Arthur Allen
Fri, 31 May 2024 09:00:00 +0000

Even a peep of news about a new flu pandemic is enough to set scientists clucking about eggs.

They worried about them in 2005, and in 2009, and they're worrying now. That's because millions of fertilized hen eggs are still the main ingredient in making vaccines that, hopefully, will protect people against the outbreak of a new flu strain.

“It's almost comical to be using a 1940s technology for a 21st-century pandemic,” said Rick Bright, who led the Health and Human Services Department's Biomedical Advanced Research and Development Authority (BARDA) during the Trump administration.

It's not so funny, he said, when the currently stockpiled formulation against the H5N1 bird flu virus requires two shots and a whopping 90 micrograms of antigen, yet provides just middling immunity. “For the U.S. alone, it would take hens laying 900,000 eggs every single day for nine months,” Bright said.

And that's only if the chickens don't get infected.

The spread of an avian flu virus has decimated flocks of birds (and killed barn cats and other mammals). Cattle in at least nine states and at least three people in the U.S. have been infected, enough to bring public health attention once again to the potential for a global pandemic.

As of May 30, the only confirmed human cases of infection were dairy workers in Texas and Michigan, who experienced eye irritation. Two quickly recovered, while the third developed respiratory symptoms and was being treated with an antiviral drug at home. The virus's spread into multiple species over a vast geographic area, however, raises the threat that further mutations could create a virus that spreads from human to human through airborne transmission.

If they do, prevention starts with the egg.

To make raw material for an influenza vaccine, virus is grown in millions of fertilized eggs. Sometimes it doesn't grow well, or it mutates to a degree that the vaccine product stimulates antibodies that don't neutralize the virus — or the wild virus mutates to an extent that the vaccine doesn't work against it. And there's always the frightening prospect that wild birds could carry the virus into the henhouses needed in vaccine production.

“Once those roosters and hens go down, you have no vaccine,” Bright said.

Since 2009, when an H1N1 swine flu pandemic swept around the world before vaccine production could get off the ground, researchers and governments have been looking for alternatives. Billions of dollars have been invested into vaccines produced in mammalian and insect cell lines that don't pose the same risks as egg-based shots.

“Everyone knows the cell-based vaccines are better, more immunogenic, and offer better production,” said Amesh Adalja, an infectious disease specialist at Johns Hopkins University's Center for Health Security. “But they are handicapped because of the clout of egg-based manufacturing.”

The companies that make the cell-based influenza vaccines, CSL Seqirus and Sanofi, also have billions invested in egg-based production lines that they aren't eager to replace. And it's hard to blame them, said Nicole Lurie, HHS' assistant secretary for preparedness and response under President Barack Obama who is now an executive director of CEPI, the global epidemic-fighting nonprofit.

“Most vaccine companies that responded to an epidemic — Ebola, Zika, covid — ended up losing a lot of money on it,” Lurie said.

Exceptions were the mRNA vaccines created for covid, although even Pfizer and Moderna have had to destroy hundreds of millions of doses of unwanted vaccine as public interest waned.

Pfizer and Moderna are testing seasonal influenza vaccines made with mRNA, and the government is soliciting bids for mRNA pandemic flu vaccines, said David Boucher, director of infectious disease preparedness at HHS' Administration for Strategic Preparedness and Response.

Bright, whose agency invested a billion dollars in a cell-based flu vaccine factory in Holly Springs, North Carolina, said there's “no way in hell we can fight an H5N1 pandemic with an egg-based vaccine.” But for now, there's little choice.

BARDA has stockpiled hundreds of thousands of doses of an H5N1-strain vaccine that stimulates the creation of antibodies that appear to neutralize the virus now circulating. It could produce millions more doses of the vaccine within weeks and up to 100 million doses in five months, Boucher told KFF Health News.

But the vaccines currently in the national stockpile are not a perfect match for the strain in question. Even with two shots containing six times as much vaccine substance as typical flu shots, the stockpiled vaccines were only partly effective against strains of the virus that circulated when those vaccines were made, Adalja said.

However, BARDA is currently supporting two clinical trials with a candidate vaccine virus that “is a good match for what we've found in cows,” Boucher said.

Flu vaccine makers are just starting to prepare this fall's shots but, eventually, the federal government could request production be switched to a pandemic-targeted strain.

“We don't have the capacity to do both,” Adalja said.

For now, ASPR has a stockpile of bulk pandemic vaccine and has identified manufacturing sites where 4.8 million doses could be bottled and finished without stopping production of seasonal flu vaccine, ASPR chief Dawn O'Connell said on May 22. U.S. officials began trying to diversify away from egg-based vaccines in 2005, when avian flu first gripped the world, and with added vigor after the 2009 fiasco. But “with the resources we have available, we get the best bang for our buck and best value to U.S. taxpayers when we leverage the seasonal infrastructure, and that's still mostly egg-based,” Boucher said.

Flu vaccine companies “have a system that works well right now to accomplish their objectives in manufacturing the seasonal vaccine,” he said. And without a financial incentive, “we are going to be here with eggs for a while, I think.”

——————————
By: Arthur Allen
Title: The Chicken and Egg Problem of Fighting Another Flu Pandemic
Sourced From: kffhealthnews.org/news/article/bird-flu-potential-pandemic-vaccine-chicken-egg-quandary/
Published Date: Fri, 31 May 2024 09:00:00 +0000

Did you miss our previous article…
https://www.biloxinewsevents.com/after-grilling-an-nih-scientist-over-covid-emails-congress-turns-to-anthony-fauci/

David Hilzenrath
Fri, 31 May 2024 09:00:00 +0000

Former National Institutes of Health official Anthony Fauci has faced many hostile questions from members of Congress, but when he appears before a House panel on Monday, he'll have something new to answer for: a trove of incendiary emails written by one of his closest advisers.

In the emails, David Morens, a career federal scientist now on administrative leave, described deleting messages and using a personal email account to evade disclosure of correspondence under the Freedom of Information Act.

“i learned from our foia lady here how to make emails disappear after i am foia'd but before the search starts, so i think we are all safe,” Morens wrote in a Feb. 24, 2021, email. “Plus i deleted most of those earlier emails after sending them to gmail.”

The pressure is on as Fauci himself prepares to appear June 3 before a House subcommittee exploring the origins of covid-19. The NIH, a $49 billion agency that is the foremost source of funding in the world for biomedical research, finds itself under unusual bipartisan scrutiny. The subcommittee has demanded more outside oversight of NIH and its 50,000 grants and raised the idea of term limits for officials like Fauci, who led the National Institute of Allergy and Infectious Diseases, an NIH component, from 1984 to 2022.

Lawmakers are likely to put Fauci on the spot about Morens' emails at a time when Republicans are questioning NIH's credibility and integrity. Even Democrats have cautioned the agency's leaders.

“When people don't trust scientists, they don't trust the science,” Rep. Deborah Ross (D-N.C.) told Morens.

The subcommittee has yet to turn up evidence implicating the NIH or U.S. scientists in the pandemic's beginnings in Wuhan, China. Nor has its work shed light on the origin of the virus.

But in a May 28 letter to NIH Director Monica Bertagnolli, the subcommittee's chairman, Rep. Brad Wenstrup (R-Ohio), said the evidence “suggests a conspiracy at the highest levels of NIH and NIAID to avoid public transparency regarding the COVID-19 pandemic.”

Rep. Jill Tokuda, a subcommittee Democrat from Hawaii, said the evidence shows no such conspiracy. She predicted the bipartisan criticism of Morens, 76, will give way to “a clash of intentions” at the hearing as Republicans try to pin covid on Fauci.

“For them, I think this is their moment to, again, bring a lot of these baseless, false allegations to the front,” Tokuda said.

On May 29, Wenstrup asked Fauci to turn over personal e-mails ahead of his testimony.

Here are things to know as the subcommittee gears up for Fauci's appearance.

What Is the Subcommittee Looking For?

The Select Subcommittee on the Coronavirus Pandemic is supposed to be investigating how the pandemic started and the federal government's response. That includes such hot-button issues as vaccination policies and school closures.

A central question is whether the covid virus leaped from animals to humans at a market in Wuhan, China, or spread from a leak at the nearby Wuhan Institute of Virology. The Wuhan lab received funding from an NIH grant recipient called EcoHealth Alliance.

The congressional probe is in some ways an extension of the nation's political, cultural, and scientific battles arising from the pandemic.

The Republican-led subcommittee has been examining NIH's performance and that of Fauci, who advised both former President Donald Trump and President Joe Biden, becoming the face of many of the government's most polarizing pandemic policies.

The panel called for the government to cut off EcoHealth's funding, a process the Department of Health and Human Services recently initiated.

EcoHealth's president, Peter Daszak, was Morens' friend and the recipient of many of the emails under scrutiny. A wildlife biologist credited with helping to develop the first covid antiviral drug, remdesivir, Daszak said he and his organization did nothing wrong.

“We were so accurate in our predictions that a bat coronavirus would emerge from China and cause a pandemic, that when it did, we're dragged in front of the crowd with their pitchforks and blamed for it,” Daszak said in an interview.

What's at Stake for NIH?

The Republican-led subcommittee is challenging NIH's credibility. The agency performs and funds a wide variety of medical and scientific research, work that is often the foundation of new medicines and other treatments, and has long enjoyed bipartisan support from Congress. The agency is home to the “Cancer Moonshot,” a Biden priority.

As head of NIAID and a presidential adviser, Fauci helped guide the public during the pandemic on measures to avoid infection, such as mask-wearing and maintaining physical distance.

But at a May 22 hearing, Wenstrup said Fauci's NIAID “was, unfortunately, less pristine than so many, including the media, would have had us all believe.”

In his letter to Bertagnolli, Wenstrup said there was evidence that a former chief of staff of Fauci's might have used intentional misspellings — such as a variant of “EcoHealth” — to prevent emails from being captured in keyword searches by FOIA officials.

Wenstrup's office did not respond to questions or an interview request.

An aide to the top Democrat on the subcommittee, Rep. Raul Ruiz of California, said he was unavailable for an interview.

Why Were Morens' Emails Alarming?

The emails show a pattern of trying to shield communications from public disclosure.

“We are all smart enough to know to never have smoking guns, and if we did we wouldn't put them in emails, and if we found them we'd delete them,” Morens wrote on June 16, 2020.

“The best way to avoid FOIA hassles is to delete all emails when you learn a subject is getting sensitive,” he wrote on June 28, 2021.

Some of Morens' emails included sexual or sexist remarks, including one from December 2020: “Beverage is always good, and best delivered by a blonde nymphomaniac.” In another email, discussing how former Centers for Disease Control and Prevention Director Rochelle Walensky got her job, he remarked, “Well, she does wear a skirt.”

Morens apologized at the May 22 hearing and called some of what he wrote “misogynistic.”

“Some of the emails I've seen that you all have provided look pretty incriminating,” he testified.

Asked if he ever sent information related to covid to Fauci's personal email, he said he didn't remember but might have.

Morens said some of his comments were “snarky jokes” intended to cheer up his friend Daszak, the EcoHealth president, who was receiving death threats over media coverage of his organization's relationship with the Wuhan lab.

Morens testified that he didn't knowingly delete official records.

Ross, the North Carolina representative, said the emails “inflict serious damage on public trust for the entire scientific enterprise.” She said the dangers can be seen in eroding public confidence in vaccines, contributing to recent outbreaks of measles.

Rep. Debbie Dingell (D-Mich.) said Morens showed disdain for the Freedom of Information Act. The subcommittee's investigation has been an unfounded effort to pin the blame for the pandemic on NIH and NIAID, and Morens' emails have helped blur the issues, she said.

Do the Emails Reveal the Origins of Covid?

No, as Democrats have emphasized.

In a way, Morens' correspondence undercuts allegations that people at the top of NIAID covered up a lab leak in Wuhan.

None of Morens' emails describe any effort to suppress evidence of a lab leak and, in an email sent from a private account, he ridiculed the idea, calling it “false to the point of being crazy.” But the subcommittee's senior Democrat, Ruiz, criticized Morens for dismissing the lab leak theory.

“Unless and until we see specific evidence on the origins” of the virus that causes covid, “the scientific process requires that we examine all possible hypotheses with objectivity,” Ruiz said.

KFF Health News senior correspondent Arthur Allen contributed to this report.

——————————
By: David Hilzenrath
Title: After Grilling an NIH Scientist Over Covid Emails, Congress Turns to Anthony Fauci
Sourced From: kffhealthnews.org/news/article/nih-scientist-covid-emails-congress-anthony-fauci-hearing/
Published Date: Fri, 31 May 2024 09:00:00 +0000

Thu, 30 May 2024 18:45:00 +0000

The Host

Julie Rovner
KFF Health News

@jrovner

Read Julie's stories.

Julie Rovner is chief Washington correspondent and host of KFF Health News' weekly health policy news podcast, “What the Health?” A noted expert on health policy issues, Julie is the author of the critically praised reference book “Health Care Politics and Policy A to Z,” now in its third edition.

June means it's time for the Supreme Court to render rulings on the biggest and most controversial cases of the term. This year, the court has two significant abortion-related cases: one involving the abortion pill mifepristone and the other regarding the conflict between a federal emergency care law and Idaho's near-total abortion ban.

Also awaiting resolution is a case that could dramatically change how the federal government makes health care (and all other types of) policies by potentially limiting agencies' authority in interpreting the details of laws through regulations. Rules stemming from the Affordable Care Act and other legislation could be affected.

In this special episode of “What the Health?”, Laurie Sobel, an associate director for women's health policy at KFF, joins host Julie Rovner for a refresher on the cases, and a preview of how the justices might rule on them. 

The cases highlighted in this episode:

• Loper Bright Enterprises v. Raimondo and Relentless Inc. v. Department of Commerce, about how much discretion federal agencies should have in interpreting laws passed by Congress.
• U.S. Food and Drug Administration v. Alliance for Hippocratic Medicine, about whether the FDA exceeded its authority in relaxing restrictions on the abortion pill mifepristone.
• Moyle v. United States and Idaho v. United States, about whether the federal Emergency Medical Treatment and Labor Act requirement for hospitals participating in Medicare to provide needed medical care overrides Idaho's near-total abortion ban in emergency cases.

Previous “What the Health?” coverage of these cases:

• KFF Health News' ‘What the Health?': Abortion — Again — At the Supreme Court

  Apr 24, 2024

• KFF Health News' ‘What the Health?': The Supreme Court and the Abortion Pill

  Advertisement

  Mar 28, 2024

• KFF Health News' ‘What the Health?': Health Enters the Presidential Race

  Jan 25, 2024

• KFF Health News' ‘What the Health?': The Supreme Court vs. the Bureaucracy

  Advertisement

  Jan 18, 2024

Where to find Supreme Court opinions as they are announced:

• The Supreme Court's official website
•  The SCOTUSblog (not an official government website but run by lawyers and journalists)

Credits

Francis Ying
Audio producer

Rebecca Adams
Editor

To hear all our podcasts, click here.

And subscribe to KFF Health News' “What the Health?” on Spotify, Apple Podcasts, Pocket Casts, or wherever you listen to podcasts.

——————————
Title: KFF Health News' ‘What the Health?': Waiting for SCOTUS
Sourced From: kffhealthnews.org/news/podcast/what-the-health-349-supreme-court-abortion-cases-may-30-2024/
Published Date: Thu, 30 May 2024 18:45:00 +0000

Did you miss our previous article…
https://www.biloxinewsevents.com/an-obscure-drug-discount-program-stifles-use-of-federal-lifeline-by-rural-hospitals/