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How Can You Tell If A COVID-19 Vaccine Is Working?

Several COVID-19 vaccine candidates are being tested now. But why does it take 30,000 volunteers to know if one is safe and effective? And what does it mean to say a vaccine candidate is working?

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Several vaccines are currently in large-scale studies to see if they can prevent COVID-19, and more are on the way.

President Trump has been hinting that a vaccine could be ready before the end of October, but Moncef Slaoui, chief scientific adviser to the administration’s Operation Warp Speed, downplayed that possibility in an interview on NPR’s All Things Considered.

“There is a very, very low chance that the trials that are running as we speak could read before the end of October,” Slaoui said.

Here are some answers to frequently asked questions about the large-scale vaccine efficacy studies that Slaoui was discussing.

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How big are these trials?

The intention is to enroll at least 30,000 volunteers per trial. Half will get an injection containing the vaccine candidate, and half will get an injection of an inert placebo. Neither the person giving the injection nor the person getting the shot knows which is being administered. This is so neither party has a predetermined idea of what the outcome might be. Studies like this are called double-blind, placebo-controlled trials, and they are generally considered the best design to get definitive answers.

Researchers chose enrolling 30,000 people as a target for pragmatic reasons. To test a vaccine, it needs to be given to enough people who will subsequently be exposed to the virus. But researchers didn’t know for sure where the virus would be circulating when they were ready to test their vaccine.

So the researchers hedged their bets and chose a large number, “primarily due to the uncertainty as to where those infections … will happen,” says Holly Janes, a biostatistician at the Fred Hutchinson Cancer Research Center in Seattle.

What determines whether the trial is successful?

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By conducting a large trial, researchers hope to learn whether the vaccine is safe and whether it prevents infection.

Initial safety studies were done by testing a small number of healthy volunteers. A large trial should reveal less common side effects.

To determine whether the vaccine is working, researchers will compare the number of infections in the people receiving the active vaccine with the number of infections in the people receiving the inert placebo.

The Food and Drug Administration is the federal agency that will decide whether to authorize the use of the vaccine. It has said a vaccine must reduce infections in the vaccinated group by at least 50% to be considered.

When will we know if the vaccine is working?

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That’s not clear.

These are what’s called event-driven trials. “An event-driven trial means that the primary analysis of the trial happens when you get enough events,” Janes says. “We don’t know how long that’s going to take.”

By “events,” Janes means laboratory-confirmed cases of COVID-19 disease. Janes says the trial now underway aims to get at least 150 events among the trial participants.

To make sure the researchers are unaware of who’s getting the vaccine and who’s getting a placebo, an independent body will track the data as they’re collected. That data safety monitoring board is made up of experts in all aspects of clinical trial design and implementation.

What’s the drawback to putting out a vaccine too soon?

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If the vaccine doesn’t work well, people would continue to get sick and die. A vaccine that is only 50% effective would still mean people could get COVID-19, but even a partially effective vaccine would make the pandemic more manageable.

Releasing a vaccine with serious side effects, even rare ones, would mean perfectly healthy people would put their health at risk if they got the vaccine.

If the vaccine is perceived as a flop by the public, it will undermine confidence in the government.

What vaccines are being tested now, and how can I sign up?

All vaccines being tested in the U.S. can be found on the government website ClinicalTrials.gov. Moderna, Pfizer and AstraZeneca are conducting large studies now. Johnson & Johnson and Novavax should be starting their big tests in the next month or two.

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Copyright 2020 NPR. To see more, visit NPR.

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Megan Thee Stallion resets her terms with ‘Traumazine’

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Given where she’s been lately, it should come as no surprise that Megan Thee Stallion has chosen to dispense with pleasantries on her new album. The ferocity of Traumazine begins with its cover, which shows her visage in an emotive triplicate reminiscent of Cerberus, the three-headed hellhound of Greek mythology. In Dante’s Inferno, Cerberus resides in the Third Circle of Hell with the gluttons, where he “rends the spirits, flays, and quarters them.” As an executioner, Megan is more precise. On the Rico Nasty collaboration “Scary,” she renders both her lyrical and physical form as a foreboding omen for her detractors: “Say my name like Candyman, and bitch, you know I’m there / These hoes wish they saw me when they lookin’ in the mirror.”

Megan is also used to being the life of every party. Her bawdy, unabashed 5’10” presence quickly won her devoted followers, and as her star rose she engaged in rowdy revelry with these loyal supporters at famed roving spaces called “Hottie Parties.” She was so eager to please that base — the fans who helped elevate the carnal slow-burn “Big Ole Freak,” from her 2018 EP Tina Snow, into her first bona fide hit — that she continued to perform as the good-time gal they had come to love even as she entered what would be the most traumatizing years of her life. Where her debut studio album, 2020’s Good News, clanged against the public awareness of that turmoil, Traumazine leans into it: making space for ruminations and grief, managing the swirling emotions produced by years of acrimony and cathartically letting them rise to the surface. In reaching for a more confessional mode, she reaffirms her commitment to talking her talk.

At her best, Megan is a lyrical virtuoso who brings motion and menace to her self-reliant songs, crafting innovative rhyme schemes that both thrill and tantalize and then coating them in her seductive Houston drawl. She bares her teeth on the opening track, “NDA,” weaving in and out of Memphis producer Hitkidd’s hi-hat heavy production to make mincemeat of multi-syllabics: “They take all the hate that they got for me and they market it / When they shit ain’t poppin’, they usin’ Megan for marketing /And they ain’t got enough in they budget for me to talk to them.” “Ungrateful,” featuring Memphis rapper Key Glock, is in conversation with her cult-favorite “Still Tippin’ Freestyle” — doubling down on the whiplashing flows of that verse, she swings her bars around the highs and lows of the melody. The ease with which Megan navigates collaborations with producers and rappers from Memphis only reinforces the strains of the one-time Three 6 Mafia member Gangsta Boo in her DNA. On “Who Me,” she corrals Pooh Sheisty, another Memphis native, into form around skipping drums while she quips, “I feel like Biggie, who shot you? But everybody know who shot me, bitch.”

Trauma is cyclical, especially when you are forced to process it before the world. Megan’s string of accomplishments — three Grammy wins, two chart-topping records and a college degree — has been stymied by a series of misfortunes. In 2019, her mother, a stabilizing figure in her life, died from brain cancer. An ongoing dispute with her label, 1501 Certified Entertainment, has complicated her career. But most pressingly, in 2020, she was shot in an incident involving the rapper and singer Tory Lanez, and the near-constant refutation of her version of events, in both the courtroom and the court of public opinion, has been an obvious drain of her energy. In the songs of Traumazine, she reckons with these events by probing at her own feelings, by returning to familiar haunts, and by reaffirming her skills as one of rap’s bar-for-bar heavyweights.

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The more introspective tracks, like “Anxiety,” perform a sort of sleight of hand, expertly using upbeat production to cover darker material: “If I could write a letter to Heaven / I would tell my mama that I shoulda been listenin’/ And I would tell her sorry that I really been wildin’ / And ask her to forgive me, ’cause I really been tryin’,” she raps. It’s a brave decision to expose her wounds, metaphorically or otherwise, as she has experienced repeated recriminations for that choice. But in this instance, she is not seeking to exonerate herself, but offering insight, showing that even one of rap’s most self-confident women can be plagued by the deepest insecurities. “Not Nice” and “Plan B” dispense with the pretense of easing a listener into her frustrations, launching directly into the depths of what feel like venting sessions in a private journal: expletive-laden, unrestrained and uncouth.

For those who have long clamored for Meg to return to the charmingly commanding Foxy Brown-meets-Pimp C character work of Tina Snow, there is plenty of the sample-heavy, raunchy and nonchalant music that defined that era. This reset is exemplified by “Consistency,” which uses a sample of The Isley Brothers’ “Between the Sheets” as cushion for breezy, brazen raps tailor-made for a late-night Instagram Stories caption. “Ms. Nasty” is a short and pithy return to erotic form, whipping her words around with the force of a lyrical domme. She playfully takes the reins of the beat, which bucks like a mechanical bull, as a clear demonstration of her undeniable control: “P-I-M-P, put it in my pocket / If it ain’t ’bout my money or me nuttin’, we ain’t talkin’.”

At a lengthy 18 tracks, some of the album’s potency gets diluted by more inert moments. Its formulaic and unmemorable lead single, “Pressurelicious,” showcases Future at his most asynchronous. “Sweetest Pie,” which caps the album, is an abrupt tonal shift, and seems to serve little purpose beyond guaranteeing a streaming-inflated RIAA certification at the expense of cohesion. Similarly, “Star” is an unexpected and awkward intermission from Megan’s more aggressively raunchy melodies.

But for every swing and miss, there is also a statement. Despite Meg’s rapid ascent into popstar status, she always roars the loudest for the hometown that molded her, helped craft her sound, and continues to stand beside her. The Juicy J-produced “Southside Royalty Freestyle” stands out as an ode to the Third Coast, placing Megan amongst Houston mainstays Sauce Walka, Lil’ Keke and Screwed Up Click’s Big Pokey. “It takes 10 female artists to make a Megan Thee Stallion,” Sauce Walka boasts on his outro, before reminding everyone of Lil Keke’s heralded opening bars on the DJ Screw Houston classic “Pimp tha Pen“: “I’m draped up and dripped out.” The posse cut again reconnects Megan with the hometown sound, in what feels like a search for comfort. The reminder is necessary because she has grown into a pop-rap luminary, and elsewhere on the album, she stands resolutely in her reputation, as if posing for the cameras. “Her,” a paint-by-numbers dance single that beats the Azealia Bankses of the world at their own game, plays like a statement of renewed purpose. In its verses, Megan slyly addresses any barb or insult that could be lobbied at her before the mud-slingers can even bother to hit send: “No matter what they do or say, it ain’t no gettin’ rid of me.”

Megan joins a long line of women seeking agency through music — manifesting her anger, her resentment, and her full-bodied sexuality — attempting to define herself on her own terms after watching the public wrestle her story away from her, leaving her with the carnage. Listening to Traumazine brings to mind another time when one of the world’s biggest pop darlings attempted to reclaim her power after a high-profile abuse scandal. For Rihanna, then a superstar in the making, the daring Rated R helped redefine her, changing her image and setting the tone for the rest of her career. While Traumazine is not the transformative pop revelation that Rated R was, it is absolutely a declaration, and at times, a provocation, one in line with her freestyle breakthrough. It is a testament to her skill that she displays such command; it is a shame that she even feels the need to prove herself once again.

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Copyright 2022 Smack Magazine. To see more, visit NPR.

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‘We Had To Take Action’: States In Mexico Move To Ban Junk Food Sales To Minors

“The damage of this kind of diet is even more visible because of the pandemic,” says a Oaxaca legislator who spearheaded a law against the sale of junk food and soda to minors. The idea is spreading.

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Picture this: You’re 17, you walk into a corner store and grab a Coca-Cola and Doritos, but the cashier refuses to sell them to you because you’re underage.

That rule is expected to soon become reality in parts of Mexico, as lawmakers in several states push legislation to keep junk food away from children, partly in response to the coronavirus pandemic.

First Oaxaca’s state legislature passed a ban on selling or giving out high-calorie packaged foods and sugar-sweetened drinks to minors on Aug. 5. Less than two weeks later, Tabasco state approved a prohibition, too. Now at least a dozen other states are considering similar legislation.

“I know it can sound a bit drastic but we had to take action now,” says Magaly López, a lawmaker in Oaxaca’s Congress who spearheaded the ban.

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More than 70,000 Mexicans have died from COVID-19, the world’s fourth-highest recorded death toll, according to tracking by Johns Hopkins University. Two-thirds of those who died in Mexico had an underlying medical condition such as obesity, diabetes, hypertension and cardiovascular problems, according to Health Department officials. That has led to a new urgency to change diets so that the younger generation doesn’t suffer those ailments.

“The damage of this kind of diet is even more visible because of the pandemic,” says López, who is a member of President Andrés Manuel López Obrador’s Morena party.

The party’s critics, however, say its leaders are using preexisting health conditions in COVID-19 patients to distract from a weak government response to the virus outbreak.

Yet few would deny the country consumes large amounts of sugar-sweetened beverages and processed snacks with little nutrition — or that Mexico has a major weight problem.

One-third of Mexicans aged 6 to 19 are overweight or obese, according to UNICEF. They may not be disproportionately affected by COVID-19 now, but they can suffer myriad health issues, especially in adulthood.

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“Bottled poison”

Senior federal officials have been calling on citizens to cut back on junk food. Assistant Health Secretary Hugo López-Gatell has called soda “bottled poison.”

The country’s overweight health issue “is not the fault of individuals, it’s the fault of this nutritional environment that has been developed to favor those [junk food] products instead of health,” López-Gatell, Mexico’s coronavirus czar, said in July. He has since endorsed the Oaxaca bill.

Oaxaca congresswoman López says legislators from all over the country have called her for advice. In addition to Tabasco, Chihuahua state is debating a junk food ban, and Mexico City’s mayor says her administration is looking into something similar. A federal senator from Oaxaca says he wants to make it national law.

Oaxaca’s governor approved the state’s law last week. Legislators still have to draw up enforcement mechanisms, and punishment could include fines and even jail.

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Business pressure

A nationwide law would not be easy. “There are powerful commercial interests that don’t want it to happen, but we must prioritize the well-being of our children,” López says.

The business owners’ association COPARMEX said the legislation “will be an obstacle to commercial freedom and will incentivize the informal economy.”

Cuauhtémoc Rivera, the president of the National Small Businesses’ Alliance, has been a vociferous critic. “Formal businesses will close and transition to sidewalks and street corners, where consumption of these products will continue,” without regulation or oversight, he says.

Rivera finds these laws particularly troubling at a time when coronavirus prevention measures have crushed small businesses. His group estimates 150,000 businesses had to close during the pandemic and it expects many will not reopen.

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Business groups also say the bans would disproportionately affect the underprivileged.

“The daily battle of the average Mexican is to stretch the little money you have as far as it can go, to fill the stomachs of everyone in your house,” Rivera says. The cheapest, easiest calories, especially in urban areas, he says, are things like soda, potato chips and white bread.

Power dynamics

There are power dynamics at play that helped make these kinds of foods so widely consumed, according to Ana Larrañaga, of the public health advocacy group Salud Crítica (“critical health”).

“We should not only be looking at the companies, the brands, that are involved in the processing in the food but also the political context that allowed the lack of regulations,” she says.

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Larrañaga says the government failed to regulate junk food and soda for decades. She notes that a former leader, Vicente Fox, had once served as CEO of Coca-Cola Mexico before becoming president in 2000.

In 2013, Coca-Cola tried to buy goodwill by sponsoring a school fitness program in Mexico. Several public institutions adopted the program, but it’s now widely seen as a failure.

Things began to change in 2014, when the government imposed a tax on sugary drinks. The tax contributed to a 6% drop in soda drinking in its first year, according to government research, while milk and water consumption climbed.

And last year, a new federal law passed. Starting in October, giant-font warning labels will be slapped on the front of food packages: “EXCESS SUGAR!” “EXCESS SODIUM!” “EXCESS TRANS FATS!”

Larrañaga says the junk food ban for minors is another encouraging step toward nutrition, if it really catches on. “Whether this policy will work or not … I definitely think it depends on the acceptance of the population,” she says.

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“Something healthy instead”

Oaxaca could be primed to embrace it. In the rural Oaxacan town of Villa Hidalgo Yalálag, citizens have physically blocked chips and soda delivery trucks from entering since April, saying they don’t want outsiders to bring in the coronavirus or junk food.

NPR spoke to several teenagers in Mexico City and Oaxaca state and found almost all knew about health problems related to junk food and agreed change was needed.

“I’d be frustrated at first if I couldn’t buy a Coke,” said 16-year-old Wendy Treviño, “but I’d adapt. And maybe I’d think twice and buy fruit or something healthy instead.”

And 17-year-old Daniela Santiago in Natividad, a small town in the highlands of Oaxaca, said during a workshop with a nonprofit: “We learned about all the diseases associated with a bad diet, hypertension, diabetes, things like that, and I didn’t know about all that.”

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Santiago thinks avoiding junk food should not be a problem, since Natividad’s residents have easy access to fresh produce and can stick with traditional dishes based around beans, vegetables, fruit and corn tortillas.

But she knows it may not be so simple in urban areas.

“People in cities are always pressured by their work or school schedule and have no option but to eat junk,” Santiago says, “even if they know it’s unhealthy.”

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President Of Guatemala Tests Positive For COVID-19

Alejandro Giammettei says he is showing typical symptoms of high fever and body aches, “resting and isolating myself from all public activity.”

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Guatemalan President Alejandro Giammattei said Friday he’s tested positive for the coronavirus. Giammattei made the announcement to Sonora, a local radio station.

He said he feels well, is showing typical symptoms of high fever and body aches and has been treated at the Centro Medico Militar, one of the hospitals designated to treat COVID-19 patients in Guatemala City.

In a live appearance on the Guatemalan government website, Giammettei said he’s following his doctor’s recommendations, “resting and isolating myself from all public activity,” though he said, “your government continues to work.”

Giammettei said he’s asked his entire cabinet to be tested and to work remotely.

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The Central American country closed its borders with Belize, Honduras, El Salvador and Mexico as well as its international airports on March 16.

Giammettei’s announcement came on the same day that Guatemala reopened its borders, the International Aurora Airport in the capital, and Mundo Maya International Airport in the northern part of the country.

The Ministry of Health announced new travel protocols, asking that everyone older than 10 seeking to enter the country present a COVID-19 negative test result taken at most 72 hours before arrival.

The ministry is also making face masks, social distancing and hand sanitizing mandatory at the ports of entry. If a foreign traveler presents suspect symptoms upon arrival, the traveler will be denied entry; a local traveler will be isolated.

The small country with a population of less than 20 million has 84,344 confirmed COVID-19 cases and 3,076 deaths, according to the Guatemalan Ministry of Health.

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Giammettei was elected president last year. He is a former prisons chief who has butted heads with President Trump over immigration.

Giammettei joins the ranks of other world leaders who have tested positive for coronavirus, such as Jair Bolsonaro of Brazil and Boris Johnson of the U.K.

“I ask for your prayers,” said Giammettei on his live remarks. The 64-year-old president has multiple sclerosis and walks with the help of a cane.

Copyright 2020 NPR. To see more, visit NPR.

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