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The Philadelphia Inquirer from Philadelphia, Pennsylvania • E3

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Philadelphia, Pennsylvania
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E3
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and Drug Administration choose what is called the end or of for the trials they design to get vaccines or drugs approved for mass market- ing (a dangerous conflict of interest in its own right). By focusing on mild symptoms, it is much easier for a company to claim a vaccine is effective and bring it to market, but it might not prove as effective in serious cases. On Nov. 9, Pfizer and BioNTech jointly announced a vaccine that was more than effective in pre- venting COVID-19 in their large trial where 38,995 participants received both the first and second shot. The question that remains is: What does mean here? It does not necessarily mean pre- venting infections.

As is standard in clinical trials, half of these participants received an injection of salt water and half received the real vaccine. Three weeks later, still blinded from know- ing which they received, partici- pants received the second injection. Seven days later, the data monitor- ing committee found that more than of the 94 cases that developed a mild COVID symptom like a sore throat were among the approximate- ly 19,500 participants in the placebo group, with fewer than among the other half receiving the real vac- cine. This is the basis of the an- nouncement that the vaccine is more than effective in ing Although vague word- ing has led many to believe other- wise, Pfizer provided no evidence about preventing infections. As for serious cases, Pfizer announced Wednesday data showing promising preliminary results but saying noth- ing about hospitalizations or death.

Last week, Moderna announced that its vaccine was 94.5% effective in preventing symptomatic cases (not infections) in more than 30,000 U.S. participants, based on its study in collaboration with Anthony Fau- National Institute of Allergy and Infectious Diseases. The study found 90 cases in the placebo half but only five cases in the half get- ting its vaccine. Moderna also ana- lyzed a secondary end point of se- vere cases. Eleven occurred in the placebo group not taking the vac- cine, and none among those taking it.

While the numbers are small, the finding is important and bodes well for more information on how the vaccines prevent severe cases. Once a vaccine is approved effec- tive, however, it becomes more ex- pensive and difficult to develop and test a more effective vaccine for seri- ous COVID-19 cases. The trial may have to prove the new vaccine is more effective than the first autho- rized vaccine, rather than a placebo or inert substance, requiring a much larger sample and greater ex- pense. Furthermore, new trials are likely to be restricted to groups not approved to receive the first vac- cine, such as health-care workers, the elderly, or other high-risk groups. Recruitment also becomes more difficult.

Other concerns associated with vaccine trials include stopping trials prematurely or not monitoring pa- tients for at least two months after they receive a vaccine. Both Pfizer and Moderna have followed up by a median of more than two months, but ending trials early may down- play or hide potential health risks, making a vaccine look safer and more effective than it is. Because vaccines are adminis- tered to entire populations, they need to be tested using volunteers from the whole population. But the Food and Drug Administration al- lows companies to exclude or un- der-represent certain populations from the sampling, and companies commonly exclude or under-repre- sent those at higher risk and people with preexisting conditions. Both companies have made efforts to in- clude older and minority partici- pants, but the British Medical Jour- nal thinks not enough.

We need to know more about how well these and other vaccine candidates pro- tect the elderly, minorities, and oth- er high-risk groups against serious COVID. In theory, a safe and effective vac- cine should protect the health of the population from serious illness, hos- pitalization, and deaths; it should en- able the economy to revive and re- store millions of jobs; and it could also restore some of the damaged reputation of the pharmaceutical in- dustry. But based on my years of research on the policies and the FDA as its paid partner, I am concerned that COVID vaccines will generate billions in revenue without much reducing hospitaliza- tion or deaths. The wariness about the rush to count on a COVID vaccine to end the pandemic is understand- able. Our best hope is to learn from other countries that have used so- cial isolation, masking, testing, and monitoring to drive down infec- tions, serious cases, and deaths.

In the near term, we cannot rely on vaccines to stop this pandemic. Donald Light is a visiting scholar at the Institute for Advanced Study and a professor of psychiatry and health policy at the Rowan School of Osteopathic Medicine. He is a faculty affiliate of the New York University Division of Medical Ethics. Continued from E1 OP-ED people who catch COVID wind up dealing with simi- lar long-term symptoms. That would mean more than a million people in this country already.

So my wife and I have pared down our Thanksgiv- ing plans repeatedly, from large, to medium, to now very small. For the first time since my son could crawl, be spending the holiday with just our kids and nobody else. This makes us very sad, and I understand why people are searching for any rationalization to avoid making this choice. But an isolated Thanksgiving is, this year, more true to the real spirit than any other choice. After all, Thanksgiving is not really about cram- ming the maximum number of people possible into your dining room, any more than really about eating turkey.

At its core, Thanksgiving is meant to be a harvest festival. Like all such festivals, it is centered on a bountiful feast that recognizes the mind-boggling pow- er of the natural world to feed and sustain us. Implicit is a not-so-veiled plea to the natural world to please not kill us during the winter. In the modern era, when we can spend the coldest months in our heated homes snacking on strawber- ries flown in from Mexico, that plea felt quite as necessary. This year is different.

The coronavirus pandemic makes winter a threat to our health and survival in a way it been in living memory. COVID cases are spiking just as the flu season hits and our hospitals are on the brink. People will need to spend more time indoors, where the virus thrives. The cold will make outdoor dining and gym classes impossible, likely leading to more layoffs and more people in poverty. The vaccines will not get here in time to prevent any of this.

We need to approach winter the way the Pilgrims probably did. gather around the fire (the TV) and spend time darning our socks (Marie-Kondoing our closets) and telling each other long stories (binge- ing The Crown) while we wait for spring. Winter this year something to be enjoyed. It is something to be endured. And of course, Thanksgiving for most of us is about family.

when we go home. when we see our people. When we list what thankful for, usual- ly looking across the table at our parents, children, grand- parents, grandkids, uncles, aunties, cousins, stepparents, half-brothers, who really related, hus- bands, wives, or that new main squeeze hoping becomes family in the near future. Well, what could be a more deeply meaningful way to show your family you love them than sacrificing some joy to keep them safe? I miss my family. But I know see them again.

I want to be sure see them again. For their health and the health of your family, and your family spend this Thanksgiving glumly waving to them over a laptop screen, wishing they were here. It sucks. But what we all have to do. Jonathan Lipman is a strategy and communications consultant for progressive organizations and nonprofits.

He lives in South Philadelphia. Continued from E1 Thanksgiving By Carolyn Wyman ramming into a tiny dining room with hordesof friends and relatives for a pass-and-sharefeast is a recipe for disaster right now. Thanks- giving: The Pandemic Edition promises a lot of small gatherings of the weary, wary, and worried. the perfect year to serve individual, hermetical- ly sealed turkey frozen entrees for Thanksgiving. I love frozen entrees: I eat them almost daily.

This love dates back to my rare when the then-called were a welcome respite from my cooking. I loved the chance to choose my own dinner destiny, the compartments that kept the fried chicken safe from the pea juice, and, best of all, the option (often exercised, in the absence of the aforementioned to eat dessert first. I genuinely liked the apple compote and the rest of the prefab fare. I still do. Like me, frozen meals have evolved: their original industrial-grade rectangular aluminum trays of mushy meat and pasty potatoes giving way to well-rounded whole-grain and veggie delights in natural brown paper bowls.

Like Mom, I hitched my ego to my career rather than my cooking abilities. One of the things I thank God for at Thanksgiving are the professionals at Nestle and Conagra who feed me all year while I fulfill my profession as a writer of unopened emails. In my house, means perusing the freezer to see where my stomach wants to go that evening: Mexico, courtesy Birds Eye Fiesta Chicken Bowl? India, thanks to Mattar Paneer? The past, via Lean Salisbury Steak with Macaro- ni Cheese? Then just a matter of slapping place mats on the table and rotating trays in and out of the microwave with robotic ease. I know not everyone shares my enthusiasm for factory food, especially not on big national cooking holiday. But who wants to cook a 20-pound turkey and 10 side dishes for a pandemic pod of two or three? not dinner a sentence: three weeks of hard times eating leftovers.

If COVID get you from family-style serving, food poi- soning will. Lean Cuisine and Healthy frozen turkey bowl dinners to the rescue. safer, cheaper, and easier than making a traditional Thanksgiving dinner from scratch and also more in line with how we live and eat today. We live online, and coax dinner to our doorsteps by touch and swipe vs. gather and hunt.

The Pil- grims and Native Americans needed all the carbs and calories in stuffing, gravy, pie, and potatoes. But the 240 to 300 calories of string bean pieces and turkey and potato chunks under these plas- tic shrink-wrap are more than enough to fuel our flying fingers. These Thanksgiving-dish updates in- clude that darling of dietitians, the sweet potato (begone, ye stodgy white!) chunked and baked or roasted, rather than mashed with retro marshmal- low. (I actually prefer Healthy roasted ver- sion for a char reminiscent of my own rare attempts at real cooking.) Unadorned green beans and sweetened dried cran- berries give props to the classic fried-onion-topped green bean casserole and jellied cranberry sauce, respectively, without their soporific effects, thus keeping you from nodding off during the post-feast extended-family Zoom (maybe). Thanksgiving traditionalists might protest these lack of stuffing or gravy.

Buy them Hungry- one-pound Roasted Carved White Meat Tur- key with mixed vegetables and apple cranberry des- sert instead. (Unless a Hungry-Feminist.) Serve dieters Smart zero-sum-game Slow Roasted Turkey Breast with gravy and mashed pota- toes (i.e., raising a fork up and down should wipe out its 170 calories). Please a vegetarian with a purchase of Butternut Squash Sage Ravioli. In fact, the true beauty of a frozen-dinner Thanks- giving is in the way it allows people of different backgrounds and tastes to sit down together at the same table without killing one another (by COVID or anything else). that what this holiday is sup- posed to be all about? Carolyn Wyman is a South Philly-based junk-food fan, journalist, and historian, and author of Than Homemade: Amazing Foods That Changed the Way We (Quirk Books) and Great Philly Cheesesteak (Running Press).

The first person enrolled in vaccine clinical trial at the University of Maryland in Baltimore is shown in a May photograph. Courtesy of University of Maryland Vaccines Frozen dinners on Turkey Day? Yum! I loved them as a kid and still do. 2020 is the perfect year for hermetically sealed fare. iStock INQUIRER.COM SUNDAY, NOV. 22, 2020 THE PHILADELPHIA INQUIRER E3.

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Pages Available:
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Years Available:
1789-2024