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Hundreds of doctors have asked the FDA not to rush—or politicize—a coronavirus vaccine

Photo by CDC on Unsplash, Andy Slavitt/Twitter

"There's only one thing more dangerous than a bad virus, and that's a bad vaccine," Dr. Mike Ryan, executive director of WHO's health emergencies programme, said in March. "We have to be very, very, very careful in developing any product that we're going to inject into potentially most of the world population."

Since the beginning of the pandemic, experts have said that developing a vaccine and getting it through the necessary safety and efficacy protocols would take, at minimum, 12 to 18 months. Yet here we are, 7 months in, and Vladimir Putin has just announced that Russia has already approved a vaccine for the coronavirus.

According to the BBC, there are more than 100 vaccines in various stages of development and testing. Six of those have reached phase 3 trials, involving more widespread testing in humans. Russia's vaccine is not among those six.

— (@)

Meanwhile, hundreds of U.S. doctors have signed a letter urging the FDA not to rush or politicize vaccine trials.

"We are experts in virology, epidemiology, vaccinology, infectious disease, clinical care and public health," the letter opens, before declaring the "urgent" need for a COVID-19 vaccine. "We are committed to promoting the broad uptake of safe and effective COVID-19 vaccines. The need is urgent but all vaccines must be rigorously studied to determine whether their benefits exceed their risks."

The letter expresses concern that public confidence in a vaccine will be greatly undermined by rushing the process, and that thorough safety trials must be followed through in order for doctors themselves to confidently recommend and administer one.

For those reasons, the doctors urged transparency in the process of trialing and documenting any potential vaccines:

"The foundation of public confidence in vaccine safety has long been, and must remain, the well-established and trusted FDA approval procedures. The public is typically and rightly able to comment on vaccine approval. It is important that investigators share Phase 3 trial design details. For example, Data Safety Monitoring Boards apply predetermined 'stopping rules' to decide whether a study should be terminated early based on the detection of early benefits, the likelihood of no benefit, or the emergence of serious safety problems. These stopping rules should be publicly available. There must also be continuous monitoring for unexpected severe side effects that might only become apparent after large numbers of people are vaccinated."

Finally, they drove home the point that doctors can only recommend a vaccine if they believe it is safe, and that evaluating safety can only be done with a transparent process unmarred by politics.

"We can only perform as advocates if we ourselves are persuaded that the vaccine(s) truly is safe and effective. We must be able to explain to the public what we know and what we don't know about these vaccines. For that to happen, we must be able to witness a transparent and rigorous FDA approval process that is devoid of political considerations."

Russia's announcement could very well push vaccine makers and the government to rush the development and trialing process, which would be a mistake. Vaccine development usually takes years, not months, and skipping safety steps in the name of competition or expediency could make public health problems worse, not better.

As always, government needs to listen to the health experts on this front. We need a vaccine as soon as possible, but we also need to make sure we utilize the knowledge and processes that will ensure any vaccine will be safe to administer, no matter which company or country gets there first.

From Your Site Articles

5 things that made us smile this week

The animal edition!

True

Been stressed this week? Who hasn’t. That’s why we’re bringing you the latest in good news—five animal-themed stories we guarantee will put a smile on your face.

This week, we’re celebrating:

The most entertaining animal photos you've ever seen

Jason Moore/Comedy Wildlife Photography Awards 2023 and © Tzahi Finkelstein /Comedy Wildlife Photography Awards 2023

Need a laugh? How about a dozen laughs? Look no further than the 2023 Comedy Wildlife Photography Awards, a competition started in 2015 that focuses on the lighter side of wildlife photography. More than 1,800 photographers from around the world submitted photos, and the finalists—from a kangaroo playing air guitar to an arguing set of greenfinches—will absolutely make your day.

Healthier, happier, rescued pets

Hundreds of thousands of pets are relinquished to shelters each year, and many vulnerable pet populations—such as disabled and elderly dogs—can be hard to place in loving homes. Fortunately, Subaru has sponsored the rescue, rehabilitation, and adoption of more than 134,000 of these pets through the Subaru Share the Love® Event. As the largest corporate donor to the ASPCA® (The American Society for the Prevention of Cruelty to Animals®), Subaru and its retailers are donating a minimum of $300 to charities like the ASPCA for every new Subaru purchase or lease during the 2024 Subaru Share the Love Event, happening now through January 2, 2025.

This animal-centric (and adorable) creative writing assignment

View this post on Instagram
A post shared by Amy • 3rd Grade Teacher (@theuniqueclassroom)

Amy McKinney, a third-grade teacher in Pennsylvania, recently had a genius idea for teaching her class persuasive writing: Rather than have them formulate an argument for an imagined audience (boring!), McKinney partnered with a local animal shelter and had her class write persuasive descriptions of each animal to help them get adopted. Each student chose a pet to write about and sent their essays to the shelter to display and post to the shelter’s social media channels. Student engagement was “tremendous,” said McKinney, and there’s no doubt these persuasive paragraphs made a huge difference in these shelter pet’s lives. Adorable.

The dog who saved his owner with CPR (yes, really)

Dogs have made the news for saving humans before, but have you ever heard of a dog performing CPR? That’s exactly what Bear, a Siberian Husky-Golden Retriever mix, did in 2022 when he found his owner unconscious on the floor after suffering a major heart attack. Not only was Bear able to quickly call for help, he even jumped on his owner’s chest repeatedly while someone else called the paramedics. Thanks to Bear, the owner survived what should have been a fatal heart attack. Now that deserves some head scritches.

Bee populations have reached a record high

macro shot photography of beePhoto by Jenna Lee on Unsplash

Honeybees are essential to the planet, as they pollinate over 130 types of fruits, vegetables, and nuts. For years, honeybee numbers have been in decline—but happily, that’s starting to change. The US has added almost a million bee colonies in the past five years, with more than 3.8 million honeybees in total.

For more ways to smile, check out how Subaru is sharing the love this holiday season.

From Your Site Articles

uplifting

Family

Woman who was pressured to quit her job to raise stepdaughter's baby makes a bold decision

This sparked an important conversation about family responsibility.

via Pixabay

When parents can't step up, should grandparents step in?

A story that recently went viral on Reddit’s AITA forum asks an important question: What is a parent’s role in taking care of their grandchildren? The story is even further complicated because the woman at the center of the controversy is a stepparent.

At the time of writing her post, the woman, 38, met her husband Sam, 47, ten years ago, when his daughter, Leah, 25, was 15. The couple married five years ago after Leah had moved out to go to college.

Leah’s mom passed away when she was 10.

When Leah became pregnant she wanted to keep the baby, but her boyfriend didn’t. After the disagreement, the boyfriend broke up with her. This forced Leah to move back home because she couldn’t afford to be a single parent and live alone on a teacher’s salary.

Leah’s story is familiar to many young mothers facing similar difficulties.

The father isn’t involved in the baby’s life as a caretaker or financially. Sadly, research shows that 33% of all children in the U.S. are born without their biological fathers living in the home.

Single motherhood comes with unique hardships.

via Alexander Grey/Unsplash

The new mother is a teacher and can’t afford to live on her own with a child. In 2019, a study found that out the top 50 U.S. cities, Pittsburgh is the only one where a new teacher could afford rent.

Today, Portland, OR has joined the very short list of cities where an "average teacher can afford 91.3% of apartments within community distance of their school" according to a recent study.

The stressors of taking care of the baby made Leah realize she needed help.

“But once she had the baby around 4 months back, Leah seemed to realize having a baby is not the sunshine and rainbows she thought it was,” the woman wrote on Reddit. “She barely got any sleep during the last four months. All the while Sam was helping her with the baby while I did almost all chores myself.”

“Now her leave is ending. She did not want to leave the baby at daycare or with a nanny,” the woman continued. “Sam and I both work as well.”

Leah asked her stepmother if she would stay home with the baby. The stepmother said no because she never wanted to have a baby and she has a job. “I asked why Leah can't stay home with the baby herself,” the woman wrote. “She said how she was young and had to build a career. I said many people take breaks to raise kids, and she broke down crying about how she was so tired all the time being a mom and needed something else in her life too.”

The demands of new motherhood are usually all-encompassing.

via Pixabay

After the woman told her stepdaughter no, her husband pressured her to stay home with the baby. But she refused to give up her job to raise her stepdaughter’s child. “Leah said yesterday how she wished her mom was alive since she would have had her back. She said I didn't love her, and my husband is also mad at me,” the woman wrote. The woman asked the Reddit community if she was in the wrong for “refusing to help my stepdaughter with the baby,” and the community responded with rapturous support.

"[The woman] should tell her husband to knock it off and stop trying to pressure her into raising his daughter’s baby. If he wants a family member to look after her baby while she works, then he can do it," user Heavy_Sand5228 wrote.

"This is Leah's baby that she alone chose to have. That doesn't obligate you to change YOUR life to suit her desires. The whole business of saying you don't love her because you won't quit your job to watch her baby is manipulative and messed up, and I'm shocked your husband is siding with her," user SupremeCourtJust-a** added.

Leah and many women like her are in this situation because, in many places, teachers are underpaid, rent is high, and not all dads pay child support, even those required by law.

Another commenter noted that the baby is much more the father’s responsibility than the stepmother's. "To add, Leah should consider seeking child support from her ex. Her kid should be getting that money," Obiterdicta wrote.

While there are resources to help stepparents connect with their stepchildren and step-grandchildren, it's important to remember that the responsibility to raise a child ultimately rests with the parent(s).

This article originally appeared last year.

From Your Site Articles

family

Health

Hospice nurse reassures people worried by recent footage of Jimmy Carter at 100

Carter has been in hospice care for nearly 2 years.

via Hospice Nurse Julie and Commonwealth Club/Wikimedia Commons

Julie McFadden and former President Jimmy Carter.

Former President Jimmy Carter is known for being one of the most beloved former presidents in American history for his resolve to use his talents to help others, whether it was eradicating the Guinea worm or his work with Habitat for Humanity into his late 90s. Carter says that his faith is the big reason for his resilience. “I have one life and one chance to make it count for something,” he said. “My faith demands that I do whatever I can, wherever I am, whenever I can, for as long as I can with whatever I have to try to make a difference.”

The man who held the presidency from 1977 to 1981 went into hospice in February 2023 but has lived much longer than most expected. Carter has made 2 public appearances in that time, the first in November 2023 for the funeral of his wife of 77 years, Rosalynn and on October 1, 2024 for his 100th birthday. When Carter was wheeled into his wife’s funeral, some family members expressed shock and worry about Cartter’s appearance.

— (@)

Since beginning hospice care, Carter has appeared frail and gaunt without expression and mouth agape. It shouldn’t be shocking for a person who has reached the age of 100 to appear so fragile, but it’s right to be concerned that he may be uncomfortable in such a state. However, Julie McFadden, also known as Hospice Nurse Julie, settled a lot of people’s fears in a TikTok video where she explained Carter’s appearance and why he’s most likely comfortable during his transition.

McFadden has assisted over a hundred people in their final days and is the author of the bestseller, "Nothing to Fear."

@hospicenursejulie
#greenscreenvideo #greenscreen Jimmy Carters 100th birthday! #hospicenursejulie #hospicenurse #jimmycarter #education

What is Jimmy Carter's condition?

“I have been tagged in this Jimmy Carter turns 100 years old today video,” she begins her viral TikTok with over 600,00 views. “So many times people asking me, why does he look like this? Is he okay? Does this mean anything? As a hospice nurse, this video was not alarming to me. Jimmy Carter, to me, looks just like someone who was 100 years old on hospice and getting towards the end of their life.”

She then speculated on what his life is like at age 100. “Jimmy Carter is likely sleeping 20 to 22 hours a day. He is likely not really eating and drinking, which is all normal and to be expected at the end of life. So that's why he looks so thin. He looks cachectic. His body is slowly shutting down and the more we just let his body be the guide, the better he will be.”

A lot of people are concerned about the way that Carter’s mouth seems to be permanently open. McFadden says that is due to muscle wasting. “His mouth is hanging open because it takes muscles to keep your mouth shut. And at the end of life, those muscles relax. So he is likely so relaxed that when he's sleeping, which is most of the time, even when he's in a wheelchair, he's asleep, and his muscles relax, so his mouth hangs open.”

McFadden also addressed many people's concerns: Should Carter have been brought outside to celebrate his birthday with his family in such an advanced state? Should he have been in front of the cameras?

“In my opinion, it's up to the family. The family knows that person best,” McFadden said. “From what we know of Jimmy Carter, he was a family man who loved being around his family. So why not be around him and celebrate his one hundred? One-hundredth birthday and bring family around, bring him outside. They know his personality. They must think he would love this. So let's do it. We don't have to keep dying people hidden away.”

McFadden is such an incredible gift because we tend to lock away the dying and talking about death and hospice is a very uncomfortable topic for most. This lack of information leads us to believe that someone in Carter’s position suffers. But, according to McFadden, he’s probably comfortable and relaxed. McFadden knows that when people better understand Carter’s condition, they will probably feel better about their final days as well.

From Your Site Articles

Hundreds of doctors have asked the FDA not to rush—or politicize—a coronavirus vaccine

The animal edition!

The most entertaining animal photos you've ever seen

Healthier, happier, rescued pets

This animal-centric (and adorable) creative writing assignment

The dog who saved his owner with CPR (yes, really)

Bee populations have reached a record high

This sparked an important conversation about family responsibility.

Leah’s story is familiar to many young mothers facing similar difficulties.

Carter has been in hospice care for nearly 2 years.

What is Jimmy Carter's condition?

They're funny because they're true.

Gordon shared 15 of his oh-so-real comics with us. They're all funny 'cause they're true.

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I love Gordon's comics so much because they're just about the reality of parenting — and they capture it perfectly.

"I just hope this is a reminder to everyone that the simplest act of kindness from you can completely brighten a stranger’s day."

Passengers were annoyed, but commenters had some empathetic theories.

Commenters on the video — unlike some passengers on the flight — had a lot of empathy for the mysterious standing woman.