re-post of Politico article about the FDA’s “nerdy virologists” panel working on Covid-19 vaccine approval

VACCINE RACE

The ‘nerdy virologists’ steering the U.S. vaccine race

The political backdrop could make the first coronavirus gathering of the advisory committee one of the most-watched in FDA history.

A single-dose Covid-19 vaccine being developed by Johnson & Johnson. | Cheryl Gerber/Courtesy of Johnson & Johnson via AP

A single-dose Covid-19 vaccine being developed by Johnson & Johnson. | Cheryl Gerber/Courtesy of Johnson & Johnson via AP

By SARAH OWERMOHLE

10/16/2020 04:30 AM EDT

As the race for the first coronavirus vaccines rounds the final turn, an obscure but influential panel of Food and Drug Administration advisers is emerging as a crucial referee.

The group of academic scientists, doctors and federal healthofficials will scrutinize safety and efficacy data on every coronavirus vaccine candidate, and make a pivotal recommendation to the FDA on whether to greenlight or shelve each shot.

Although its decisions aren’t binding, the panel has taken on an outsized importance leading up to its first coronavirus meeting on Oct. 22. President Donald Trump has repeatedly said that a shot could come before Election Day — and has accused the FDA of standing in the way of progress. Meanwhile, the agency is trying to hold the line on new, stricter standards for authorizing the emergency use of any vaccine,and safety concerns have paused late-stage trials of two of the four frontrunner vaccine candidates.

The political backdrop, and plummeting public confidence in the race for a vaccine, could make the first coronavirus gathering of the Vaccines and Related Biological Products Advisory Committee one of the most-watched in FDA history. Topics the group expects to cover include some of the thorniest and most fundamental questions in vaccine development, such as when a vaccine can truly be declared safe and where to set the bar for efficacy during a deadly global pandemic.

“It’s a group of nerdy virologists sitting around,” said Paul Offit, a University of Pennsylvania vaccine expert who sits on the panel and co-developed the rotavirus shot. “You don’t see many situation comedies about a group of fun-loving virologists and epidemiologists. For a reason.”

Nevertheless, the FDA is preparing for tens of thousands of people to tune into the panel’s initial meeting — a departure from past practice for similar advisory committees attended largely in person by DC-area experts and academics. Such meetings normally attract an online audience of just 100 to 1,500 people, an FDA spokesperson said.

No single vaccine is expected to be ready for review by Oct. 22. But the advisory group is on standby to discuss the merits of each shot as drugmakers file applications for FDA authorization or approval — making the panel a prominent player in the final crucial months of the United States’ vaccine push.

“We don’t work for the government nor do we work for the industry. We’re just supposed to come there and look at data,” said Offit.

The 20-member committee is a mix of physicians, statisticians, vaccine and infectious disease experts along with two drug company representatives and a consumer representative, in this case a lawyer. A five-person cluster hails from FDA, the Centers for Disease Control and Prevention and the National Institutes of Health, but the rest work outside the government.

The vaccine group is one of dozen expert panels convened by the FDA to review data or discuss a hot-button issue in a specific field — others are for food, tobacco and drugs, for instance — and advise the agency on what they should do.

Although the FDA does not have to follow its advisory committees’ advice, it generally does. Commissioner Stephen Hahn and other agency officials including vaccine chief Peter Marks have repeatedly pointed to the Oct. 22 vaccine meeting as evidence that the agency is led by science and data, not politics.

“It’s critical for FDA to make the public aware of our expectations of the data requirements to support safety and effectiveness,” Hahn tweeted Thursday with a link to the upcoming meeting, adding that a discussion between outside scientific and public health experts will help the public understand the vaccine review process.

The biggest issue on the table — and the subject of recent disputes between FDA and the White House — is when a vaccine maker can declare their shot safe and effective. Committee members also told POLITICO that they expect to discuss diversity in volunteer enrollment and the impact that emergency authorization could have on ongoing trials for other shots.

“We want to assure the American people that the process and review for Covid-19 vaccine development will be as open and transparent as possible,” Marks, director of the Center for Biologics Evaluation and Research, said in a statement to POLITICO.

While a specific vaccine is not on the table for Oct. 22, the discussion about enrollment, safety follow-up and the bar for efficacy could have implications for all the manufacturers in late-stage trials.

Pfizer, considered a frontrunner as it works through Phase III trials, told POLITICO last week that it does not plan to submit data ahead of the meeting. AstraZeneca and Johnson & Johnson, two other manufacturers in the sweeping final stages of trials, have each paused those studies because of serious side effects in a patient. AstraZeneca, which announced the halt in September, still has not restarted its U.S. trials.

Manufacturers have refused to promise to file within a specific timeframe, noting that their speed will be dictated by the data they collect — and unanticipated factors, like pausing a study for safety reasons, could slow them down.

FDA also bolstered its expectations for vaccine makers earlier this month, saying each needs to follow at least half of the participants in their Phase III trials for two months before applying for an emergency-use authorization. The new standards all but shut the window to any company filing before Election Day, prompting the president to accuse career scientists of holding back progress for political reasons.

“We don’t live in a bubble. We hear and see what is happening around the world and the concern that many people in the public have expressed of, in their words, the vaccine is being rushed [and] corners being cut,” said Archana Chatterjee, dean of Rosalind Franklin University’s Chicago Medical School and member of the committee.

The intense public scrutiny and vast demand for a coronavirus vaccine, along with the record speed at which shots have been developed — many using untested technologies — make the FDA panel’s October meeting unlike any before, said Chatterjee.

“Part of our job is to make sure that we can act as we always do,” she said. “To the best of our ability, reassure the public that we are doing our job free from any kind of interference from anyone with regard to the safety and effectiveness of those vaccines.”

By function, FDA advisory committees meet on testy topics. Recent hot-button issues before other panels include e-cigarettes, cancer-linked breast implants and how to fix opioid approvals amid an addiction crisis. But nothing has captured the president’s attention more than finding a vaccine to help end the pandemic that has killed nearly 220,000 people in the U.S. and ground the economy to a halt.

“I think this upcoming meeting will be important to establish the ground rules for evaluating vaccine safety and efficacy, in anticipation of [emergency use authorization] applications that could come from multiple manufacturers in the coming year,”said Paul Spearman, a professor and director for infectious diseases at the Cincinnati Children’s Hospital. He usually sits on the FDA vaccine-advisory committee but will not participate on Oct. 22 because he is involved in Covid-19 vaccine trials.

Panel chair Hana El Sahly, a virologist and microbiologist at Baylor University, and Fred Hutchinson Cancer Research Center biostatistician Holly Janes, are also recused from the Oct. 22 panel because of potential conflicts. They and Spearman may be recused from future meetings on specific vaccines depending on their research, leading FDA to draw other experts temporarily into the committee.

An FDA spokesperson said the full committee roster, including possible temporary replacements, will be published 48 hours before the Oct. 22 meeting.

Emergency use authorizations, a bar lower than full FDAapproval, have become a contentious issue in the Trump administration. The White House pushed the FDA to authorize the malaria drug hydroxychloroquine for the coronavirus, a charge that FDA denies. The agency ultimately revoked the authorization after studies showed no positive effect from the pills. Other emergency authorizations, such as one forconvalescent plasma, have been roiled in bumpy rollouts that were also colored by the president’s calls for FDA to speed its review.

HHS has pushed the FDA to re-brand the authorization of any coronavirus vaccine as a “pre-licensure” to bolster public confidence — something the drug agency has so far resisted over fears of politicizing its scientific determinations, POLITICO revealed this week.

The advisory committee is likely to discuss how awarding one vaccine an emergency authorization could make it harder for other companies to find participants for clinical trials of their own shots, Spearman said, since those shots would be unproven and some volunteers would receive a placebo.

Another hot topic is whether trials have enrolled sufficiently diverse groups of participants. The coronavirus has disproportionately infected, hospitalized and killed Black and Latinx populations, but the two groups have historically been under-represented in trials. Lawmakers such as Sen. Maggie Hassan (D-N.H.) have also raised concerns that trials aren’t including enough elderly people to determine whether shots are safe and effective in the elderly, since the immune system weakens with age.

Broadly, committee members told POLITICO they are sharply aware of balancing the need for vaccines against the potential disaster of greenlighting something dangerous or ineffective because regulators moved too soon.

“We are in very extraordinary times,” said Chatterjee. “Ordinarily I take this role seriously anyhow, but I think under these circumstances I’ve been thinking about it in a slightly different way.” POLITICO

Let the sunshine, let the sunshine in…. re-blog from Meeka’s Mind

Here’s an interesting and timely post from a blogger friend in Australia. Thanks for the share, Meeka.

Meeka's Mind

The lyrics come from a very famous Fifth Dimension song, but this is not a post about music.

The Fifth Dimension

It’s a post about Covid-19 and an update on its spread, and how to live with it. And guess what? Sunshine really does make a difference, in ways that are not immediately obvious.

First up I’m going to start with some research conducted by the Australian Centre for Disease Preparedness, Geelong, VIC, Australia. As some of you know, my state of Victoria is at the centre of the largest outbreak in Australia. And we’re not over it [completely] yet.

What the Australian study did was to measure the infectiveness of the virus – ON SURFACES – in a rather unusual way. As the UV in light is known to kill viruses, the researchers conducted their study on the virus in the dark. They also controlled the temperature of…

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Science in Fiction …and vice-versa

(Originally published June 17, 2016 on SOMETIMES.)

SOMETIMES

cropped-deep-space.jpg

Being a real fan of Science Fiction requires a flexible imagination, and have an open mind that is capable of accepting for consideration any concept at all.  Its OK to have compartments, or niches, or organizational charts in which these concepts reside—such as:  Possible, Improbable, Unlikely, Impossible But Intriguing, Far-Fetched, Ridiculous, and Boring.

In the first place, anything can apply to classification of Science Fiction.  The “Science” part places restrictions on the subject matter in that purists will want divisions into Real Science…topics that are accepted by almost everybody.  For instance, here is a true scientific fact:  “when we look up into the sky we see  specks of what looks like sparkly things reflecting (or generating) light.”

On the other hand Science Fiction fans might propose that there are, up in the sky, great big diamonds twinkling and shining back at us.  These are very valuable heavenly bodies…which in fact…

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rats and sinking ships

SOMETIMES

Donald Trump finally succeeded
in shocking his fellows…
now he’s watching in dismay
while they scramble to jump ship.

It was OK when Mr T made nasty remarks
about Megan and Rosie and Miss Universe
that were just worthy of snickers…
his followship barely wrinkled.

The insane idea of using the nukes
as long as they are stacked up waiting
to annihilate or “educate”
various would-be belligerants.

A good idea to plan alternatives
for marching aliens back to their spaceships
peacefully and obediently…even citizens.
Build a wall…keep ’em out in the first place.

Women don’t know what’s good for them,
so The Don and his lackeys will teach them
that they have no say over their bodies or lives.
Population control through legislation.

Playing footsie with long-time enemies
is acceptable, if frowned-upon….  effective
as long as it insults and  slanders the President.
Were they not paying attention during the Cold War?

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piggy-back grasshoppers

(photo ©Sometimes, 2020)

(I was sitting outside, minding my own business, when this critter ran into me and landed on the pavement nearby. I didn’t get a good look at it until later, when editing on my mainframe some snaps taken with my camera phone. Actually my subject was cats…so this grasshopper shot was a bonus.)

Yellow

SOMETIMES

This poem goes with my Haiku submission for Carpe Diem.  https://mumbletymuse.com/2016/03/24/mixed-blessing-a-haiku/

an oxymoron–a beautiful weed
a pox on the purists’ perfect gardens and showy lawns
intended for display…but not for play
these snooty specimen of culture and prestige
Do not Touch!   Do not Pluck!

But here–over here! –in the field, untended
except by Nature and open (without saying)
to children and others to do with as they will.
Make a bouquet…or a linked fairy chain,
roll in the softness of dandelion fields,
created by Abundance without Design.
These flowers never fail to attract lovers of Yellow…
just take heed of the Bees!

© Sometimes, 2016

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once there was a man who died…

Once there was a man who died
and no one knew what to do—
or even who would decide.

Mourners sighed
and wrung their hands, and cried—
“What a shame! Such a wasted life!”
and embarked on self-righteous lectures.

“Well I,” said God, with a nod
“… have no doubts—for it is I who decide—
and I say he shall ever sit by My side.”

“Where he remains for eternity
is not subject to debate and
conjecture.”

©Sometimes, 2020

clouds and memories, a poem

SOMETIMES

jet trails2

Draw me gently to your chest
my heart will linger there;
across the ages, along time’s trails,
the memories ever return.

Wait for me!—oh, wait for me!
the plaintive echo pleads.
When least expected, awakening
to memories in words of a poem.

Oh tell me—where do they dwell?
Among the dreams and reveries
apart from the wrack of reality
forever a blend of torture and joy.

©Sometimes, 2017

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Who am I — and What am I doing here?

SOMETIMES

Here is a re-run from several years ago.   The information may be familiar to some of the old-timers, but new to those who haven’t read it before.   Every now and then I am driven to publish a reminder of who I am and why I am writing, so I go back to one of these treatises from “back in the day.”

This is a hard thing to do, making up a sort of resumé, putting the right foot forward and all that. I have written about parts of my life story, so I’ll just fill in a few blanks and say a few facts. Facts are good.

Writing is my first love…since I was old enough to hold a pencil without poking out an eye, letters and words on a page have always fascinated me. Finally learning to actually read and write was thrilling for me. I read everything available…

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Writings from the past

On my “writing shelf” there is an assortment of notebooks and journals, which surface now and then and entice my writers’ eye to once again peruse the long forgotten, ignored, or awaiting rediscovery, and perhaps publication, of some of my literary works of yore.

As I struggle to surface from my self-imposed sabbatical, or writer’s sulk… it occurs to me that these scraps and bits of pencil-scribbled wisdom, born of a deep need for self- expression, may deserve to be brought to a venue where they may be read if anyone chooses to do so.

Word for Writers:
The worst thing you’ll ever write
is better than
the best thing you’ll never write.
(Sol Saks)

…………………………………………………………

This item was part of an exercise designed to find a point to start writing. In the center of a page write a word…this one I used was AFRAID. Then connect with arrows various thoughts pertaining to the key word, until a viable prompt starts your writing. (This was February 23, 1984)

Here’s my effort, using the word “Fear” as my prompt:

“The biggest fear I have is that I may run out of time to do what I must, which is simply, to write—that the day that marks the end of my life will come and I will say “no—not yet!” I’m afraid of sadness, of my own feelings of inadequacy…of the sadness of my children…the inability to do those things that I want to do, yet not to find the time—or inclination to do so. To be, to write, to fulfill my own destiny. I spend too much time worrying about the “children” who are not children at all, but worrying about them, yet most of all worrying about myself and the fear of not becoming what I must become.”

That’s it, what I wrote back then. 46 years ago! Good grief. Today those children are grown…so are their children, and THEIR children are teenagers. I still worry about them all, though they are no longer my personal responsibility. I still worry about my self-proclaimed goal as a “Writer.” Yes I have been a writer of sorts all through my life, at times even a professional newspaper writer. Now I’m a blogger…and I worry and fret about not writing.

Yep, the more we change the more we stay the same.

………………………………………………………

{More from the Green Notebook:]

I had just acquired my first computer in 1983, and I was enamored of it to the point of writing this:

“What does a square, cold, metal blox with a few strange things called “chips.” offer to a middle-aged woman? The answer is … the future, the past, the beginning and the end.”

That ancient Kaypro II was really was all that to me. I supported my five kids for awhile single-handedly as a single mom, as a newspaper reporter. Earned supplemental income as a newspaper writer. Then worked my way through my college degrees … and even now I blog and write. Not the same computer all those years of course…I’ve never been without since that first machine arrived.

The rise of the machines has had real meaning to me all through the last four decades…and beyond. In fact one of my early blogging attempts is extant, entitled “Rise of the Machines” or something like that here on Sometimes. A search of “computers” should locate it.

This is fun, I think I’ll do some more meandering backwards through my notebooks and computer disks… I’m having some writers’ block issues after my almost four years of “not writing much.” I love being back at SOMETIMES, and getting reacquainted with many of the “old gang” of the bloggersphere…

children are