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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The Tryin’ of Speaker Ryan…revisited (re-posted)

The Tryin’ of Speaker Ryan

I have to hand it to Paul Ryan
the man just doesn’t quit trying!
Caught in a den of experts at lying,
and vying for votes by begging or buying.
Speaking loudly above all the jeering and swearing,
off this way or that…slipping and veering.
Poor Speaker Ryan, his smile running thin
against all the prying and querying…
wearying, not crying, he’s plying his wiles
and biding his time…working at herding his cats…
while trying to stay INSIDE the frying pan!
© Sometimes, 2016

Stranger than Fiction: again

This is one of my personal favorite assignments from writing class last year…in response to rules that the work be a limerick and contain certain other attributes of writing poetry.    I had great fun writing it—

THE DONALD’S MARCH TO INFAMY

There once was a boy named Donald
Who wanted to be rich, and grow up to be President
ha ha! said the people as he started to
stump
but he knew what he was doing and had all the cards he needed to
trump,
and win the game
opponents screamed like angry cat matrons
and picked on his hair and his noisy patrons
but Donald just said they should “lump it!”

“You haven’t a chance, you’re not one of us,” they wailed
“is that so?” said Donald as he placed a standing order for tea and crumpets
to serve to his fans to keep them from starving on the campaign trail
His crowd of the faithful grew and grew
’til they filled the land
so they bought him a very big trumpet.

© Sometimes, 2015

Politics – do we really care? Re-blogged from Meeka’s Mind

This excellent post from friend acflory on her blog MEEKA’S MIND is the best thing I’ve read about the coming Year 2018 and Australian voters in particular and all Voters in general. Thanks for the re-blog!

Meeka's Mind

I’ve always had a problem with ‘-isms’ – communism, socialism, facism, capitalism, republicanism, you name it – because they all seem to miss the point about people. Homo Sapiens doesn’t give a flying fruit bat about politics until things go wrong.

I was a kid in the late Menzies era of Australia [1949-1966], and I remember hearing some adults moan about elections while others moaned about the general apathy of the Australian voter. You see, in Australia, we have compulsory voting…and the times were good.

In fact, by the early 60’s, the populations of the Western world were better off, generally, than they had ever been before. Not quite the age of surplus envisioned by Marx, but close, and some of us really were able to live ‘…from each according to his ability, to each according to his need.’ That’s what the Age of Aquarius, Flower Power and Free…

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Quoting Flip Wilson & a Post from Gronda Morin.

 

As comedian Flip Wilson once said in his “Ruby Begonia” monologue: “The King said: Those who have nothing, shall have less—and that which they have shall be taken from them.” And the people cheered, “Yay King, Yay King…”

 

 

Gronda Morin

It is bad enough that the republicans in the US Congress are hard at work to pass their 2017 Donor/ Corporation tax cut bill around December 19, 2016, which does little to grow the economy; where the economy is on an upswing and unemployment numbers are low, where at least 1 trillion dollars will be added to the deficit; where a major blow will be dealt to Obamacare with the ending of its mandate; and where it is very unpopular with Americans (about 26-29%), but it will please their donor base by which some lawmakers have been honest enough to admit this. If a corporation was acting on this bill, it is so bad that the executives would be guilty of malfeasance and for not honoring their fiduciary duties to their clients.

With this bill, we taxpayers who pay their wages are being shortchanged. Every tax break for the middle/…

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Betrayal in Utah—a Sad Poem

Bears Ears—Listening in Pain

Sacred are the lands once protected
by more honorable men…
betrayal stings by smiling lies

Navaho gods are weeping,
for the fork-tongued leader
has betrayed their hearts

Let thunder crash as the deed
becomes known in shameful terms—
greed and deceit are the law of the land

Drums echo in the desert valleys,
vibrating the monuments of the ages
now damp with tears of the betrayed.

As the horrors and heartbreak meet
where arrows once flew…perhaps again?
Fate twists the work of Evil… to wreak revenge.

©Sometimes, 2017

 

Caribbean geography lesson…

Every now and then I like to get out a map and reassure myself that when not knowing the location of Yemen, or Utah, or Antiqua (for example) all I have to do is look it up on a map. A paper map, preferably, but sometimes even an online map will do.

So I wanted to see if Puerto Rico was really far out in the middle of the ocean someplace, or, as I suspected…in the Caribbean. So I did a search “Puerto Rico” and Bing zeroed in on a nice map of the island, in great detail of cities and even roads and topographical details like mountains. Zooming out to get the big picture…including the Pacific Ocean and all of Russia…the exact location of Puerto Rico became instantly remembered.

Looking Southward, from Florida, the island is sort of beyond Cuba, north of Venezuela, and in a line with other islands and chains of islands in the Caribbean, forming a line of defense reinforced by territories possessed by friendly allies: the French, Dutch, and British. This was perfect—especially back in the days of the conquest by Spain of the New World.

Actually the United States was interested in keeping the Spanish at bay as much as possible, while maintaining a strategic position of buffering between the British (our best friends forever) and “other” European or South American nations from getting any ideas. Or Japan…or anyone else.

The last good-size war the U.S. had with Spain was the Spanish-American War, which effectively booted the Spanish out of the area and declared US hegemony in the close-in islands, including Puerto Rico. It is true that the U.S. had a good line of defense in the Caribbean, and although U.S.-Cuban relations suffered during the Cold War…to the point where until the Cubans would acquiesce in being beaten by the U.S. Embargo, which effectively put Cuba and the Castro Dictatorship in its place as an oppressed and bullied island which “refused to straighten out” and endured sixty years or so of hardship and political hassles because of it.

At the end of the Spanish-American War in 1899, part of the spoils agreed on by the two nations was the prize of Puerto Rico…ceded to the U.S. by Spain. One of the results was that the Spanish-speaking citizens were required to speak and use English-only.

Puerto Rico is a U.S. Territory, and thus Puerto Rican citizens are citizens of the United States, and are entitled to vote in U.S. elections…except for the office of President. They elect representatives to the U.S. Congress, who are on the same basis as reps and Senators from the 50 other states.

One difficult hang-over from the early 20th Century is THE JONES LAW, which forbids Puerto Rico to receive shipments of any materials or products from any sources except on officially sanctioned United States registered Ships. The result of this is that now that Hurricane Maria has devastated the Puerto Rican island, the Jones Law limits what foreign aid they can receive. The U.S. Congress has the power to rescind or modify the law…but has so far declined. It may be nteresting to note that the Jones Law has been suspended in other U.S. ports under emergencies created by Hurricanes that hit Texas and Florida, as well as other U.S. controlled islands in the Caribbean.

The U.S. Navy Hospital Ship Comfort has, as of this Wednesday morning, been sent to Puerto Rico. The reasons for the delay apparently have been worked out, especially the excuse of the ship being “too big to park in the harbor…” and the hospital ship will anchor off-shore and apparently transfer patients from the mainland of the island by helicopter.

https://www.bing.com/maps?&ty=18&q=Puerto%20Rico&vdpid=202&mb=19.029888040912922~-69.22080993652341~17.464867724672842~-64.03526306152341&ppois=18.2491397857666_-66.6280364990234_Puerto%20Rico_~&cp=18.2491397857666~-66.6280364990234&v=2&sV=1&style=r&trfc=&lvl=7

Sticks and Stones and “Dotards”

Re the sticks-and-stones contest, following the old adage that “sticks and stones will break my bones, but names will never hurt me.”      Remember when some kid would spew off a string of bad words and mean but innocuous insults, and Mom or Grandma would sooth hurt feelings with the little rhyme…which in effect meant “if some kid hits you let me know, but if he calls you a bad name just laugh it off.”   Now like as not she might look around for someone to sue.

The North Korean leader Kim Jong-Il  has resurrected a good old  English word to toss at Donald Trump in insult: “dotard,” an Old-English word from the 14th Century. This cool new word, according to the excited media,  spurred linguists and English teachers all over the world to research the word—dotard.

Not that the word “dotard” is especially archaic, not to disappoint media writers that want to insinuate that Kim Jong-Il may be more knowledgeable than Donald Trump.  Within arms reach I find a variety of dictionaries, including a nifty little volume called New Oxford Spelling Dictionary:  The Writers’ and Editors’ Guide to Spelling and Word Division.  Edited by Maurice Waite, published by Oxford University Press, 2014.*

There, right in alphabetical order between the words “dotage” and “dot-com” is— “dotard,”   pronounced to rhyme with soldered, watered.    The etymology is from the same as:  doting,  one-who-dotes…as in a doting-grandfather.

It was a fun image to imagine the North Korean leader poring over his archaic English dictionaries searching for insults.

  • The most recent Merriam-Webster Dictionary (2004) also features the word “dotard” right in proper order.

 

 

Time Cat Band…Akron, Ohio Porchrokr Music Festival at Will Christy Park

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This is shameless promotion!    I admit it.    The Band is TIME CAT, a local Akron, Ohio band which happens to be my granddaughter as vocalist, guitarist.

Time Cat was the headliner band at this event, which was sponsored by the Highland Square Neighborhood Association.   Included were up to 130 area bands, which performed on front porches of various Highland homeowners.

I am also including a video which I made during the performance.  This is my first attempt at video making, so it is obviously an amateur production.    The footage could benefit from some editing/trimming, but that would cut out the audio/music portions, which I want to leave uncut.

Hey…it’s a rock concert…that means it’s good old rock n roll.    Here’s a link to my video… I hope.       oops…malfunction…I don’t know how to do the file type and all that tech stuff…I’ll post it separately…maybe. 🙂

In the event you don’t want to suffer through my videos…here’s a link to the Time Cat site.      https://timecatmusic.bandcamp.com/

 

 

 

Of Statues and Soldiers…

Why are angry mobs allowed to destroy Civil War statues?      If they have to be taken down, properly and carefully by local government authorities—why not store them temporarily at a museum or some other place appropriate.     Smashing them to rubble is foolish…no, let me say stupid…and knee-jerk reactions to political correctness.   Gratuitous pandering, perhaps.

Except for one thing—there seems to be NO thought or reasoning to these actions, only public showing-off.       This kind of destruction of public property is against the law, for one thing, and morally wrong for a few hot-heads to decide for entire communities that historic statues need to be not only removed…but demolished.

Most villages and towns have a statue of a civil war soldier in its town park, or round-about in the highway, or city hall.     The statue stands proudly with his rifle, standing vigil of pride and gratitude to the soldiers who died fighting for their side in the Civil War.     North of the Mason-Dixon Line, approximate borders between states (Ohio and Pennsylvania in the North, Kentucky and West Virginia, etc. in the South.

It boggles the mind thinking about the problems involved in removing Southern statues…and by extension perhaps Northern statues as well?   That action would likely cause great unrest, being that the Union troops were on the winning side, therefore perceived to be the “right” side.     The fact is that the Civil War, was fought over state’s rights to maintain slavery….simplified, but that’s how it was…hyperbole and “regional history” aside.

The Generals and other high-ranking bigshots are usually the ones mortalized in statues:  the southern generals Robert E. Lee,  Thomas “Stonewall” Jackson,  James Longstreet…etc., etc., etc.     But the rank-n-file soldiers were young volunteers, then draftees, pressed into service by their respective sides, especially in the latter years of the war.  They had    little choice, and high-minded rhetoric about noble causes and patriotic duty hardly affected the lowest level Johnny Reb…who went to war because he had to.

 

 

Johnson’s Island, Confederate officers prison on Lake Erie, Ohio (Part Two)

(all photos on this page © Sometimes, 2017)   These photos were taken in May 1981 by Bob Dreger, my late husband.

The island prison housed Confederate military officers who were originally  captured during Civil War battles, and imprisoned  at Camp Chase, Columbus Ohio.   The object was to separate the officers from the rank-and-file soldiers and house them in the Northern prison where they remained until the end of the Civil War in 1865, or their death, which ever came first.    Over two hundred of them remain there, in their graves, to this day.

There is more to come from SOMETIMES, so please check back for more information about Johnson’s Island.     (I would continue now, but I have a lunch date with my best friend where we will fight the Civil War again.   We are on the same side…North, anti-Slavery, but present upheaval over Civil War statues opens up new debate across our nation—as if we don’t have plenty to debate! 🙂   For what it’s worth, this on-going perennial battle never dies.