compromise emerged in the media a month ago, pressure from civil society groups has been rising for the parties — the United States, the European Union, India and South Africa — to walk away from the deal. Other public figures have also criticized it such as German Chancellor Olaf Scholz and former U.N. Secretary-General Ban Ki-moon, saying it is too narrowly focused on vaccines.
India and South Africa, backed by dozens of other WTO members, had proposed a broad waiver of IP rights for COVID-19 drugs and vaccines but failed to overcome opposition from members like Britain and Switzerland who argued that pharmaceutical research required such protections.
What Proportion of Doctors Are Vaccine Hesitant? Far Higher Than Expected, Survey Says + More
What Proportion of Doctors Are Vaccine Hesitant? — Researchers Conducting a New Survey Said the Answer Was Far Higher Than Expected
Levels of vaccine hesitancy among physicians may be higher than expected, with 1 in 10 primary care doctors not believing that vaccines are safe, according to a new survey.
Among 625 physicians, 10.1% did not agree that vaccines were safe; 9.3% did not agree that vaccines were effective; and 8.3% did not agree that they were important, Timothy Callaghan, PhD, of Texas A&M School of Public Health in College Station, and colleagues reported online in Vaccine.
The high proportion of hesitancy among primary care doctors “was certainly a surprise for us,” Callaghan told MedPage Today. “We thought it might be a very small proportion of physicians who hold hesitancy about vaccines given that we have lots of evidence of the safety and effectiveness of vaccines. However, once we dug into the data, we found that concerns about vaccines, in general, were far more widespread in the physician population than we might have expected.”
Britain Approves Moderna’s COVID Shot for 6- to 11-Year-Olds
Britain’s medicines regulator on Thursday approved the use of Moderna‘s (MRNA.O) COVID-19 vaccine in children between six and 11 years, as the country bolsters itself for fighting coronavirus infections amid the spread of new virus variants.
While most children develop mild or no symptoms with COVID-19, they could still spread the virus and some remain at risk of becoming seriously ill as new, highly contagious variants such as Omicron and its sub-variants are driving up cases.
Official data on Thursday showed that COVID-19 prevalence in England fell to 1 in 14 people in the week ending April 9, compared with a record high of 1 in 13 recorded in the previous two weeks.
UK Clears 6th COVID Shot Despite Canceling Deal for Doses
British authorities have authorized a coronavirus vaccine for adults made by French drugmaker Valneva, despite the government’s decision last year to cancel an order for at least 100 million doses.
The UK is the first country to authorize Valneva’s vaccine, which is also under review by the European Medicines Agency. Britain’s medicines regulator said Thursday that the two-dose vaccine is intended for adults ages 18 to 50, with the second dose given about a month after the first.
The Valneva vaccine is made with the decades-old technology used to manufacture shots for flu and polio. It is the sixth COVID-19 vaccine the U.K. has cleared and the only one that utilizes a “killed” virus; scientists grow the coronavirus in a lab and then inactivate the virus so it cannot replicate or infect cells.
The U.K. government scrapped an agreement with Valneva in September to purchase at least 100 million doses, saying at the time that British regulators probably would not clear the shot. Valneva said Britain canceled the deal because of supply concerns.
Pfizer to Seek COVID Booster for Healthy 5- to 11-Year-Olds
Pfizer said Thursday it wants to expand its COVID-19 booster shots to healthy elementary-age kids. Pfizer says new data shows healthy 5- to 11-year-olds could benefit from another kid-sized shot.
In a small study, 140 youngsters who’d already gotten two shots were given a booster six months later, and researchers found the extra shot generally revved up their immune response. But a closer look at 30 of the children found a 36-fold increase in virus-fighting antibodies, levels high enough to fight the super-contagious Omicron variant, Pfizer and its partner BioNTech said in a press release.
U.S. COVID Cases on the Rise Again
After two months of plummeting COVID cases across the U.S., the virus is on the rise again, with the Northeast accounting for many of the new cases.
We knew this was coming. Now it’s just a matter of seeing how large an impact this surge of the BA.2 subvariant of Omicron has in the U.S.
“We’ve got to be careful, but I don’t think this is a moment where we need to be excessively concerned,” White House’s COVID-19 response coordinator Ashish Jha told the Today show this week, pointing to low infection numbers and hospitalizations.
Homeschooling Surge Continues Despite Schools Reopening
The coronavirus pandemic ushered in what may be the most rapid rise in homeschooling the U.S. has ever seen. Two years later, even after schools reopened and vaccines became widely available, many parents have chosen to continue directing their children’s education themselves.
Families that may have turned to homeschooling as an alternative to hastily assembled remote learning plans have stuck with it — reasons include health concerns, disagreement with school policies and a desire to keep what has worked for their children.
In 18 states that shared data through the current school year, the number of homeschooling students increased by 63% in the 2020-2021 school year, then fell by only 17% in the 2021-2022 school year. Around 3% of U.S. students were homeschooled before the pandemic-induced surge, according to the U.S. Census Bureau.
New Omicron Sub-Types BA.4 and BA.5 May Be More Able to Dodge Antibodies
Scientists are monitoring two newly characterized Omicron variant sub-types, BA.4 and BA.5, that have emerged in a few countries.
In recent weeks researchers have noted a small number of sequences of two new types of Omicron — now being referred to as BA.4 and BA.5 — so far detected in relatively few people. Both sub-variants have been detected in a few countries, including the UK, Denmark and Botswana, but have largely been present in South Africa.
BA.4 and BA.5 are both similar to BA.2 except with a few mutations that make them distinct. Both have additional mutations in their spike region — the part of the virus used to latch onto cells and cause illness.
U.S. FDA Delays Decision on Regeneron/Roche COVID Antibody Therapy
The U.S. Food and Drug Administration has extended by three months its review of Regeneron Pharmaceuticals Inc’s (REGN.O) application for the full approval of its COVID-19 antibody therapy, the U.S. drugmaker said on Thursday.
Before making its decision, the health agency wants to look at additional data submitted by Regeneron on using the antibody cocktail as a preventive treatment. The FDA has not asked for any extra studies to complete its review and will now decide on the drug by July 13, Regeneron said.
Regeneron’s “cocktail” of two monoclonal antibodies, casirivimab and imdevimab, had received an emergency use authorization in the United States in late 2020 to treat patients who were 12 years and older with mild-to-moderate COVID-19.
U.S. CDC to Shrink COVID Int’l Travel Avoidance List
The Centers for Disease Control and Prevention (CDC) said on Wednesday it will revise its COVID-19 travel recommendations for international destinations and shrink the number of countries the government recommends avoiding.
About 90 countries and regions, including most of Europe, Brazil, Turkey, Russia, South Korea, Singapore, Hong Kong, Israel and Australia are currently rated by CDC as “Level 4: Very High” and the CDC recommends Americans, even if vaccinated, to avoid travel to those countries.
“This new system will reserve Level 4 travel health notices for special circumstances, such as rapidly escalating case trajectory or extremely high case counts,” the CDC said in a statement, adding that it will be effective Monday.
New COVID Rapid Test Said to Be More Sensitive Than Any Other
COVID-19 rapid test that is said to be more sensitive than any other has been developed by scientists in the United Kingdom.
It detects temperature changes when the virus binds to nanoparticles molecularly impressed on a 3D printed device.
Antigen tests quickly and conveniently tell a person they are positive for COVID-19, but they fail to detect early infections with low viral loads. Corresponding author Dr. Marloes Peeters, of Newcastle University, said: “The new test is more sensitive and works under more extreme conditions than antibody-based tests.”
Poorer Nations Shun AstraZeneca COVID Vaccine — Document
Poorer nations have refused tens of millions of AstraZeneca (AZN.L) COVID-19 vaccines from the global program COVAX, a document shows, the latest sign that its short shelf life is sapping demand for the shot.
COVAX is the world’s largest COVID-19 vaccine-sharing program. It has so far distributed 1.4 billion jabs to 144 countries and is co-managed by the World Health Organization (WHO) and the vaccine alliance Gavi.
Countries declined to receive nearly 35 million AstraZeneca doses, opting to replace them with vaccines manufactured by Johnson & Johnson (JNJ.N), Pfizer (PFE.N) and Moderna (MRNA.O), the document says.
COVID Cases Down but Too Soon to Tell if UK Has Passed Peak, Say Experts
Coronavirus infections have fallen slightly in most of the UK, figures from the Office for National Statistics show, although experts analyzing the data say it is too soon to say whether infections have passed their peak.
“Across most parts of the UK infections have thankfully begun to decrease. It is too early to say if we have passed the peak of infections, and infections overall remain high,” said Sarah Crofts, the head of analytical outputs for the COVID-19 Infection Survey. “We will continue to carefully monitor the data moving forward.”
According to recent hospital data, the number of COVID patients in hospital and admissions appear to have reached a peak in the UK, with signs that both may now be falling.
WHO: COVID Cases, Deaths in Africa Drop to Lowest Levels Yet
The number of coronavirus cases and deaths in Africa have dropped to their lowest levels since the pandemic began, marking the longest decline yet seen in the disease, according to the World Health Organization.
“This low level of infection has not been seen since April 2020 in the early stages of the pandemic in Africa,” WHO said, noting that no country in the region is currently seeing an increase of COVID-19 cases.
The agency warned, however, that with winter approaching for Southern Hemisphere countries, “there is a high risk of another wave of new infections.” The coronavirus spreads more easily in cooler temperatures when people are more likely to gather in larger numbers indoors.
Pandemic Propels Global Effort to Study Rare Vaccine Side Effects + More
Pandemic Propels Global Effort to Study Rare Vaccine Side Effects
Scientists in more than 20 countries, on every continent save Antarctica, have started to gather data for the largest ever vaccine safety project. Members of the effort, called the Global Vaccine Data Network (GVDN), fruitlessly sought funding after conceiving the project more than 10 years ago.
But the mass vaccinations during the COVID-19 pandemic breathed new life into the project. With the ability to draw on data from more than 250 million people, the network will investigate rare complications linked to COVID-19 vaccines in hopes of improving the prediction, treatment and potential prevention of these side effects.
“You really need global data in order to understand” rare vaccine side effects, says Gregory Poland, a vaccinologist at the Mayo Clinic. Poland, who’s not involved in GVDN, himself developed severe tinnitus about 90 minutes after his second vaccine dose, which he suspects is related to the shot. Studying potential vaccine complications “is a very neglected area,” he says.
U.S. Renews COVID Public Health Emergency
International Business Times reported:
The United States on Wednesday renewed the COVID-19 public health emergency, allowing millions of Americans to keep getting free tests, vaccines and treatments for at least three more months.
The public health emergency was initially declared in January 2020, when the coronavirus pandemic began. It has been renewed each quarter since and was due to expire on April 16.
The public health emergency is one of four pandemic-related nationwide emergencies currently in effect, including a national emergency Biden renewed in March and a separate health emergency that allows the Food and Drug Administration to grant emergency use authorizations for COVID-19 treatments, tests and vaccines.
Bill Gates Says He Warned Us About the Pandemic in His 2015 TED Talk — but ‘90% of the Views Were After It Was Too Late’
Bill Gates gave a key note speech at the TED2022 conference on Tuesday, and referenced his 2015 talk in which he warned a pandemic was on the horizon, and we weren’t ready for it.
Today, Gates said he hoped the current COVID-19 crisis would spur his audience at TED2022 in Vancouver, Canada to pay closer attention to his advice about how to prevent another pandemic from wreaking similar havoc on society.
“When I was on this stage in 2015, I was one of many people who said we weren’t ready and we needed to get ready. We didn’t,” Gates said. “The speech actually was watched by a lot of people, but 90% of the views were after it was too late.”
In the 2015 talk, Gates said the world was “not ready for the next epidemic” and viruses pose the “greatest risk of global catastrophe” compared to other threats to humanity. A YouTube video of his 2015 presentation has garnered more than 36 million views so far.
The Public’s Business Ought to Be Public
Last November my organization, Empower Oversight, sued the National Institutes of Health (NIH) for failing to comply with Freedom of Information Act requests related to the agency’s response to the COVID-19 pandemic. Around half a dozen other entities have also been forced to go to court to compel the NIH to make pandemic documents public.
Only after suing NIH did we receive any documents. In March, we released hundreds of emails in a report about the NIH deleting the sequences of viruses from a database they operate. These viruses are closely related to the COVID-19 virus. Experts say that analyzing them may help us understand how the pandemic began.
In the last 18 months, two news organizations have taken the NIH to court, where judges forced the agency to release public documents. In early June, Buzzfeed published emails sent and received by Dr. Fauci, who is now chief medical adviser to the president. The public has a right to understand how the government handled a pandemic that has killed so many Americans, but the agency only made the documents public after Buzzfeed sued.
Amid the Nation’s Mental Health Crisis, We Need More Psychiatrists Now
Every day, people call my office looking for help: A loved one has not left their bed in a week. A father is experiencing panic symptoms while preparing his children for school. A young woman is using substances in a way that feels dangerous to her.
Before the pandemic, I could almost always help. I would be able to find time to meet someone for a consultation or make a few calls to secure the right referral. But now, my every available hour — even those that jut into my ability to meet my obligations to my family — is full. My colleagues tell me the same. They are starting work earlier, working later, contending with long waitlists and their own limits. All the while, patients in crisis are going without psychiatric help.
In the most recent Household Pulse Survey, one-third of U.S. adults reported experiencing symptoms of depression or anxiety. This comes on top of the burden experienced by the 40 million Americans living with substance use disorders and the 14 million who live with serious mental illnesses.
Omicron Subvariant Now Almost 90% of U.S. COVID Cases: CDC
Nearly 90% of new COVID-19 cases in the United States are now a more transmissible subvariant of Omicron known as BA.2, according to new data from the Centers for Disease Control and Prevention.
The BA.2 variant is estimated to be about 30% more transmissible than the original Omicron variant, which already spread more easily than earlier variants. Importantly, though, there is not evidence that the BA.2 subvariant evades the vaccines to a greater extent or causes more severe disease.
WHO Says COVID Still a Global Public Health Emergency Even as Deaths Fall to Lowest Level in Two Years
The World Health Organization on Wednesday said COVID-19 remains a global public health emergency despite the fact that deaths from the virus have fallen to their lowest level since the early days of the pandemic.
The world recorded more than 22,000 deaths from COVID during the week ended April 10, the lowest level since March 30, 2020, according to WHO data. The organization first declared COVID a global health emergency on Jan. 30, 2020, just over a month after the virus emerged in Wuhan, China.
WHO Director-General Tedros Adhanom Ghebreyesus said declining COVID deaths is good news, but some countries are still experiencing a spike in cases. Tedros said a WHO committee this week unanimously agreed that COVID remains a public health emergency.
Meet This Year’s Healthcare Billionaires
There may be 87 fewer billionaires on Forbes’ annual ranking of the world’s richest people this year, but healthcare leaders still managed to climb the list.
Thomas Frist Jr., MD, founder of the sprawling, publicly-traded health system Hospital Corporation of America (HCA), topped the U.S. healthcare billionaires on the list, followed by Carl Cook, CEO of the medical device manufacturer Cook Group and Li Ge, Ph.D., co-founder and chair of WuXi AppTec, the R&D and manufacturing services company.
Internationally, Frist was second to Cyrus Poonawalla, Ph.D., chair of the Poonawalla Group that includes the Serum Institute of India, the “world’s largest vaccine maker (by doses),” according to Forbes. Poonawalla ranked 56th on the overall list with a net worth of $24.3 billion.
Others in the vaccine market also did well, such as Jiang Rensheng of China, chair of Chongqing ZFSW Biological Products (net worth $17.7 billion) and twins Andreas and Thomas Struengmann, who were early backers of BioNTech that partnered with Pfizer on a COVID-19 vaccine (net worth $11.9 billion).
COVID Vaccines Didn’t Work for Many Cancer Patients — but Researchers Are Designing a New Shot for Them
Researchers at the University Hospital Tübingen are designing a vaccine to elicit a deeper T cell response than the currently approved vaccines by targeting several key points on viral proteins — epitopes — that are good at stirring up immune T cells.
The researchers, who presented Phase 1/2 clinical data at the American Association for Cancer Research conference on Tuesday, said they hoped their approach would protect immunocompromised patients from COVID, even if they still cannot make antibodies. Other experts said it was an intriguing idea, though whether it’ll actually protect against COVID has yet to be shown.
To create this vaccine, the investigators first scoured the coronavirus genome using an algorithm that would highlight any viral protein fragments or peptides that would cause a T cell to perk up, said Juliane Walz, the medical director of translational immunology at the University Hospital Tübingen and the lead author of the study.
Moderna Sets Sights on Flu Vaccine, Starts Giving Shots to Trial Participants
The Cambridge-based biotech giant that created one of the earliest and most effective COVID-19 vaccines is now looking to develop a flu shot.
Moderna on Monday announced that the first trial participants have been dosed in the Phase 1/2 study of the company’s seasonal influenza vaccine candidates. The biotech is applying its messenger RNA (mRNA) platform to the flu vax.
This Phase 1/2 randomized study will evaluate the safety and immune response of a single dose of mRNA-1020 or mRNA-1030 in healthy adults 18-plus in the U.S. The company intends to enroll about 560 participants in the study.
Coronavirus Pandemic Pushed 77 Million Into ‘Extreme Poverty’: UN
The coronavirus pandemic pushed 77 million people into extreme poverty last year, according to a new report from the United Nations (U.N.) released on Tuesday.
The 208-page report from the U.N. Department of Economic and Social Affairs also says 1 in 5 developing countries will not see a gross domestic product return to 2019 levels within the next year.
Debt has also increased, and the poorest developing countries are paying about 14 percent of revenue on average to pay it off, compared to 3.5 percent for developed countries.
Shionogi to Not Recommend Use of Oral COVID Drug for Pregnant Women
Japanese pharmaceutical firm Shionogi & Co. is considering not recommending the use of its oral COVID-19 drug for pregnant women due to animal testing finding fetal abnormalities after it was administered, a source familiar with the matter told Kyodo News on Tuesday.
The Osaka-based drugmaker applied for approval of the drug with the Health, Labor and Welfare Ministry in February. But the finding may indicate a safety management system is needed to prevent pregnant women from taking the drug.
According to the source, the company found abnormalities in fetuses when pregnant rabbits were given the drug, which was higher in concentration compared with that taken by people during clinical trials.
The oral COVID-19 drug Molnupiravir developed by U.S. pharmaceutical firm Merck & Co. and approved by the Japanese government last year is not to be administered to pregnant women.
Fauci Admits Defeat: COVID Here to Stay, People Need to ‘Calculate Individual Risk’ + More
Fauci Admits Defeat: Says COVID Here to Stay, People Need to ‘Calculate Individual Risk’
While President Joe Biden campaigned on a promise to “shut down the virus, not the economy,” Dr. Anthony Fauci — the highest-paid employee in the U.S. government — was taking a much more cautious approach — suggesting that COVID might never go away.
And with Washington, DC, now a superspreader party town for the far-less deadly Omicron strain, Fauci has now explicitly thrown in the towel on trying to rid the world of COVID-19 — telling ABC’s “This Week” that the virus is here to stay, and people will just have to decide what level of risk they’re willing to take.
“This is not going to be eradicated and it’s not going to be eliminated,” Fauci told host Jonathan Karl. “What’s going to happen is that we’re going to see that each individual is going to have to make their calculation of the amount of risk that they want to take in going to indoor dinners and in going to functions, even within the realm of a green zone map of the country where you see everything looks green but it’s starting to tick up.”
“We’re going to have to live with some degree of virus in the community,” Fauci continued, adding that “the best way to mitigate that, Jon, is to get vaccinated.” Yes, a vaccine developed for a completely different strain that wanes in protection just six weeks after the receipt of a fourth dose, according to a recent Israeli study.
Visual Disturbances After Each COVID Shot? — Rare Sequence of Ischemic Optic Neuropathy in Both Eyes After First and Second Doses
A 53-year-old man presented to the hospital after losing vision in his left eye. He explained that he had been given his second dose of Pfizer‘s COVID vaccine (Comirnaty) 10 days previously. He said that he had experienced similar symptoms 7 days after he received his first dose of the vaccine.
Clinicians presenting this case (one of two originally published) of non-arteritic anterior ischemic optic neuropathy after receiving the Pfizer vaccine emphasized that the case “describes an association, not causation, between NA-AION and COVID-19 vaccination.”
However, they noted that “the timing between the vaccine and the development of the ischemic optic neuropathy,” in addition to the patient’s symptom onset “in one eye after the first dose and in the other eye after the second dose makes a potential role of the COVID-19 vaccines in the pathogenesis of this condition plausible in these two cases.”
How Can Schools Combat the COVID Slide? Bullying Prevention Is the Best Place to Start
Thus far, much of the discussion surrounding the pandemic‘s lingering impacts has centered on learning loss, which has resulted in testing declines of as much as six percentile points in reading and 12 percentile points in math in grades three through eight.
But the more important story might not be what’s down due to the pandemic but rather what’s up. Because as test scores drop, reports of mental health problems are on the rise — and you can’t address learning loss if students are overwhelmed by challenges outside the classroom.
Over the past two years, many schools have reported elevated levels of anxiety, stress and behavioral problems among students. Perhaps most troubling of all is an increase in reports of bullying as more kids take their anger and frustration out on peers and exacerbate a problem that was already reaching epidemic proportions before the pandemic. Just a few years ago, 90% of students in fourth through eighth grades had already reported being bullied or harassed. Of that overwhelming majority, 41% believed it would happen again.
Why White House COVID Czar Dr. Jha Says He’s ‘Not Overly Concerned’ About Rising BA.2 Cases
COVID-19 cases are rising again in the Northeast, due in part to the Omicron’s highly contagious BA.2 subvariant — but the White House’s new COVID czar isn’t too worried about it just yet.
On Monday, Dr. Ashish Jha acknowledged the growing number of COVID cases in parts of the country: 27 states, plus Washington DC, have experienced a jump in new cases over the past seven days, according to data from Johns Hopkins University.
But, Jha said, the data doesn’t point toward another full-on COVID surge because hospitalizations are currently “the lowest they have been in the entire pandemic.” According to the Centers for Disease Control and Prevention, the U.S. is currently averaging just over 1,300 hospitalizations per day, which is indeed a pandemic-era low point.
Why the Latest Rise in COVID Cases Is Being Treated Differently
COVID-19 cases are showing signs of rising again, even as many Americans are eager to move on.
Washington, DC, has been hit with a string of high-profile cases in Congress and the administration, and cases in the city overall are on the rise. New York and other areas in the Northeast are also seeing increases, with Philadelphia announcing on Monday that it will reintroduce a requirement that people wear masks in indoor public places.
But there are important ways that any coming spike in COVID-19 cases, fueled by a subvariant of Omicron known as BA.2, is likely to be less damaging than previous surges, experts say. And that may lead the nation to treat a new rise in cases differently.
Axios-Ipsos Poll: Most Americans Say COVID Is No Longer a Crisis
Less than one in 10 Americans now describe COVID-19 as a crisis — with about three in four calling it a manageable problem and one in six saying it’s no problem at all — according to the latest installment of the Axios/Ipsos Coronavirus Index.
These sentiments — and the public’s growing desire to be done with mask mandates and other restrictions — raise significant challenges for public health officials in managing new surges, and could create real political headwinds ahead of the midterms.
The latest wave of our national survey actually found a slight uptick in people’s perceptions of the risks of certain activities, including flying, attending sports events and returning to work. Yet it shows the highest share of Americans visiting friends and family members outside the home — and the lowest rate of social distancing — since the early part of last summer.
New Omicron XE COVID Variant First Detected in the UK Spreads to Japan as Cases Rise
Japan has reported its first case of Omicron XE — a new COVID-19 strain first detected in the U.K. — just as British cases of the subvariant rise.
The XE variant was found in a woman in her 30s who arrived at Narita International Airport from the U.S. on March 26. The woman, whose nationality was not immediately disclosed, was asymptomatic, Japan’s health ministry said Monday.
It comes as cases of the new strain have almost doubled in Britain, according to the latest statistics from the U.K. Health Security Agency.
XE has since been detected in Thailand, India and Israel. It is suspected that the latter Israeli cases may have developed independently. The U.S. has not yet reported any XE cases.
COVID Hospitalizations, Cases Continue to Rise in Most Provinces Amid 6th Wave
COVID-19 hospitalizations and cases are on the rise once again across Canada, according to public health data, as the reality of a sixth wave of the pandemic begin to take shape.
Although every province except Ontario and Quebec has moved from reporting COVID-19 data daily to now posting weekly updates, a majority of jurisdictions in Canada is seeing a rise compared to last month.
Canada’s chief public health officer Dr. Theresa Tam and her provincial counterparts have said an even more transmissible subvariant of Omicron, dubbed BA.2, is behind the current wave.
RedHill Pill Shows Promise Vs Omicron; mRNA Vaccines Appear Effective in Those With Well-Controlled HIV
An experimental drug being developed by RedHill Biopharma Ltd (RDHy.F) that improved outcomes in a randomized trial involving severely ill COVID-19 patients infected with earlier versions of the coronavirus is showing promise against the Omicron variant in test-tube experiments, researchers said.
The oral drug, opaganib, has dual anti-inflammatory and antiviral effects. When opaganib was added to treatment with Gilead Sciences’ (GILD.O) remdesivir and corticosteroids in hospitalized patients infected before Omicron was predominant, it improved the average time until patients no longer had detectable virus in their blood by four days, sped up recovery by 34%, and reduced mortality by 70%, compared to a placebo, according to data released previously by the company but not yet formally published.
Opaganib’s antiviral/anti-inflammatory mechanism “is expected to act independently of viral spike protein mutations and remain effective against Omicron subvariants BA.2, XE and other emerging and future variants,” the company said.
People living with well-controlled HIV infections are likely to have immune responses to the mRNA COVID-19 vaccines from Moderna (MRNA.O) and from Pfizer (PFE.N)/BioNTech (22UAy.DE) similar to those of otherwise healthy individuals, according to new data.
Pfizer Bids $100 Million for Brisbane App That Listens for COVID
ResApp, a Brisbane-based company that promises to diagnose COVID-19 through an app that listens to the sound of a cough, has agreed to a $100 million takeover by pharmaceutical giant Pfizer.
The ASX-listed company made headlines last month when it announced that it had developed an app that can screen for COVID-19 through a smartphone app.
The company claimed the app’s algorithm “exceeds the real-word measured sensitivity of rapid antigen tests”. ResApp said in the announcement that it was preparing to gain regulatory approval for the product.
The algorithm correctly detected COVID-19 in 92% of infected people in a pilot clinical trial of 741 patients in India and the U.S., ResApp said.
Germany Agrees to Deal With CureVac, GSK for mRNA Vaccines Until 2029
Germany has signed a contract with CureVac (5CV.DE) and its British partner GlaxoSmithKline (GSK.L) for domestically produced mRNA vaccines to bolster supplies in case of public health emergencies, the German biotech firm said on Monday.
The five-year contract allows for the production of up to 80 million doses at short notice until 2029, CureVac said, adding that those doses could be for the remainder of the current pandemic or future outbreaks.
