Miss a day, miss a lot. Subscribe to The Defender's Top News of the Day. It's free.

Fauci Says China Has Done a Bad Job of Vaccinating the Elderly and Their Shots Are Not Very Effective Against COVID

CNBC reported:

Dr. Anthony Fauci, the top infectious disease expert in the U.S., criticized China’s COVID lockdowns as “draconian” and said the Beijing government should focus on vaccinating the elderly.

“The vaccination of the elderly has not been well performed and the vaccine they have has been not a particularly effective vaccine,” Fauci told The Washington Post in an interview on Thursday, as he prepares to step down as director of the National Institute for Allergy and Infectious Diseases later this month.

“If there was any advice, it’s pretty simple and it’s not just coming from me — it’s coming from any number of people involved in this outbreak: Do whatever you can to get your people vaccinated and boosted with a highly effective vaccine,” said Fauci, who has decades of experience in responding to infectious diseases, from the HIV pandemic to the emergence of Ebola.

China uses a domestically developed vaccine called CoronaVac manufactured by Sinovac. The shots contain a killed virus that induces an immune response. Beijing has not approved Pfizer’s and Moderna’s messenger RNA vaccines.

The Chinese Center for Disease Control and Prevention, in a September report, said vaccination rates for older adults are lower in China than in other nations because the elderly are skeptical of the country’s domestically developed vaccine.

The Business of Clinical Trials Is Booming. Private Equity Has Taken Notice.

Kaiser Health News reported:

After finding success investing in the more obviously lucrative corners of American medicine — like surgery centers and dermatology practices — private equity firms have moved aggressively into the industry’s more hidden niches: They are pouring billions into the business of clinical drug trials.

To bring a new drug to market, the FDA requires pharmaceutical firms to perform extensive studies to demonstrate safety and efficacy, which are often expensive and time-consuming to conduct to the agency’s specifications. Getting a drug to market a few months sooner and for less expense than usual can translate into millions in profit for the manufacturer.

That is why a private equity-backed startup like Headlands Research saw an opportunity in creating a network of clinical sites and wringing greater efficiency out of businesses, to perform this critical scientific work faster. And why Moderna, Pfizer, Biogen and other drug industry bigwigs have been willing to hire it — even though it’s a relatively new player in the field, formed in 2018 by investment giant KKR.

In July 2020, Headlands announced it won coveted contracts to run clinical trials of COVID-19 vaccines, which would include shots for AstraZeneca, Johnson & Johnson, Moderna and Pfizer.

Dr. Aaron Kesselheim, a professor of medicine at Harvard Medical School, called private equity involvement in trials “concerning.” “We need to make sure that patients” know enough to provide “adequate, informed consent,” he said, and ensure “protections about the privacy of the data.”

Pfizer and Moderna Launch Mandated Vaccine Myocarditis Studies

The Epoch Times reported:

As reported in a handful of media outlets, Pfizer and Moderna’s new trials closely investigating vaccine myocarditis are underway. As part of its vaccine approval, the FDA has mandated both companies to conduct clinical trials tracking vaccine myocarditis months and years beyond diagnosis.

As NBC reports, “Moderna has already launched two trials, the most recent in September. Pfizer confirmed that at least one of its trials, which will include up to 500 teens and young adults under age 21, is slated to begin in the next couple of months.”

While the clinical myocarditis rate has been quantified in several high-quality studies, many serious concerns remain unaddressed. One major concern is subclinical myocarditis — the rate of serious myocardial symptoms post-vaccination that don’t formally qualify as myocarditis.

The FDA has required Pfizer and Moderna to conduct a “substudy to prospectively assess the incidence of subclinical myocarditis following administration of the second dose of [vaccine] in a subset of participants 5 through 15 years of age.”

Pfizer to Invest More Than $2.5 Billion to Expand European Manufacturing

Reuters reported:

Pfizer Inc. (PFE.N) is investing more than $2.5 billion at its drug-making plants in Belgium and Ireland, gearing up to launch new products it hopes can replace lost revenue as patents expire and COVID-19 vaccine sales decline.

The drugmaker said on Friday it plans to spend more than 1.2 billion euros ($1.26 billion) to expand its Puurs, Belgium, manufacturing site, matching the investment at its Dublin, Ireland, plant announced on Thursday.

The Puurs site has played a key role in the production of COVID-19 vaccine shots Pfizer developed with its German partner BioNTech (22UAy.DE) using messenger RNA (mRNA) technology.

Pfizer’s revenue is expected to top $100 billion this year — more than double its pre-pandemic level — on the strength of sales of its COVID-19 vaccine and treatment Paxlovid. But COVID-related sales are expected to drop sharply over the next few years, and Pfizer also faces the loss of patent protections for some big-selling medicines after 2025, such as cancer treatment Ibrance and arthritis drug Xeljanz.

CDC’s Remote-Work Policy May Hinder Efforts for Agencywide Reform, Experts Say

CNN Health reported:

Earlier this year, top leadership at the Centers for Disease Control and Prevention began a monumental task: turning the sprawling, labyrinthine organization known for its highly specialized, academically focused scientific research into a sleek, flexible public health response agency primed to serve the American public. It’s an attempt to keep the CDC from repeating the mistakes it made while responding to COVID-19.

But agency veterans, outside public health officials, and workplace organization experts said the current workplace structure could be a major barrier to that goal. Like directors before her, agency head Dr. Rochelle Walensky spends a considerable amount of time away from the CDC’s headquarters in Atlanta. The agency has also embraced a workplace flexibility program that has allowed most of its scientists to stay remote.

Experts said the lack of face-to-face work will likely be a substantial obstacle to the top leadership’s effort to overhaul the agency after its failures during the pandemic — a botched testing rollout, confusing safety guidance, the slow release of scientific research and a loss of public trust.

‘Zombie’ Viruses Are Thawing in Melting Permafrost. But Don’t Panic — Yet

The Washington Post reported:

The thawing of the permafrost due to climate change may expose a vast store of ancient viruses, according to a team of European researchers, who say they have found 13 previously unknown pathogens that had been trapped in the previously frozen ground of Russia’s vast Siberian region.

The scientists found one virus that they estimated had been stranded under a lake more than 48,500 years ago, they said, highlighting a potential new danger from a warming planet: what they called “zombie” viruses.

The same team of French, Russian and German researchers previously isolated ancient viruses from the permafrost and published their findings in 2015. This concentration of fresh viruses suggests that such pathogens are probably more common in the tundra than previously believed, they suggest in a preprint study they published last month on the BioRxiv website, a portal where many scientists circulate their research before it is accepted in a scientific journal.

Virologists who were not involved in the research said the specter of future pandemics being unleashed from the Siberian steppe ranks low on the list of current public health threats. Most new — or ancient — viruses are not dangerous, and the ones that survive the deep freeze for thousands of years tend not to be in the category of coronaviruses and other highly infectious viruses that lead to pandemics, they said.

Millions Suffer From Long COVID — and It Costs Them $9,000 a Year in Healthcare Expenses, on Average

CNBC reported:

Long COVID has affected as many as 23 million Americans to date — and it’s poised to have a financial impact rivaling or exceeding that of the Great Recession. By one estimate, the chronic illness will cost the U.S. economy $3.7 trillion, with extra medical costs accounting for $528 billion.

Costs on a household and national scale are tough to quantify because the illness — also known as long-haul COVID, post-COVID or post-acute COVID syndrome — is so new. Anyone with a prior COVID-19 infection is susceptible, regardless of factors such as age, health or vaccine status.

David Cutler, an economist at Harvard University who projected the $3.7 trillion economic cost of long COVID, estimates the individual medical costs of the disease to be about $9,000 a year, on average. However, typical costs can range from roughly $3,700 up to almost $14,000, Cutler said.

Costs can be much higher, depending on the severity of the illness. And because symptoms often impact a person’s ability to work, someone suffering from long COVID may not be able to lean on a regular paycheck — or employer-sponsored health insurance — to help cover those medical bills.

Exclusive: HHS Partners With U.S. Men’s Soccer Team to Promote Updated COVID Vaccines

Axios reported:

The Department of Health and Human Services is partnering with the U.S. national men’s soccer team to promote vaccinations with the updated COVID-19 shot, which are currently at a low.

Driving the news: The updated bivalent COVID shot is available for people aged five and up. However, only around 12% of the U.S. population has received the new booster shot, compared to the 69% that have completed their primary series, per data from the Centers for Disease Control and Prevention.

The big picture: The video is part of HHS’ “We Can Do This” public education campaign, which looks to encourage vaccinations through partnerships with influencers and organizations with large media followings. The department has worked with NASCAR and Major League Baseball in the past to increase the uptake of the updated vaccine.

These Monkeypox Researchers Warned That the Disease Would Go Global

Nature reported:

In May, when monkeypox began to spread across Europe and beyond, many public-health specialists were taken by surprise. But for researchers who have tracked and studied the viral disease for years in Central and West Africa, the only shock was seeing how accurate their predictions were.

“We had always warned that in favorable circumstances, like what led to this outbreak, the disease could pose a great threat to global health,” says Adesola Yinka-Ogunleye, an epidemiologist at the Nigeria Centre for Disease Control (NCDC) in Abuja who led the country’s investigation and response to a 2017 monkeypox outbreak.

Now, with more than 80,000 confirmed cases in over 100 countries, monkeypox is a stark reminder of what happens when such warnings go unheeded. Scientists such as Yinka-Ogunleye and epidemiologist Anne Rimoin, who has worked on monkeypox outbreaks in the Democratic Republic of the Congo (DRC) since 2002, have amassed decades of experience investigating how the virus spreads.

Their fieldwork has helped to inform the global response, and yet much more remains to be uncovered. “There are lots of questions that we need to answer,” says Rimoin, who is based at the University of California, Los Angeles (UCLA).

HIV Vaccine Candidate Induces Immune Response in Early Clinical Trial: ‘an Important Step Forward’

CNN Health reported:

An experimental HIV vaccine has been found to induce broadly neutralizing antibody precursors among a small group of volunteers in a Phase 1 study. The findings suggest that a two-dose regimen of the vaccine, given eight weeks apart, can elicit immune responses against the human immunodeficiency virus.

The clinical trial results, published Thursday on World AIDS Day in the journal Science, establish “clinical proof of concept” in support of developing boosting regimens to induce immune responses against HIV infection, for which there is no cure and which can cause acquired immunodeficiency syndrome, known as AIDS.

“Learning how to induce broadly neutralizing antibodies against pathogens with high antigenic diversity, such as HIV, influenza, hepatitis C virus or the family of betacoronaviruses, represents a grand challenge for rational vaccine design,” the researchers wrote. “Germline-targeting vaccine design offers one potential strategy to meet this challenge.”

The eOD-GT8 60mer vaccine candidate is germline-targeting, meaning it was designed to induce the production of broadly neutralizing antibodies by targeting and stimulating the right antibody-producing cells.