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Covid News Watch

Sep 09, 2022

Health Canada Approves Pfizer-BioNTech COVID Vaccine for Kids Under 5 + More

Health Canada Approves Pfizer-BioNTech COVID Vaccine for Kids Under 5

CBC reported:

Pfizer-BioNTech’s COVID-19 vaccine for kids under five has been approved by Health Canada, making it the second vaccine option for children in this age group.

Health Canada has approved a three-dose primary series of three micrograms each of Pfizer-BioNTech’s vaccine for children aged six months to four years old.

That differs from Moderna’s vaccine for this age group, a two-dose series and a higher amount of vaccine per dose which was approved in July.

The government recently approved a newer version of Moderna’s vaccine that targets the Omicron variant of COVID-19, but its use has not yet been approved for the youngest cohort.

Fauci: ‘We Don’t Have Time’ to Run Clinical Trials for Updated Boosters

The Epoch Times reported:

Dr. Anthony Fauci is claiming that there was not enough time to wait for clinical trial data before clearing updated COVID-19 booster shots.

“We don’t have time to do a clinical trial because we need to get the vaccine out now,” Fauci said on CBC this week, pointing to how about 400 Americans are dying per day with COVID-19 and thousands of others are in hospitals with the disease.

Both shots contain elements of the Wuhan, BA.4 and BA.5 virus variants. No human data was or is available for the formulations. Pfizer and Moderna presented data on preclinical testing, done on mice. They also referenced human data for a different formulation, combinations of the Wuhan and BA.1 strains.

Dr. Harvey Risch, a professor of epidemiology at the Yale School of Public Health, said that Fauci’s comments were “reckless” in light of the fact that regulators didn’t rush to have vaccine companies update the vaccines during previous periods, such as when the Delta variant was dominant in 2021.

He also criticized Walensky’s remarks, pointing to how the CDC’s variant monitoring shows that BA.4.6, which is not part of the updated boosters, is growing in proportion in recent weeks.

You Can Still Get Long COVID If You’re Vaccinated and Boosted

Time reported:

By now, it’s clear that even people who are fully vaccinated and boosted can get Long COVID, and recent research suggests that vaccines aren’t the Long COVID shields people wished for.

Studies have come to very different estimates about the degree of protection vaccines offer against Long COVID. But some of the latest findings point to fairly disappointing protection. In one July report from the U.K.’s Office for National Statistics, more than 4% of vaccinated and boosted adults in the U.K. who were infected by Delta, Omicron BA.1 or BA.2 still had symptoms at least 12 weeks later.

A preprint posted online on Sept. 6 (which has not yet been peer-reviewed) suggests the situation isn’t any better in the U.S. Researchers surveyed people from June into July, as the BA.5 variant was taking over. Among those who said they’d had COVID-19 at least a month earlier, roughly 20% had symptoms that lasted at least four weeks, with little difference between vaccinated and unvaccinated people.

New York Declares State of Emergency Over Polio to Boost Low Vaccination Rates

CNBC reported:

New York Gov. Kathy Hochul on Friday declared a state of emergency over polio to boost vaccination rates in the state amid further evidence that the virus is spreading in communities.

Poliovirus has now been detected in sewage samples from four counties in the New York metropolitan area as well as the city itself. The counties include Rockland, Orange, Sullivan and now Nassau.

The emergency declaration will expand the network of vaccine administrators to include pharmacists, midwives and EMS workers in an effort to boost the immunization rate in areas where it has slipped.

U.S. Orders 100 Million COVID Tests, White House Says More Needed

Reuters reported:

The United States will boost its stockpile of at-home COVID-19 tests, ordering more than 100 million tests from domestic manufacturers, the White House said on Thursday but warned it was a short-term solution.

President Joe Biden‘s administration has repeatedly and unsuccessfully asked Congress for more pandemic money. It said last week it would request $22.4 billion in emergency funding for COVID-19 relief ahead of a potential case surge in autumn.

The administration has warned it would be unable to provide enough tests, vaccines and treatments without more funding. Thursday’s announcement comes a week after it suspended orders of free tests from its COVIDTests.gov website as of Sept. 2.

‘Don’t Wait’ to Get the New COVID Shot, White House Says

NBC News reported:

The Biden administration is making a major push to get the updated COVID vaccine in arms ahead of what could be another fall surge of the virus as children head back to the classroom, and employees return to the workplace.

The plans include the acquisition of more than 170 million doses of the new boosters, which will be available to consumers without an out-of-pocket cost. “We want Americans to know that the vaccine is here and that they shouldn’t wait” to get it, a senior administration official told NBC News on Thursday.

The plans urge schools across the United States to hold at least one vaccination clinic before Thanksgiving, as well as university-led vaccination campaigns this fall.

Overall, COVID cases have been falling in the U.S., down by 23.1% over the past two weeks, according to NBC News data. But some experts worry that with cooler weather and increased indoor gatherings the trend will be reversed.

Post-Paxlovid Rebounds Look Common, Contagious

Bloomberg reported:

I recently returned from vacation with COVID and though my symptoms were mild, my doctor prescribed Paxlovid as a precautionary measure. I quickly improved, but not for long. I became one more person stuck at home with a post-Paxlovid COVID rebound. At least I’m in good company.

Back in February, VA Boston Healthcare System Chief of Staff Michael Charness experienced a rebound after he took Paxlovid. He explored his illness the way a good physician-scientist does, storing his samples next to the yogurt in the family fridge and getting them analyzed. He even tweeted for the first time in his life to spread the word.

His and others’ findings are officially out now in the New England Journal of Medicine, joining a stream of recent research that has been turning what was once a collection of anecdotes into published data.

A spokesperson for Pfizer, the maker of Paxlovid, describes rebounds as “uncommon and not uniquely associated with any specific treatment.” The researchers’ findings, though, suggest a different story: Infectious disease specialists say the rebounds aren’t uncommon, and patients should watch for them. They should also feel reassured that symptoms are almost always mild when a rebound occurs.

End of Government Purchases May Make COVID Drugs Less Lucrative

Axios reported:

Dwindling public demand for COVID vaccines and private market pressures should combine to cost manufacturers billions of dollars once the federal government stops buying the shots, eating into Pfizer and Moderna‘s pandemic profits.

Between the lines: The federal government bought far more vaccines than Americans would ever use to ensure that vaccines would be accessible. But private purchasers won’t tolerate redundancy or waste.

Driving the news: Sometime next year, health providers will take over purchasing COVID treatments and vaccines, and Americans will start accessing COVID care the way they do other medical needs.

The big picture: Vaccines account for all of Moderna’s sales and have swelled Pfizer’s.

How Helpful Will the New COVID Booster Really Be?

Los Angeles Times reported:

Last week, the Food and Drug Administration approved Omicron-specific vaccines and the Centers for Disease Control and Prevention followed, recommending updated boosters for everyone age 12 and up who has gotten at least two doses of the original COVID vaccines.

The message to a nation still struggling with the pandemic: The cavalry — in the form of a shot — is coming over the hill.

But for people familiar with the business tactics of the pharmaceutical industry, that exuberant messaging — and the lack of completed studies — has raised an array of still-unanswered concerns.

As we move into the next phase of the pandemic, the pharmaceutical industry may be headed for familiar territory: developing products that may be a smidgen better than what came before, selling — sometimes overselling — their increased effectiveness absent adequate controlled studies or published data, advertising them as desirable for all when only some stand to benefit significantly, and, in all likelihood, raising the price.

Why so Few Young Kids Are Vaccinated Against COVID — and How to Change That

Scientific American reported:

The Food and Drug Administration authorized COVID vaccines for children six months through four years old — the last age group to become eligible — in June. Yet, just 3.5% of U.S. kids in that group have received at least one dose, according to the CDC. And only about a third of children ages five through 11 have received one or more doses.

In a Kaiser Family Foundation (KFF) survey of parents conducted in July, more than four in 10 of those with children aged six months through four years said they would “definitely not” get their child vaccinated against COVID. Others said they will only do so if school or childcare requires them to or that they want to wait and see how the vaccine is working.

Of parents of children in this age group, nearly two-thirds of Republicans and of people who are unvaccinated themselves said they would not vaccinate their child. But even among parents who are vaccinated themselves, more than a quarter said they would not make the same choice for their little ones.

“Pretty much everybody knows somebody who’s gotten COVID despite being vaccinated,” says survey co-author Liz Hamel, vice president and director of public opinion and survey research at KFF. “The promise of what the vaccine will do for you is different now.”

Potential to Confuse Omicron-Targeting COVID Booster With Conventional Vaccine Raises Concerns: Report

FOXBusiness reported:

Health experts are reportedly concerned about potential vaccine mix-ups between the Omicron-specific booster shots and vials of conventional COVID-19 vaccines, which are intended to protect only against the original coronavirus strain.

The Los Angeles Times reports the issue was raised both at a Centers for Disease Control and Prevention (CDC) meeting and a gathering of the Western States Scientific Safety Review Workgroup.

“The Workgroup remains concerned about the potential for errors in the administration of the various COVID-19 vaccines, given that formulations for different age groups look alike,” chair Dr. Arthur Reingold said.

“To minimize the frequency of such errors, which should be reported to VAERS (Vaccine Adverse Event Reporting System), it is imperative that clear COVID-19 vaccination guidelines be disseminated to all vaccine providers. The Workgroup reiterates the importance of reporting to VAERS any suspected adverse events following receipt of a COVID-19 vaccine, whether as part of an initial series or as a booster dose and continued national safety surveillance efforts.”

According to the Times, the potential for confusion stems from the color of the cap of the vials being identical, as well as vials containing the same amount of vaccine.

U.S. May Expand Monkeypox Vaccine Eligibility to Men With HIV

Associated Press reported:

U.S. officials are considering broadening recommendations for who gets vaccinated against monkeypox, possibly to include many men with HIV or those recently diagnosed with other sexually transmitted diseases.

Driving the discussion is a study released Thursday showing that a higher-than-expected share of monkeypox infections are in people with other sexually transmitted infections.

Dr. John T. Brooks, chief medical officer for the Centers for Disease Control and Prevention’s monkeypox outbreak response, said the report represents a “call to action.”

Brooks told The Associated Press on Thursday that he expected vaccine recommendations to expand and that “the White House, together with CDC, is working on a plan for what that will look like.”

Sep 08, 2022

Young Adults Dying in Record Numbers, but Not From COVID + More

Data: Young Adults Dying in Record Numbers, but Not From COVID

The Epoch Times reported:

Nurse educator Dr. John Campbell is sounding the alert on a wave of unexplained deaths.

According to the government data that Campbell has reviewed, many more people are dying than would be expected based on averages from the last five to seven years, and averages from years prior to COVID. Many of these excess deaths are occurring in young, otherwise healthy adults.

Campbell has 2.44 million subscribers on his YouTube channel. He recently shared more government data showing that young and healthy people keep unexpectedly dying, and not of COVID.

In the first week after Campbell posted one such video, “Excess deaths, the data,” on Aug. 28, it had garnered over 916,000 views and more than 20,000 comments.

‘They Are Being Ignored by the System’: Plaintiffs’ Attorneys Say Those Injured by COVID Vaccines Have Little Recourse

Law.com reported:

Plaintiffs’ attorneys have expressed concerns about the growing number of COVID-19 vaccine injury claimants who may be unable to receive compensation because of what the lawyers describe as an overloaded and underequipped government program.

As Politico reported in June, the Countermeasure Injury Compensation Program (CICP) received just 500 complaints between 2010 and 2020. But over the course of two years during the COVID-19 pandemic, the program received more than 8,000 complaints.

As of Aug. 1, the federal CICP had received 9,657 injury claims between 2020 and 2022 — 9,153 of which were related to COVID-19 vaccines. More than 6,000 allege injuries or deaths from the vaccine. The CICP has thus far not actually compensated a COVID claim and has determined just one of them to be eligible for compensation. That claim is pending review.

The CICP was established through the federal Health Resources and Services Administration (HRSA) with the goal of compensating claimants alleging injuries caused by vaccine products. But, according to Andrew Downing of Phoenix-based personal injury firm Downing, Allison & Jorgenson, the program was not designed to handle such a sudden influx of claims.

Two Antibodies Identified in Israel Can Fight All Known COVID Strains, Study Finds

The Times of Israel reported:

Israeli scientists say they have identified antibodies that are so powerful in neutralizing the coronavirus that they could eliminate the need for more vaccine boosters.

A research team at Tel Aviv University experimented with numerous antibodies and found that two, in particular, neutralize all known strains of the coronavirus, including Delta and Omicron, in a lab setting.

Antibody infusions are already used to treat some coronavirus patients, and microbiologist Dr. Natalia Freund, who directed the new study, said the antibodies she identified could be used to concoct a particularly potent infusion.

Based on their performance in lab conditions, the antibodies could provide the extra protection that today comes from booster shots, she said, adding that this could potentially make extra shots unnecessary among vaccinated people.

U.S. COVID Vaccine Market Could Reach $13 Billion — Moderna Exec

Reuters reported:

The annual U.S. COVID-19 vaccine market going forward could be in the range of $5.2 billion to $12.9 billion, depending on the price of shots and who is eligible to receive them, Moderna Inc.’s (MRNA.O) chief commercial officer said on Thursday.

Arpa Garay, speaking at Moderna’s annual research and development event, said that range was based on price assumptions of $64 to $100 per shot.

The low end of the estimate also assumes only the high-risk population in the United States would be eligible for boosters — some 82 million people. The high end is based on all 258 million American adults being eligible for the shots and assumes half would get them.

GOP Gives Thumbs Down to Biden’s $47 Billion Emergency Request

Associated Press reported:

President Joe Biden’s request for more than $47 billion in emergency funding to help Ukraine and tackle COVID-19, monkeypox and natural disasters is encountering deep skepticism from Senate Republicans, signaling a showdown ahead.

The early resistance on the size and scope of the spending request points to the fraught negotiations to come as Congress labors to pass a stopgap spending bill that would keep the federal government running past Oct. 1 or risk a federal shutdown.

Long COVID’s Link to Suicide: Scientists Warn of Hidden Crisis

Reuters reported:

Long COVID is a complex medical condition that can be hard to diagnose as it has a range of more than 200 symptoms — some of which can resemble other illnesses — from exhaustion and cognitive impairment to pain, fever and heart palpitations, according to the World Health Organization.

There is no authoritative data on the frequency of suicides among sufferers. Several scientists from organizations including the U.S. National Institutes of Health and Britain’s data-collection agency are beginning to study a potential link following evidence of increased cases of depression and suicidal thoughts among people with long COVID, as well as a growing number of known deaths.

Among key questions now being examined by researchers: does the risk of suicide potentially increase among patients because the virus is changing brain biology? Or does the loss of their ability to function as they once did push people to the brink, as can happen with other long-term health conditions?

Billionaire-Backed Group Steps up Hunt for Long COVID Treatment

Forbes reported:

A group of top researchers, clinicians and patients stepped up efforts to combat Long COVID on Thursday, launching a new billionaire-backed initiative to search for drivers of the poorly understood condition and ultimately find treatments to help the millions of people around the world living with the disease.

The Long COVID Research Initiative (LCRI) hopes to accelerate efforts to understand and treat Long COVID, a sometimes disabling condition that lingers for months or years after infection with SARS-CoV-2, the virus that causes COVID-19.

The group’s first goal — supported by $15 million dollars in funding from Balvi, a scientific investment fund led by crypto mogul and Ethereum co-founder Vitalik Buterin — will be to investigate the causes of Long COVID, with a particular focus on whether the virus stubbornly persists in the body after initial infection.

Vitamin D Supplements Won’t Shield You From COVID, Studies Find

U.S. News & World Report reported:

While vitamin D got some attention early in the pandemic, it does not reduce the risk of either COVID-19 or other respiratory infections, two new clinical trials found.

Both studies, one done in the United Kingdom and the other in Norway, found that boosting levels of vitamin D in adults during the pandemic didn’t help protect against respiratory viruses, even though byproducts from the vitamin have long been noted for their support of immune responses to viruses and bacteria.

Limitations were that in the British trial, participants who were taking vitamin D knew it and about half of the control group took a vitamin D supplement on at least one occasion during the trial. In Norway, limitations were that participants were young and healthy and those tested started the trial with adequate vitamin D levels.

Both studies were published online on Sept. 7 in the BMJ.

Sep 07, 2022

Providers Report Dozens of Errors Giving Pfizer’s COVID Vaccine + More

Providers Report Dozens of Errors Giving Pfizer’s COVID Vaccine. Experts Worry New Boosters Will Fuel More.

USA TODAY via Yahoo!News reported:

At least 87 times in the last few months, a healthcare provider has given a young child the wrong dose of the COVID-19 vaccine. Luckily, none resulted in a serious medical problem, according to the Centers for Disease Control and Prevention.

But it shows the challenge of delivering a vaccine that comes in multiple doses from different companies, some that require diluting and others that don’t. The decision last week to add new COVID-19 boosters for everyone over 12 adds another layer of complexity.

Add to the mix new monkeypox vaccines, which have a delivery system most providers haven’t used before, and the onset of the annual flu shot season — administering vaccines today can be complicated.

According to the CDC’s VAERS reporting system, 87 dosage mistakes were made when giving a Pfizer-BioNTech COVID-19 vaccine to a child younger than 5, representing 18% of the reported errors with that vaccine in that age group but only a fraction of the total 890,000 shots administered.

Nearly 1 in 4 Young U.S. Adults Sought Mental Healthcare During Pandemic

U.S. News & World Report reported:

The stresses of the COVID-19 pandemic may have led to a significant jump in the number of young American adults seeking help for mental health woes, new data shows.

Between 2019 and 2021, the percentage of American adults overall who said they’d sought and received any mental health treatment over the past year rose from 19.2% to 21.6%, according to a report from the National Center for Health Statistics at the U.S. Centers for Disease Control and Prevention.

But the rise was concentrated among younger adults — those aged 18 to 44. In this group, the receipt of mental healthcare rose from 18.5% in 2019 to 23.2% in 2021. That means that close to 1 in every 4 young American adults is now battling some mental health issue.

White House: COVID Boosters Will Become Annual Shot, Just Like the Flu Vaccine

Politico reported:

The Biden administration said Tuesday that it is rolling out the newest COVID-19 booster and anticipates that going forward, Americans can expect to get annual updates to the shot just like they do for the flu vaccine.

“This week, we begin a new phase in our COVID-19 response. We are launching a new vaccine — our first in almost two years — with a new approach. For most Americans, that means one COVID-19 shot, once a year, each fall,” President Joe Biden said in a statement.

His remarks show that the administration is now validating a change in the nation’s COVID response policy, which officials have telegraphed for several months.

At a White House press briefing earlier Tuesday Anthony Fauci, Biden’s chief medical adviser, had suggested that the policy change was coming soon. But that single yearly shot prediction hinges on the lack of “any new variant curve balls,” White House coronavirus response coordinator Ashish Jha said earlier Tuesday.

What You Need to Know About ‘Original Antigenic Sin’ With Fall COVID Boosters Around the Corner

ABC News reported:

With new COVID variant-specific booster shots set to roll out in the coming week, vaccine scientists argue that more research is needed to understand how a person’s early immune response — either through vaccination or infection itself — may impact future protection against a constantly evolving virus.

The body learns its best defensive moves during its first encounter with a virus, according to experts. However, once a virus evolves, the immune system is slower to respond. That is a phenomenon called “original antigenic sin,” or “immune imprinting.”

Some experts say they are concerned that frequent boosting with the original version of the vaccine may have inadvertently exacerbated immune imprinting. At this point in the pandemic, some adults have received four or more doses of the same vaccine.

Although still theoretical, some scientists worry about a potential backfire, with frequent boosting handcuffing the body’s natural immune system and leaving it exposed to radically different variants that might emerge in the future.

People Who Recently Caught COVID Can Wait a Few Months to Get Omicron Booster, Top Health Official Says

CNBC reported:

People who recently caught COVID can wait a few months to get a new Omicron booster, White House COVID response coordinator Dr. Ashish Jha said on Tuesday.

Studies have found people who caught COVID after vaccination have substantial protection against the virus, though the data is based on Omicron variants that are no longer circulating in the U.S. and immunity wanes over time.

It’s unclear how long people are protected after recovering from a BA.5 infection, Jha said in July. The CDC previously thought that infection provided about 90 days of protection, though it’s become more common for people to get reinfected before then, Jha said.

Mystery as to Why New COVID Variants Have Stalled in Growth

ABC News reported:

Throughout much of the pandemic, there has been a constant shifting in terms of which COVID-19 variants are most dominant, at a given time, in the U.S.

However, for the last five weeks, federal data shows that there has been little to no growth in the different proportions of COVID-19 variants in the country.

For more than nine months, the Omicron variant, and its subvariants, have been dominant in the U.S. But now, health experts say it is unclear why the growth of the Omicron strains appears to have stagnated, or why it is that no other significant variants have emerged to challenge its dominance.

Combined, the BA.4 and BA.5 subvariants account for nearly 100% of new cases in the U.S., according to the CDC data.

How Nasal-Spray Vaccines Could Change the Pandemic

Nature reported:

Are sprays the future of COVID-19 vaccines? That’s the hope of dozens of research groups and companies working on new kinds of inoculation. Rather than relying on injections, these use sprays or drops administered through the nose or mouth that aim to improve protection against the virus SARS-CoV-2.

This week, an inhaled version of a COVID-19 vaccine, produced by the Chinese company CanSino Biologics in Tianjin, was approved for use as a booster dose in China.

It’s one of more than 100 oral or nasal vaccines in development around the world. In theory, these vaccines could prime immune cells in the thin mucous membranes that line cavities in the nose and mouth where SARS-CoV-2 enters the body, and quickly stop the virus in its tracks — before it spreads.

Vaccine developers hope that these ‘mucosal’ vaccines will prevent even mild cases of illness and block transmission to other people, achieving what’s known as sterilizing immunity. A few mucosal vaccines are already approved for other diseases, including a sprayable vaccine against influenza.

Biden Administration Awards $20 Million Contract to Expand Monkeypox Response

The Hill reported:

The Department of Health and Human Services (HHS) on Tuesday announced it was awarding a nearly $20 million contract to AmerisourceBergen to expand the distribution of treatments and vaccines to respond to the ongoing monkeypox outbreak.

The $19.8 million contract to AmerisourceBergen, one of the largest drug distribution companies in the U.S., will allow for the shipment of up to 2,500 shipments of frozen Jynneos vaccine vials as well 2,500 “ambient temperature” shipments of the Tpoxx antiviral treatment per week.

HHS said about 800,000 vials of Jynneos and 37,000 courses of Tpoxx have been distributed across the country so far. As of last week, more than 352,000 doses of vaccines to treat monkeypox have been administered.

No deaths directly caused by monkeypox have been confirmed so far, though one man in Texas who was “severely immunocompromised” did recently die after having been diagnosed with monkeypox.

Sep 06, 2022

Bats Should Not Be Blamed for COVID, Say Israeli Researchers + More

Bats Should Not Be Blamed for COVID, Say Israeli Researchers

The Jerusalem Post reported:

More than two-and-a-half years after COVID-19 was first discovered and blamed on bats in China, researchers at Tel Aviv University (TAU) have declared that this correlation between the pandemic and flying mammals “was not based on sufficient compelling scientific proof and caused unnecessary stress and confusion worldwide. Bats have a highly effective immune system that enables them to deal relatively easily with viruses considered lethal for other mammals.”

“The comprehensive study we’ve conducted raises serious doubts regarding the possibility of bats being the origin of the COVID-19 outbreak. The findings give rise to the opposite perspective, according to which we must study in-depth the immunological anti-viral capabilities of bats and thus obtain new and effective means of coping in humanity’s struggle against a contagious disease, aging and cancer,” the researchers concluded.

Trauma, Time and Mental Health — New Study Unpacks Pandemic Phenomenon

The Washington Post reported:

Did you lose track of time during the early days of the pandemic? If so, you’re not alone. A new study says a majority of Americans experienced time distortions at the beginning of the pandemic, which are common during traumatic times.

Researchers say those who lost their time sense could be at greater risk for mental health disorders — such as depression and anxiety — and screening for time distortions could help get treatment to those who need it.

In a study published in the journal Psychological Trauma: Theory, Research, Practice, and Policy, researchers surveyed a nationally representative sample of 5,661 U.S. adults about their mental health in March-April and September-October 2020. Participants answered questions about their experiences with the coronavirus, their history of stressful life events and their financial and life stressors related to the virus.

The pandemic was “an unprecedented, protracted collective trauma,” the researchers write. Though more research is needed, they conclude that time distortion is probably associated with mental health symptoms in the pandemic.

New Omicron Boosters Are Now Available, but It’s Unclear How Effective They Will Be

CNBC reported:

The U.S. authorized the first major makeover of the COVID-19 vaccines this week in an effort to stem an expected tide of infections and hospitalizations this fall.

But it’s unclear how much protection the new booster shots will provide. The Food and Drug Administration and the Centers for Disease Control and Prevention cleared the shots without any data from clinical trials that are testing the reformulated doses in humans.

The new boosters, authorized for people ages 12 and older, target the highly contagious and immune-evasive Omicron BA.5 subvariant that has caused a wave of breakthrough infections over the summer. The shots also target the original strain of the virus that first emerged in Wuhan, China, in 2019.

Deaths and hospitalizations have climbed since April among the elderly, the most-vaccinated age group in America, as Omicron has continued to mutate into more and more transmissible subvariants that dodge the protection of the original vaccines, according to Heather Scobie, a CDC epidemiologist.

COVID Pandemic Has Brought a Life-Threatening Infection Spike in Hospitals, Raising Serious Concerns

The Epoch Times reported:

During the COVID-19 pandemic, a life-threatening infection of a superbug spiked in hospitals, raising a big concern.

MRSA, which stands for methicillin-resistant Staphylococcus aureus, is one of the well-known superbugs, bacterias resistant to most antibiotics.

Since 2010, laboratory-identified cases of MRSA infection have been significantly decreasing. However, as the COVID-19 pandemic swept through the United States, hospitals have experienced an increase in the number of MRSA infections. The hospital overload has resulted in higher healthcare-associated infections.

During the fourth quarter of 2020, the national MRSA bacteremia standardized infection ratio was 34% higher than that of 2019. Several states reported even greater increases in 2020, such as Arizona with an 80% increase and New Jersey with a 99% increase.

China Approves World’s First Inhaled COVID Vaccine for Emergency Use

CNN World reported:

China has become the first country to green-light an inhaled COVID-19 vaccine, paving the way for the potential use of the needle-free product in the country, where suppressing the spread of COVID-19 remains a top priority.

The vaccine maker, CanSino Biologics, said in a statement Sunday that China’s medicines regulator had approved the inhaled dose for emergency use as a booster vaccine.

The product, known as Convidecia Air, delivers a vaccine dose through a puff of air from a nebulizer that is then inhaled by mouth. CanSino’s injected Convidecia COVID-19 vaccine is already in use in China and has been approved in a handful of other countries.

Meet Mary Wakefield, the Nurse Administrator Tasked With Revamping the CDC

Kaiser Health News reported:

It’s been a rough couple of years for the Centers for Disease Control and Prevention. Facing a barrage of criticism for repeatedly mishandling its response to the COVID-19 pandemic and more recently monkeypox, the agency has acknowledged it failed and needs to change.

CDC Director Dr. Rochelle Walensky has tapped Mary Wakefield — an Obama administration veteran and nurse — to helm a major revamp of the sprawling agency and its multibillion-dollar budget. Making the changes will require winning over wary career CDC scientists, combative members of Congress, and a general public that in many cases have stopped looking to the agency for guidance.

Wakefield will have to navigate rough waters in the wake of a series of missteps by the agency. The CDC botched the COVID testing rollout early in the pandemic, issued confusing guidance on prevention measures such as masking and quarantining and has been slow to release scientific findings on the fast-moving coronavirus.

Could High-Dose Folic Acid Raise COVID Risks?

U.S. News & World Report reported:

Folic acid, a B vitamin that’s used widely to fortify foods and lower the risk of birth defects, may carry a hidden risk for those who have to take huge quantities of it: A new study shows those folks were more likely to get COVID-19 and to die from it.

“We examined whether COVID-19 diagnosis and death were related to the large doses of folic acid — five times the safe upper limit — prescribed to patients for a variety of medically approved indications,” said study co-author Dr. Ralph Green, an expert on B vitamins from the University of California, Davis. “We found that the risk of becoming infected and dying from COVID-19 was significantly greater in the group treated with folic acid.”

Some patients taking methotrexate, a drug used to treat some cancers and autoimmune diseases, also take folic acid to help reduce side effects from the folate-inhibiting drug. Interestingly, the study found that methotrexate countered any increased COVID risk for those patients.

Green said he was first motivated to investigate the link between folic acid supplementation and COVID by studies published last year in Nature Communications. That research suggested that SARS-CoV-2 uses a host’s folate to replicate. That means the virus may be sensitive to both folate and folate inhibitors like methotrexate.

Anger at Plans to Roll Back COVID Vaccines to Under-11s in England

The Guardian reported:

The decision to reduce the number of children who are offered COVID jabs has prompted an outcry from parent groups and academics.

The U.K. Health Security Agency (UKHSA) said children who had not turned five by the end of last month would not be offered vaccination. The agency said the offer of COVID jabs to healthy five to 11-year-olds was always meant to be temporary.

UKHSA’s Green Book, which provides information on the vaccine rollout for public health professionals, states: “Subject to further clarification, on-going eligibility in 2022/23, after the one off-program, is expected to be for children in the academic years where children are aged 11 or 12 years.”

Adam Finn, professor of pediatrics at the University of Bristol, and a member of the Joint Committee on Vaccination and Immunisation (JCVI), pointed out that in the U.K., the proportion of parents who had chosen to have their young children immunized had been small, despite the offer being open.

The COVID Pandemic May Be Making Other Diseases Worse

Bloomberg reported:

There was severe liver inflammation in kids in April, monkeypox in May, polio in July and “tomato flu” in August. Each appears to be the result of an unusual manifestation or proliferation of a virus scientists have studied for decades. So why are they a problem now?

“Viruses have been doing strange things since the COVID pandemic started,” Sarah Pitt, a principal lecturer in the University of Brighton’s school of applied sciences, wrote in a recent article about a freaky tomato-shaped rash in India. Turns out, it wasn’t an exotic new pathogen, but Coxsackie A16, a common cause of hand, foot and mouth disease.

“You’ve got the best part of 100 million to half a billion people in the world who are very changed in their capacity to respond to viruses,” microbiologist Brendan Crabb, who is director of Melbourne’s Burnet Institute, told me over Zoom. “There’s no way that can mean business as normal for microbial ecology.”

Crabb sees at least three potential consequences for the immune dysfunction left in COVID’s wake:

Pfizer, BioNTech Seek to Revoke CureVac’s Patent Infringement Claims

Reuters reported:

Pfizer (PFE.N) and its German partner BioNTech have filed proceedings at the High Court of England and Wales, seeking a judgment that their COVID-19 vaccine, based on mRNA technology, does not infringe on CureVac’s European patents, according to a regulatory filing on Friday.

In July, CureVac filed a patent lawsuit against BioNTech over its use of mRNA technology, seeking fair compensation from the company and two subsidiaries for infringement of its intellectual property rights.

Pfizer and BioNTech later filed a complaint with a U.S. district court, seeking a judgment that they did not infringe U.S. patents held by CureVac.

Pfizer and BioNTech are also facing patent infringement lawsuits from other companies. Last month, rival mRNA vaccine maker Moderna filed a patent lawsuit against the companies related to their COVID-19 shot.

Britain Approves Pfizer/BioNTech’s Updated COVID Booster Vaccine

Reuters reported:

Britain’s medicines regulator on Saturday approved Pfizer (PFE.N)/BioNTech’s (22UAy.DE) updated bivalent COVID-19 booster shot for people aged 12 years and older.

The Medicines and Healthcare products Regulatory Agency said the decision was based on data from a clinical trial that showed a booster dose with the bivalent Pfizer/BioNTech vaccine triggers a strong immune response against both the Omicron and the original strain.

The Biden Administration Is Gambling That a Little-Studied Vaccine Can Stop Monkeypox

Politico reported:

Since monkeypox began its unprecedented spread through the nation in May, more than 352,600 people in the U.S. have placed their trust in a vaccine that has never undergone trials to evaluate how well it fights the virus in humans.

The vaccine was designed to prevent smallpox, a related virus, and studies conducted by its Danish manufacturer have shown it works against monkeypox too, in animals.

Much less is known about how it works in people. But the Biden administration is gambling not only that it will work, but also that it can stop another debilitating, communicable disease from becoming endemic in the U.S., as it has been for decades in parts of Africa.