Friday, October 22, 2021

August 23, 2021   WASHINGTON (AP) — The U.S. gave full approval to Pfizer’s COVID-19 vaccine Monday, potentially boosting public confidence in the shots and instantly opening the way for more universities, companies and local governments to make vaccinations mandatory.

The Pentagon promptly announced it will press ahead with plans to force members of the military to get vaccinated amid the battle against the extra-contagious delta variant. The University of Minnesota likewise said it will require its students to get the shot, as did Louisiana’s major public universities, including LSU, though state law there allows broad exemptions.

More than 200 million Pfizer doses have been administered in the U.S. under emergency provisions — and hundreds of millions more worldwide — since December. In going a step further and granting full approval, the Food and Drug Administration cited months of real-world evidence that serious side effects are extremely rare.

President Joe Biden said that for those who hesitated to get the vaccine until it received what he dubbed the “gold standard” of FDA approval, “the moment you’ve been waiting for is here.”

Pfizer CEO Albert Bourla called the FDA’s action “an important milestone that I think will unlock some of the more skeptical minds.”

Pfizer said the U.S. is the first country to grant full approval of its vaccine, in a process that required a 360,000-page application and rigorous inspections. Never before has the FDA has so much evidence to judge a shot’s safety.

The formula, jointly developed with Germany’s BioNTech, will be marketed under the brand name Comirnaty.

Moderna has also applied to the FDA for full approval of its vaccine. Johnson & Johnson, maker of the third option in the U.S., said it hopes to do so later this year.

Just over half of the U.S. population is fully vaccinated. Vaccinations in this country bottomed out in July at an average of about a half-million shots per day, down from a peak of 3.4 million a day in mid-April. As the delta variant fills hospital beds, shots are on the rise again, with a million a day given Thursday, Friday and Saturday.

Full approval of Pfizer’s COVID-19 vaccine means it meets the same “very high standards required of all the approved vaccines we rely on every day,” said Dr. Jesse Goodman of Georgetown University, a former FDA vaccine chief. That should help “anyone who still has concerns gain confidence” in the shots.

Earlier this month, Defense Secretary Lloyd Austin said he would seek the president’s OK to make the vaccine mandatory by mid-September or once the FDA grants final approval, whichever comes first. On Monday, after the FDA acted, the Pentagon said guidance on vaccinations will be worked out and a timeline will be provided in the coming days.

The approval also opened the way for swift action by colleges to require vaccines and solidified the legal ground for hundreds of universities that have already issued mandates for students and staff.

The public university systems in Louisiana and Minnesota had been waiting for FDA action before making vaccinations mandatory. Louisiana has become a COVID-19 hot spot, repeatedly breaking records for the number of people hospitalized with the virus. But certain other states forbid universities to require shots, including Texas and Florida.

“Mandating becomes much easier when you have full approval,” said Dr. Carlos del Rio of Emory University. “I think a lot of businesses have been waiting for it.”

On the same day the FDA decision came down, New York City announced that all public school teachers and other staffers will have to get vaccinated.

The delta variant has sent cases, deaths and hospitalizations soaring in recent weeks in the U.S., erasing months of progress. Deaths are running at about 1,000 a day on average for the first time since mid-March, and new cases are averaging 147,000 a day, a level last seen at the end of January.

Elizabeth Nichols, 18, of Akron, Ohio, said she felt “a rush of relief” after hearing the news of the FDA’s approval. She already was on her way to get her first vaccine shot Monday morning after months of hesitation.

“I had an internal battle of whether I should get the shot or not,” Nichols said in an email. “It can be scary subjecting yourself to something that is unapproved.” But she added: “The authorization proves how safe it is.”

The FDA, like regulators in Europe and much of the rest of the world, initially allowed emergency use of Pfizer’s vaccine based on a study that tracked 44,000 people 16 and older for at least two months — the time period when serious side effects typically arise.

That’s shorter than the six months of safety data normally required for full approval. So Pfizer kept that study going, and the FDA also examined real-world safety evidence.

Pfizer’s shot will continue to be dispensed to 12- to 15-year-olds under an emergency use authorization until the company files its application for full approval.

Normally, doctors can prescribe FDA-approved products for other reasons than their original use. But FDA’s acting Commissioner Dr. Janet Woodcock strongly warned that the Pfizer vaccine should not be used “off-label” for children under 12 — a warning echoed by the American Academy of Pediatrics.

Both Pfizer and Moderna have vaccine studies underway in youngsters, and they are using lower doses than those available for people 12 and older.

Pfizer’s Bourla said he expects study results from 5- to 11-year-olds by the end of September, but data for those younger than 5 will take a couple of months.

Also, Woodcock said health providers are offering COVID-19 vaccines under agreements with the government that should preclude using Monday’s approval as a pretext for offering booster shots to the general population.

Currently, the FDA has authorized third doses of either Pfizer’s or Moderna’s vaccine only for certain people with severely weakened immune systems, such as organ transplant recipients. For everyone else, the Biden administration is planning for boosters starting in the fall. But the FDA is evaluating that question separately.

In reaching Monday’s decision, the FDA said serious side effects remain very rare, such as chest pain and heart inflammation a few days after the second dose, mostly in young men.

As for effectiveness, six months into Pfizer’s original study, the vaccine remained 97% protective against severe COVID-19. Protection against milder infection waned slightly, from a peak of 96% two months after the second dose to 84% by six months.

Those findings came before the delta variant began spreading, but other data from the Centers for Disease Control and Prevention shows the vaccine is still doing a good job preventing severe disease.

SXM Radio Online

Entertainment

September 7, 2021  NEW YORK (AP) — Actor Michael K. Williams, who as the rogue robber of drug dealers Omar Little on “The Wire” created one of the most beloved and enduring characters in a prime era of television, died Monday. Williams was found dead Monday afternoon by family members in his Brooklyn penthouse apartment, New York City police said. He was 54. His death was being investigated as a possible drug overdose, the NYPD said. The medical examiner was investigating the cause of death. Little, a “stick-up boy” based on real figures from Baltimore, was probably the most popular character among the devoted fans of “The Wire,” the HBO show that ran from 2002 to 2008 and is re-watched constantly in streaming.

September 8, 2021 LOS ANGELES (AP) — Britney Spears’ father filed Tuesday to end the court conservatorship that has controlled the singer’s life and money for 13 years. James Spears filed his petition to terminate the conservatorship in Los Angeles Superior Court. “As Mr. Spears has said, again and again, all he wants is what is best for his daughter,” the document says. “If Ms. Spears wants to terminate the conservatorship and believes that she can handle her own life, Mr. Spears believes that she should get that chance.” Judge Brenda Penny, who oversees the case, will need to approve the move. Britney Spears attorney Matthew Rosengart said in an email the filing “represents another legal victory for Britney Spears — a massive one — as well as vindication for Ms. Spears.”

September 8, 2021  NEW YORK (AP) — With Katie Holmes and Lil’ Kim on his front row and singer Marina on the mic high above his runway, Christian Siriano helped kicked off New York Fashion Week’s first big pandemic round of in-person shows Tuesday with a flurry of neon and lace-inspired in part by all the Italian women in his life. From ornate Gotham Hall, beneath a stained-glass skylight 70 feet up, Siriano’s commitment to size inclusivity was never stronger as he opened and closed the show with plus-size breakout model Precious Lee. She first walked in a stunning yellow trouser suit with wide loose pants and an asymmetrical jacket, a matching crossover bralette underneath.

September 7, 2021  VENICE, Italy (AP) — Paul Schrader knows he has a limited number of films left, so whatever he does from here on out is going to be for himself. At 75 years old, the writer of “Taxi Driver” and “Raging Bull” and director of “American Gigolo” and “Mishima” was even somewhat prepared to call it a day after his 2018 film “First Reformed,” for which he got his first Oscar nomination. He didn’t want to. He just knew it might be the reality. “I thought I would go back to this character again for about the fifth time,” Schrader said in a recent interview. By “this character” he means “the man in the room.” It’s Travis Bickle. It’s John LeTour. It’s Julian Kay. And it’s a formula he’s been working with for 45 years.

Business News

September 8, 2021  -Stocks were mostly lower in Asia on Wednesday after a lackluster session on Wall Street, where weak jobs data and pandemic concerns weighed on sentiment. Shares rose in Tokyo after economic growth for the April-June quarter was revised upward to an annualized 1.9% from an earlier estimate of 1.3%. “Any feel-good factor was ignored, though, given the climb was less than half of the 4.20% fall in Q1,” Jeffrey Halley of Oanda said in a commentary. “Japan will be lucky to break even this year as the current Covid-19 wave will almost certainly have weighed on domestic consumption,” he said.

September 8, 2021 NEW YORK (AP) — There will be something missing at two Whole Foods stores opening next year: the rows of cashiers. Amazon, which owns the grocery chain, said Wednesday that it will bring its cashier-less technology to two Whole Foods stores for the first time, letting shoppers grab what they need and leave without having to open their wallets. Cameras and sensors track what’s taken off shelves. Items are charged to an Amazon account after customers leave the store with them. But there will be an option for those who want to shop the old-fashioned way: Self-checkout lanes will be available that take cash, gift cards and other types of payment. Amazon first unveiled the cashier-less technology in 2018 at an Amazon Go convenience store and has expanded it to larger Amazon supermarkets. But it will be the first time it has appeared at Whole Foods, a chain of more than 500 grocery stores Amazon bought four years ago.

September 8, 2021  BEIJING (AP) — An avalanche of changes launched by China’s ruling Communist Party has jolted everyone from tech billionaires to school kids. Behind them: President Xi Jinping’s vision of making a more powerful, prosperous country by reviving revolutionary ideals, with more economic equality and tighter party control over society and entrepreneurs. Since taking power in 2012, Xi has called for the party to return to its “original mission” as China’s economic, social and cultural leader and carry out the “ rejuvenation of the great Chinese nation.” The party has spent the decade since then silencing dissent and tightening political control. Now, after 40 years of growth that transformed China into the world’s factory but left a gulf between a wealthy elite and the poor majority, the party is promising to spread prosperity more evenly and is pressing private companies to pay for social welfare and back Beijing’s ambition to become a global technology competitor.

Fashion News

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