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Covid News Watch

Oct 21, 2022

Pfizer Expects to Hike U.S. COVID Vaccine Price to $110-$130 per Dose + More

Pfizer Expects to Hike U.S. COVID Vaccine Price to $110-$130 per Dose

Reuters reported:

Pfizer Inc. expects to roughly quadruple the price of its COVID-19 vaccine to about $110 to $130 per dose after the United States government’s current purchase program expires, Pfizer executive Angela Lukin said on Thursday.

Lukin said she expects the vaccine — currently provided for free to all by the government — will be made available at no cost to people who have private insurance or government-paid insurance.

Reuters earlier on Thursday reported that Wall Street was expecting such price hikes due to weak demand for COVID vaccines, which meant vaccine makers would need to hike prices to meet revenue forecasts for 2023 and beyond.

The U.S. government currently pays around $30 per dose to Pfizer and German partner BioNTech SE (22UAy.DE). In 2023, the market is expected to move to private insurance after the U.S. public health emergency expires.

CDC Advisers Recommend Adding COVID Shots to Routine Immunization Schedules for Kids, Adults

Politico reported:

The CDC’s independent vaccine advisers voted 15-0 Thursday to add most COVID-19 vaccines offered in the U.S. to the childhood, adolescent and adult immunization schedules.

COVID vaccines’ inclusion on the schedules doesn’t constitute mandates, particularly for schoolchildren, which are the purview of states, localities or jurisdictions, depending on local laws. Still, the committee’s vote sparked controversy and debate on social media about what the additions mean for vaccine requirements after Fox News’ Tucker Carlson asserted Tuesday that the CDC would trigger mandates for students.

Advisory panel member Matthew Daley, a senior investigator at the Institute for Health Research at Kaiser Permanente Colorado, said, “I will acknowledge … there is symbolism in adding COVID-19 to the childhood immunization schedule, and that symbolism is that we view this as routine and that we view this as COVID is here to stay.”

CDC: Monovalent Vax Has ‘Limited’ Protection Against BA.4/5 Hospitalization — Vaccine Effectiveness Against Latest Variants Declined to 29% at 4 Months After Third Dose

MedPage Today reported:

A monovalent mRNA booster dose offered “limited” protection against COVID-related hospitalizations from the currently circulating Omicron variants, a CDC analysis found, likely due to the waning effects of the vaccines and potentially more immune evasion with BA.4/BA.5.

During the period of BA.4/BA.5 specifically, protection against hospitalization declined from 60% (95% CI 12-81) in the first 4 months from the third dose to 29% (95% CI 3-48) thereafter, according to their findings in the Morbidity and Mortality Weekly Report (MMWR).

A second study, also published in MMWR, showed similar declines for individuals with immunocompromising conditions during the period of Omicron predominance. Vaccine effectiveness against COVID-related hospitalizations with three doses was 67% (95% CI 63-71) during the BA.1 period in this population, which fell to 32% (95% CI 22-42) during periods of BA.2/BA.2.12.1 and BA.4/BA.5 circulation, according to researchers led by Amadea Britton, MD, also of the CDC’s COVID-19 Emergency Response Team.

Cases of BQ.1/BQ.1.1 Variants Double in U.S., Europe Warns of Rise

Reuters reported:

U.S. health regulators on Friday estimated that BQ.1 and closely related BQ.1.1 accounted for 16.6% of coronavirus variants in the country, nearly doubling from last week, while Europe expects them to become the dominant variants in a month.

The European Centre for Disease Prevention and Control said the variants are likely to drive up cases in the coming weeks to months in the European region.

The two variants are descendants of Omicron‘s BA.5 subvariant, which is the dominant form of the coronavirus in the United States. Regulators in Europe and the U.S. have recently authorized vaccine boosters that target it.

‘No Quick Fixes’: Walensky’s Push for Change at CDC Meets Reality

Politico reported:

The CDC’s new push to get information about health crises out faster to Americans is already running up against its limited authority, congressional inaction and the agency’s own entrenched culture.

In August, Director Rochelle Walensky ordered an overhaul of the CDC after its bungled COVID-19 response, including a drive to share research and data sooner and be more open with the public about what agency scientists do — and don’t — know.

But the CDC’s inability to compel states to share information about disease outbreaks is getting in the way of the effort, said Walensky, who added that the agency needs more money from Congress to draw in new talent and train the public health workforce to speed up the information flow to the public.

In an interview with POLITICO, Walensky said it is critical for the CDC to communicate with Americans more quickly — even when it doesn’t know everything.

What Europe’s COVID Wave Means for the U.S.

The Atlantic reported:

Winter is coming. Again. For the past two years, colder temperatures have brought seasonal COVID upticks, which turned into massive waves when ill-timed new variants emerged. In Western Europe, the first part of that story certainly seems to be playing out again. Cases and hospitalizations started going up last month. No new variant has become dominant yet, but experts are monitoring a pair of potentially troubling viral offshoots called BQ.1 and XBB.

“We have the seasonal rise that’s in motion already,” says Emma Hodcroft, a molecular epidemiologist at the University of Bern, in Switzerland. If one of these new variants comes in on top of that, Europe could end up with yet another double whammy.

The U.S. may not be far behind. America’s COVID numbers are falling when aggregated across the country, but this isn’t true in every region. The decline is largely driven by trends in California, says Samuel Scarpino, the vice president of pathogen surveillance at the Rockefeller Foundation’s Pandemic Prevention Initiative. In chillier New England, hospitalization numbers have already ticked up by as much as nearly 30%, and more virus is showing up in wastewater, too.

Telemedicine Works. But States Are Killing It off.

NBC News reported:

Texans dodged a bullet Wednesday when Gov. Greg Abbott decided to extend the state’s COVID-19 disaster declaration and, with it, to avoid extinguishing one of the few bright lights of the pandemic. Thanks to the extension, Texans can continue the expanded access to telemedicine conferred under the declaration. But the extension is only certain for the next month. Without recertification, the Lone Star State will join the 39 others that have re-erected their pre-COVID barriers to telehealth.

Red tape and restrictions on telemedicine — healthcare services provided to patients remotely via the internet or telephone — need to be removed to make such care viable, particularly state licensing requirements and insurance reimbursement policies that require in-person visits. During the pandemic, states and insurers overnight did what years of advocacy for telemedicine had failed to accomplish.

Now, though, as the country works its way back to a “new normal,” fewer states are maintaining any of the loosened requirements. If the exemption in Texas expires, only 10 states will provide the waivers that continue to make telehealth more accessible.

Oct 20, 2022

Let’s Make Sure Lab-Grown Viruses Stay in the Lab + More

Let’s Make Sure Lab-Grown Viruses Stay in the Lab

Bloomberg reported:

Researchers at Boston University sparked alarming headlines this week by creating a more lethal version of the Omicron COVID variant. At the heart of the uproar is the fact that the researchers didn’t have any obligation to inform anyone beyond an internal review board about what they were doing. Some officials at the National Institutes of Health only heard about the research through the media.

Another recent development could prove even more concerning: Nature reported last week on plans for 40 new virology labs being built around the world. Known as BSL-4 labs, designed to deal with the most dangerous pathogens, they’re being built in India, Singapore, the Philippines, Kazakhstan and Russia, among other countries.

The ostensible aim is to make us safer, but even before this current pandemic, some virologists saw these BSL-4 labs as a problem — the germ equivalent of nuclear proliferation.

European Medicines Agency Recommends Comirnaty and Spikevax COVID Vaccines for Children Over 6 Months

Times Now News reported:

The European Union‘s drug watchdog on Wednesday recommended Pfizer and Moderna‘s COVID-19 jabs for children aged six months and up. The vaccines were recommended by the European Medicines Agency (EMA) amid growing fears of the winter wave of COVID-19.

“EMA’s human medicines committee (CHMP) has recommended extending the use of Comirnaty and Spikevax targeting the original strain of SARS-CoV-2,” the EU’s drug watchdog said in a statement.

The committee recommended the use of Comirnaty for children aged six months to four years and the use of Spikevax in children aged six months to five years. Notably, Comirnaty and Spikevax are already approved in both adults and children aged five and six years respectively. Comirnaty is Pfizer-BioNTech’s vaccine, while Spikevax is Moderna‘s COVID-19 jab.

The agency said that doses of both vaccines in the younger age groups will be lower as compared to doses for already authorized age groups above five years. The EMA also approved a separate shot by Moderna against the BA.4 and BA.5 strains of the Omicron variant of coronavirus.

NIH Probes Whether Boston University COVID Experiments Should Have Triggered Review

CBS News reported:

The National Institutes of Health is now examining whether experiments performed at Boston University should have triggered a federal review, the agency says, after scientists at the school tested strains they created of the COVID-19 virus combining the ancestral and Omicron variants.

Federal health authorities say they are looking into whether the scientists should have sought their permission before undertaking research that could lead to a “gain of function” in the virus gaining new or enhanced abilities, which can be “inherently risky.”

And locally, a spokesperson for the Boston Public Health Commission says it is now reviewing application materials from the study’s scientists “to confirm that the research was conducted in conformity with protocols and that they were properly overseen.” The commission approved a proposed research protocol submitted by the scientists in March 2020, the spokesperson said.

However, Boston University says its research followed “all required regulatory obligations and protocols” to safely experiment with the viruses. The scientists were studying what role the Omicron variant’s highly-mutated spike protein might play in its generally milder severity compared to previous waves.

Analysis: Falling Demand for COVID Boosters Puts Price Hikes on the Table

Reuters reported:

With most Americans delaying or skipping new COVID-19 booster shots, analysts and investors are now predicting far fewer will be given each year, pushing the number of shots well below annual flu vaccinations.

With fewer shots needed, vaccine makers including Pfizer Inc., partner BioNTech SE, rival Moderna Inc. (MRNA.O) and Novavax Inc. (NVAX.O) could have to hike prices as much as three times current levels if they hope to meet Wall Street revenue forecasts for the shots for 2023 and beyond, several analysts said.

Last year, many on Wall Street were estimating the number of COVID-19 shots would be in line with the annual flu vaccine, which is the vaccine market leader with more than 160 million shots per year in the United States and 600 million shots globally.

Now the slowing pace of the early COVID revaccination campaigns — particularly in the key U.S. market — is changing that view. A recent poll by Kaiser Family Foundation found that two-thirds of American adults do not plan on getting a COVID vaccine soon. Analysts are expecting the U.S. market to be as low as one-third the size of the flu.

Uninsured Kids Will Still Receive COVID Vaccines for Free After Shots Move to Commercial Market

CNBC reported:

The Centers for Disease Control and Prevention took a major step Wednesday toward ensuring that kids who are uninsured can receive COVID-19 vaccines for free after the federal government shifts its immunization program to the commercial market.

The CDC’s independent advisors voted unanimously on Wednesday to include COVID shots authorized for kids by the Food and Drug Administration in the federal government’s Vaccines for Children program.

The Vaccines for Children program provides vaccines to kids under age 19 whose families cannot afford them. Children are eligible for the program if they qualify for Medicaid or are uninsured, underinsured or Native American.

The federal government has been providing COVID vaccines to everyone in the U.S. for free during the pandemic. But the Biden administration is working on a plan to transition the vaccination program to the commercial market as soon as 2023, which means people will have to start paying for the shots.

Swiss to Destroy 9 Million Expired Moderna COVID Jabs

Reuters reported:

Switzerland will destroy 9 million doses of Moderna (MRNA.O) COVID-19 vaccine that have reached their expiry date, with another 5.1 million vaccine jabs set to meet the same fate by February, the government said on Wednesday.

The wastage reflects the Swiss strategy of ordering more vaccines than it needed to ensure its population of around 8.7 million would get sufficient supplies even in the event of supply bottlenecks or quality issues.

Other countries too have destroyed hundreds of millions of doses of expired vaccines.

Omicron Subvariants Reflect a ‘Viral Evolution on Steroids’

NBC News reported:

An Omicron subvariant is once again demonstrating immune-dodging abilities, posing a threat to both vaccinated and previously infected individuals.

A report published Wednesday in the New England Journal of Medicine suggests that the subvariant, called BA.4.6, could drive reinfections.

These subvariants are far from the only strains that experts worldwide are keeping their eyes on. Other Omicron subvariants that have piqued the interest — and concerns — of scientists read like a viral alphabet soup: BQ.1, BQ.1.1, BF.7. (Those three, as it turns out, each account for around 5% of new U.S. cases.)

Gone are the days of identifying COVID by Greek letters, such as Alpha and Delta. Ever since the Omicron variant emerged, it’s been Omicron all the way down, with Omicron subvariants splitting off into their own subvariants.

The Extraordinary Rise and Fall of the COVID Billionaires

Bloomberg reported:

In a little less than three years, COVID-19 has changed everything: how we live, work and play, educate our kids. And, it turns out, how vast wealth can be made — and lost — faster than anyone might’ve thought possible.

The roll-out of Moderna Inc.’s vaccine propelled scientist Stephane Bancel’s net worth to $15 billion as the shares soared almost 2,400%. Eric Yuan, denied a U.S. visa eight times before moving from China, watched his fortune hit $29 billion as Zoom Video Communications Inc. became the world’s go-to video-conferencing tool. And the father-son duo behind online used-car seller Carvana Co. amassed a $32 billion fortune at the peak.

The men belong to an exclusive club of 58 billionaires whose wealth multiplied at an eye-popping pace thanks to changes brought about by COVID and cheap money, only to plummet even quicker. Their rise and subsequent slump were sharper than the other 131 members of the Bloomberg Billionaires Index whose net worth more than doubled but weren’t as reliant on how COVID altered lives across the globe.

Together, they’re a monument to these strange financial times that both spawned extraordinary fortunes and plunged legions into extreme poverty.

What We Know and Don’t Know About Long COVID

The Hill reported:

After two years of research and one of the largest public health campaigns in human history, doctors and scientists don’t yet have a test to detect the mysterious affliction called long COVID-19, let alone a head count of the afflicted.

Based on the latest wave of studies, long COVID-19 may beset 4% of the population who catch the virus, or 14.8% or 48%. Its toll on the body spans dozens of possible symptoms, from fatigue to chest pains to fuzzy thinking to hair loss. The symptoms overlap with those seen in scores of other illnesses.

Many long COVID-19 cases clear up after several months or a year. Some seem to be permanent. Only time will tell. A long COVID-19 study released last week by Scottish researchers raised eyebrows around the globe. Six to 18 months after COVID-19 infection, 48% of people surveyed said they had not fully recovered.

That report is an outlier. The World Health Organization puts the prevalence of long COVID-19 at 10 to 20%. Other recent estimates range across the map. An ongoing survey by British health officials, updated in July, found long COVID-19 in only 4% of cases. A Canadian government survey, updated this week, found that 14.8% of adults with COVID-19 retained symptoms three months after infection. A U.S. government survey, updated this month, found that 30% of adults who had the coronavirus believed they had experienced long COVID-19.

Study Debunks Use of Antidepressant Luvox as COVID Treatment

U.S. News & World Report reported:

A study testing drugs that are used for other conditions for their potential in treating COVID-19 has found that the antidepressant fluvoxamine (brand name Luvox) offered no benefit, at least at an initial smaller dose. Study participants took 50 mg of the medication twice daily for 10 days, hoping to treat mild-to-moderate COVID-19 symptoms. A control group took a placebo.

The institute led the study in partnership with Vanderbilt University in Nashville, Tenn. It was part of ACTIV-6, a nationwide virtual study. The researchers looked at rates of sustained recovery — or three days without symptoms. About 75% of participants were still reporting symptoms at day seven, though 82% of them reported no limitation in activities.

Fluvoxamine is one of three U.S. Food and Drug Administration-approved repurposed medications being tested in ACTIV-6. A selective serotonin reuptake inhibitor used to treat obsessive-compulsive disorder and depression, it was chosen because previous evidence suggested it might reduce inflammation from the virus.

WHO: COVID Vaccination Rates Have Dropped 50% in Africa

Associated Press reported:

The number of COVID-19 vaccine doses given in Africa has dropped by more than 50% over the last three months, the World Health Organization said Thursday, even though less than a quarter of all Africans have been vaccinated.

Despite the increased availability of vaccines on the continent, Africa still lags far behind the global average, with only 24% of the population having completed their primary series of COVID-19 vaccination compared to 64% worldwide.

Africa now has adequate vaccines available, Dr. Matshidiso Moeti, the WHO regional director for Africa, said Thursday. But as case numbers have fallen, so too has an interest in being vaccinated. Only 4,281 new cases were reported on the continent last week — about 1.3% of Africa’s peak during December 2021, the WHO said.

The Black Death Is Still Affecting the Human Immune System

CNN World reported:

The Black Death, the world’s most devastating plague outbreak, killed half of medieval Europe’s population in the space of seven years in the 14th century, shifting the course of human history.

But what about the survivors of what remains the single greatest mortality event ever recorded? New research published Wednesday in the journal Nature suggests it was more than luck that determined who lived and who died.

Analysis of centuries-old DNA from both victims and survivors of the Black Death has identified key genetic differences that helped people survive the plague, according to a study published in the journal Nature.

These genetic differences continue to shape human immune systems today, with genes that once conferred protection against the plague now linked to a greater vulnerability to autoimmune diseases such as Crohn’s and rheumatoid arthritis, the study said.

Oct 19, 2022

CDC Recommends Novavax’s COVID Shots as Mix-and-Match First Booster to Pfizer or Moderna + More

CDC Recommends Novavax’s COVID Shots as Mix-and-Match First Booster to Pfizer or Moderna

CNBC reported:

The Centers for Disease Control and Prevention on Wednesday recommended Novavax COVID boosters for adults in the U.S., including for people who received Pfizer, Moderna or Johnson & Johnson‘s shots as their primary series.

The CDC gave the final go-ahead for pharmacies to start administering the Novavax boosters just hours after the Food and Drug Administration had authorized the shots. Dr. Evelyn Twentyman, a CDC official, announced the Novavax recommendation during a meeting of the agency’s independent vaccine experts Wednesday afternoon.

The CDC recommended Novavax’s boosters without a debate or vote from its independent experts.

The company’s shares jumped by almost 6% in morning trading but were flat by noon.

CDC Could Add COVID Vaccine Requirement for Children to Immunization List With ‘No Clinical Data’: Dr. Makary

Fox News reported:

The CDC‘s Advisory Committee on Immunization Practices (ACIP) is expected to announce later this week that the COVID-19 vaccine will be added to the list of required childhood vaccines.

Johns Hopkins School of Medicine professor Dr. Marty Makary told “Tucker Carlson Tonight” Tuesday it will be the first vaccine added “with no clinical data.”

“There has never been a vaccine added to the child immunization schedule without solid clinical evidence that it reduces disease significantly in the community,” he said. Makary added that the CDC only has data from eight mice on the effects of the Omicron vaccine in young people. White House Coronavirus Response coordinator Dr. Ashish Jha has seen the data on the vaccines’ effects, according to Makary, but it is not publicly available.

If the CDC’s ACIP puts the COVID-19 vaccine on the child immunization schedule, children could be required to get it in order to attend school. The Johns Hopkins professor told host Tucker Carlson, 1 in 5,000 vaccine doses result in a “severe adverse event.” Makary added that it will be up to states to implement the policy if the ACIP passes the vaccine requirement.

Scientists, Doctors, Parents Speak out About Harms of COVID Vaccines

The Epoch Times reported:

Just one day after she got a COVID-19 booster shot, Regan Lewis, a 20-year-old nursing student at Colby Community College in Colby, Kansas, had a heart attack. Her mom, Connie Werth Lewis, desperately asked for prayers for her daughter in a public post on Facebook. That night, Regan Lewis died.

As of Oct. 7, 31,470 deaths have been reported to the Centers for Disease Control and Prevention and Food and Drug Administration via their Vaccine Adverse Events Reporting System, a passive post-market surveillance system designed to help government officials and researchers pick up safety signals about vaccines.

At a recent Sedona conference (where Jennifer Margulis also was a speaker) several physicians pointed out that there has been a growing number of “unexplained” sudden deaths among young people who have received COVID-19 injections as well as booster shots.

That point was made by several of the speakers, including Dr. Sherri Tenpenny, a physician based in Cleveland; and Dr. Jeffrey Barke, a medical doctor in private practice in California. These untimely, age-inappropriate deaths, they pointed out, often were the immediate result of heart dysfunction, blood clots or seizures. But, they said, where there was a history of prior COVID-19 injection, the health condition that ostensibly led to death may actually have been caused by the shots.

Audit Hits N. Dakota on Vaccine Handling; Agency Disputes It

Associated Press reported:

The North Dakota Health Department stored thousands of COVID-19 vaccine doses at incorrect temperatures or without temperature data over the past two years, according to a state audit Tuesday that said some of the vaccines were administered to patients.

The health department disputed the findings. Tim Wiedrich, who heads the agency’s virus response, said: “no non-viable vaccine” was given to patients. In responses that accompanied the audit, the department said clerical errors or other errors of documentation erroneously suggested that expired or bad doses were given.

The state analysis said nearly 2,000 Moderna doses were stored at incorrect temperatures and were administered to patients. The audit also found that nearly 13,000 doses of the Pfizer vaccines were issued from storage with missing temperature data. The audit covered a two-year span that ended on June 30. An inventory of the vaccines was conducted on Aug. 8, 2021, the audit said.

Biden’s Plan for Next Pandemic Eyes Vaccine Supply Within 130 Days

Bloomberg reported:

President Joe Biden’s strategy for the next deadly pandemic calls for the U.S. to produce a test for a new pathogen within 12 hours of its discovery and enough vaccine to protect the nation within 130 days.

Those instructions are outlined in the administration’s plan to defend against biological threats, from naturally occurring infectious diseases to man-made weapons of mass destruction. Known as the National Biodefense Strategy, the new framework seeks to better define the government’s responsibilities, objectives and deadlines in a crisis and places the White House at the center of the response.

Addiction Drug Shows Promise Lifting Long COVID Brain Fog, Fatigue

Reuters reported:

Lauren Nichols, a 34-year-old logistics expert for the U.S. Department of Transportation in Boston, has been suffering from impaired thinking and focus, fatigue, seizures, headache and pain since her COVID-19 infection in the spring of 2020.

Last June, her doctor suggested low doses of naltrexone, a generic drug typically used to treat alcohol and opioid addiction.

Researchers chasing long COVID cures are eager to learn whether the drug can offer similar benefits to millions suffering from pain, fatigue and brain fog months after a coronavirus infection.

The drug has been used with some success to treat a similar complex, post-infectious syndrome marked by cognitive deficits and overwhelming fatigue called myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS).

XBB, BQ.1.1, BA.2.75.2 — A Variant Swarm Could Fuel a Winter Surge

The Washington Post reported:

For two years, coronavirus variants emerged, one by one, sweeping the globe. But this fall and winter are expected to be different: Instead of a single ominous variant lurking on the horizon, experts are nervously eyeing a swarm of viruses — and a new evolutionary phase in the pandemic.

This time, it’s unlikely we will be barraged with a new collection of Greek alphabet variants. Instead, one or more of the multiple versions of the omicron variant that keep popping up could drive the next wave. They are different flavors of Omicron, but eerily alike — adorned with a similar combination of mutations. Each new subvariant seems to outdo the last in its ability to dodge immune defenses.

“It is this constant evolutionary arms race we’re having with this virus,” said Jonathan Abraham, an assistant professor of microbiology at Harvard Medical School.

Will EU Prosecutor’s COVID Vaccine Probe Ensnare Von Der Leyen?

Politico reported:

It’s the scandal that won’t go away — and produces more intrigue than answers. The EU’s public prosecutor’s office on Friday said it was investigating the EU’s purchase of coronavirus vaccines during the pandemic’s peak.

Yet the cagey announcement offered almost no details — nothing on whom it was investigating, what potential crimes it was looking for or why it had taken the step now. Enter the Brussels speculation machine. Its top chatter: Ursula von der Leyen’s texts.

For months, pressure has been piling up on the European Commission president since her admission that she swapped texts with Pfizer Chief Executive Albert Bourla while the EU was negotiating its vaccine contract with the company. Two EU watchdog agencies have already chided her over the matter, venting over the Commission’s refusal to produce the texts.

In April 2021, von der Leyen told the New York Times that she had traded texts with the Pfizer CEO for a month in the run-up to the EU signing its contract with the U.S. pharmaceutical giant. In the deal, the Commission committed to buying 900 million Pfizer-BioNTech shots on behalf of EU members, with an option to purchase another 900 million. The remarks prompted chatter about whether von der Leyen had freelanced during the contract negotiations and circumvented normal channels.

Roche’s COVID Drugs Tumble $1 Billion as New Eye Launch Vabysmo Rushes to Counter Biosimilar-Hit Lucentis

Fierce Pharma reported:

Roche’s COVID-19 therapies Ronapreve and Actemra gave the drugmaker a sales boost a year ago amid a surge in infections. But as cases ebb and new coronavirus variants emerge, sales of the drugs are falling sharply.

Sales from Regeneron-partnered COVID antibody Ronapreve and anti-inflammation med Actemra slid nearly 1 billion Swiss francs year over year in the first nine months of 2022. About 900 million Swiss francs of the drop happened in the third quarter alone, Roche CEO Severin Schwan said during a conference call Tuesday.

Ronapreve’s revenue was nearly wiped out with a 92% decline to just 22 million Swiss francs in the third quarter. And Actemra sales plummeted 42% during the same period to 584 million Swiss francs.

Uganda to Deploy Ebola Vaccine in 2 Weeks, Says WHO Official

Associated Press reported:

Experimental Ebola vaccines will be deployed in Uganda in about “two weeks,” a World Health Organization official said Wednesday, as the East African country carried out tough preventive measures that include a lockdown in the Ebola-hit areas.

Potentially hundreds of thousands of trial vaccine doses will buttress a response effort that still must focus on tracing Ebola contacts and community engagement, Dr. Yonas Tegegn Woldemariam, the WHO representative in Uganda, told The Associated Press.

Vaccines developed by the U.S.-based Sabin Vaccine Institute and Oxford University “are ready to be shipped” to Uganda, which is finalizing protocols for the study before the National Drug Authority issues import permits, he said.

WHO Forced to Ration Vaccine as Cholera Cases Surge Worldwide

The Guardian reported:

A “dire shortage” of cholera vaccines amid an unprecedented rise in global cases has forced health officials to halve the number of doses given to people in outbreak hotspots, the World Health Organization has said.

The “exceptional decision” to reduce the number of doses from two to one would allow for the vaccines to be eked out until the end of the year and given to more people in more countries, the WHO said today.

The organization conceded the move would inevitably lead to a “reduction and shortening of immunity”, adding: “The one-dose strategy has proven to be effective to respond to outbreaks, even though evidence on the exact duration of protection is limited, and protection appears to be much lower in children.”

Oct 18, 2022

Heart Risks, Data Gaps Fuel Debate Over COVID Boosters for Young People + More

Heart Risks, Data Gaps Fuel Debate Over COVID Boosters for Young People

Science reported:

Florida Surgeon General Joseph Ladapo ignited a furor this month when based on a state analysis purporting to show COVID-19 vaccines were linked to cardiac deaths in young men, he advised men ages 18 to 39 to steer clear of the shots. Scientists slammed his warning and decried the eight-page analysis, which was anonymous and not peer-reviewed, for its lack of transparency and flawed statistics.

Still, COVID-19 vaccines do have a rare but worrisome cardiac side effect. Myocarditis, an inflammation of the heart muscle that can cause chest pain and shortness of breath, has disproportionately struck older boys and young men who received the shots. Only one out of several thousand in those age groups is affected, and most quickly feels better. A tiny number of deaths have been tentatively linked to vaccine myocarditis around the world.

But several new studies suggest the heart muscle can take months to heal, and some scientists worry about what this means for patients long term. The U.S. Food and Drug Administration (FDA) has ordered vaccine makers Pfizer and Moderna to conduct a raft of studies to assess these risks.

As they parse emerging data and fret over knowledge gaps, scientists and doctors are divided over whether such concerns should influence vaccine recommendations, especially now that a new COVID-19 wave is looming and revamped boosters are hitting the scene.

Nearly all urge vaccinating young people with the first two vaccine doses, but the case for boosters is more complicated. A key problem is that their benefits are unknown for the age group at the highest risk of myocarditis, who are at lower risk of severe COVID-19 and other complications than older adults.

Biden Admin Unveils New Pandemic Preparedness and Biodefense Strategy

Politico reported:

President Joe Biden is expected to sign a national security memorandum Tuesday that aims to ensure the U.S. is ready to detect and respond to the next large-scale viral or biological threat.

The plan pulls from goals set by the White House Office of Science and Technology Policy that focus on the U.S. investing in research and development of tools that would help expand the country’s early warning systems.

The strategy could take years to implement, another senior administration official said on Monday, noting that the U.S. needs time and resources to develop shots, drugs and tests for potentially dozens of pathogens.

In his 2023 budget, Biden asked Congress for $88 billion over five years to help combat pandemics and biological threats. The funding has yet to be approved, but the administration is moving forward with its expansive plan with the idea that Congress will sign off on the money to help the country prepare for another virus like COVID-19.

New Lab-Made Coronavirus at Boston University Raises Questions

Forbes reported:

This was one of those should-have-seen-it-coming moments. On October 14, a team of researchers posted on bioRxiv a preprint that described how they had created a new hybrid version of the COVID-19 coronavirus in their lab at Boston University and used this lab-created virus to infect mice, which ended up killing 80% of the mice. These days, if you think that posting something that talks about a lab-created virus killing mice wouldn’t create a commotion, then in the words of the heavy metal band Judas Priest, you’ve got another thing coming.

Yep, it wasn’t too long before GOF claims about this research began on social media, with GOF in this case meaning “gain of function” rather than “go on friend.” For example, Senator Roger Marshall, MD, (R-Kansas) tweeted, “This research must stop immediately. It is unconscionable that NIH sponsors this lethal gain-of-function virus research through Boston University and EcoHealth Alliance in densely populated areas, creating the potential to kill more people than any singular nuclear weapon.”

So what’s the truth? Was this truly gain-of-function research where an even more deadly severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) was created? Or was this perhaps loss-of-function research that was indeed of public benefit that could lead to better therapeutic interventions? Or was it something in between? And should the team led by Mohsan Saeed, Ph.D., an Assistant Professor of Biochemistry at Boston University, have taken more precautions before conducting the research and posting the preprint?

Researchers Speed Efforts for Vaccine Against Virus Linked With Mono, MS

CNN Health reported:

Maybe you’ve never heard of the Epstein-Barr virus. But it knows all about you. Chances are, it’s living inside you right now. About 95% of American adults are infected sometime in their lives. And once infected, the virus stays with you.

Scientists have spent years trying to develop vaccines against Epstein-Barr or EBV. But recently several leaps in medical research have provided more urgency to the quest — and more hope for success. In just the past year, two experimental vaccine efforts have made it to human clinical trials.

And just as crucial to the momentum: Advances in vaccine science spurred by the pandemic, including the mRNA technology used in some COVID vaccines, could accelerate the development of other vaccines, including ones against Epstein-Barr, said Dr. Peter Hotez, dean of the National School of Tropical Medicine at Baylor College of Medicine. Hotez co-created a low-cost, patent-free COVID vaccine called Corbevax.

Some researchers question the need for a vaccine that targets a disease like multiple sclerosis, that, while debilitating, remains relatively rare. Eliminating Epstein-Barr would require vaccinating all healthy children even though their risk of developing cancer or multiple sclerosis is small, said Dr. Ralph Horwitz, a professor at the Lewis Katz School of Medicine at Temple University.

Biden COVID Officials Scramble to Plan for Omicron Subvariant Threat

Politico reported:

Top Biden health officials are increasingly concerned about the rise of new COVID variants in the U.S. that appear to evade existing treatments used to protect immunocompromised people from severe illness, according to three senior administration officials.

The variants — known as BQ1 and BQ1.1 — have spread swiftly throughout the U.S. over the past few weeks, and now account for more than 11% of all cases nationwide, according to the Centers for Disease Control and Prevention, roughly double the proportion they represented a week earlier.

The emergence of the “BQs,” as health officials have referred to the variants internally, represents a fresh threat to Biden’s broader pandemic strategy, which has increasingly hinged on shielding vulnerable populations while encouraging a return to normalcy for most other Americans.

The rapid growth of the variants puts them on track to become the dominant strains of COVID within the next month, officials said. While the vaccines and the administration’s main COVID treatment, Paxlovid, still work against those strains, the development could leave hundreds of thousands of people with compromised immune systems vulnerable to a winter wave without the two therapies that they’ve come to rely upon.

The XBB Family of Omicron Has Landed in the U.S. Here’s What It Means for This Fall’s COVID Wave

Fortune reported:

XBB — a new, extremely immune-evasive Omicron variant surging in Singapore — hasn’t yet been detected in the U.S. But its child has. XBB.1 was first detected in the U.S. on Sept. 15 and comprised 0.26% of cases that were genetically sequenced over the past 15 days, Dr. Raj Rajnarayanan, assistant dean of research and associate professor at the New York Institute of Technology campus in Jonesboro, Ark., told Fortune.

He cited data from GISAID, an international research organization that tracks changes in COVID and the flu virus. Only 16 XBB.1 cases have been detected in the U.S. so far, and most have been found in New York — considered a bellwether state due to its volume of incoming international travelers and robust genetic sequencing capabilities, Rajnarayanan said.

XBB is a combination of two different Omicron spawns. It, along with BQ.1.1, is considered to be the most immune-evasive COVID variant so far, surpassing the immune-evasiveness of shared ancestor BA.5, which was dominant across the globe this summer.

Scientists, including top U.S. infectious disease expert Dr. Anthony Fauci, expect a fall and winter wave of cases in the U.S. that begins to surge in October and peaks in January. It’s still unclear which COVID variant may fuel that wave.

U.S. Life Expectancy Drops as Europe Shows Signs of Recovery After COVID, Study Finds

USA TODAY reported:

In 2020, most countries around the world experienced a shocking decline in life expectancy as COVID-19 wreaked havoc on society. But as some countries show signs of recovery, a new study found the United States continues to see its life expectancy in free fall.

Researchers examined data from 29 countries around the world and found seven countries in Western Europe saw a significant increase in life expectancy in 2021, according to the study published Monday in Nature Human Behavior. Four of those countries — France, Belgium, Switzerland and Sweden — returned to pre-pandemic levels.

Meanwhile, the U.S. reported the third-largest decline in life expectancy, following closely behind Bulgaria and Slovakia.

The study is the latest example of how issues relating to the U.S. healthcare system, policies and public behavior, which affected life expectancy before COVID-19, were exacerbated by the pandemic, experts say.

Ports Reveal Unprecedented Surge in Harmful Emissions; Officials Blame COVID Logjam

Los Angeles Times reported:

As a veil of gray exhaust settled over the ports of Los Angeles and Long Beach, Janet Schaaf-Gunter worried about how much more diesel pollution she and her neighbors would be inhaling during the shipping logjam.

At the Port of Los Angeles, cancer-causing diesel particulate matter rose 56% compared with 2020. The emissions of nitrogen oxides, the precursor to smog, increased by 54% while lung-irritating sulfur oxides rose by 145%.

Last year, both ports witnessed a 16% rise in cargo movement as the COVID-19 pandemic stoked demand for e-commerce goods. However, ocean-faring ships tarried in San Pedro Bay as crews struggled to keep up with the pace.

The workforce was also hampered by COVID and pandemic-related precautions that limited the number of crews moving cargo from ships to trucks and trains. Farther inland, some warehouses and distribution centers had also reached storage capacity and suffered labor shortages.

Monkeypox Cases in U.S. Fall, Hit Lowest Level Since June: CDC

ABC News reported:

Monkeypox cases are continuing to decline in the United States as the outbreak keeps showing signs of receding. Trends seen in cities across the country mirror those nationwide.

In New York City — the epicenter of the outbreak — the seven-day average has fallen to 2 as of Oct. 11 from the city’s Department of Health & Mental Hygiene. This is a sharp decline from the peak of 73 recorded in late July and early August.