Plus, the data Biden's team leans on to favor boosters, NIH to study long-haul COVID, food costs are increasing, and more. Email not displaying correctly?
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** Pfizer and Moderna press for booster shots. Will the FDA’s decision come today?
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A health worker prepares Pfizer vaccines during the national COVID-19 vaccination campaign in Pamplona, northern Spain, on Sept. 2, 2021. In a statement Monday Sept. 6, 2021, the European Medicines Agency says it has started an expedited evaluation on whether to recommend a booster dose of the coronavirus vaccine made by Pfizer-BioNTech. (AP Photo/Alvaro Barrientos, File)

When a Food and Drug Administration advisory committee ([link removed]) meets today to consider whether you need a COVID-19 booster shot, the committee will not have a recommendation from the FDA staff that has been studying the issue. The staff filed its report with no recommendation ([link removed]) , which is not a ringing endorsement, for sure. In fact, the staff writes:

There are many potentially relevant studies, but FDA has not independently reviewed or verified the underlying data or their conclusions.

Some of these studies, including data from the vaccination program in Israel, will be summarized during the September 17, 2021 VRBPAC meeting.

The FDA committee will see data that shows the kinds of reactions people have had to booster shots. About 83% of people in the test groups had mild or moderate pain at the injection sites. Two-thirds said they experienced fatigue and headaches. Those are about the same numbers as the second dose. In the first and second doses, some people reported diarrhea and chills, but none in the booster study reported those symptoms. Importantly, no severe reactions were reported in the booster shot study groups so far.

The FDA staff conclude, “Overall, data indicate that currently US-licensed or authorized COVID-19 vaccines still afford protection against severe COVID-19 disease and death in the United States.”

Moderna and Pfizer ([link removed]) are pressing hard to get the FDA’s approval for Americans to get booster shots. They both stand to make millions of dollars from additional vaccine sales. Both companies say they have convincing data that shows the COVID-19 vaccine loses some protection over time and that a third dose would protect people against a new surge.

Moderna says ([link removed]) its new testing shows a booster shot provides protection against so-called breakthrough cases, in which fully vaccinated people still get infected. Moderna says it studied 14,746 people who were vaccinated from July through October 2020, and another 11,431 people who were vaccinated between December and March. They found that there were 88 breakthrough cases among more recently vaccinated people but 162 cases — twice as many — among people who were vaccinated longer ago.

This week, Pfizer sent the FDA data showing that, over time, its vaccine loses some of its protection (while still being quite effective compared to most vaccines). Pfizer said:

* From 7 days to less than 2 months after the second dose, vaccine efficacy was 96.2%
* From 2 months to less than 4 months after the second dose, vaccine efficacy was 90.1%
* From 4 months after the second dose to the data cutoff date, vaccine efficacy was 83.7%

That would mean Pfizer’s vaccine has an average efficacy decline of approximately 6% every two months.

That, Moderna says, seems to indicate that protection wanes over time. CNBC spoke with Moderna president Stephen Hoge ([link removed]) , who said:

There’s a large debate, we all know, about whether or not vaccine boosters are going to be necessary into the fall. That debate, what makes it really hard is it’s not really about whether the vaccine worked last month. It’s really about whether it’s going to work this winter.

Vanity Fair has a really good roundup ([link removed]) of how the Biden administration has created confusion around booster shots.


** The data the Biden team leans on in favor of booster shots
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A man receives a third Pfizer-BioNTech COVID-19 vaccine from medical staff at a coronavirus vaccination center in Tel Aviv, Israel, Tuesday, Aug. 10, 2021. (AP Photo/Oded Balilty)

The Centers for Disease Control and Prevention said one of the sources of data that it used to back up its recommendation that everyone needs booster shots comes from Israel ([link removed]) . But that study is still unpublished. In July, the Israelis launched a booster campaign for people over age 60. Now, every Israeli over age 30 can get a booster shot. And still, Israel has not released the data that supports such a program.

Politico says people who are familiar with the Israeli data claim it is comprehensive and alarming, especially for senior citizens. Politico reports ([link removed]) :

The administration’s focus on Israel’s data underscores the extent to which the U.S. is leaning on other countries’ experiences to forecast the next phase of the pandemic here. That is partly because the highly contagious Delta variant swept through other parts of the world first, and partly because of better data tracking in countries like Israel that have national health care systems. The U.S. continues to struggle to collect and analyze reliable Covid-19 data ([link removed]) because the federal government has long neglected the country’s public health infrastructure.

Senior administration officials working on the federal government’s response to the pandemic have for weeks debated whether to recommend booster shots for Americans. The White House and top health officials said in mid-August that they planned to roll out the shots for most adults beginning on Sept. 20. The move has sparked tensions ([link removed]) between Biden’s top aides, the CDC and the FDA, amid questions about whether domestic data supported the goal. Two senior FDA vaccine scientists who are leaving the agency co-authored an analysis published Monday in the Lancet that found no evidence to support giving booster shots to the general population.


** Some people have already gotten the booster shot
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Well overa million people ([link removed]) have already gotten a COVID-19 booster shot.


** NIH to study thousands of cases of long-term COVID effects
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The National Institutes of Health plans to spend $470 million for 100 researchers at 20 institutions to track the lingering effects of long-haul COVID-19 on so many people. It is a significant issue considering new CDC data ([link removed]) that says one in three people who got sick with COVID-19 had long-term symptoms in a small Long Beach, California study ([link removed]) .

NIH reports ([link removed]) :

Studies will include adult, pregnant, and pediatric populations; enroll patients during the acute as well as post-acute phases of the SARS-CoV-2 infection; evaluate tissue pathology; analyze data from millions of electronic health records; and use mobile health technologies, such as smartphone apps and wearable devices, which will gather real-world data in real time. Together, these studies are expected to provide insights over the coming months into many important questions including the incidence and prevalence of long-term effects from SARS-CoV-2 infection, the range of symptoms, underlying causes, risk factors, outcomes, and potential strategies for treatment and prevention.

“Given the range of symptoms that have been reported, intensive research using all available tools is necessary to understand what happens to stall recovery from this terrible virus. Importantly, the tissue pathology studies in RECOVER will enable in depth studies of the virus’s effects on all body systems” said Walter J. Koroshetz, M.D., director of NIH’s National Institute of Neurological Disorders and Stroke and one of the RECOVER co-chairs.


** Should you put your vaccination status on your resume when job-hunting?
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Recruiters and job application websites say ([link removed]) lots of applicants now say upfront that they are vaccinated, hoping it will give them an edge.


** Food costs are going up and will go up more
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Just about all of the food in your shopping cart is more expensive now than it was at the beginning of the pandemic and costs will continue to rise, experts say ([link removed]) .
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(The Washington Post)

Delays in the supply chain make corn, wheat, cocoa and other basic foods cost more. Weather problems are contributing to supply interruptions.


** Want a religious exemption to the vaccine? You will also have to swear off Tums and Tylenol
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Becker’s Hospital Review spoke with Matt Troup ([link removed]) , the head of the Conway (Arkansas) Regional Health System, who said that the hospital was getting an unusually high number of people who wanted a vaccine exemption based on religious beliefs. The people seeking the exemption said they opposed the vaccine and cited the use of fetal cell lines in their development and testing.

Troup responded to the requests by saying that, to get the exemption, they would need to sign a form that says they also do not use 30 medications that have “used fetal cell lines in their development and/or testing.”

Ars Technica says ([link removed]) , “The list includes Tylenol, Pepto Bismol, aspirin, Tums, Lipitor, Senokot, Motrin, ibuprofen, Maalox, Ex-Lax, HIV-1, Benadryl, Sudafed, albuterol, Preparation H, MMR vaccine, Claritin, Zoloft, Prilosec OTC, and azithromycin.”

Becker’s reports ([link removed]) :

“I understand why people have concerns,” James Lawler, MD, (an infectious disease expert) who is a practicing Catholic, told the news station. “The bottom line is almost all the medical products we use have in some way been touched by research that's been done on fetal cell lines.”

Mr. Troup said the purpose of the form is to be educational and “provide information on other commonly used medications that may go against a sincerely held religious belief.”

If you want to know what the whole fetal cell issue is about,go to this from PolitiFact. ([link removed])

The Associated Press says ([link removed]) :

An estimated 2,600 Los Angeles Police Department employees are citing religious objections to try to get out of the required COVID-19 vaccination. In Washington state, thousands of state workers are seeking similar exemptions.

The allowance was enshrined in the federal Civil Rights Act of 1964 ([link removed]) , which says employers must make reasonable accommodations for employees who object to work requirements because of “sincerely held” religious beliefs.

A religious belief does not have to be recognized by an organized religion, and it can be new, unusual or “seem illogical or unreasonable to others,” according to rules laid out by the Equal Employment Opportunity Commission. But it can't be founded solely on political or social ideas.


** Why electric vehicles may change how states tax fuel and your driving
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A 2022 Bolt electric vehicle sits outside a Chevrolet dealership on Sunday, Aug. 29, 2021, in Englewood, Colo. (AP

Axios has an interesting story ([link removed]) about how electric vehicles change the gas tax income game for states. If we use less fuel, then who will pay for the roads that gasoline taxes fund? Axios says a couple of states are trying out the idea of taxing you by how many miles you drive on public roads:

States like Oregon and Utah are experimenting with new road user fees — known as "vehicle mileage taxes ([link removed]) " or VMTs — that reflect changing mobility trends.
* Under a VMT system, drivers report their mileage electronically, using a plug-in device in their cars or a smartphone app.
* Per ([link removed]) the Deseret (Utah) News: “Users are given the option to pay 1.5 cents per mile traveled or an annual flat fee of $120 for electric vehicles or $20 for gas hybrids.”
* Oregon is testing several potential funding models ([link removed]) based on the time of day and other factors.
* Under one potential scenario, a driver could pay a statewide 1.8-cents-per-mile fee, plus a 20-cent metropolitan Portland surcharge, plus a virtual toll on Interstate 5 and another fee for entering downtown Portland.

There are all sorts of issues that will surface. Privacy is one. As a reporter, I wrote a lot of stories about sales tax and gas tax reforms. Every time there was a reform and they changed the tax calculation, they would start to raise the tax right back up to where it was within a few years, so you get to pay the new fee plus the old tax rate. The federal Highway Trust Fund is already running low on dough, so we need to think this one through soon.


** Why do we say we love good news, but consume so much bad news?
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In all of my years of being a journalist — and there have been a bunch of them — a theme I always heard is, “You news people should give us more good news.” It makes sense to me that people say they want good news. But ask any online producer what gets the most traffic, ask any circulation manager what sells papers and, like it or not, it is not good news.

Maybe it is that good news is optional while bad news might be about a pandemic or crime or storm that I have to know about right now.

Which brings me to Jim Beckerman ([link removed]) of NorthJersey.com, who wonders why doomscrolling is such a thing ([link removed]) . I have come to appreciate conversations with Jim, who thinks his own thoughts and digs around for answers.


** 3 of these 12 nominees will be inducted into the Toy Hall of Fame
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(National Toy Hall of Fame)

Imagine you are a Cabbage Patch doll and you were competing against sand for a spot in the Toy Hall of Fame ([link removed]) . Seriously, sand is one of the nominees, along with the toy fire engine and billiards. At least they do not have to compete against the ball, which was inducted in 2009. The baby doll got in the hall in 2008. Blocks got voted in in 2003. I notice the only gun that made the Hall of Fame is a Super Soaker squirt gun.

Somehow Barbie got in before the ball or the coloring book. Barbie got in before the bicycle. Barbie got in before “the stick.” That old reliable toy the cardboard box got inducted in 2005.

The new inductees will be named Nov. 4. You can vote here ([link removed]) .

I wonder how long it will take for somebody to claim this vote was stolen.

We’ll be back Monday with a new edition of Covering COVID-19. Are you subscribed? Sign up here ([link removed]) to get it delivered right to your inbox.
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