FDA authorizes Pfizer COVID-19 vaccine for kids ages 5 to 11: 5 things to know

FDA authorizes Pfizer COVID-19 vaccine for kids ages 5 to 11: 5 things to know
FDA authorizes Pfizer COVID-19 vaccine for kids ages 5 to 11: 5 things to know
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(NEW YORK) — COVID-19 vaccine shots for kids ages 5 to 11 may be available as soon as next week after the Food and Drug Administration (FDA) on Friday authorized the Pfizer vaccine for kids.

With the FDA’s authorization, the initial 15 million doses of the vaccine are expected to start shipping out of Pfizer’s manufacturing plant within 24 hours.

It will then be up to Dr. Rochelle Walensky, director of the U.S. Centers for Disease Control and Prevention (CDC), to make the final decision on whether to recommend the Pfizer vaccine for the approximately 28 million U.S. children aged 5 to 11.

She is expected to make her decision quickly after a CDC advisory panel meets on Tuesday, meaning vaccinations could start as early as next week.

Dr. Francis Collins, director of the National Institutes of Health, said on “Good Morning America” this week that getting more kids vaccinated will be key to ending the pandemic in the U.S.

“If we can create a situation where more of these kids are not getting infected, we should be able to drive this pandemic down, which is what we really hope to do, even as we face the cold [weather] and other concerns about whether we might see another surge,” said Collins. “We don’t want that, and this would be one significant step forward in getting our country really in a better place.”

As the countdown begins, here are five things parents should know about COVID-19 vaccines and kids under the age of 12.

1. Kids ages 5 to 11 are still not yet eligible for a COVID-19 vaccine.

With the FDA’s authorization, the decision has now moved to the Centers for Disease Control and Prevention’s vaccine advisory group.

That group, the Advisory Committee on Immunization Practices, is scheduled to meet Tuesday to review the same data reviewed by the FDA advisers.

Then, once the ACIP recommends the vaccine, the CDC director must sign off on it, the final step in the authorization process.

Once that decision is made, the vaccine would be able to be administered relatively quickly to children across the country.

At the same time, the FDA will continue to review data to decide whether to grant full FDA approval for the vaccine in kids ages 5 to 11.

The FDA approved the Pfizer vaccine for people ages 16 and older in August. It is currently authorized for emergency use in children ages 12 to 15.

The two other vaccines currently available in the U.S., Moderna and Johnson & Johnson, are currently available only for people 18 years and older.

Moderna said Monday it plans to submit data to the FDA soon showing its vaccine for children ages 6 to 11 produces a strong immune response and appears safe.

2. The Pfizer dose is different for kids under age 12.

In Pfizer and BioNTech’s clinical trial of more than 2,200 children, the COVID-19 vaccine was administered in two doses, but the doses were one-third the amount given to adults.

The clinical trial results, which have not yet been peer-reviewed, showed the antibody response in children at that dose was at least as strong as the full adult dose in patients ages 16 to 25.

Pfizer and BioNTech say the vaccine produced minimal side effects in children ages 5 to 11, and the side effects were similar to those experienced by adults and older children.

For 12- to 15-year-olds, the FDA has authorized the same dosing as adults with the Pfizer two-dose vaccine.

3. The vaccine’s focus is on kids’ immune systems.

Children have different immune systems than adults, so it should be reassuring for parents that the Pfizer/BioNTech vaccine has been shown to be safe in kids.

Differing immune systems among people of different ages also help explain why the cutoffs for vaccine eligibility rest on age and not body size.

In addition to the COVID-19 vaccine, other immunizations are also scheduled and administered based on age and not weight. This is partially due to the fact that the body’s immune responses to vaccinations and infection are known to be different based on age.

4. The vaccine will be distributed to kids through pediatricians, pharmacies, health clinics and more.

Once greenlighted, the pediatric doses of the vaccine will be sent to thousands of sites across the country, including more than 25,000 pediatricians’ offices, more than 100 children’s hospitals, tens of thousands of pharmacies and hundreds of school- and community-based clinics, the White House announced Oct. 20.

Though the White House has purchased 65 million Pfizer pediatric vaccine doses — more than enough to fully vaccine all children ages 5 to 11 in America — the first launch will dole out doses in waves based on states’ eligible population of kids.

The distribution plan will also include a national public education campaign to “reach parents and guardians with accurate and culturally-responsive information about the vaccine and the risks that COVID-19 poses to children,” according to the White House.

White House officials told the nation’s governors on Oct. 12 that it has enough pediatric doses on hand for the 28 million children ages 5 through 11 expected to become eligible once the CDC gives the green light.

To troubleshoot any confusion in distribution, federal health officials are outlining a new color-coded cap system for each formulation of the vaccine, though still “preliminary.” Purple-capped vials will contain doses for adult and older adolescents, a chart offered to states said; orange-capped vials will contain doses for kids aged 5 to 11.

5. Families need to remain vigilant against COVID-19.

Unvaccinated children can not only become ill from COVID-19 themselves, but they can also spread the virus to more vulnerable family members and other adults with whom they interact.

Both the CDC and the American Academy of Pediatrics recommend universal mask-wearing in schools to help slow the spread of COVID-19.

Experts said that in addition to unvaccinated children wearing face masks, parents and siblings who are vaccinated should also continue to wear face masks indoors because of the rates of breakthrough infections in the U.S.

Families should also continue to follow other safety guidelines shared throughout the pandemic, including social distancing and hand-washing.

Copyright © 2021, ABC Audio. All rights reserved.

Biden administration considering payments for families separated under Trump policy

Biden administration considering payments for families separated under Trump policy
Biden administration considering payments for families separated under Trump policy
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(WASHINGTON) — The Biden administration is considering making settlement payments to migrants who were separated from their children during the Trump administration’s “zero-tolerance policy,” according to two people familiar with the planning.

Enacted in April of 2018, the policy that led to family separation drew widespread condemnation for removing children who crossed the border with their families and putting the adults into CBP custody, as opposed to keeping families together.

An Inspector General report in January found that former Attorney General Jeff Sessions was the “driving force” behind the policy, which was stopped in June 2018 after then-President Donald Trump signed an executive order.

The ACLU, among others, sued on behalf of families — seeking damages. The Wall Street Journal first reported on the payments, citing sources familiar with the matter saying an amount of around $450,000 a person — which could amount to nearly $1 million a family — was being discussed.

Officials who spoke with ABC News stressed on Friday that payment amounts have not yet been determined and could fluctuate per individual.

Former acting Department of Homeland Security Secretary Chad Wolf slammed the proposal as “insulting to American taxpayers” and “dangerous” in an interview with ABC News on Friday.

“It appears as though they refused to go into court and to advocate against paying individuals or compensating individuals that have knowingly broken the law,” he said.

The Biden administration’s family reunification task force found that 3,913 children were separated from their families under the Trump administration.

Homeland Security Secretary Alejandro Mayorkas met with families who were separated in August and has previously called the policy “cruel.”

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New York firefighters suspended after threatening state senator’s staff over vaccine mandate while on duty

New York firefighters suspended after threatening state senator’s staff over vaccine mandate while on duty
New York firefighters suspended after threatening state senator’s staff over vaccine mandate while on duty
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(NEW YORK) — Four New York City firefighters have been suspended after driving their truck to a state senator’s office while on duty, asking for the politician’s home address and telling him the city would have “blood on its hands” over the city’s vaccine mandate.

The group, from Ladder 113 in Brooklyn, went to the office of state Sen. Zellnor Myrie in the company’s fire district in uniform and asked to speak to him, although as a state official he had no involvement in the city mandate from Mayor Bill de Blasio.

All city personnel, including firefighters, must have received at least one dose of the COVID-19 vaccine by the time they show up to work on Monday. Those who do not get vaccinated will be placed on unpaid leave.

The senator was not there at the time, but the firefighters spoke to a staff member.

“They said they wanted to let people in the community know that the trucks weren’t going to be running and that they were going to shut down firehouses,” a person familiar with the conversation told ABC News.

It was, the person said, a “cordial conversation” though at one point the firefighters said the “city would have blood on its hands.”

“I think it is highly inappropriate,” Myrie, a Democrat, said in an interview with New York ABC station WABC. “It is incredibly disturbing that those entrusted with keeping us safe would be on duty, protesting a vaccine mandate that had nothing to do with a state elected official. … My staff is rattled, they’re shaken up by it. And frankly, I am upset that we’re even having this conversation.”

The firefighters told the senator’s staff member they wanted the choice of whether to get vaccinated and expressed a view that it would be safer for them to get tested every week.

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FDA authorizes COVID-19 vaccine for kids 5-11

FDA authorizes COVID-19 vaccine for kids 5-11
FDA authorizes COVID-19 vaccine for kids 5-11
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(NEW YORK) — Another 28 million Americans are one step closer to getting vaccinated against COVID-19 after the Food and Drug Administration on Friday authorized the Pfizer shot for 5-11-year-olds.

Children will be one of the last groups in the U.S. to become eligible for the vaccine. Protecting them against COVID-19 is a major step in getting the country back on the path to normalcy after an unexpected late-summer surge that disproportionately impacted unvaccinated Americans and filled hospitals to the brim.

“As a mother and a physician, I know that parents, caregivers, school staff, and children have been waiting for today’s authorization. Vaccinating younger children against COVID-19 will bring us closer to returning to a sense of normalcy,” Acting FDA Commissioner Janet Woodcock said in a statement Friday afternoon.

The process now heads to the Centers for Disease Control and Prevention. An advisory committee for the CDC will meet on Tuesday to discuss the pediatric vaccine safety and efficacy data, as an advisory FDA panel did this past week, and then CDC Director Rochelle Walensky is expected to give the final signoff soon afterward.

That means kids could begin getting shots at some point next week and become fully vaccinated by December.

In anticipation, the White House planned to unleash millions of vaccine shipments across the nation as soon as FDA authorization was announced. Vaccine sites will have to wait for the CDC’s word to begin administering the vaccine, but stock will be on hand.

“The bottom line is that we will be ready immediately following FDA and CDC decisions so that parents can get their kids vaccinated quickly, easily and conveniently,” White House COVID-19 coordinator Jeff Zients said at a briefing with reporters on Thursday.

The White House purchased enough shots for all 28 million 5-11-year-olds and on Thursday announced plans to purchase another 50 million shots by April 30, 2022, which could also be used for children under 5, if and when there is authorization for that age group.

Though there was some debate at the FDA advisory meeting about the potential side effects for children 5-11 — particularly because myocarditis, a condition involving inflammation of the heart, has been linked to the vaccine in teenage boys and young men — the panel nearly unanimously voted in favor of the vaccine, deciding that the risk was worth the benefit.

None of the 2,200 kids who received the Pfizer-BioNTech pediatric vaccine last June in the clinical trials have experienced serious side effects, including myocarditis.

Meanwhile, nearly 2 million kids ages 5-11 have gotten COVID, and 8,300 have been hospitalized with COVID-19. A third of those children ended up in the ICU and over 100 have died.

“To me the question is pretty clear. We don’t want children to be dying of COVID, even if it is far fewer children than adults, and we don’t want them in the ICU,” Dr. Amanda Cohn, an epidemiologist with the CDC, said at the FDA meeting on Tuesday.

Dr. William Gruber, the senior vice president of Pfizer Vaccine Clinical Research and Development, told ABC News in an interview Friday that he also saw the vaccine as a way to protect children from the emotional instability the virus has wrought. Widespread vaccination could keep children out of quarantine after being exposed at school and ensure the safety of indoor activities ahead of the winter.

He pointed to the benefits of “allowing children to be children.”

“This allows that to open up again, we’ve been seeing step-by-step progress and opening up society. It’s time for that to happen with children as well,” Gruber said.

Whether parents will embrace the vaccines for their kids is still a question. In an October poll, the Kaiser Family Foundation found that about a third of parents with kids ages 5-11 were willing to vaccinate their kids right away, while another third wanted to “wait and see.” The figures represented a slight uptick in vaccine acceptance among parents of elementary-school-aged kids since July, but they have stayed steady since September.

The CDC director on Thursday emphasized the urgency of getting kids vaccinated, even as the country recovers from an alarming uptick of cases and begins to relax again.

“There’s urgency because we’re seeing disease in children, we’ve seen deaths in children and we’ve seen long COVID,” Walensky said at a White House briefing.

And as America saw during the delta surge, unvaccinated areas will be the most vulnerable if there are future spikes in cases.

“Certainly we have seen cases come down before and a way to prevent surges again is to get more and more people vaccinated and make sure that we have protection,” Walensky said.

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Biden to push schools to set up routine COVID testing for kids, staff

Biden to push schools to set up routine COVID testing for kids, staff
Biden to push schools to set up routine COVID testing for kids, staff
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(WASHINGTON) — The Biden administration is launching a new effort with The Rockefeller Foundation to encourage schools to set up surveillance COVID testing for students and staff, ABC News has learned.

The effort, which will be led by the Education Department and Centers for Disease Control and Prevention, comes seven months after President Joe Biden pledged $10 billion for testing by schools.

The idea is that school districts around the country, particularly elementary schools with large populations of unvaccinated children, would routinely test kids, teachers and other staff for COVID-19 to prevent the spread of the virus.

But some states have rejected their share of the $10 billion in federal funds for COVID-19 testing in schools while others have been painfully slow in actually implementing virus mitigation plans.

A survey of the nation’s 100 largest school districts from the Center on Reinventing Public Education found that less than 15% of those schools are utilizing federal funding dollars to establish COVID-19 in-school screening programs.

Meanwhile, pediatric COVID cases increased this summer with many school districts reporting mass quarantines at the beginning of the school year.

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A COVID vaccine for kids is coming. Will parents let them take it?

A COVID vaccine for kids is coming. Will parents let them take it?
A COVID vaccine for kids is coming. Will parents let them take it?
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(NEW YORK) — Michael and Jennifer Spaetti of Salisbury, North Carolina, were both vaccinated last spring as soon as shots became available. But when it comes to their 6-year-old grandson who lives with them, they aren’t so sure.

As his primary caregiver, they wonder about long-term side effects. He also hates getting shots, guaranteeing that an extra trip to the pediatrician would be tough emotionally.

“I’m not sure. It just seems like it came out so fast,” said Jennifer Spaetti. “And we’re talking about a child. I feel like it’s different for me, but I just I’m not sure. I don’t think I know enough about it.”

Denise, a mother of two from Columbia, South Carolina, expressed similar concerns. Asked to withhold her last name for privacy reasons, Denise jokes she would feel more comfortable seeing the neighborhood kids get their shots fist, just in case there is some rare side effect that researchers missed.

And as a Black mother, Denise said she worries not enough African American children were represented in the clinical trials.

“My husband is gung-ho,” she said. “And I’m definitely not opposed to it. But I do just want to wait and see … I want to make the best decision as a parent.”

With the first pediatric vaccine for COVID-19 expected to roll out as early as Nov. 3, only 27% of parents with kids ages 5-11 say they will vaccinate them “right away,” according to the latest poll by the Kaiser Family Foundation.

Another 33% of parents with the elementary-aged kids say they want to “wait and see” how it works in others before getting their child vaccinated. And at least two thirds of those parents say they are concerned about potential long-term and serious side effects.

This hesitancy is worrying many health officials, who contend widespread vaccinations in schools will be critical to vaccinate kids ahead of the cold weather to prevent another surge in cases.

They also counter that parents should be much more worried about the virus than the vaccine. Of the 1.9 million kids ages 5-11 who contracted the virus, 8,300 wound up hospitalized. One third of those children hospitalized had no underlying health conditions.

Another concern pediatricians have is that children exposed to the virus are at risk of developing “long-haul” symptoms. While very rare for children, the symptoms such as brain fog, chest pain and debilitating fatigue persist for weeks after exposure.

None of the 2,200 kids who received the Pfizer-BioNTech pediatric vaccine last June in the clinical trials has experienced serious side effects, including the myocarditis that’s been seen in a small group of older teen and adult males. Experts say any side effects to a vaccine typically occur within two months of getting a shot.

The Centers for Disease Control and Prevention, along with independent vaccine and health experts, also have found no evidence that the vaccine could impact a person’s fertility and is safe for pregnant and breastfeeding moms.

The CDC also warns that people shouldn’t count on prior exposure to the virus. In a study released Friday, the CDC found adults with “natural” immunity through infection were more than five times more likely to develop COVID-19 compared to people who were fully vaccinated.

Still, even vaccine experts say it can be nerve-wracking to make a decision for millions of children based on a study involving only a few thousand kids.

The trial also wasn’t as diverse as some experts would like. Of the children participating in the clinical trials, the vast majority of participants – 78% — were white. Six percent were Black, while 21% were Hispanic and 6% were Asian.

Dr. Paul Offit, an adviser to the U.S. Food and Drug Administration, who voted in favor of authorizing the vaccine at a meeting this week, said he still supports the rollout because he believed the benefits outweigh the risks.

The FDA was expected to authorize the pediatric vaccine as early as Friday, with the Centers for Disease Control and Prevention expected to sign off next week.

“The question is when do you know enough? And I think we certainly know that there are many children between five and 11 years of age who are susceptible to this disease who could very well be sick and are hospitalized or die from it,” said Offit, director of the Vaccine Education Center and an attending physician in the Division of Infectious Diseases at Children’s Hospital of Philadelphia.

For its part, the White House is planning to launch a social media campaign to urge parents to vaccinate their kids. To increase trust, federal officials also have pushed to make the vaccine for kids – which is a third of the dosage used in adults and comes in a special orange-capped vial — widely available in pediatrician offices and pharmacies, rather than relying on mass vaccination sites.

Still, many parents don’t want to be rushed.

Paul Ekeoha, a father of four kids in Odessa, Texas, says he’s not convinced yet that his kids need it because they seem healthy now and strong. At the same time, he’s not opposed to vaccines for other people and said he is open to changing his mind.

“If my hands are tied, and I don’t have options, I wouldn’t have any objection,” Ekeoha said.

Other parents said they would be keeping a close eye on how the rollout goes for pediatric vaccines.

“Probably what I’ll do is just wait and see how it goes,” said Jennifer Spaetti.

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NY Attorney General Letitia James announces run for governor

NY Attorney General Letitia James announces run for governor
NY Attorney General Letitia James announces run for governor
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(NEW YORK) — Letitia James, the attorney general of New York whose sexual harassment investigation led to the resignation of former Gov. Andrew Cuomo, announced a run for governor Friday, mounting a formidable primary challenge to Kathy Hochul, the state’s first female governor.

James could become the state’s first Black governor and the nation’s first Black female governor.

James announced her candidacy in a video and through a campaign website highlighting her election promises and past work as attorney general.

“New Yorkers need a governor who isn’t afraid to stand up to powerful interests on behalf of the vulnerable,” James said.

Two other Brooklyn Democrats, New York City Public Advocate Jumaane Williams and New York City Mayor Bill de Blasio, are also interested in the job, along with Long Island Democratic Congressman Tom Suozzi.

In August, James released a report that found Cuomo sexually harassed multiple women, including a state trooper on his security detail. Cuomo attacked the report as politically motivated.

New York State Republican Committee Chairman Nick Langworthy called James a “radical left ideologue” who “turned a blind eye to Cuomo’s unethical behavior and corruption … when it suited her needs” in a statement Friday.

As attorney general, James has bolstered her profile with a lawsuit against the National Rifle Association. Her office is also investigating whether former President Donald Trump manipulated the value of some of his real estate holdings for tax and insurance purposes.

“I’ve sued the Trump administration 76 times,” James mentioned in her announcement video. “But who’s counting?”

She previously served in the New York City council and as the city’s public advocate.

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Where NYC stands as COVID-19 vaccine deadline looms for city employees

Where NYC stands as COVID-19 vaccine deadline looms for city employees
Where NYC stands as COVID-19 vaccine deadline looms for city employees
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(NEW YORK) — As the clock counts down, nearly 80% of New York City municipal employees have complied with a COVID-19 vaccine mandate, city officials said.

Nearly all city workers, including police officers, firefighters and emergency medical technicians, have until 5 p.m. Friday to get at least one dose of the vaccine or be placed on unpaid leave, starting Monday.

Mayor Bill de Blasio has said the city anticipates that many outstanding employees will get vaccinated close to the deadline, and city agencies have been making final pushes to drive up their numbers.

On Thursday, more than 1,000 NYPD members got their first shot, Commissioner Dermot Shea said. As of Friday morning, 80% of the department was vaccinated, Shea said on 1010 WINS radio. He said he believes that the department will be in “good shape for Monday morning,” but will move resources to ensure appropriate coverage.

Prior contingency plans are “being actually scaled-down” as NYPD officials watch vaccination rates rise, with Shea telling Channel 5 on Friday they’re now more concerned about filling “individual shifts” than staffing precincts on Monday.

“We will move resources around. We have had significant increase in people getting vaccinated in the past three days, and that’s the good news,” Shea told Channel 5. “The contingencies are there. New Yorkers should not, should not, be worried about this.”

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Biden admin makes another attempt to end ‘Remain in Mexico’ policy

Biden admin makes another attempt to end ‘Remain in Mexico’ policy
Biden admin makes another attempt to end ‘Remain in Mexico’ policy
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(WASHINGTON) — The Biden administration on Friday said it would make another attempt to end the “Remain in Mexico” protocols, a Trump administration initiative that forced tens of thousands of asylum seekers back into Mexican border towns to await their court dates in the U.S.

The administration has been under pressure from immigrant advocacy groups to end the policy but has met with legal roadblocks.

In a briefing before the announcement, Department of Homeland Security officials told reporters they had reassessed the policy, also known as the Migrant Protection Protocols, and Secretary Alejandro Mayorkas once again determined it was appropriate to end it despite acknowledging its impact in reducing unauthorized migration. One official pointed out that multiple factors can drive migration, but based on the department’s own assessment, the protocols had been effective in deterring border crossing attempts.

“In looking at the data from 2019, there is a fairly clear reduction in encounters at the land border starting around the time that the MPP was implemented across the entire border,” one DHS official said. “That said, you know, correlation is not necessarily causation.”

However, the officials said the humanitarian consequences outweigh the potential benefits of reduced illegal entries. Humanitarian organizations have documented high rates of murder, kidnapping and extortion on top of squalid conditions facing those subjected to “Remain in Mexico.”

A new policy memo to DHS officials dives deeper into the decision-making process by considering potential costs to states as well as potential improvements that could be made to MPP. However, the officials maintained that certain issues with returning migrants back across an international boundary will persist. Immigrant advocacy organizations have been principally concerned with the lack of access to legal services for migrants who are sent back.

“Once individuals are returned across an international border, there’s limited opportunities for the United States to be able to affect their safety and security once they’re in the control of another sovereign nation,” one DHS official said.

The acknowledgment of MPP’s deterrence capabilities is a significant concession for the Biden administration. For months, Republicans have condemned the administration for repealing “Remain in Mexico,” citing the decision as a driving force behind the record number of arrests at the border.

Biden suspended “Remain in Mexico” on his first day in office and Secretary Mayorkas attempted to officially end it in June. A federal judge ordered the Biden administration to reinstate the protocols last August in response to a legal challenge by the state of Texas and Missouri. The Justice Department continues to fight the order and hopes an appellate court will reverse it or remand the decision back to the district court.

Embedded in the district court’s order to reinstate was a suggestion that the administration needs to be capable of either detaining every migrant who attempts an illegal entry or subject them to “Remain in Mexico.” MPP was implemented by the Trump administration in 2019 and, as DHS officials point out, Congress has never provided enough funds to detain every unauthorized migrant.

Much of the administration’s ability continue the practice relies on cooperation from the Mexican government, which was initially opposed to the idea, but has since considered conditions under which it could be reinstated. Talks with Mexican officials are ongoing, DHS officials said.

Depending on whether the Mexican government will agree, the Biden administration is on track to reinstate “Remain in Mexico” by mid-November. Oral arguments are scheduled in the Fifth Circuit Court of Appeals on Nov. 2.

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GOP Rep. Adam Kinzinger, outspoken Trump critic, announces he won’t seek reelection

GOP Rep. Adam Kinzinger, outspoken Trump critic, announces he won’t seek reelection
GOP Rep. Adam Kinzinger, outspoken Trump critic, announces he won’t seek reelection
rarrarorro/iStock

(WASHINGTON) — Illinois Rep. Adam Kinzinger, one of two Republicans serving on the House Jan. 6 select committee, and one of the most vocal critics of the GOP’s embrace of former President Donald Trump and the “big lie,” announced on Friday he is not running for reelection to Congress next term.

In referencing his first campaign, Kinzinger made the announcement in a nearly five-minute video to supporters and posted to social media.

“I also remember during that campaign saying that if I ever thought it was time to move on from Congress I would, and that time is now, but let me be clear, my passion for this country has only grown. My desire to make a difference is bigger than it’s ever been. My disappointment in the leaders that don’t lead is huge. The battlefield must be broader and the truth needs to reach the American people across the whole country,” he said.

“I cannot focus on both a re-election to Congress and a broader fight nationwide,” he said.

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