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CDC clears reformulated Covid pictures concentrating on omicron in time for varsity

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The Centers for Disease Control and Prevention have released reformulated Covid shots targeting the latest Omicron subvariants for the fall, allowing many people to get an extra boost in days.

The agency’s independent committee on vaccines voted 13-1 in favor of the shots on Thursday after reviewing the available safety and efficacy data in a nearly seven-hour session. CDC Director Dr. Rochelle Walensky approved the injections a few hours later, clearing the way for pharmacies to administer the injections soon.

Pfizer’s Omicron boosters were approved for ages 12+, while Moderna’s updated shots were approved for ages 18+. The eligible age groups can receive the boosters no earlier than two months after the completion of their primary series or their last booster with the old vaccinations.

Walensky said her decision followed “a thorough scientific evaluation and sound scientific discussion.”

“If you are eligible, there is no bad time to get your Covid-19 booster and I strongly encourage you to get it,” she said in a statement.

Pfizer plans to ask the Food and Drug Administration to also approve the new boosters for children ages 5 to 11 in early October, company executives told the committee Thursday.

The original vaccines are no longer used as a booster dose in people aged 12 and over as the reformulated vaccines are now online.

Public health officials expect another wave of Covid infections this fall as immunity to the legacy vaccines wanes, more contagious omicron subvariants spread and people spend more time indoors as the weather turns colder and families close gather for the holidays.

The CDC and FDA hope the new boosters will provide more durable protection against infection, mild illness, and serious illness. The reformulated shots target omicron BA.5, the dominant variant of Covid, as well as the strain that emerged in China more than two years ago.

The US has so far secured 171 million doses of the new boosters from Pfizer and Moderna. More than 200 million people are entitled to the recordings, according to the CDC. dr Sara Oliver, a CDC official, told the committee Thursday there should be enough vaccine supplies to meet demand this fall.

No omicron BA.5 human data

There is no human trial data on the new BA.5 boosters, so it is unclear how they will perform in the real world. The CDC and FDA used human clinical trial data for vaccinations against the original version of Omicron, BA.1, which elicited a stronger immune response than the old vaccines.

Pfizer and Moderna originally developed Omicron boosters for BA.1, but the FDA told the companies to change gears in June and develop BA.5 shots instead after the subvariant became dominant. The decision to focus on BA.5 did not leave enough time to wait for data from human trials before a vaccine launch in the fall.

The lack of human data for the BA.5 vaccines has caused some controversy, but Dr. Peter Marks, a senior FDA official, said the agency has followed the same process it has used for years to change strains for flu vaccines. Marks said Wednesday flu vaccine strains are being changed even without human clinical data.

dr Pablo Sanchez, the only committee member who voted against the injections, called the recommendation premature and said the US should have waited for human data before proceeding with the boosters.

“There’s already a lot of hesitation with vaccines — we need the human data,” said Sanchez, a professor of pediatrics at Ohio State University. But Sanchez said he believes the new boosters are safe and he will likely receive one himself.

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Board member Dr. Oliver Brooks, chief medical officer at Watts HealthCare Corporation in Los Angeles, questioned why the FDA chose a BA.5 vaccine when clinical data is available for the BA.1 vaccine that vaccine manufacturers are initially developing had. Brooks eventually voted for the shots.

But dr Sarah Long, also a committee member, said there was no reason to believe the BA.5 boosters will be inferior to the old vaccines as they also contain the original Covid strain and have the potential to increase hospitalizations and deaths along the way in the future to reduce autumn and winter. Long also voted in favour.

mouse studies

FDA and CDC officials have said that the omicron BA.1 and omicron BA.5 boosters are similar enough that the immune response data of the BA.1 vaccine should give a good indication of how the BA.5 vaccine will work. Omicron BA.1 and BA.5 are according to Dr. Jacqueline Miller, who works on vaccine development at Moderna, are closely related and share a difference of four mutations.

Moderna completed enrollment in clinical trials on the BA.5 shots last week and should have results by the end of the year, Miller told the CDC committee on Thursday. Pfizer’s clinical trial is also ongoing, although the company hasn’t said when it expects results.

Health authorities also reviewed data on the BA.5 shots from mouse studies. Moderna presented data showing that the BA.5 shots increased antibodies in mice more than four-fold compared to the old shots. The mice express the same cellular protein as humans, to which the virus attaches. Pfizer’s BA.5 booster increased antibodies in mice by 2.6-fold compared to the original vaccine.

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According to the FDA, the most common side effects from the human trials of BA.1 injections were pain, redness, swelling at the injection site, fatigue, headache, muscle pain, joint pain, chills, nausea, vomiting, and fever.

Oliver, the CDC official, told the committee that health officials do not expect a difference in the safety profile of the BA.1 and BA.5 shots because the subvariants differ by only a few mutations.

However, Oliver noted that the risk of myocarditis following a BA.5 booster dose is unknown. Young men and adolescent boys are at increased risk of myocarditis after the second dose of Pfizer and Moderna, but the risk of myocarditis from Covid infection is higher, according to the CDC.

“We know that the risk of myocarditis is unknown, but expect a risk similar to that seen after the monovalent vaccines,” Oliver said. The monovalent vaccines are the old vaccines that have been given to millions of people in the US over the last two years.

Old vaccines are losing their effectiveness

The original vaccines, which were first approved in December 2020, no longer offer any meaningful protection against infection because the virus has mutated so much in the last two years. The shots were developed against the first strain to appear in China, so they are no longer tailored to attack the expanding Omicron subvariants.

Infections, hospitalizations and deaths have all fallen dramatically since last winter’s massive Omicron outbreak, but have leveled off at stubbornly high levels this summer. Omicron BA.5 is the most contagious and immune-avoidable variant to date, and breakthrough infections have become increasingly common as a result.

The effectiveness of the old vaccines against hospitalization also decreased after omicron BA.5 became dominant. A third dose was 77% effective at preventive hospitalization four months after receiving the shot, but protection dropped to as much as 34% at 120 days, according to CDC data. A fourth dose in people aged 50 and over was 56% effective in preventing hospitalization at four months.

Deaths and hospitalizations from Covid among people aged 65 and older have increased since April, according to Heather Scobie, a CDC epidemiologist who presented data during Thursday’s meeting. The number of deaths has increased, particularly among people aged 75 and over, Scobie said.

The CDC has shifted to a more focused public health response, with a focus on protecting the most vulnerable — the elderly, those with serious illnesses and those with weakened immune systems. Though there’s no data on the real-world effectiveness of the new boosters, the US is moving quickly to introduce them in hopes they’ll protect people this fall.

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Politics

Concentrating on ‘Important Race Concept,’ Republicans Rattle American Faculties

Still, he acknowledged that Republicans had “figured out how to message this.”

The messaging goes back to Mr. Trump, who, in the final weeks of the 2020 campaign, announced the formation of the 1776 Commission, set up explicitly to link what he said was “left-wing indoctrination” in schools to the sometimes violent protests over police killings.

A report by the commission was derided by mainstream historians; Mr. Biden canceled the project on his first day in office, but its impact endures on the right.

Media Matters for America, a liberal group, documented a surge of negative coverage of critical race theory by Fox News beginning in mid-2020 and spiking in April, with 235 mentions. And the Pew Research Center found last year that Americans were deeply divided over their perceptions of racial discrimination. Over 60 percent of conservatives said it was a bigger problem that people see discrimination where it does not exist, rather than ignoring discrimination that really does exist. Only 9 percent of liberals agreed.

Some Democratic strategists said the issue was a political liability for their party. Ruy Teixeira, a senior fellow at the left-leaning Center for American Progress, recently wrote, “The steady march of ‘anti-racist’ ideology” into school curriculums “will generate a backlash among normie parents.”

In an interview, he criticized leading Democrats for not calling out critical race theory because of their fear that “it will bring down the wrath of the woker elements of the party.”

In Loudoun County, Va., dueling parent groups are squaring off, one that calls itself “anti-racist” and the other opposed to what it sees as the creep of critical race theory in the school district, which enrolls 81,000 students from a rapidly diversifying region outside Washington.

After a 2019 report found a racial achievement gap, disproportionate discipline meted out to Black and Hispanic students, and the common use of racial slurs in schools, administrators adopted a “plan to combat systemic racism.” It calls for mandatory teacher training in “systemic oppression and implicit bias.”

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Politics

Texas Republicans Concentrating on Voting Entry Discover Their Bull’s-Eye: Cities

HOUSTON – Voting in the 2020 election presented Zoe Douglas with a tough choice: As a therapist who met with patients through Zoom late into the evening, she simply couldn’t complete before the polls closed during the early voting.

Then Harris County introduced 24-hour voting for a single day. On the Thursday before the 11pm election, Ms. Douglas met with fast food workers, nurses, construction workers, night owls and other late shift workers at the NRG Arena, one of eight 24-hour polling stations in the county where more than 10,000 people were voting cast their ballots in a single night.

“I can clearly remember people who still wear uniforms. You can tell that they have just left work or maybe go to work. It’s a very varied mix, ”said Ms. Douglas, 27, a native of Houston.

The 24-hour voting was one of the numerous options Harris County had introduced to help residents cast their votes, along with drive-through voting and proactive sending of ballot requests. The new alternatives, tailored to cater to a diverse workforce struggling amid a pandemic in Texas’ largest county, helped increase voter turnout by nearly 10 percent compared to 2016. Nearly 70 percent of registered voters cast ballots, and a task force found that there was no evidence of fraud.

However, Republicans are pushing for action through state law to target the very process that led to such a large turnout. Two bulk bills, including one the house is slated to tackle in the coming week, aim to undo virtually any expansion of the county for 2020.

The bills would make Texas one of the toughest states in the country to pass. And they’re a prime example of Republican-led efforts to roll back access to elections in Democratic cities and populous regions like Atlanta and Maricopa Counties, Arizona, while having far less control over voting in rural areas that tend to be Republicans lean.

Bills in several states indeed create a two-pronged approach to urban and rural areas, raising questions about the different treatment of cities and the large numbers of color voters who live in them. This gap helps fuel opposition from companies that are based in or have a workforce in these locations.

In Texas, Republicans have taken the rare approach of sketching restrictions that only apply to counties over a million residents and target the booming and increasingly diverse metropolitan areas of Houston, Austin, San Antonio, and Dallas.

Republicans’ focus on different urban areas, electoral activists say, is reminiscent of the state’s history of racially discriminatory electoral laws – including election taxes and “white primary laws” during the Jim Crow era – that essentially excluded black voters from the electoral process.

Most early Harris County voters were white, according to a study by the Texas Civil Rights Project, a nonprofit group. But the majority of those who used drive-through or 24-hour voting – the early voting methods that Republican bills would ban – were people of color, the group noted.

“It is clear that they are trying to make it harder for people to choose who are exposed to everyday circumstances, particularly things like poverty and other situations,” said Chris Hollins, a Democrat and former Harris County interim clerk who advised many of them overseen and implemented policies during the November elections. “With a 24-hour vote, there weren’t even any claims or legal challenges during the elections.”

Efforts to further restrict voting in Texas come against the backdrop of an increasingly tense showdown between lawmakers and Texas-based companies. Republicans in the House of Representatives are proposing financial retaliation for companies that speak out.

American Airlines and Dell Technologies both strongly opposed the bill, and AT&T issued a statement in support of “electoral laws that make it easier for more Americans to vote,” despite no explicit mention of Texas.

American Airlines also dispatched Jack McCain, son of former Senator John McCain, to the Republican lobby in Austin to help lift some of the more stringent restrictions.

Republicans in state legislature appear to be unbowed. In amendments tabled to the state budget this week, House Republicans suggested that “a company that publicly threatened negative reactions related to” electoral integrity “would be ineligible for some state funding.

While these changes did not end up in the final budget, a broader proposal was added to the state’s “wish list,” a compilation of Longshot proposals, threatening companies who comment on “legislative or executive action”. Even if the likelihood of existence is unlikely, the mere inclusion of the proposals on files is viewed by Austin lobbyists and activists as a thinly veiled warning to corporations to keep quiet on voting bills.

The Perryman Group, an economic research and analysis firm based in Waco, said in a recent study that implementing controversial voting measures could result in conferences or events being taken out of the state and causing companies or workers to avoid them. The group estimated that restrictive new laws would cause a huge decline in business activity in the state by 2025 and cost tens of thousands of jobs.

Restrictions in two bulk acts in Texas law include a ban on 24-hour voting, a ban on drive-through voting, and harsh criminal penalties for local election officials who provide support to voters. There are also new limits on the distribution of voting machines, which could lead to a reduction in the number of districts and a ban on the promotion of postal voting.

The bills also include a measure that would make it much more difficult to remove an election observer for inappropriate behavior. Partisan poll observers trained and empowered to observe elections on behalf of a candidate or party have occasionally crossed the line into voter intimidation or other types of misconduct. Harris County election officials said they had received several complaints about Republican election observers over the past year.

Mr. Hollins, a former Harris County employee, said Republicans have recognized that “blacks and browns and the poor and youth” are more likely than others to use flexible choices. “You’re scared of it,” he said.

As Republican-controlled legislatures in Georgia and Arizona pass new electoral bills after November’s Democratic victories, Texas pushes for new restrictions despite the support of former President Donald J. Trump with more than 600,000 votes. The effort reflects the dual reality that Republicans are facing in state lawmaking: a base that is intent on voting changes following the loss of Mr Trump in 2020, and a booming population that is becoming increasingly diverse.

Senator Bryan Hughes, a Northeast Texas Republican who sponsored the Senate bill, defended it as part of a long effort to strengthen “electoral security” in Texas.

“I know there is a big national debate going on now and we may get drawn into this, but this is nothing new to Texas,” said Hughes in an interview. He said lawmakers had tried to reset access to email voting as the process was more prone to fraud. He offered no evidence, and numerous studies have shown that electoral fraud is exceptionally rare in the United States.

Mr Hughes said the proposed ban on thoroughfare was due to the difficulty of gaining access to partisan election observers at the sites and that a 24-hour vote was problematic as it was difficult to find election observers to work night shifts.

But many voters in Harris County, with its 4.7 million population ranks third in the country and larger than 25 states, see a different motive.

Kristie Osi-Shackelford, a Houston costume designer who worked on temporary contracts to support her family during the pandemic, was voting 24/7 because it gave her the flexibility she needed when juggling work and her three Raised children. She said it took her less than 10 minutes.

“I’m sure there are people who may not have voted in the last election but got the chance to do so at night, and it’s kind of sad that the powers that be who feel that way have to be taken away for the integrity of the elections to protect, ”said Ms. Osi-Shackelford. “And I struggled to find words because it’s so irritating and I’m tired. I’m tired of hearing the same stuff and seeing the same stuff so blatantly over and over for years. “

Brittany Hyman, 35, was eight months pregnant by the time election day approached and was also raising a 4-year-old. For fear of Covid-19, but also of the mere logistics of navigating a line in the surveys, Ms. Hyman voted at one of the transit locations.

“The opportunity to go through the set-up was a savior for me,” said Ms. Hyman. She added that because she would have been pregnant, she likely would not have risked waiting in a long line to vote.

The Harris County’s drive-through vote, which was used by more than 127,000 voters in the general election, immediately caught the attention of Republicans, who sued Mr. Hollins and the county to outlaw the practice and overturn all votes cast -through process. The Texas Supreme Court ruled against the Republicans in late October.

Other provisions in the GOP bill, while not targeting Harris County as directly, will most likely still have the greatest impact on the state’s largest county. A proposal to provide a uniform number of voting machines in each district could affect the ability to deploy additional machines in densely populated areas.

This month, in another escalation of public pressure on lawmakers, Houston Mayor Sylvester Turner, a Democrat, gathered more than a dozen speakers, including business leaders, civil rights activists and former athletes, for a 90-minute press conference in which he denounced the bill.

“What is happening here in Texas is a warning shot for the rest of the country,” said Lina Hidalgo, Harris County judge and Democrat, who is campaigning for more electoral access in the county. “First Georgia, then Texas, then more and more states, and soon we will take the biggest step back since Jim Crow. And it’s up to all of us to stop that. “

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Politics

Biden calls on U.S. to unite towards hate concentrating on Asian People

President Joe Biden and Vice President Kamala Harris called on the US to unite against hatred and speak out against violence against Asian Americans in a speech in Atlanta on Friday.

“Harm to one of us is harm to all of us,” said Harris, the country’s first Asian-American vice president.

The public statements came after the President and Vice President met with Asian American leaders in Georgia after the Atlanta area rampage that killed eight people, including six Asian women.

While law enforcement was still investigating the suspect’s motive, both Biden and Harris realized: the shootings are taking place amid mounting discrimination and violence against Asians and Asian Americans, and the country must work together to address the problem.

“Hate and violence are often hidden in public. There is often silence,” said Biden. “Our silence is complicit. We cannot be complicit. We have to express ourselves. We have to act.”

“It is up to all of us, all of us together, to stop it,” said the president, emphasizing that “words have consequences”.

Biden called on Congress to pass hate crime law to combat the rise in violence against Asian Americans during the Covid pandemic and the law against violence against women.

“I believe with every fiber in my being there are simply some core values ​​and beliefs that should bring us together as Americans, and one of them stands together against hatred, against racism – the ugly poison that has long plagued our nation . ” Said Biden.

President Joe Biden speaks after meeting executives from the Georgian Asian-American and Pacific islander communities at Emory University in Atlanta on Friday, March 19, 2021 while Vice President Kamala Harris listens.

Patrick Semansky | AP

The president, who himself mourned the loss of family members, offered words of comfort to the families of those who lost their lives in the shootings.

“I assure you the one you lost will always be with you,” said Biden. “The day will come when her memory will bring a smile to your face before it brings a tear to your eye, incredible as this is. It will be a while. And I promise you it will come. When it does doing that, it’s the day you know you will make it. “

The meeting with Asian American lawmakers and community advocates was held at Emory University, where Biden and Harris later made their comments.

The Atlanta visit, Biden and Harris’ first trip together since taking office, was originally part of a national tour that announced the passage of the $ 1.9 trillion Covid aid package. The White House announced Thursday that it would postpone the planned political event after the deadly shootings and focus on increasing discrimination and violence against Asian Americans.

The President and Vice-President will also meet with experts from the Centers for Disease Control and Prevention for information on the Covid pandemic.

Biden and Harris also planned to meet with proxy and former gubernatorial candidate Stacey Abrams during their visit to Atlanta, a White House official told NBC News.

The official said Abrams “played a leading role in accessing voting and protecting voters, and she will be an important partner in taking important action in this important area in the future.”

Abrams is widely credited for her years of electoral mobilization efforts that fueled Georgia’s democratic victories in the November presidential runoff and January Senate runoff.

The President and Vice President meeting with Abrams comes as civil rights activists in Georgia roll back voting restrictions proposed by Republican lawmakers. The activists are calling on Biden and Congress to pass federal voting rights, such as the For the People Act introduced in the Senate on Wednesday.