Tuesday, October 19, 2021

FDA Panel Unanimously Recommends Authorization of Moderna COVID-19 Vaccine Booster

Moderna officials presented data from clinical trials, including a small trial that studied the safety and effectiveness of a booster shot, as did officials from Israel, one of the first countries in the world to start giving booster shots, and the FDA, which performed an analysis of Moderna’s data but didn’t support or oppose the company’s application for an emergency use authorization expansion.

The FDA can overrule the panel’s recommendations but rarely does so. If the recommendation is approved, anyone aged 65 and older will be able to get a Moderna booster shot if they’ve received the primary two doses of the Moderna series. People between the ages of 18 and 64 who are deemed “at high risk of severe COVID-19” or whose “frequent institutional or occupational exposure to SARS-CoV-2 puts them at high risk of serious complications of COVID-19” will also have access to the booster shot.

The boosters would be a 50 microgram dose for people at least six months after they’ve received their second dose, which is itself typically administered one month after the initial dose. The primary two-dose series is 100 micrograms each.

Moderna said its small trial, consisting of just 171 people who got the regular primary series and a half-dose booster, showed a smaller amount could still bolster protection against CCP virus infection.

Officials discussed how data from other trials signal that the vaccine is still holding up well against severe disease, but that there’s been plummeting effectiveness against infection, particularly after the Delta variant became dominant in the United States.

Some panel members struck a skeptical tone on widespread boosters, pointing to the small number of people who got another shot and were studied and highlighting how some populations, including young, healthy people, don’t seem to need another shot.

“I’m not wild about a bunch of 20-year-olds going out and getting a booster dose, unless they’re at increased risk of either exposure or severe outcome,” Dr. Mark Sawyer, professor of clinical pediatrics at the University of California–San Diego School of Medicine and a temporary panel voting member, said before the vote.

The Centers for Disease Control and Prevention advisory panel will ultimately make the decision on who should get a Moderna booster, Sawyer said, though it’s in danger of being overruled by the agency’s head, as happened with Pfizer’s additional shot.

There was discussion about amending the third piece of the recommendation, but a number of members brushed aside the talk, in part because of a desire to match the recommendation the same panel gave for a booster for Pfizer’s COVID-19 vaccine in September. No one dissented.

“We already approved it for Pfizer. I don’t see how we can possibly not approve it for Moderna and not have most U.S. folks be completely confused. I know that’s not part of what we’re supposed to think about, but I think it’s a pragmatic issue,” said Dr. Stanley Perlman, a temporary voting member and a professor in the University of Iowa’s Departments of Microbiology and Immunology.

Dr. Cody Meissner, a professor of pediatrics at the Tufts University School of Medicine and a panel member, twice asked for evidence that people can be at high risk for serious complications based on their work. Dr. Doran Fink, an FDA official, said there was no “specific data,” but that there’s concern about so-called long COVID, or alleged problems that stem from COVID-19 and are seen even after somebody stops testing positive for the disease.

Meissner endorsed the recommendations, but warned the panel against voting for evidence-free language. “If we can’t defend these recommendations based on evidence, it’s going to further complicate getting this vaccine into every single adult American, and that’s really what we want to do,” Meissner said.

Dr. James Hildreth, president and CEO of Meharry Medical College and a temporary voting member (pdf), challenged Meissner, saying that the only evidence he needed for the occupational risk advice was that minorities are more likely to have underlying conditions, putting them at higher risk of severe cases of COVID-19.

Perlman said the piece was important because the United States can’t afford to have health care workers test positive for COVID-19, because that means they’ll have to miss work, even if they’re not showing symptoms.

Many spoke in favor of advising the FDA to widen the emergency use authorization again, after previously allowing people with weak immune systems to get a third dose of the vaccine. They said the fact that the Pfizer and Moderna vaccines are similar means that data regarding Pfizer booster shots, including virtually all the information from Israel, informed their decision, as did the millions of Americans who have already gotten the third shot. “We need boosters in some populations,” Sawyer said.

Dr. Patrick Moore, a temporary voting member and a professor at the University of Pittsburgh Cancer Institute, said his vote was based on “more of a gut feeling” than serious data.

“The data itself is not strong but it is certainly going in a direction that is supportable of this vote,” Moore said.


Is America Repeating Cultural Split Between Rome and Byzantium?

In A.D. 286, the Roman emperor Diocletian split in half the huge Roman Empire administratively—and peacefully—under the control of two emperors.

A Western empire included much of modern-day Western Europe and northwest Africa. The Eastern half controlled Eastern Europe and parts of Asia and northeastern Africa.

By 330, the Emperor Constantine institutionalized that split by moving the empire’s capital from Rome to his new imperial city of Constantinople, founded on the site of the old Greek polis of Byzantium.

The two administrative halves of the once huge empire continued to drift apart. Soon there arose two increasingly different, though still kindred versions, of a once unified Romanity.

The Western empire eventually collapsed into chaos by the latter fifth century A.D.

Yet the Roman eastern half survived for nearly 1,000 years. It was soon known as the Byzantine Empire, until overwhelmed by the Ottoman Turks in 1453 A.D.

Historians still disagree over why the East endured while the West crumbled. And they cite the various roles of differing geography, border challenges, tribal enemies, and internal challenges.

We moderns certainly have developed unfair stereotypes of a supposedly decadent late imperial Rome of Hollywood sensationalism that deserved its end. And we likewise mistakenly typecast a rigid, ultra-orthodox bureaucratic “Byzantine” alternative that supposedly grew more reactionary to survive in a rough neighborhood.

Yet in both cases, separate geography multiplied the growing differences between a Greek-speaking, Orthodox Christian and older civilization in the East, versus a more or less polyglot and often fractious Christianity in the Latin West.

Byzantium held firm against ancient neighboring Persian, Middle Eastern, and Egyptian rivals. But the West disintegrated into a tribal amalgam of its own former peoples.

Unlike in the West, the glue that held the East together against centuries of foreign enemies was the revered idea of an ancient and uncompromising Hellenism—the preservation of a common, holistic Greek language, religion, culture, and history.

By A.D. 600, at a time when the West had long ago fragmented into tribes and proto-European kingdoms, the jewel at Constantinople was the nerve center of the most impressive civilization in the world, stretching from the Eastern Asia Minor to southern Italy.

There is now much talk of a new American red state/blue state split—and even wild threats of another civil war. Certainly, millions of Americans yearly self-select, disengage from their political opposites, and make moves based on diverging ideology, culture, politics, religiosity or lack of it, and differing views of the American past.

More conservative traditionalists head for the interior between the coasts, where there is usually smaller government, fewer taxes, more religiosity, and unapologetic traditionalists.

These modern Byzantines are more apt to define their patriotism by honoring ancient customs and rituals—standing for the national anthem, attending church services on Sundays, demonstrating reverence for American history and its heroes, and emphasizing the nuclear family.

Immigration in fly-over country is still defined as melting pot assimilation and integration of new arrivals into the body politic of a hallowed and enduring America.

While red states welcome change, they believe America never had to be perfect to be good. It will always survive, but only if it sticks to its 234-year-old Constitution, stays united by the English language, and assimilates newcomers into an enduring and exceptional American culture.

In contrast, the more liberal blue state antithesis is richer from globalist wealth. The West Coast, from Seattle to San Diego, profits from trade with a thriving Asia. It is bookended by the East Coast window on the European Union from Boston to Miami.

The great research universities of the Ivy League—the Massachusetts Institute of Technology, Caltech, Stanford, and the University of California System—are bicoastal. Just as Rome was once the iconic center of the entire Roman project, so blue Washington, D.C., is the nerve center for big-government America.

The salad bowl is the bicoastal model for immigration. Newcomers can retain and reboot their former cultural identities.

Religion is less orthodox; atheism and agnosticism are almost the norm. And most of the recent social movements of American feminism, transgenderism, and critical race theory grew out of coastal urbanity and academia.

Foreigners see blue coastal Americans as the more vibrant, sophisticated, cosmopolitan—and reckless—culture, its vast wealth predicated on technology, information, communications, finance, media, education, and entertainment.

In turn, they concede that the vast red interior—with about the same population as blue America but with vastly greater area—is the more pragmatic, predictable, and home to the food, fuels, ores, and material production of America.

Our Byzantine interior and Roman coasts are quite differently interpreting their shared American heritage as they increasingly plot radically divergent courses to survive in scary times.

But as in the past, it is far more likely that one state model will prove unsustainable and collapse than it is that either region would ever start a civil war.


Also see my other blogs. Main ones below:

http://edwatch.blogspot.com (EDUCATION WATCH)

http://antigreen.blogspot.com (GREENIE WATCH)

http://pcwatch.blogspot.com (POLITICAL CORRECTNESS WATCH)

http://australian-politics.blogspot.com/ (AUSTRALIAN POLITICS

http://snorphty.blogspot.com/ (TONGUE-TIED)


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