Tag: Light

Health

Dr. Peter Hotez applauds CDC’s endorsement of vaccines for pregnant ladies in gentle of harmful antivaccine rhetoric

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Post date August 12, 2021

Dr. Peter Hotez told CNBC he was glad the Centers for Disease Control and Prevention updated their guidelines and urged pregnant women to get vaccinated, especially given the widespread misinformation campaigns targeting pregnant women.

“Unfortunately, the bad guys, the anti-vaccine groups, have published a lot of fake information claiming that Covid-19 vaccines can cause infertility,” said Hotez, co-director of the vaccine development center at Texas Children’s Hospital.

“They copied and pasted their fake news about the HPV vaccine for cervical cancer and other cancers, which was also wrong, that they said caused infertility, and they just copied / pasted it right on Covid-19 vaccines . There was never any truth to it. “

The CDC’s recommendation comes because the highly transmissible Delta variant is causing a further increase in Covid-19 infections and the daily cases nationwide are rising over 100,000. According to CDC statistics, by July 31, around 23% of pregnant women had received at least one dose of the Covid vaccine.

Hotez underlined in an interview on Wednesday evening in “The News with Shepard Smith” how dangerous it is for some pregnant women to become infected with Covid-19.

“We have seen many and many pregnant women over the past year and a half who got very sick, went to the pediatric intensive care unit, lost their baby, lost their own life to Covid-19, and this is the really scary piece” “, said Hotez. “Pregnant women have not coped well with this virus, and that is the big message.”

Tags AntiVaccine, applauds, CDCs, dangerous, Endorsement, Hotez, Light, Peter, pregnant, rhetoric, vaccines, Women

Health

Scientists Drove Mice to Bond by Zapping Their Brains With Mild

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Post date May 25, 2021

From ghosts to bats

When research on so-called interbrain synchrony emerged in the 2000s, some scientists dismissed it as parapsychology, a trippy field of the 1960s and ’70s that claimed to find evidence of ghosts, the afterlife and other wonders of the paranormal.

In 1965, for example, two ophthalmologists published in the prestigious journal Science an absurd study of 15 pairs of identical twins. Each twin, with electrodes on their scalps, was placed in a separate room and asked to blink on command. In two of the pairs, the study reported, one twin showed distinctive patterns of brain activity while the sibling was blinking in the other room. The doctors called it “extrasensory induction.”

“The paper is hilarious,” said Guillaume Dumas, a social physiologist at the University of Montreal who has studied brain-to-brain synchrony for more than a decade. In that far-out era, he said, “there were many papers with methodologically questionable conclusions claiming to demonstrate interbrain synchronization with two people.”

Since then, however, many sound studies have found brain synchronies emerging during human interactions, starting with a paper in 2002 that described how to collect and merge data from two brain scanners simultaneously as two people played a competitive game. This enabled researchers to observe how both brains were activated in response to each other. In a Science paper in 2005, this “hyperscanning” technique showed correlations of activity in two people’s brains when they played a game based on trust.

In 2010, Dr. Dumas used scalp electrodes to find that when two people spontaneously imitated each other’s hand movements, their brains showed coupled wave patterns. Importantly, there was no external metronome — like music or a turn-taking game — that spurred the pairs to “tune in” to each other; it happened naturally in the course of their social interaction.

“There’s no telepathy or spooky thing at play,” Dr. Dumas said. Interacting with someone else is complicated, requiring an ongoing feedback loop of attention, prediction and reaction. It makes sense that the brain would have some way of mapping both sides of that interaction — your behaviors as well as the other person’s — simultaneously, although scientists still know very little about how that happens.

Tags Bond, Brains, drove, Light, Mice, Scientists, Zapping

Entertainment

New York Theaters Are Darkish, however These Home windows Mild Up With Artwork

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Post date March 27, 2021

New York Theaters Are Dark, but These Windows Light Up With Art

Like many cultural organizations, the Irish Repertory Theater in Manhattan has streamed pandemic programs on its website.

A few days ago, the theater added a new type of broadcast to its repertoire: two 60-inch screens were installed in windows overlooking the sidewalk, speakers were installed high up on the building’s facade, and a collection of films were shown in which people read Poems in Ireland, London and New York.

One recent morning, Ciaran O’Reilly, the Representative’s production director, was standing by the theater on West 22nd Street looking at the screens as they showed Joseph Aldous, a British actor, reading a poem, “An Advancement of Learning” by Seamus Heaney describing a short break with a rat along a river bank.

“These are not dark windows,” said O’Reilly. “They are illuminated with poetry, with music, with the words of actors who perform.”

Over the past year, theaters and other performing arts in New York have turned to creative means of bringing work to the public, and sometimes bringing a bit of life to otherwise enclosed facades. These agreements continue, even though New York state has announced that a third of the art venues will reopen in April and some outdoor shows like Shakespeare will resume in the park.

However, the panes of glass have created a safe space. At the end of last year, for example, the artists Christopher Williams, Holly Bass and Raja Feather Kelly performed at different times in the lobby or in a smaller vestibule-like part of the New York Live Arts building in Chelsea. All were visible to the outside through glass.

Three other performances by Kelly of “Hysteria,” in which he takes on the role of an alien in pink and explores what is called “pop culture and its suppression of queer black subjectivity” on the Live Arts website, are for the 8th through the 20th century Scheduled April 10th.

Another street-level performance took place behind glass in Downtown Brooklyn last December, where the Brooklyn Ballet staged nine 20-minute shows of selected dances from its “Nutcracker”.

The ballet turned its studio into a theater, which its artistic director, Lynn Parkerson, referred to as a “jewel box” theater. chose dances that socially distanced masked ballerinas; and used barricades on the sidewalk to restrict the audience.

“It was a way to bring some people back to something they love and enjoy and maybe forget,” Parkerson said in an interview. “It felt like a real achievement.”

She said live performances were scheduled for April and would include ballet members in “Pas de Deux” with Jean-Philippe Rameau’s “Gavotte et Six Doubles” with live music by pianist Simone Dinnerstein.

Pop-up concerts were organized by the Kaufman Music Center in a store on the Upper West Side – the address is not given but is described as “not hard to find” on the center’s website – north of Columbus Circle.

These performances, which run through the end of April, are announced in the store on the same day to limit crowds and encourage social distancing. Participants included violinist Gil Shaham, mezzo-soprano Chrystal E. Williams, the Gabrielle Stravelli Trio, and the JACK Quartet.

St. Ann’s Warehouse in Brooklyn is showing Julian Alexander and Khadijat Oseni’s “Supremacy Project,” a public art that explores the nature of injustice in American society.

The word “domination” superimposes a photo of police officers in riot gear, and there are photos of Michael T. Boyd by Sandra Bland, Elijah McClain, and Emmett Till.

And at Playwrights Horizons in Midtown, Mexican-American artist Ken Gonzales-Day places photographs of sculptures of human figures in display cases to encourage viewers to expect definitions of beauty and race. These exhibitions are part of a rotating public art series organized by artist, activist and writer Avram Finkelstein and set designer and costume designer David Zinn.

The goal, said Finkelstein in January when the series was announced, was to show works that “use dormant facades constructively to create a temporary street museum” and “remind the city of its buoyancy and originality”.

O’Reilly of the Irish Representative said the theater was heard from last year by Amy Holmes, executive director of the Adrian Brinkerhoff Poetry Foundation, who believed the theater was a good place to show some of the short films the organization had commissioned Make Make poetry a part of an immersive experience.

The series shown in the theater, titled “Poetic Reflections: Words on the Window-pane,” includes 21 short plays by Irish filmmaker Matthew Thompson.

Featuring contemporary poets reading their own works, as well as poets and actors reading the works of others, including William Butler Yeats and JM Synge, they were created in collaboration with Poetry Ireland in Dublin, the Druid Theater in Galway and 92nd Street Y Produced in New York and Poet in the City of London.

“I think there is something special about encountering the arts in unexpected ways in the city, especially an art form like poetry,” said Holmes.

Readers of the films include people who were born in Ireland, immigrants to Ireland, people who live in the UK, and some from the US, like Denice Frohman, who was born and raised in New York City.

Frohman was on the theater screens Tuesday night reading lines like “The beaches are fenced and nobody knows the names of the dead” from her poem “Puertopia” when Erin Madorsky and Dorian Baker stopped to listen.

Baker said he saw the films in the window symbolizing a “revival of poetic energy”.

Madorsky had been to theatrical performances regularly before the pandemic, but now she’s missed that connection, she said, and was delighted to have a dramatic reading on the way home.

She added that the sound of the verses read contrasted with what she called the city’s “standard” backdrop of booming horns, sirens and rumbling garbage trucks.

“I think it’s wonderful,” she said. “There’s something so reassuring about your voice that it just pulled me into it.”

Tags Art, dark, Light, Theaters, Windows, York

World News

Covid-19: F.D.A. Panel Offers Inexperienced Mild to Johnson & Johnson’s Vaccine

Post author By
Post date February 27, 2021

Empty vials of the Johnson & Johnson vaccine at a hospital in South Africa.

Here’s what you need to know:

Credit…Phill Magakoe/Agence France-Presse — Getty Images

Johnson & Johnson’s Covid-19 vaccine was endorsed on Friday by a panel of experts advising the Food and Drug Administration, clearing the last hurdle before a formal authorization expected on Saturday, according to two people familiar with the agency’s plans. The nation’s first shipments will go out in the days after that.

It will be the third shot made available to the United States in the year since the first surge of coronavirus cases began washing over the country, and it will be the first vaccine to require just one dose instead of two.

Johnson & Johnson’s formulation worked well in clinical trials, particularly against severe disease and hospitalizations, even though it did not match the sky-high efficacy rates of the first two vaccines made by Pfizer-BioNTech and Moderna.

The panel, made up of independent infectious disease experts, statisticians and epidemiologists, voted unanimously in favor of authorizing the vaccine.

“We’re dealing with a pandemic right now,” said Dr. Jay Portnoy, an allergist at Children’s Mercy Hospital in Kansas City, Mo., and a member of the board. “It’s great that we have this vaccine.”

During Johnson & Johnson’s presentation to the panel, Dr. Gregory Poland, a virologist at the Mayo Clinic and a paid external consultant for the company, noted the vaccine’s efficacy, ease of use and low rate of side effects. It “nearly checks all the boxes,” he said. “To me, it is clear that the known benefits vastly outweigh the known risks.”

The vaccine had an overall efficacy rate of 72 percent in the United States and 64 percent in South Africa, where a concerning variant emerged in the fall. The shot showed 86 percent efficacy against severe forms of Covid-19 in the United States, and 82 percent against severe disease in South Africa.

Those are strong numbers, but lower than the roughly 95 percent efficacy rates of Pfizer-BioNTech and Moderna’s vaccines against mild, moderate and severe cases of Covid.

Johnson & Johnson’s vaccine is a single dose and uses a different kind of technology than the authorized vaccines. And the scale and size of the Johnson & Johnson trial was vast, spanning eight countries, three continents and nearly 45,000 participants.

Although the vaccine works with one shot, studies are underway to determine if a second dose would increase its protective effects.

Dr. Paul Offit, a pediatrician at the Children’s Hospital of Philadelphia and one of the panelists, pointed out on Friday that in early clinical trials that took place over the summer, Johnson & Johnson found that a second dose led to levels of coronavirus antibodies that were almost three times higher than those produced by one dose alone.

The results of Johnson & Johnson’s two-dose, late-stage clinical trial are not expected until July at the earliest. If those results turn out to be better than a single dose, Dr. Offit asked, “Does this then become a two-dose vaccine?”

Dr. Johan Van Hoof, the global head of vaccine research and development at Janssen Pharmaceuticals, the drug development arm of Johnson & Johnson, said that the company decided to pursue the one-shot strategy after its studies on monkeys last spring showed that a single dose was enough to provide strong protection against the disease.

“It’s clear that in a situation of an outbreak, in a raging epidemic, the big challenge is to get the epidemic under control,” he said. “The regimen is extremely well positioned to be used in outbreak situations.”

But Dr. Van Hoof also noted that it will be important to track volunteers who received a single dose to see if their immunity changes in the months to come. It might be necessary to deliver a booster shot for long-term protection. “The big question mark still is, how long does protection last?” he said.

After the vote, the F.D.A. told Johnson & Johnson that it “will rapidly work toward finalization and issuance of an emergency use authorization,” according to a statement. The F.D.A. also said that it had notified other government agencies “so they can execute their plans for timely vaccine distribution.”

United States ›	United StatesOn Feb. 26	14-day change
New cases	78,262	–29%
New deaths	2,266	–20%

World ›	WorldOn Feb. 26	14-day change
New cases	410,857	–5%
New deaths	9,468	–23%

U.S. vaccinations ›

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Decline in Coronavirus Cases ‘May Be Stalling,’ C.D.C. Director Warns

Dr. Rochelle Walensky, director of the Centers for Disease Control and Prevention, said on Friday that a recent decline in coronavirus cases across the U.S. “may be stalling” and urged governors not to relax restrictions.

Over the last few weeks, cases in hospital admissions in the United States have been coming down since early January and deaths have been declining in the past week. But the latest data suggest that these declines may be stalling, potentially leveling off at still a very high number. We at C.D.C. consider this a very concerning shift in the trajectory. We are watching these concerning data very closely to see where they will go over the next few days. But it’s important to remember where we are in the pandemic. Things are tenuous. Now is not the time to relax restrictions. Although we’ve been experiencing large declines in cases and admissions over the past six weeks, these declines follow the highest peak we have experienced in the pandemic. We may be done with the virus, but clearly, the virus is not done with us. We cannot get comfortable or give in to a false sense of security that the worst of the pandemic is behind us. Not now, not when mass vaccination is so very close.

Dr. Rochelle Walensky, director of the Centers for Disease Control and Prevention, said on Friday that a recent decline in coronavirus cases across the U.S. “may be stalling” and urged governors not to relax restrictions.CreditCredit…Josh Bell/The Sun News, via Associated Press

The federal government warned impatient governors against relaxing pandemic control measures on Friday, saying that a recent steep drop in U.S. coronavirus cases and deaths “may be stalling” and “potentially leveling off at still a very high number” — a worrisome development that comes as more cases of concerning new variants have been found and could suggest that a return to normalcy is not yet quite as near as many Americans had hoped.

“Things are tenuous,” Rochelle Walensky, the director of the Centers for Disease Control and Prevention, said at a White House briefing on the pandemic. “Now is not the time to relax restrictions.”

Her warning was bolstered by Dr. Anthony S. Fauci, the government’s top epidemiologist, as the Biden administration scrambled to stay ahead of any new wave. President Biden himself flew to Houston to showcase the government’s latest mass vaccine site.

According to a New York Times database, virus cases across the United States appear to be leveling off from the steep decline that began in January, with figures comparable to those reported in late October. Cases have slightly increased week over week in recent days, though severe weather limited testing and reporting in Texas and other states the previous week, and not all states reported complete data on the Presidents Day holiday. The seven-day average of new cases was 77,800 as of Thursday.

While deaths tend to fluctuate more than cases and hospital admissions, Dr. Walensky said at the briefing on Friday, the most recent seven-day average is slightly higher than the average earlier in the week. The seven-day average of newly reported deaths was 2,165, as of Thursday.

“We at C.D.C. consider this a very concerning shift in the trajectory,” she said, adding, “I want to be clear: cases, hospital admissions and deaths — all remain very high and the recent shift in the pandemic must be taken extremely seriously.”

Dr. Walensky said some of the rise may be attributable to new variants of the coronavirus that spread more efficiently and quickly. The so-called B.1.1.7 variant, which first emerged in Britain, now accounts for approximately 10 percent of all cases in the United States, up from one to four percent a few weeks ago, she said. The U.S. ability to track variants is much less robust than Britain’s.

“I know people are tired; they want to get back to life, to normal,” she said. “But we’re not there yet.”

As cases had declined, some governors around the United States have begun to relax pandemic restrictions. States with Republican governors appeared to be more eager to make rollbacks, though New York, which has a Democrat as governor, has also been easing restrictions on a variety of activities.

On Friday, Gov. Henry McMaster of South Carolina, a Republican, announced that on Monday, restaurants would be able to serve alcohol past 11 p.m., and residents would not need to get approval from the state to hold events with 250 people or more. To try to limit the spread of the virus, the state last year ordered bars to stop serving alcohol after 11 p.m., which is three hours earlier than the late-night bar crowd was used to.

Brian Symmes, a spokesman for Mr. McMaster, said the governor “appreciates perspectives that differ from his own” but “respectfully disagrees” with Dr. Walensky’s assessment.

In Arkansas, Gov. Asa Hutchinson announced Friday that he’d be lifting restrictions around capacity limits for bars, restaurants, gyms and large venues, but extending the state’s emergency order and mask mandate until March 31. The current emergency order was set to expire February 27.

On Thursday, Gov. Greg Abbott of Texas said he was considering lifting a statewide mask mandate in place since July.

In Mississippi, Gov. Tate Reeves said he was also considering pulling back some restrictions, particularly mask mandates for people who have been fully vaccinated. As of Friday, 13 percent of the state’s population has received at least one shot, and 6.2 percent have received two, according to a Times database.

Dr. Fauci echoed Dr. Walensky’s warnings that more rollbacks at state or local levels would be unwise, noting that case levels remained at a “very precarious position.”

“We don’t want to be people always looking at the dark side of things, but you want to be realistic,” he said. “So we have to carefully look at what happens over the next week or so with those numbers before you start making the understandable need to relax on certain restrictions.”

In Oregon, Gov. Kate Brown extended the state’s emergency order until May 2. The state recorded a sharp decreases in daily cases, hospitalizations and deaths this week, but citing the new variants Ms. Brown said that “now is not the time to let up our guard.”

Eileen Sullivan Remy Tumin, Nicholas Bogel-Burroughs and Mitch Smith contributed reporting.

Credit…Adriana Zehbrauskas for The New York Times

The federal government has agreed to buy 100,000 doses of a recently authorized Covid-19 treatment from Eli Lilly, increasing the supply of such drugs for patients who are high risk of becoming seriously ill but are not yet hospitalized.

Under the deal, announced on Friday, the government will pay $210 million and Eli Lilly will ship out the doses by the end of March. The government has the option to buy 1.1 million more doses of the treatment through November, but how many of those doses ultimately get ordered will depend in part on the course of the pandemic in the United States.

The treatment is a cocktail of monoclonal antibodies combining the Eli Lilly drug known as bamlanivimab — which was authorized last November and is in use for high-risk Covid-19 patients — with a second drug known as etesevimab. The combination received emergency authorization earlier this month from the Food and Drug Administration. Both drugs consist of artificial copies of the antibodies that are naturally generated when a person’s immune system fights off an infection.

The U.S. government previously agreed to buy nearly 1.5 million doses of bamlanivimab alone. Eli Lilly has delivered more than 1 million doses already, with the remainder to be delivered by the end of March. More than 660,000 doses of bamlanivimab have been shipped out to states and other jurisdictions.

Eli Lilly’s new combination therapy could offer an advantage over bamlanivimab alone if worrisome coronavirus variants — particularly B.1.351, the one first identified in South Africa — take off in the United States. While bamlanivimab alone was found in a lab study to be powerless against the B.1.351 variant, preliminary data suggest that the combination therapy may be better able to fight off variants. That’s because so-called escape mutations in the variants that may enable them to avoid one antibody may not work against the second.

Another monoclonal antibody cocktail, made by Regeneron, is also authorized in the United States. Nearly 100,000 doses of that therapy have been shipped out.

Antibody treatments got a publicity boost last fall when they were given to Donald J. Trump when he was infected in the last months of his presidency, and to other high-profile Republicans, but they were surprisingly underused in many places in their first months of availability. Overwhelmed hospitals did not prioritize the treatments, which are cumbersome and must be given via intravenous infusions. Many patients and doctors did not know to ask for them or how to find them.

In December, the federal government’s early data collected from hospitals suggested that they had given only about 20 percent of their supply to patients. But that picture is changing. Eli Lilly has seen usage of bamlanivimab alone rise to around 40 percent nationwide, with uptake much higher in some places, Janelle Sabo, who leads Eli Lilly’s work on Covid-19 antibodies, said in an interview earlier this week.

Credit…Philip Cheung for The New York Times

As more people in the United States learn of someone close to them who has received a Covid-19 vaccine, they are becoming more open to getting the vaccine themselves, according to the latest survey from the Kaiser Family Foundation, which has been monitoring attitudes since December.

Across most demographic groups, vaccine hesitancy, though still substantial, continues to abate. Fifty-five percent of adults now say they have either received one dose or will get it as soon as they can, up from 34 percent in December.

The so-called “wait and see” group is inching down, too, to 22 percent in February from 31 percent in January. But Black adults (34 percent) and Latino adults (26 percent) remain more inclined than white adults (18 percent) to take a wait-and-see approach.

About one in five Americans still refuses to get the shot, or said they would only do so if compelled by work or school.

Kaiser also took note of the political affiliation of its survey respondents. From December to February, the proportion of Democrats who had either gotten the shot or wanted to soared to 75 percent from 47 percent. Republicans remained more hesitant, but there was a notable increase in the amount who were vaccinated or hoped to be, to 41 percent from 28 percent.

Views of the vaccine were divided by age as well. People 65 and older, among the first demographic groups eligible for the shot, were among the most enthusiastic, an attitude that crossed racial lines. But while nearly half of older white people said they had already received at least one dose, only about one-third of older Black people said they had.

The survey also examined the most common reasons for hesitation. People were most concerned about side effects and also about the rapidity with which the vaccines were developed. They were also still gripped by misinformation, fearing they would have to pay for the vaccine (it is available at no cost) and that it would give them Covid (it does not).

The Centers for Disease Control and Prevention said on Friday about 47.2 million people in the U.S. have received at least one dose of a vaccine, including about 22.6 million people who have been fully vaccinated.

Credit…Mark Weber/Daily Memphian, via Associated Press

The top health official in Memphis submitted her resignation after state health officials accused her department, which oversees the vaccine rollout in the state’s most populous county, of wasting thousands of doses, the mayor of Shelby County, Tenn., said on Friday.

The swift downfall of Alisa Haushalter, the Shelby County Health Department director, came hours after a news conference in which Dr. Lisa Piercey, Tennessee’s health commissioner, laid out a series of stunning accusations of mismanagement by Ms. Haushalter’s department, including episodes in which a volunteer may have stolen doses and another administered shots to two children.

State health officials have been investigating the department for at least a week after Ms. Haushalter first reported that vaccine doses had expired, Dr. Piercey said.

Investigators confirmed the expiration of 1,578 doses last week, but it was only this week that Shelby County health officials acknowledged that an additional 840 doses had expired on Feb. 15, bringing the total to more than 2,400.

And Dr. Piercey said that when she met with the mayor on Thursday, he said that he had heard a rumor about a volunteer possibly stealing vaccines on Feb. 3, but Dr. Piercey said the theft was never reported to any state or federal authorities. The state health department alerted the Federal Bureau of Investigation to the possible theft shortly after that conversation, she said. Dr. Piercey also said that a volunteer had wrongly vaccinated two children on Feb. 3.

The City of Memphis on Wednesday took over the responsibility of storing, transporting and allocating the vaccines.

Credit…Christinne Muschi/Reuters

Canada’s drug regulator authorized the AstraZeneca vaccine on Friday as well as a version of it developed by the Serum Institute of India. The vaccine, which was developed with Oxford University, has not yet been authorized for use in the United States but has been key to Britain’s rapid vaccination rollout.

The addition of a third vaccine, in addition to the offerings from Moderna and Pfizer-BioNTech, may help Canada alleviate a growing dissatisfaction about the sluggish pace of vaccination in the country.

“Vaccines will keep arriving faster and faster,” Prime Minister Justin Trudeau told a news conference. “We now have a third safe and effective vaccine.”

Mr. Trudeau said that the government expects to receive, within days, about 500,000 doses out of an order of two million doses of the Serum Institute version of the vaccine, known as Covishield. About 20 million doses will start arriving from AstraZeneca in the spring.

The AstraZeneca vaccine, the first virus vector-based inoculation for Covid-19 authorized in Canada, has had some stumbles. In trials in South Africa, where a more contagious virus variant has become dominant, it did not appear to protect people from mild or moderate illness, which led the country to halt its use of the vaccine.

Drug approval officials with Health Canada said on Friday that while some studies suggested that the AstraZeneca vaccine is less effective overall than others, the sample sizes used were not large enough to yield a clear conclusion. But in Germany, many people regard it as “second-class” compared to the vaccine developed by the German company BioNTech and Pfizer, and are avoiding AstraZeneca’s.

Credit…Lyndon French for The New York Times

Across the United States and the world, the coronavirus seems to be loosening its stranglehold. The curve of cases, hospitalizations and deaths has yo-yoed before, but never has it plunged so steeply and so quickly.

Is this it, then? Is this the beginning of the end?

The road ahead is potholed with unknowns: how well vaccines prevent further spread of the virus, whether emerging variants remain susceptible enough to the vaccines and how quickly the world is immunized, so as to halt further evolution of the virus.

And the greatest ambiguity is human behavior. Will Americans desperate for a return to pre-pandemic lifestyles continue to wear masks and distance themselves from family and friends? How much longer can communities keep businesses, offices and schools closed?

Covid-19 deaths are unlikely to again rise quite as precipitously as in the past, and the worst may be behind us. But if Americans let down their guard too soon and if the variants spread in the United States as they have elsewhere, another spike in cases may well arrive in the coming weeks.

Buoyed by the shrinking rates over all, governors are lifting restrictions across the United States and are under enormous pressure to reopen completely.

“Everybody is tired, and everybody wants things to open up again,” said Ashleigh Tuite, an infectious disease modeler at the University of Toronto. “Bending to political pressure right now, when things are really headed in the right direction, is going to end up costing us in the long term.”

Looking ahead to late March or April, the majority of scientists interviewed by The Times predicted a fourth wave of infections. But they stressed that it is not an inevitable surge if precautions are maintained for a few more weeks.

“Just hang in there a little bit longer,” Dr. Tuite said. “There’s a lot of optimism and hope, but I think we need to be prepared for the fact that the next several months are likely to continue to be difficult.”

Credit…Doug Mills/The New York Times

In Washington, Republicans stand united in opposition to President Biden’s first major legislative proposal, a $1.9 trillion economic rescue plan that they have labeled a bloated, budget-busting “blue state bailout.”

But in rural Maine, Anthony McGill, a self-identified conservative Republican, describes the bill as something else entirely: “Most of it sounds like a good idea,” he said.

While Mr. McGill doesn’t agree with all the provisions, he supports the central thrust of the bill — another round of direct stimulus payments to nearly all Americans.

“There’s a lot of people that could use those checks. I don’t know about needing them, but we could all use them,” said Mr. McGill, 52, who voted for former President Donald J. Trump in November. “The debt is so far out of hand that it’s a fantasy number at this point. We might as well just blow it out till everything collapses.”

As Democrats prepare to vote as soon as Friday to pass the relief package in the House, Republican elected officials are struggling to overcome intraparty divides over whether to embrace the major pieces of the proposal — as well as to reconcile with the fact that many Republican voters support the plan. While Democrats are working swiftly to move their bill, Republicans are consumed by sideshows like false claims of voter fraud and what they call cancel culture, which are two major themes of the annual Conservative Political Action Conference, known as CPAC, starting on Friday in Orlando, Fla.

The lack of a unified Republican economic message reflects an unsettled party that is unable to agree on how to chart a path through a Democratic-controlled Washington. While congressional Republicans take a scattershot approach to try to undermine the legislation, mayors and governors in their party are pushing for the plan, saying their states and cities need the federal aid to keep police officers on their beats, reopen schools and help small businesses.

Polling shows a significant number of Republican voters agree: More than four in 10 Republicans back Mr. Biden’s aid package, according to polling from the online research firm SurveyMonkey for The New York Times. Over all, 72 percent of Americans said they supported the bill, a number that includes 97 percent of Democrats.

Global Roundup

Credit…Andrea Mantovani for The New York Times

BRUSSELS — In vaccine-hungry, cash-rich Europe, the hunt for more doses has nations trading with each other, weighing purchases from Russia and China, and fielding offers from middlemen ranging from real to outright frauds.

Anger has been building over the European Union’s sluggish Covid vaccine rollout, which has left the E.U. member nations far behind several other wealthy countries, and many E.U. states are now looking beyond the bloc’s underwhelming joint purchasing strategy.

An immense black — or at least gray — market has arisen, with pitches from around the world at often exorbitant prices. Sellers have approached E.U. governments claiming to offer 460 million doses of vaccines, according to early results of an investigation by the bloc’s anti-fraud agency that were shared with The New York Times.

While they still plan to get vaccines from the bloc, some nations are also trying to negotiate directly with drug makers and eyeing the murky open market, where they are still unsure of the sellers and the products. Some have also agreed to swap vaccines with each other, deals some of them now have reason to regret.

The European Union last year was slow to make massive advance purchases from drug companies, acting weeks after the United States, Britain and a handful of other countries. This year, the bloc was blindsided by slower-than-expected vaccine production, and individual countries have fumbled the rollout.

About 5 percent of the E.U.’s nearly 450 million people have received at least one dose of a vaccine, versus almost 14 percent in the United States, 27 percent in Britain and 53 percent in Israel, as of earlier this week, according to the Our World in Data database and governments.

The stumbles by the world’s richest bloc of nations have turned vaccine politics toxic. Particularly galling to many Europeans is the sight of a former E.U. member, Britain, forging ahead with its vaccination and reopening plans, while many of their own societies remain under lockdown to contain a new surge of dangerous variants, their economies sinking deeper into recession.

In other international news on the pandemic:

The government in France has announced stricter border checks between Germany and the eastern Moselle region, one of several areas experiencing a spike in coronavirus infections. It is the latest pandemic measure to challenge the E.U.’s open borders. Officials said that starting Monday, those wanting to cross the border would have to present a negative coronavirus test from the past 72 hours. Cross-border workers in the area will be exempt.
President Emmerson Mnangagwa of Zimbabwe threatened this week to punish residents who do not take Covid vaccines. “You are not going to be forced to be vaccinated, but the time shall come when those who are not vaccinated won’t get jobs,” he said on Wednesday. The country of 15 million people received 200,000 donated doses from the Chinese company Sinopharm, and 600,000 more doses are expected in early March. Zimbabwe is also set to receive more than 1.1 million doses as part of the Covax distribution program for poor and middle-income countries.
North Korea’s borders have been closed for a year because of the pandemic, but some Russian diplomats and their families found a way home on a route that included a bus ride and a trip on a hand-pushed railroad trolley. Russia’s Foreign Ministry said on Friday that the journey by trolley was the only possible way for them to cross the border.

Credit…James Estrin/The New York Times

Members of the Congressional Black Caucus and Dr. Anthony Fauci sought to reassure Black Americans that vaccine rollouts would be as equitable as possible and tried to quell anxieties over the safety of the inoculation among people of color during a televised forum Friday night.

Dr. Fauci, the government’s top infectious disease expert, said increasing pharmacies’ vaccine inventory and creating mobile units to get to hard-to-reach areas will help.

Experts say that Black and Latino Americans are being vaccinated at lower rates because they face obstacles like language barriers and inadequate access to digital technology, medical facilities and transportation. But mistrust in government officials and doctors also plays a role and is fed by social media misinformation. And in cities across the country, wealthy white residents are lining up to be vaccinated in low-income Latino and Black communities.

“It’s affecting us like no other disease, like no other epidemic has. That’s because for Black Americans, we were already behind,” Representative Barbara Lawrence, Democrat of Michigan, said during the forum on MSNBC’s “The Reid Out.”

“We’re looking at historic fear of vaccines and a fear of the health care industry because are they going to hurt us, harm us, ignore us or are they going to help us?” she said.

President Biden has said he wants to make racial equality a centerpiece of his vaccination rollout plan. He has begun shipping vaccines to federally qualified community health centers in Black and Latino communities.

While new data shows rates of vaccination in New York City’s Black and Latino communities are lower than rates in largely white communities and New York State’s Latino and Black residents were behind in vaccination totals, the absence of comprehensive national data on race and ethnicity makes it impossible to know just how equitable vaccine distribution is.

“This vaccine does not discriminate,” Ms. Lawrence said. “It hurts me when I see a line of people getting vaccines and my people are not represented but I’m invited to the funerals of those who have died. I have taken the vaccine. I believe in it. I need my people, my community, to step up.”

Credit…Tasos Katopodis/Getty Images

The phone and online registration system set up by the District of Columbia for its residents to use to schedule Covid-19 vaccination appointments has been faltering after the city broadened the eligibility of prioritized residents who can make appointments on Thursday.

D.C. widened the criteria from people 65 and older to include residents with certain health conditions and those working jobs that require contact with multiple people.

But many complained on Thursday and Friday that the phone number listed for scheduling a jab was not in service, and that the website was returning error messages. Some people were able to secure an appointment, though it was not immediately clear why they were successful when others were not.

“In short … it did not go well,” one of the city’s council members, Charles Allen, said in an email to constituents on Thursday.

Mayor Muriel Bowser blamed the problems on the “high volume of traffic” on the city’s vaccination site and said in a tweet that the city was trying to fix the problems quickly. The mayor’s office did not immediately respond to a request for comment.

The city’s health department apologized for the problems and said the “technical review failure” on Thursday had been addressed. However, the problems persisted on Friday when the city released another 4,350 vaccine appointments.

As of Friday, nearly 11 percent of D.C. residents had received one dose of a vaccine, and nearly 5 percent had received two doses, according to a New York Times database.

Credit…Ueslei Marcelino/Reuters

RIO DE JANEIRO — The daily death toll of Covid-19 in Brazil hit a record high of 1,582 on Thursday, according to a news consortium’s survey of local health departments. The painful milestone came as President Jair Bolsonaro railed against face masks, despite compelling scientific evidence that they are effective at preventing infections.

A rise in coronavirus infections in several states in Brazil, which officials say is being driven by more contagious variants, has overwhelmed hospitals across the country.

While epidemiologists and health officials warn of a worsening crisis in the weeks ahead, Mr. Bolsonaro took aim at masks during his weekly address on Facebook Thursday. Citing an unspecified German study, the president said masks were bad for children and that wearing them could lead to headaches, difficulty concentrating and a “decreased perception of happiness.”

Mr. Bolsonaro has been criticized at home and abroad for his cavalier response to the coronavirus pandemic. He has questioned the use of quarantine measures, social distancing and has sowed doubts about vaccines, saying he does not intend to get a shot.

While new cases and deaths are dropping in a number of other countries that were hard hit by the pandemic, including the United States, Brazil is in the grip of a second wave that began in November and shows no sign of easing.

The country began vaccinating medical professionals and older people last month, but the campaign is off to a slow start because the government has struggled to procure enough doses to quickly inoculate its 212 million citizens.

This week, Brazil’s Covid death toll surpassed 250,000, which is second only to the U.S. count of more than 500,000 deaths. The Brazilian health minister, Eduardo Pazuello, said on Thursday that the country had entered a “new stage of the pandemic” as a result of variants that he said are three times more contagious than earlier strains of the virus. “That is the reality we’re living today in Brazil,” he said.

Credit…Neil Hall/EPA, via Shutterstock

For people who have had Covid-19, a single dose of the Pfizer vaccine is enough to provide robust protection from the coronavirus, according to two new studies from Britain that were published late Thursday in The Lancet, a prominent medical journal.

The studies, among the first fully vetted papers to weigh in on how to vaccinate people who have had Covid-19, added strong evidence to the case for inoculating people who already have antibodies against the virus — but only with one dose of the Pfizer vaccine.

One of the studies, led by researchers at University College London and Public Health England, described the benefits of that strategy.

“This could potentially accelerate vaccine rollout,” they said. And that in turn could forestall dangerous new mutations: “Wider coverage without compromising vaccine-induced immunity could help reduce variant emergence,” the paper said.

In recent weeks, several studies on the topic were posted online that were not yet published in scientific journals, showing that one dose of a coronavirus vaccine amplified people’s antibodies from an earlier infection.

People’s immune responses to being infected are highly variable: Most people make considerable and long-lasting antibodies, while others who had milder infections produce relatively few, making it difficult to know how protected they are from the virus.

Vaccines act as a sort of booster for those people’s immune responses, inducing enough antibodies to offer protection. But a single dose, rather than the full two-dose protocol, is enough for those who have been infected, a number of studies have suggested.

Some researchers in the United States are trying to persuade the Centers for Disease Control and Prevention to recommend giving only one dose to people who have recovered from Covid-19. The studies from Britain seem likely to put pressure on health officials there to consider the same approach.

More than 28 million people in the United States and four million people in Britain, along with many others whose illnesses were probably never diagnosed, have been infected so far.

One of the new studies — led by Charlotte Manisty, a professor at University College London, and Ashley D. Otter, a research scientist at Public Health England — tracked 51 health workers in London who have submitted to routine tests for antibodies and infection since March. That gave researchers an unusually detailed picture of any pre-existing protection from the virus.

Roughly half of the health workers had experienced a mild or asymptomatic infection. And a single dose of the Pfizer vaccine increased their antibody levels more than 140-fold from their peak levels before being inoculated, the study said. That appeared to give them better protection against the coronavirus than two doses of the vaccine did in people who had never been infected, the researchers wrote.

The study raised the idea of giving people blood tests in the weeks before they became eligible for a Pfizer vaccine to determine whether they already had antibodies. People’s immune responses to an infection are highly variable, making it difficult to predict without a blood test who can be fully protected with a single dose.

As a further benefit of the single-dose strategy, the researchers wrote that it would spare people who have already been infected from the unpleasant side effects that sometimes follow a booster shot in that group.

The second study, led by scientists at Imperial College London, measured the immune responses of 72 health workers who were vaccinated in late December. A third showed signs of having previously been infected.

For those people, one dose of the Pfizer vaccine stimulated “very strong” antibody responses, the study said, as well as “very strong T-cell responses,” referring to another arm of the immune system.

It is not clear how long the post-vaccine immune response will last in people who have previously been infected compared with those who have not.

Credit…Lucy Nicholson/Reuters

The head of Canada’s largest pension fund stepped down on Thursday evening after news broke that he had flown to the United Arab Emirates to receive a coronavirus vaccine, despite federal rules banning inessential travel and a long line of older and immunocompromised citizens across the country waiting for their shots.

The Canada Pension Plan Investment Board announced in a news release on Friday that it had accepted the resignation of its chief executive, Mark Machin, who had “decided to travel personally to the United Arab Emirates where he arranged to be vaccinated against Covid-19.” The board added: “We take that responsibility of leadership very seriously.”

At about $375 billion, the fund is Canada’s largest, with more than 20 million contributors and beneficiaries.

Mr. Machin, who last year earned about $4.2 million at the helm of the crown corporation, is the latest public figure in the country to be publicly sanctioned for traveling abroad for personal reasons, while much of the country is hunkered down during the pandemic’s second wave.

His trip was perceived as not just selfish, but as queue-jumping by many Canadians, who have grown increasingly impatient with the sluggish rollout of vaccinations across the country. Less than 4 percent of the country’s 38 million people have received a dose — far fewer than most Western nations.

The Canada Pension Plan Investment Board is an independent corporation, but the country’s finance minister appoints its directors. Through her spokeswoman, the deputy prime minister and finance minister, Chrystia Freeland, called Mr. Machin’s decision “very troubling” and said Canadians expect the organization to “be held to a higher standard.”

Mr. Machin’s trip was first reported by The Wall Street Journal on Thursday night. Soon after, he sent an internal memo to staff stating the trip was supposed to be “very private” and that he was disappointed it has become the focus of “expected criticism,” The Globe and Mail reported.

Credit…Cameron Pollack for The New York Times

Even as the overall number of coronavirus cases in South Carolina declines, the situation away from the state’s coastline has remained stubbornly dangerous, with some counties in the central and western parts of the state reporting some of the most dire case counts relative to their populations in the Southeast.

Those regions have kept the state’s case count from declining further, and over the last week, South Carolina has reported more cases per capita than any other state, as of Thursday.

The cases are staying high in a mix of small and large counties, including the metropolitan areas of Columbia, the state’s capital and second-largest city, and Spartanburg. Those two metro areas have reported more cases per capita over the last two weeks than all but three other metro areas in the United States, according to a New York Times database. And they are doing so even as cases in Charleston, the state’s largest city, have consistently fallen.

Gov. Henry McMaster cited the overall decline in U.S. cases on Friday in deciding to roll back several public health measures beginning next week. Starting Monday, there will no longer be an 11 p.m. curfew for alcohol sales at restaurants, and large gatherings can resume, though he encouraged people to voluntarily follow the guidelines that had been in place.

“With the spread of the virus consistently decreasing across the country and more of the most vulnerable South Carolinians being vaccinated every day, I believe these targeted and limited safety measures are no longer necessary,” Mr. McMaster said in a statement. “The virus is still among us and we all must continue to make responsible decisions to take care of ourselves and our loved ones, but those decisions are for South Carolinians to make.”

The move from Mr. McMaster came on the same day that Dr. Rochelle Walensky, the director of the Centers for Disease Control and Prevention, warned that the recent decline in cases may be stalling and said governors should keep public health measures in place. “Now is not the time to relax restrictions,” she said.

Brian Symmes, a spokesman for Mr. McMaster, said the governor “appreciates perspectives that differ from his own” but “respectfully disagrees” with Dr. Walensky’s assessment.

One day earlier, on Thursday, South Carolina’s top epidemiologist, Dr. Linda Bell, said in an interview with a local television station that while it was understandable that residents would be optimistic as vaccines rolled out, it was important for them to not forget that the situation was still severe in much of the state.

“We cannot say yet that we have passed the worst part of the pandemic,” Dr. Bell said on WIS-TV.

“I don’t want people to be too encouraged to the point that they stop doing the preventive measures, looking at the current decline in cases,” she added, “because we have declined to a level that has taken us to the height of cases that we were seeing after the Fourth of July, and I want to remind people that we were actually very alarmed.”

Mitch Smith contributed reporting.

Credit…Charlie Riedel/Associated Press

Colleges and universities across the country are pledging to reopen more fully in the fall, with some administrators worried that students won’t return to campus if normality, or some semblance of it, isn’t restored by September.

Schools from large state institutions to small private ones have announced they are laying plans to bring students back to dormitories, deploy professors to teach most (if not all) classes in person and restart extracurricular activities, in stark contrast to the past academic year of largely virtual courses and limited social contact. The announcements of these changes coincide with the sending of acceptance letters to the class of 2025.

Some schools have taken a financial hit because of deferred admissions or lost room-and-board fees.

Bradley University, in Peoria, Ill., which has 5,600 undergraduate and graduate students, said earlier this month that it would return to “traditional residential education” in the fall, with in-person classes and activities on campus.

Kansas State University announced on Wednesday that it too is planning a “more normal” fall semester, with largely in-person classes, events and activities. Ohio State announced on Thursday that it plans to offer “robust” in-person activities and classes, allowing students to live in residence halls and fans to attend football games.

Katherine Fleming, New York University’s provost, told colleagues in an email on Tuesday of plans to have “all faculty teaching their classes in-person, in the classroom, in the fall 2021.” She conceded, however, that this would depend in part on whether enough professors were vaccinated by then.

Indeed, most school officials said that whether they can deliver on these promises hinges on factors like how much the virus can be suppressed, the availability of the vaccine — which is still in scarce supply, even for those who are eligible — and guidance from government authorities.

Despite their hopefulness about the fall, schools have struggled with keeping the virus in check. Positivity rates rose among college students, as among the general population, over the holidays, when people traveled. Administrators have put out many stern warnings that small parties and gatherings have been a source of infection. Many have noted, however, that the classroom itself has not proven to be a vector of infection, as long as students and teachers follow safety guidelines like wearing masks and social distancing.

More than 120,000 coronavirus cases have been linked to American colleges and universities since Jan. 1, and more than 530,000 cases have been reported since the beginning of the pandemic, according to a New York Times survey. The Times has identified more than 100 deaths, but the vast majority involved employees, not students.

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Biden Tours Texas Emergency Aid Centers After Winter Storms

President Biden spent the day in Houston touring a local food bank and other areas hit by recent snowstorms. Storm damage is expected to total $20 billion, according to the Insurance Council of Texas.

Mr. President, welcome. This is our emergency operations center, Harris County Emergency Operations Center. For me and these folks you see here, this has been our home away from home. Over fire, flood, Covid and now this winter weather event. These folks are the tip of the sphere. Thank you for What you are doing. All I did is I got a call and before you asked the question I just said yes. He did. He said yes before I even asked the question. Absolutely. It’s incredible. It’s an incredible place. They’re doing — and they have so many talented people here, not just volunteers, really talented people.

President Biden spent the day in Houston touring a local food bank and other areas hit by recent snowstorms. Storm damage is expected to total $20 billion, according to the Insurance Council of Texas.CreditCredit…Doug Mills/The New York Times

At an emergency response center in Houston, President Biden praised officials who’d slept in stairwells as they worked around the clock to answer the call of terrified residents who had no power or drinkable water when devastating snowstorms hit. At a food bank, Mr. Biden hugged a little girl who was volunteering. He then turned to a woman to discuss the death of his eldest son, plugging into the pain of people around him by accessing his own.

“Incredible,” Mr. Biden said as he surveyed what was happening around him. “It’s absolutely amazing, and we could do so much more.”

Infrastructure and coronavirus relief may be on the official agenda in Washington, but the overwhelming nature of grief was the unofficial theme of the week.

On Monday, Mr. Biden presided over a solemn observance of a grim pandemic milestone: more than 500,000 Americans dead. “While we have been fighting this pandemic for so long, we have to resist becoming numb to the sorrow,” he said during a speech at that White House that evening.

And when he traveled to Houston with Jill Biden, the first lady, the president for the first time used his new platform to show support for a community ravaged by twin crises of devastating snowstorms and the pandemic.

“You’re saving people’s lives,” Mr. Biden told a group of officials at an emergency operations center. “As my mother would say, you’re doing God’s work.”

Across Texas, the damage from the storms is extensive and the recovery is expected to be slow. The damage is expected to cost upward of $20 billion, according to the Insurance Council of Texas. Coronavirus vaccinations had all but stalled because of the storm, but are beginning to rebound — Mr. Biden was expected to visit a mass-vaccination site at a nearby stadium later Friday.

As soon as Mr. Biden hit the ground, the tone of his visit was different from what victims of natural disasters encountered when his predecessor, Donald J. Trump, would visit. Mr. Trump more than once threatened to withhold disaster funding if he had toxic political relationships with officials in those places.

Mr. Biden, who has been pushing a $1.9 trillion coronavirus relief package, was joined by Republicans who praised him for approving a major disaster declaration for Texas, ensuring the flow of federal resources to some 126 counties across the state that were hit by the storms — about half the number requested by Gov. Greg Abbott, who joined Mr. Biden on the trip.

“The governor and Senator Cruz and I asked for a declaration from the federal government which provides access to public and private assistance through FEMA,” said Senator John Cornyn, Republican of Texas and another participant on the trip, referring to the state’s junior senator, Ted Cruz. “That’s going to be important for our recovery.”

Mr. Cruz did not participate. He was in Florida, speaking at the Conservative Political Action Conference.

In Harris County, where Houston is, about 50 percent of 4.9 million residents lost power as the storms hit. Nearly two weeks later, about 10,000 residents are still boiling their water, according to county officials. More than 50,000 across the state still do not have access to safe water, according to officials with the Federal Emergency Management Agency.

During the visit to the food bank, Dr. Biden slipped cans of peaches into packages of food for students who rely on free school meals. Mr. Biden talked to children and told them about his own family.

It was a marked difference from Mr. Trump, who was criticized in 2018 for visiting a disaster relief center in Puerto Rico, only to throw paper towels at people who’d survived a Category 5 hurricane. “I was having fun,” Mr. Trump said afterward. “They were having fun.”

Tags Covid19, FDA, Green, Johnson, Johnsons, Light, Panel, Vaccine

Business

Bud Mild to launch arduous seltzer lemonade as new rivals enter market

Post author By
Post date January 11, 2021

All four flavors of Bud Light Seltzer Lemonade

Bud Light

Bud Light is launching a range of Hard Seltzer sodas to make a solid claim on the increasingly competitive category.

The Anheuser-Busch InBev brand entered the market for hard seltzer a year ago as part of a broader push by the parent company. Anheuser-Busch InBev also owns the seltzer maker Bon & Viv. As beer consumption has declined in recent years, brewers have turned to the hard seltzer to increase sales.

In the 52 weeks ending December 26, retail sales of selters rose 160% to $ 4.1 billion, according to Nielsen data. The trend started with the popularity of White Claw, owned by Mike’s Hard Lemonade brewer Mark Anthony Brands, but newcomers have boosted sales even further. Coca-Cola is entering the fray this year with Topo Chico Hard Seltzer, its first alcoholic beverage in the US since 1983, through a partnership with Molson Coors Beverage.

According to Euromonitor International, White Claw still holds more than half of the market share for hard seltzer through 2019. Truly Spiked & Sparkling, owned by Boston Beer, ranks second with a 28% share. At almost 10%, Bon & Viv is a distant third.

According to Bud Light, the success of its seltzer helped the beer brand gain more market share in 2020 than it has over the past five years. Its strong performance coincided with the coronavirus pandemic, which led more consumers to drink alcohol at home rather than in bars. AB InBev’s shares, valued at $ 122 billion, fell 13% last year after falling 8.2% in volume in the first nine months of last year.

“When we looked at the different types of seltzer, we tried to differentiate a segment of seltzer,” said Andy Goeler, vice president of marketing at Bud Light.

The seltzer was first launched with mainstream flavors like strawberry and black cherry, but Bud Light launched a special “ugly sweater” package with seasonal flavors for eight weeks over the holidays. The thematic beverage pack is sold out, said Goeler.

For his next seltzer innovation, Bud Light landed on lemonade, which has great appeal. According to Nielsen data, hard seltzer lemonade retailed just $ 313.97 million in the 52 weeks ended December 26. However, thanks to early entrants such as Truly’s version, the segment is growing much faster than that of hard seltzer. Nielsen data found that retail sales during this period were more than nine times higher than last year.

Bud Light tries to beat the competition by improving the taste. The brand ran blind taste tests for consumers and tweaked the recipe until Bud Light Seltzer Lemonade beat the competition every time.

“This one will have a much bolder lemonade taste,” said Goeler. “Again, we want to make sure we get the best lemonade.”

However, the nutritional profile of Seltzer lemonade is still in line with what consumers are looking for at Seltzer, which is widely considered a healthier alcoholic beverage compared to beer. It’s 100 calories and contains less than 1 gram of sugar.

After more than six months of development, the drink will hit shelves on January 18th. The 12-ounce cans will be available in packs of 12 with all four flavors: original lemonade, peach lemonade, black cherry lemonade, and strawberry lemonade.

While lemonade is usually thought of as a summer drink, Bud Light is confident of bringing the new drink to market in the dead of winter.

“The advantage of the release is that there is enough time to bring the product to market before spring begins,” said Goeler. “Things will pick up in the summer as with all beer sales and Selters is starting to follow that year-round demand.”

Promotion of the drink begins with commercials that air during the NFL playoffs, which begin Saturday. The ads play with the idea that grandma’s lemonade tastes best. Actors say the hard seltzer tastes better, leading to retribution from grandmothers.

Tags Bud, enter, Hard, launch, lemonade, Light, market, rivals, Seltzer

Health

F.D.A. Panel Provides Inexperienced Mild to Pfizer’s Covid Vaccine

Post author By Gloria Cote
Post date December 10, 2020

F.D.A. Panel Gives Green Light to Pfizer's Covid Vaccine

Pfizer’s Covid-19 vaccine passed a critical milestone on Thursday when a panel of experts formally recommended that the Food and Drug Administration authorize the vaccine. The agency is likely to do so within days, giving health care workers and nursing home residents first priority to begin receiving the first shots early next week.

The F.D.A.’s vaccine advisory panel, composed of independent scientific experts, infectious disease doctors and statisticians, voted 17 to 4, with one member abstaining, in favor of emergency authorization for people 16 and older. With rare exceptions, the F.D.A. follows the advice of its advisory panels.

With this formal blessing, the nation may finally begin to slow the spread of the virus just as infections and deaths surge, reaching a record of more than 3,000 daily deaths on Wednesday. The F.D.A. is expected to grant an emergency use authorization on Saturday, according to people familiar with the agency’s planning, though they cautioned that last-minute legal or bureaucratic requirements could push the announcement to Sunday or later.

The initial shipment of 6.4 million doses will leave warehouses within 24 hours of being cleared by the F.D.A., according to federal officials. About half of those doses will be sent across the country, and the other half will be reserved for the initial recipients to receive their second dose about three weeks later.

The arrival of the first vaccines is the beginning of a complex, monthslong distribution plan coordinated by federal and local health authorities, as well as large hospitals and pharmacy chains, that if successful, will help return a grieving and economically depressed country back to some semblance of normal, maybe by summer.

“With the high efficacy and good safety profile shown for our vaccine, and the pandemic essentially out of control, vaccine introduction is an urgent need,” Kathrin Jansen, a senior vice president and the head of vaccine research and development at Pfizer, said at the meeting.

The vote caps a whirlwind year for Pfizer and its German partner BioNTech, which began working on the vaccine 11 months ago, shattering all speed records for vaccine development, which typically takes years. It is also a triumph for the F.D.A., which has upheld its reputation as the world’s gold standard for drug reviews despite months of political pressure from President Trump, who has sought to tie his political fortunes to the success of a vaccine. The Pfizer vaccine has already been given to people in Bahrain and Britain, where it was authorized on Dec. 2. Canada approved it on Wednesday.

The U.S. authorization of Pfizer’s vaccine is expected to be followed soon by one for Moderna’s version, which uses similar technology and has also shown promising results in clinical trials. Operation Warp Speed, the Trump administration’s multi-billion-dollar program to fast-track vaccine development, pre-ordered 100 million doses of Pfizer’s vaccine in July and heavily backed the development and manufacturing of Moderna’s vaccine.

More than 100 F.D.A. employees have worked nearly round the clock to review the application Pfizer submitted on Nov. 20, compressing months of analysis into weeks as they pored over thousands of pages of clinical trial and manufacturing data.

Earlier this week, career scientists at the F.D.A. published an analysis showing the vaccine worked across a variety of demographic groups and that it was somewhat effective even after the first of two doses.

During the daylong meeting on Thursday, panel members peppered company and agency experts with detailed questions about the safety and efficacy of the vaccine, which was found to be 95 percent effective in a late-stage clinical trial. Some members expressed concern that there was not enough data from 16- and 17-year-olds to know whether the vaccine would help them, but the committee decided the benefits for that group outweighed the risks.

Some members asked about the likelihood for serious allergic reactions, given the news that regulators in Britain recommended this week that people with a history of anaphylactic allergic reactions to medicines and foods not get the vaccine while they investigate two cases of allergic reactions among health care workers. Pfizer officials said there were no cases of serious allergic reactions in the trial of 44,000 participants. People with a history of allergic reactions to vaccines were excluded from the study.

One of the panel members, Dr. Paul Offit of the Children’s Hospital of Philadelphia, said he feared that statements by British regulators as well as remarks by Moncef Slaoui, a top U.S. vaccine official, could lead “tens of millions” of people with severe allergies to reject the vaccine even though evidence of a link to the shots was unclear. He asked Pfizer to conduct a separate study of people with a history of severe allergies, because “this issue is not going to die until we have better data.”

The F.D.A. said that it had asked Pfizer to include allergic reactions in its safety tracking plan and would include a warning in its instructions on the use of the vaccine.

One of the most hotly contested issues was how the broad authorization of the vaccine might affect the continuing clinical trial. Some experts have argued that, ethically, trial volunteers who received a placebo should be offered the vaccine once it is authorized, but others worried that move could tarnish the long-term results of the trial.

During the public portion of the meeting, consumer and public health advocates largely pushed the agency to authorize the vaccine, noting the urgency of the pandemic. One speaker, who identified himself as Kermit Kubitz, noted that he had no conflicts of interest to declare except for “a lot of elderly relatives.”

“They need this vaccine yesterday,” he said.

But advocates also asked regulators to be transparent about potential safety issues and to closely track the vaccine once it becomes available. Several said such measures were necessary to reassure a public that is hesitant to take a new vaccine, particularly Black and Native American people who have historically been mistreated by the medical community. “Before authorization is granted, affected communities need to have confidence that the vaccine is safe and effective,” said Sarah Christopherson of the National Women’s Health Center.

By insisting that the advisory committee vote on any vaccine, regulators created a shield against White House pressure to approve a product before the presidential election. When the panelists met in October to discuss the F.D.A.’s guidelines for approving Covid-19 vaccines, they urged the agency to take its time and cautioned that rushing the process could risk missing vital safety data and further erode public trust.

The scene that played out on Thursday — in which outside experts spent hours engaging government officials in an intense but often highly technical discussion about vaccine science — did not always make for exciting viewing. But the circumstances were certainly dramatic, as the experts were being asked to carefully weigh the risks and benefits of the vaccine, even as the United States reached the grim milestone of recording more than 3,000 Covid deaths on Wednesday and as thousands of people in Britain had already received it.

The F.D.A. has struggled, internally and externally, to move fast on its vaccine and treatment deliberations in order to curb the deadly virus’s spread — but not so fast as to undermine public confidence. It was a thin line to walk, and not helped by the torrent of troubling accusations by Mr. Trump and his advisers that the agency was moving too slowly.

Just days before Pfizer submitted its application, the company sent an enormous tranche of manufacturing data to the F.D.A. — including materials on how it was scaling up production — leaving regulators scrambling to evaluate it in time for a possible authorization.

As part of its oversight, the F.D.A. also had teams review company production facilities and clinical trial sites, where they verified that records corresponded to the accounts Pfizer had submitted to federal regulators.

At the same time, regulators were evaluating an equally complex emergency authorization application submitted by Moderna, whose data will be examined publicly during another F.D.A. outside advisory meeting next week.

The Road to a Coronavirus Vaccine ›

Answers to Your Vaccine Questions

As the coronavirus vaccine get closer to U.S. authorization, here are some questions you may be wondering about:

- If I live in the U.S., when can I get the vaccine? While the exact order of vaccine recipients may vary by state, most will likely put medical workers and residents of long-term care facilities first. If you want to understand how this decision is getting made, this article will help.
- When can I return to normal life after being vaccinated? Life will return to normal only when society as a whole gains enough protection against the coronavirus. Once countries authorize a vaccine, they’ll only be able to vaccinate a few percent of their citizens at most in the first couple months. The unvaccinated majority will still remain vulnerable to getting infected. A growing number of coronavirus vaccines are showing robust protection against becoming sick. But it’s also possible for people to spread the virus without even knowing they’re infected because they experience only mild symptoms or none at all. Scientists don’t yet know if the vaccines also block the transmission of the coronavirus. So for the time being, even vaccinated people will need to wear masks, avoid indoor crowds, and so on. Once enough people get vaccinated, it will become very difficult for the coronavirus to find vulnerable people to infect. Depending on how quickly we as a society achieve that goal, life might start approaching something like normal by the fall 2021.
- If I’ve been vaccinated, do I still need to wear a mask? Yes, but not forever. The two vaccines that will potentially get authorized this month clearly protect people from getting sick with Covid-19. But the clinical trials that delivered these results were not designed to determine whether vaccinated people could still spread the coronavirus without developing symptoms. That remains a possibility. We know that people who are naturally infected by the coronavirus can spread it while they’re not experiencing any cough or other symptoms. Researchers will be intensely studying this question as the vaccines roll out. In the meantime, even vaccinated people will need to think of themselves as possible spreaders.
- Will it hurt? What are the side effects? The Pfizer and BioNTech vaccine is delivered as a shot in the arm, like other typical vaccines. The injection won’t be any different from ones you’ve gotten before. Tens of thousands of people have already received the vaccines, and none of them have reported any serious health problems. But some of them have felt short-lived discomfort, including aches and flu-like symptoms that typically last a day. It’s possible that people may need to plan to take a day off work or school after the second shot. While these experiences aren’t pleasant, they are a good sign: they are the result of your own immune system encountering the vaccine and mounting a potent response that will provide long-lasting immunity.
- Will mRNA vaccines change my genes? No. The vaccines from Moderna and Pfizer use a genetic molecule to prime the immune system. That molecule, known as mRNA, is eventually destroyed by the body. The mRNA is packaged in an oily bubble that can fuse to a cell, allowing the molecule to slip in. The cell uses the mRNA to make proteins from the coronavirus, which can stimulate the immune system. At any moment, each of our cells may contain hundreds of thousands of mRNA molecules, which they produce in order to make proteins of their own. Once those proteins are made, our cells then shred the mRNA with special enzymes. The mRNA molecules our cells make can only survive a matter of minutes. The mRNA in vaccines is engineered to withstand the cell’s enzymes a bit longer, so that the cells can make extra virus proteins and prompt a stronger immune response. But the mRNA can only last for a few days at most before they are destroyed.

Regulators sometimes received documents from the companies as late as midnight and worked through the Thanksgiving holiday. Dr. Peter Marks, the top vaccine regulator at the F.D.A., joked last week at an event hosted by the American Medical Association that his team ate turkey sandwiches while examining documents.

“Among all global regulators, we are the ones that actually don’t just look at the company’s tables. We actually get down and dirty and we look at the actual adverse event reports, the bad spelling errors that are made by physicians sometimes, et cetera,” he said at the event.

Dr. Stephen M. Hahn, the F.D.A. commissioner, kept a careful distance from the review, according to people familiar with it.

Dr. Hahn had caved to pressure earlier in the summer to authorize an old malaria drug, hydroxychloroquine, for use in Covid patients even though there was little evidence that it worked. That decision was reversed after the agency found the drug was unlikely to be effective in Covid patients and carried a risk of potentially dangerous side effects. And Dr. Hahn faced withering criticism from the scientific community after he exaggerated the benefits of another treatment, convalescent plasma, an error he later corrected.

Mr. Trump accused agency officials of being part of the “deep state” and hinted that a vaccine could come before “a very special day” — Election Day. The F.D.A.’s reputation appeared to be headed in the same direction as that of the Centers for Disease Control and Prevention, which was widely criticized for not standing up to the president.

But senior regulators — and eventually Dr. Hahn himself — pushed back. The agency’s top career officials published an opinion piece in USA Today, acknowledging that the F.D.A.’s integrity had been called into question and insisting that they would “follow the science” during the pandemic. The agency prevailed in a battle with the White House over imposing more stringent guidelines for companies developing Covid vaccines.

“In this sort of environment, where there has been so much pressure and concern, the process does provide an important check and balance,” said Dr. Jesse L. Goodman, who previously served as the F.D.A.’s chief scientist. Holding an open meeting also allows the public to “be sure that a broader scientific and clinical community is comfortable with the decision.”

On Tuesday, the president held a summit intended to showcase the administration’s role in developing a vaccine. “We are just days away from authorization from the F.D.A. and we’re pushing them hard,” Mr. Trump said at the event.

Many health care workers around the country are already raring to get the vaccine. Dr. Andrew Barros, a critical care physician in Charlottesville, Virginia, who is scheduled to get his Pfizer shot at 2:30 p.m. on Dec. 15, said he is “looking forward to having a sore arm and hopefully being one step closer to having Covid under control.”

Pfizer’s clinical trial will continue even after its vaccine is authorized by the F.D.A., and the company and F.D.A. will continue to watch for safety concerns.

Pfizer said on Thursday that it planned to apply for full approval in April of 2021, after the company had collected six months of safety data. At that point, Pfizer would be allowed to sell its vaccine directly to hospitals and other health care providers.

Carl Zimmer and Katherine J. Wu contributed reporting.

Tags Covid, FDA, Green, Light, Panel, Pfizers, Vaccine