FDA backs Pfizer Covid booster photographs for older and weak folks

The Food and Drug Administration authorized Pfizer and BioNTechCovid-19 booster vaccination for people 65 and older and other at-risk Americans six months after completing their first two doses, leaving many Americans now eligible to receive the vaccinations.

The FDA’s decision on Wednesday, which has yet to be reviewed by the Centers for Disease Control and Prevention, largely follows the recommendations it received more than on Friday from its main vaccine advisory committee eight-hour agency meeting.

The CDC’s Vaccine Advisory Committee is expected to vote on the FDA’s proposal on Thursday afternoon. If she recommends approval and the CDC approves it, the booster shots could start right away.

Last week, the FDA Advisory Committee on Vaccines and Related Biological Products voted 16-2 against distributing the vaccines to Americans 16 and older, before unanimously adopting an alternative plan to older Americans and those at high risk of developing serious illnesses to get sick to give a booster if they get the virus.

Although Americans 65 and older make up about 17% of the US population, they are most at risk of dying from Covid and account for more than 77% of all Covid deaths, according to the CDC.

The FDA has issued emergency clearance to administer Pfizer shots to elderly Americans and people ages 18 to 64 with conditions that put them at serious risk of disease. The agency also added a broad definition of anyone between the ages of 18 and 64 “whose frequent institutional or professional exposure” to the virus puts them at high risk of developing serious complications from Covid. That leaves enough room for the CDC to potentially release third doses for people in nursing homes, prisons, frontline health workers, and other key workers who were among the first Americans to receive their first syringes in December.

“The FDA took into account the committee’s input and conducted its own thorough review of the submitted data in order to make today’s decision,” said Dr. Peter Marks, the agency’s lead vaccines agency, in a statement. “We will continue to analyze the data submitted to the FDA regarding the use of booster doses of COVID-19 vaccines and, if necessary, make further decisions based on the data.”

The non-binding decision of the vaccination board it was expected to be controversial As the Biden administration has announced, it plans to start offering booster shots to the public as early as this week pending approval from US health regulators.

Although the agency has not always followed the advice of its committee, it often does. Still, Marks reminded the panel on Friday that federal regulators did not have to accept their written recommendation.

“We’re not tied to your vote at the FDA just for you to understand. We can adjust this as needed, ”he said.

In releasing the vaccinations, which will only apply to people who received the original Pfizer vaccine, the FDA cited a small study by the company of around 300 people who received the booster, data from the UK, as well as more comprehensive but less stringent data , from the Israeli health authorities.

Some scientists, including at least two to the FDA, had said they were not entirely convinced that every American who had received the Pfizer vaccine would need extra doses at this point. The country’s leading health authorities, including CDC director Dr. Rochelle Walensky, Acting FDA Commissioner Dr. Janet Woodcock and White House Senior Medical Advisor Dr. Anthony Fauci, however, already approved Biden’s booster plan in August.

Friday’s vote put the FDA panel in an “uncomfortable position” as the government had already announced that it would begin distributing boosters to the general public this month, said Dr. Bruce Farber, Head of Infectious Diseases at healthcare provider Northwell Health, before the panel’s recommendation.

Some committee members said they were concerned that there wasn’t enough data to make a recommendation, while others argued that the third vaccination should be limited to certain groups, e.g. Some members raised concerns about the risk of myocarditis in younger people and said more research was needed.

Dr. Phil Krause, an FDA vaccine regulator who is leaving the agency under pressure from the Biden administration to approve the shots, criticized the results presented at the meeting, saying that much of the data has not been verified by the federal agency or a peer-reviewed . He said the models used are complex and scientists need to make sure they are “getting the right results.”

“That’s part of the difficulty of looking at this type of data without a way for the FDA to review it,” he said.

In the outlines of the plans for last month’s launch Distribute boosters this week, administration officials cited three CDC studies showing that vaccines protection against Covid has waned over several months. Senior health officials said at the time they feared protection from serious illness, hospitalizations and deaths could “wear off” in the coming months, especially for those at higher risk or vaccinated during the earlier stages of vaccination.

Pfizer said in documents released last week that an observational study in Israel showed that a third dose of the Covid vaccine restored infection protection to 95% six months after a second vaccination. The data was collected from July 1 to August 30 when the rapidly expanding delta variant emerged across the country.

In a presentation on Friday, Dr. Sharon Elroy-Price of the Israeli Ministry of Health said that if officials there had not started distributing boosters in late July, the country would likely have exceeded its hospital capacity. She said health officials had seen a trend in fully vaccinated people in their 40s and 50s who became seriously ill with Covid.

“We didn’t want to wait to see these results, and we knew we had to vaccinate a larger section of the population to get the numbers down quickly,” she told the committee. Israeli health officials expected an average of 2,000 serious cases by the end of August, she said. “We have been able to dampen this effect and our severe cases are around 700 or less and have remained stable even though we still have days with 10,000 confirmed cases.”

Leisure Information Roundup: Norway wealth fund backs Vivendi’s plan to spin-off Common Music; Britney Spears says she would not know whether or not she’ll ever carry out once more and extra

The following is a summary of the latest entertainment news.

Norway’s wealth fund supports Vivendi’s plan to spin off Universal Music

Norway’s $ 1.35 trillion sovereign wealth fund, the largest in the world, said Thursday it would support Vivendi’s spin-off plan Universal music, including the distribution of shares in kind to Vivendi shareholders. Regardless, in accordance with its policy of transparent executive compensation based on the long-term shareholder interests, the Fund will vote against the compensation of Vivendi’s chairman, chief executive, top management and board members.

Britney Spears says she doesn’t know if she will ever perform again

Britney Spears says she has no idea if she will ever perform again. Spears, who has not appeared in public since late 2018 and is under a court-ordered restoration, made the statement in a video post about her Instagram Page where she answered three questions she believed her fans were asking.

Warner Music is buying French Music catalog by DJ David Guettaetta

Warner Music Group said Thursday it would buy in celebration French DJ David Guetta’s music catalog for the past two decades and sign a new contract with him for future recordings. The move will add Guetta’s work to the world’s third largest record label, which includes artists like Cardi B, Ed Sheeran, and Bruno Mars.

Diana Horse says ‘thank you’ in new music after 15 years

American singer Diana Horse expresses her gratitude in the new single “Thanks” released the title track of their first studio album in 15 years on Thursday. Horse, the former singer of the hugely successful group The Supremes from Motown Records, recorded the songs in her home studio during the COVID-19 pandemic. The album is described as “a powerful, comprehensive musical message of love and togetherness”.

In the new film “LFG”, US soccer stars tell the story of a fight for equal pay

Soccer stars Megan Rapinoe and Jessica McDonald rested their cleats and walked the red carpet at the premiere of the documentary “LFG” at the Tribeca Film Festival US National team of women. The players sued US Football governing body in 2019 on allegations of gender discrimination in compensation and almost all other aspects of playing conditions

Despite divorce, Kim Kardashian says she’s the biggest fan of Kanye West

Kim Kardashian said her ex-husband Kanye West is like family despite her divorce, and adds on a TV show airing Thursday that she will always be his biggest fan. KardashianThe 40-year-old spoke on a reunion show for “Keeping Up with the Kardashians,” which aired its last episode after 14 years on the air last week.

Kevin Spacey’s accuser, who tried to sue anonymously, is released from the trial

A federal judge on Thursday dismissed all lawsuits from one of two men suing the actor Kevin Spacey for alleged sexual misconduct in the 1980s after the plaintiff refused to provide public identification. The discharge by US District Judge Lewis Kaplan in Manhattan came to lawyers for the man who was considered on court records. is known “CD” said revealing his identity would “suddenly attract unwanted attention” and “just be too much for him to endure”.

(This story was not edited by Devdiscourse staff and is automatically generated from a syndicated feed.)

Key Pennsylvania state senator backs Arizona-style election audit · Highlight PA

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HARRISBURG – The Pennsylvania state senator, responsible for a key electoral committee, backs a November presidential contest review similar to the Arizona partisan ballot review four days after former President Donald Trump called him out and claimed he was hesitant.

Despite two reviews and assurances from all levels of government that the election was free from widespread fraud, Senator David Argall (R., Schuylkill) told Spotlight PA that he saw no “harm in trying to answer the question again” . Worries people have. “

But such an endeavor, especially when driven by a single political party, is sure to attract criticism and raise critical questions, including the cost of who would pay for it and why it would be more trustworthy than the widely accepted audits already completed .

Argall’s counterpart in the State House declined an additional review, but the Senate can order its own review, and Argall’s committee has the power to summon ballot papers.

“The results are the results,” Argall said during the Spotlight PA Capitol Live event Friday when asked if he recognized the November results as legitimate. “The electoral college has spoken, you know the president was sworn in. I understand that this is the reality.”

District election and state officials, as well as Trump’s own attorney general, have repeatedly said there is no evidence of widespread fraud in Pennsylvania and that the results are accurate and reflect the will of voters across the state.

Still, Pennsylvania was and is the focus of Trump and his most ardent supporters, who falsely claim the 2020 elections were stolen. Many Republican lawmakers, including leadership in the House, signed a letter urging Congress to turn down the state election for President Joe Biden, while prominent senators, including Argall, asked the panel to postpone certification of the electoral college because “inconsistent and questionable activity. “

On Monday, Trump targeted Argall and the President of the Senate of the state Pro Tempore Jake Corman (right, center), requested an examination and asked whether they were “stupid, corrupt or naive”.

“I am sure that if Corman continues on this path of resistance with its lack of transparency, it will be preferred and will lose in large numbers,” the former president said in a statement.

Despite continued efforts by Trump and some US Republicans to question the election results, Argall said, “I don’t know why people are so suspicious of the results.”

“I just know it’s you,” he said.

Argall said he was focused on the process, including rulings by the state Supreme Court and the Wolf Administration, which “completely ignored” the legislature’s intentions when they passed a major election overhaul in 2019, including the universal one Introduced postal voting.

Experts previously informed Spotlight PA and Votebeat that there are State Department guidelines on issues such as “healing” postal ballot papers with issues such as a missing privacy envelope was the result of loopholes in the law. In rulings by the state Supreme Court, including one that allowed postal ballot papers to be received beyond the standard deadline, the pandemic has been identified as a need for exceptional relief.

“Do I have 100 percent confidence … that everything was perfect? No, I really want us to look into this in detail, ”Argall said. “So we’re looking at changing parts of the electoral law, and I also think it wouldn’t hurt to go back, do that check and say, ‘How exactly did that work?'”

These concerns, and how to address them, have been the subject of 10 State House Panel hearings, culminating in one Comprehensive GOP proposal to change voting in Pennsylvania. Argall said he couldn’t be sure what further examination would reveal, if anything.

When asked if he thought the election was fair and safe, he said, “Can’t we take the test and respond so that we can all have a definitive answer?”

“So is that a yes or a no?” answered the interviewer.

“That means let’s do the audit and find out.”

Argall chairs the Senate’s powerful government committee, which is considering redistribution of laws in addition to electoral laws. In an in-depth interview with Spotlight PA, the Senator said there were talks to move forward with an amended version of a bill that would add additional barriers to the ten-year process of drawing new political maps.

The statement, proposed by Senator Lisa Boscola (D., Northampton), would make the process of redistributing laws and conventions more transparent. But Joe Kelly, their chief of staff, told Spotlight PA and Votebeat on Friday that Argall’s proposed change would only focus on the process by which the map of Congress is created.

Kelly said the Senator was disappointed that the bill would not include reforms to the way the State House and Senate maps were drawn up. In contrast to the congress card, only a five-member committee made up of leaders of the General Assembly and an appointed third chairman can approve the legislative cards.

Boscola was not involved in drafting the amendment, Kelly said, and was briefed on Thursday.

Argall declined to provide details on which provisions were included in the change and which could be removed, but said there seemed to be a consensus that the parish, county and school district boundaries should be kept intact. When asked why he has not given priority to laws or similar reallocation reform laws in the past, Argall said he was not interested in postponing actions that will not happen through the House.

This chamber is currently focused on a major overhaul of the elections that includes stricter rules for voter ID, signature verification requirements for postal votes and personal early voting.

Rep. Seth Grove, chairman of the government committee of the House of Representatives, said earlier this month the chamber would “not approve further reviews of previous elections” and instead focus on amending the state’s electoral law.

But Argall said Friday he thinks it would be “not a bad idea to move on to an exam” and hopes to “close” the issue in the next few weeks. He said he wanted the review to be independent, whether through the state audit office or an investigation commissioned by the Senate.

There are also options when it comes to paying for an additional exam, he said.

“One would be to do it with public funds,” he said. “The other would be the Arizona model, where I think they found private donors willing to pay the cost.”

A private option contradicts electoral legislation urging Argall’s GOP colleagues in the House of Representatives, which would prohibit counties from taking private dollars to pay for the voting administration.

WHILE YOU ARE HERE … If you have learned anything from this story, keep paying and join Spotlight PA allow someone else to contribute in the future Spotlightpa.org/donate. Spotlight PA is funded by Foundations and readers like you who are committed to accountable journalism that gets results.

Reserving Holdings CEO backs vaccine passports, says makes journey safer

According to Glenn Fogel, the travel company’s CEO, so-called vaccination records would make traveling safer as more and more people are being vaccinated against the coronavirus Postings.

“I’m not sure why people are still against it to make travel safer for people,” Fogel said in an interview on CNBCs.The exchange. “

The Biden government has announced that it will put in place a system of documenting a person’s vaccination status, which will make it easier to determine who is and who is not protected from the virus. However, it is unclear how this will play out. Several airlines have also spoken out in favor of vaccination documentation.

There are, however Critics of vaccination records for a number of reasonsThis ranges from privacy concerns to scientific reasons to questions of justice.

On Friday, the Centers for Disease Control and Prevention said People who have been vaccinated are “low risk” for travel.

Fogel said he would like to see vaccinated people travel again.

“The industry has been so devastated, travel has been so hurt by this terrible, tragic crisis, and we need all that can do to make it happen [the travel industry] go and allow people to travel because [the vaccines] are absolutely safe. “

Booking Holdings owns brands such as Kayak, Agoda, Booking.com, Priceline.com, and OpenTable.

“The idea of ​​a Covid pass that says you are fully vaccinated [means] Being a safe traveler allows you to visit places other people may not be allowed to go, “Fogel said.

The company on Monday offered travelers $ 50 credit after the trip who book a trip by the end of May and travel before the end of the year. The company continues to offer more flexibility to cancel travel plans if necessary. The action aims to get people to book summer trips.

“We see that prices are also rising, which of course is the assumption of demand, which is why I continue to advocate it [people to] Go out, see what you want, get it now, “said Fogel.

Increasing vaccination rates will also help. Since the coronavirus vaccine began distributing in December, over 165 million doses have been given to people, according to the U.S. government CDC.

Right now, Americans might be more comfortable in the US due to various Covid restrictions, he said. According to a survey by Booking.com, 69% of people said they would prefer to travel closer to their home for the foreseeable future.

“There won’t be a large amount of international travel,” he said. “In terms of people staying close to home, there is certainly still a feeling of insecurity and a desire to be close to home, but I think that will expand and as people do feel safer, they will go on longer trips. “”

Booking Holdings stock closed 1.1% on Monday at $ 2,409.18.