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Contradicting Studies Leave Biden’s COVID-19 Booster Plan Up in the Air

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While some studies show that the effectiveness of Pfizer and Moderna’s COVID vaccines decrease over time, other publications argue the decline is not substantial and a full-flung booster campaign is premature.


Booster Rollout in Flux

President Joe Biden’s plan to offer COVID-19 booster shots is facing serious hurdles just a week before it is set to roll out. Issues with the plan stem from growing divisions among the scientific community over the necessity of a third jab.

The timing of booster shots administration has been a point of contention for months, but the debate intensified in August when Biden announced that, pending regulatory approval, the government would start offering boosters on Sept. 20 to adults eight months after they received their second dose of Pfizer or Moderna.

The announcement was backed by the director of the Centers for Disease Control and Prevention (CDC), the acting commissioner of the Food and Drug Administration (FDA), and White House chief medical advisor Dr. Anthony Fauci, among others.

However, many scientists and other health experts both inside and outside of the government have continually criticized the plan. They have claimed the data supporting boosters was not compelling and argued that, while the FDA approved third doses for immunocompromised Americans, the push to give them to the general public was premature.

The plan also drew international backlash from those who argued the U.S. should not launch a booster campaign when billions of people around the world have not gotten their first dose yet. Earlier this month, the World Health Organization (WHO) extended its request that wealthy countries hold off on giving boosters until at least the end of the year.

Those arguments appeared to be bolstered when federal health regulators said earlier this month that they needed more time to review Moderna’s application for booster shots, forcing the Biden Administration to delay offering third shots to those who received that vaccine.

Now, Pfizer recipients will be the only people who may be eligible for boosters by the initial deadline, though that depends on a forthcoming decision from an FDA expert advisory committee that is set to vote Friday on whether or not to recommend approval.

Debate Continues in Crucial Week

More contradictory information has been coming out in the days leading up to the highly anticipated decision.

On Monday, an international group of 18 scientists, including some at the FDA and the WHO, published a review in The Lancet arguing that there is no credible data to show the vaccines’ ability to prevent severe disease declined substantially over time, so boosters are not yet needed for the general, non-immunocompromised public.

The experts claimed that any advantage boosters may provide does not outweigh the benefit of giving the extra doses to all those who are unvaccinated worldwide. 

On the other side, a study released Wednesday in The New England Journal of Medicine found that people who received a third shot of Pfizer in Israel were much less likely to develop severe COVID than those who just had the first two jabs.

The same day, both Pfizer and Moderna published data backing that up as well. Pfizer released an analysis that said data on boosters and the Delta variant from both Israel and the U.S. suggested “that vaccine protection against COVID-19 infection wanes approximately 6 to 8 months following the second dose.” 

Moderna also published data, that has not yet been peer-reviewed, which also found its jab provided less immunity and protection against severe disease as time went on.

Further complicating matters was the fact that the FDA additionally released its report on Pfizer’s analysis of the need for a booster shortly after Pfizer’s publication. Normally, those findings would shine a light on the agency’s stance on the issue, but the regulator did not take a clear stand.

“Some observational studies have suggested declining efficacy of [Pfizer] over time […] while others have not,” the agency wrote. “Overall, data indicate that currently US-licensed or authorized COVID-19 vaccines still afford protection against severe COVID-19 disease and death.”

Uncertain Future

It remains unclear what the FDA panel will determine when they meet Friday, or what a similar CDC expert panel that is expected to meet next week will decide regarding vaccination policies.

Notably, officials at the two agencies are not required to follow the recommendations of their expert panels, though they usually do.

Even if the FDA approves Pfizer’s application as it stands to give boosters to those 16 and older, people familiar with the matter said the CDC might recommend the third jabs only for people 65 and older or those who are especially at risk.

Regardless of what is decided, experts have said that it is absolutely essential for the agency to stand firm in its decision and clearly explain its reasoning to the public in order to combat further confusion and misinformation.

“F.D.A. does the best in situations when there are strongly held but conflicting views, when they’re forthcoming with the data and really explain decisions,” Dr. Joshua Sharfstein, a vice dean at the Johns Hopkins Bloomberg School of Public Health told The New York Times. “It’s important for the F.D.A. not to say, ‘Here’s our decision, mic drop. It’s much better for them to say, ‘Here’s how we looked at the data, here are the conclusions we made from the data, and here’s why we’re making the conclusions.’”

See what others are saying: (The New York Times) (CNBC) (The Guardian)

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FDA Authorizes Moderna and J&J COVID Vaccine Boosters, Approves Mix-and-Match Doses

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The approval will allow at-risk Americans who received Pfizer and Moderna vaccines to get any booster six months after their initial series and all Johnson & Johnson recipients 18 and older to do the same two months after their single-shot dose.


New FDA Authorization

The U.S. Food and Drug Administration (FDA) on Wednesday authorized boosters shots of Moderna and Johnson & Johnson COVID-19 vaccines and approved a mix-and-match strategy that will allow people who got one company’s shot to get a booster from a different maker.

The decision paves the way for millions of more at-risk Americans to get extra protection, and not just certain Pfizer recipients as previously approved by the FDA.

Under the authorization, people who received Moderna or Pfizer can get any one of the three booster shots six months after completing their initial series if they are 65 and older, at high risk of severe COVID, or face increased exposure because of their work.

Meanwhile, all J&J recipients 18 and older can get any of the approved vaccines two months after they received the one-shot jab.

Hazy Recommendations, For Now

Notably, the FDA did not recommend a certain combination of vaccines, nor did the agency say whether or not it would be more effective for people to stick with their original vaccine maker for their booster.

The new authorizations draw on a study from the National Institutes of Health (NIH), which found that there are no safety concerns with mixing boosters and that vaccine combinations were at least as effective in stimulating antibodies as matched vaccines.

In the case of J&J recipients, the NIH found that people actually had a higher boost from mixing either Moderna or Pfizer boosters.

However, some of the scientists who worked on the study said it should not be used to recommend one combination over another because the research was limited.

The Centers for Disease Control and Prevention (CDC), which determines vaccine recommendations, could issue more guidance on when and whether people should switch vaccine makers for their booster shots.

An advisory panel for the agency is meeting Thursday to discuss the new FDA authorizations and recommendations.

Once the panel makes its decision, the CDC director has the final say on the guidelines. If the agency agrees with the FDA’s decisions, the booster shots could be rolled out as soon as this weekend.

See what others are saying: (The New York Times) (NPR) (The Washington Post)

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Paris Hilton Urges Lawmakers To Crack Down on Abusive Teen Treatment Facilities

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The heiress alleges that she was a victim of abuse in these types of centers for two years and wants to ensure that no child suffers through the same experience.


Paris Hilton Details Abuse Within “Troubled Teen Industry”

Socialite and entrepreneur Paris Hilton spoke outside of the U.S. Capitol on Wednesday to support the Accountability for Congregate Care Act, which is set to be introduced in the near future.

Hilton joined Rep. Ro Khanna (D-CA), Rep. Adam Schiff (D-CA), Rep. Rosa DeLauro (D-Conn.), and Sen. Jeff Merkley (D-Ore.) to advocate for the legislation, which aims to create a “bill of rights” for children in treatment and behavioral centers.

The heiress has alleged that she spent two of her teenage years in these types of facilities and was subject to rampant abuse. She is far from alone. 

During a press conference, Hilton said that one night when she was 16, she woke up to two large men in her bedroom forcing her out of her house. She said she screamed for help because she thought she was being kidnapped, but her parents watched as she was taken away to a “troubled teen” program. 

“Like countless other parents of teens, my parents had searched for solutions to my rebellious behavior,” she explained in an op-ed for The Washington Post this week. “Unfortunately, they fell for the misleading marketing of the ‘troubled teen industry’ — therapeutic boarding schools, military-style boot camps, juvenile justice facilities, behavior modification programs and other facilities that generate roughly $50 billion annually in part by pitching ‘tough love’ as the answer to problematic behavior.”

Hilton said she was sent to four different facilities where she was “physically and psychologically abused.” 

“I was strangled, slapped across the face, watched in the shower by male staff, called vulgar names, forced to take medication without a diagnosis, not given a proper education, thrown into solitary confinement in a room covered in scratch marks and smeared in blood and so much more,” she explained during the press conference. 

“At Provo Canyon School in Utah, I was given clothes with a number on the tag. I was no longer me, I was only number 127,” she continued. “I was forced to stay indoors for 11 months straight, no sunlight, no fresh air. These were considered privileges.”

Goals of the  Accountability for Congregate Care Act

Hilton claims that a lack of transparency and accountability has allowed this structure of abuse to thrive for decades. In some cases, she said it has taken children’s lives. Now, she wants Congress and President Joe Biden to act. 

“This bill creates an urgently needed bill of rights to ensure that every child placed into congregate care facilities is provided a safe and humane environment,” Hilton said of the Accountability for Congregate Care Act.

“This bill of rights provides protections that I wasn’t afforded, like access to education, to the outdoors, freedom from abusive treatment, and even the basic right to move and speak freely. If I had these rights and could have exercised them, I would have been saved from over 20 years of trauma and severe PTSD.” 

Foster children, children being treated for mental disorders, and other children in youth programs would be impacted by the bill.

Hilton was one of several survivors and advocates who fought for the legislation on Wednesday. Rep. Khanna thanked them for using their stories to fight for change. 

“No child should be subjected to solitary confinement, forced labor, or any form of institutional abuse,” he wrote. “Thanks to Paris Hilton, my colleagues & the survivors & advocates who joined us today to discuss how we can hold the congregate care industry accountable.”

While only Democratic legislators are currently sponsoring the bill, Hilton called for a bipartisan effort to fight for the rights of children. 

Ensuring that children are safe from institutional abuse isn’t a Republican or Democratic issue,” Hilton said. “It’s a basic human rights issue that requires immediate attention.”

See what others are saying: (The Washington Post) (The Hill) (NBC News)

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Surgeons Successfully Test Pig Kidney Transplant on a Human

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The procedure has been hailed as a major scientific breakthrough that could eventually open the door to a renewable source of desperately needed organs.


Groundbreaking Procedure

Surgeons at the NYU Langone Transplant Institute revealed Tuesday that they temporarily attached a kidney from a genetically modified pig to a human patient and found that it worked normally.

The operation was the first of its kind and could one day lead to a vast supply of organs for those who are in severe need. According to the Associated Press, more than 90,000 people in the U.S. are in line for a kidney transplant. Each day, an average of 12 die while waiting.

With the family’s consent, the groundbreaking procedure was performed on a brain-dead patient who was kept alive on a ventilator.

According to the surgeons, the pig used was genetically engineered to grow an organ that wouldn’t produce a sugar that the human immune system attacks, which would then trigger the body to reject the kidney. 

The organ was connected to blood vessels on the patient’s upper leg, outside the abdomen, and it was observed for over 54 hours, with doctors finding no signs of rejection.

Concerns and Hurdles Ahead

While the procedure was successful, this doesn’t mean it’ll be available to patients anytime soon. Several questions about long-term functionality remain, and it will still have to go through significant medical and regulatory hurdles. 

Details of the procedure haven’t even been peer-reviewed or published in a medical journal yet, though there are plans for this. 

Experts are also considering the ethical implications of this type of animal-to-human transplant. For some, raising pigs to harvest their organs raises concerns about animal welfare and exploitation. Such medical procedures have already earned criticism from People for the Ethical Treatment of Animals, or PETA.

“Pigs aren’t spare parts and should never be used as such just because humans are too self-centered to donate their bodies to patients desperate for organ transplants,” PETA said in a statement, according to The New York Times.

On the other side of the debate are people like Dr. Robert Montgomery, the director of the N.Y.U. Langone Transplant Institute who performed the breakthrough procedure in September.

“I certainly understand the concern and what I would say is that currently about 40% of patients who are waiting for a transplant die before they receive one,” he told BBC.

“We use pigs as a source of food, we use pigs for medicinal uses – for valves, for medication. I think it’s not that different.”

See what others are saying: (CNN)(BBC) (The New York Times)

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